Gynecology

CHICAGO – The 9-valent human papillomavirus (HPV) vaccine recently approved by the Food and Drug Administration has high efficacy for preventing disease caused by the vaccine-covered viral types and is well tolerated, according to end-of study data from a randomized trial.

The vaccine was on par with the quadrivalent vaccine when it came to protection against infection with the four original viral types covered by both vaccines. Additionally, for the five new viral types, it was associated with a 97% reduction in all cervical, vaginal, and vulvar intraepithelial neoplasia, a 100% reduction in cervical intraepithelial neoplasia 3, and a more than 90% reduction in related procedures and treatments, investigators reported at the Annual meeting of Society of Gynecologic Oncology. Meanwhile, it had a good safety profile.

Susan London/Frontline Medical News

“The consistency of the data is very reassuring,” said Dr. Elmar A. Joura of the Medical University of Vienna, General Hospital, and Comprehensive Cancer Center, also in Vienna.

Dr. Marcela delCarmen, session comoderator and a gynecologic oncologist at the Massachusetts General Hospital in Boston, asked, “You’ve presented data on the efficacy of the vaccine in the study population, but do you have any data on the effectiveness or the impact that the vaccine will have on the public health atmosphere of the general population?”

“First of all, we saw that the vaccine was doing exactly what was expected. These vaccines don’t have any therapeutic effect, so those women who have been infected at the time of vaccination, we did not observe a benefit during the course of the study. But from the previous study of the quadrivalent vaccine, we know [that] over the course of time, they also will get some benefit,” Dr. Joura replied.

“The second thing is, the vaccine really has the potential with this high effectiveness to change the screening practice in the long term. But what’s definitely needed is good coverage. And in many countries and also in this country, the coverage rates are far from optimal. Once you achieve a rate like in Australia or the United Kingdom, then the next step definitely is a change of screening algorithm,” such as a switch to primary HPV screening, he added.

There is a persistent medical need to develop new HPV vaccines, even though two highly effective vaccines have been on the market for some time, Dr. Joura maintained. “With HPV 16 and 18, you cover about 70% of invasive cervical cancer and about 50% of cervical precancer. Adding the next five most common most oncogenic HPV strains would give a coverage of 90% for both invasive and precancer, giving an additional benefit of 20% for invasive cancer and 35% for cervical precancer,” he elaborated.

In the Merck-sponsored phase IIb/III trial, the investigators randomized 14,215 women aged 16-26 to double-blind receipt of the quadrivalent vaccine (Gardasil, which covers viral types 6, 11, 16, and 18) or the 9-valent vaccine (Gardasil 9, which additionally covers viral types 31, 33, 45, 52, and 58). “It was not possible to have this trial placebo-controlled since two effective vaccines were available, so the controls were vaccinated with the quadrivalent HPV vaccine,” Dr. Joura explained. The women had follow-up with sample collection for up to 54 months.

Initial results showed that antibody titers for the original four viral types in the group given the 9-valent vaccine were noninferior to those in the group given the quadrivalent vaccine, and when compared against the historical placebo arm of the quadrivalent vaccine trial, there was dramatic and near full protection against type 16- and 18-related cervical, vaginal, and vulvar neoplasia. These findings led to approval of the vaccine late last year and a recent publication (N. Engl. J. Med. 2015;372:711-23).

The new, end-of-study data, capturing roughly an additional year of observation, showed that relative to the quadrivalent vaccine, the 9-valent vaccine provided good protection for the five new viral types among women negative for these types at baseline: Efficacy was 97.7% for protection against any neoplasia of the cervix, vagina, or vulva; 97.4% for protection against high-grade neoplasia; and 96.0% for protection against 6-month persistent infection.

“What is important for public health decisions is what is the effect on procedures and treatments,” Dr. Joura said. In fact, the 9-valent vaccine was highly efficacious for reducing external genital biopsies (92.3% risk reduction), cervical biopsy (97.7%), and loop electrosurgical excision procedure/conization (90.2%) related to the five new viral types covered.

The rate of vaccine-related adverse events was 92.2% with the 9-valent vaccine and 87.6% with the quadrivalent vaccine, with the difference mainly due to more injection site reactions with the former. There was two vaccine-related serious adverse events in the 9-valent group and one in the quadrivalent group.

Prevalence data will help assess trends, tailor screening

In a related study, investigators led by Dr. Warner K. Huh, a professor in the department of obstetrics and gynecology at the University of Alabama at Birmingham, determined the relative prevalence of HPV genotypes in the U.S. population.

Susan London/Frontline Medical News

“We are going to see a transition from the quadrivalent vaccine to the 9-valent vaccine, so information regarding genotypes in this country becomes extremely important,” he said. “There is very limited information in terms of the HPV prevalence for genotypes across the U.S. and more importantly, we almost have zero information on what that prevalence is in a low-risk population. To understand changes in the prevalence in this country, particularly with vaccination and then ultimately as it relates to screening, you are going to need to understand what that baseline data is.”

The investigators analyzed data from 46,751 women aged 21 years or older in the ATHENA study (Evaluation of the Cobas 4800 HPV Test for the Detection of High-Grade Cervical Disease), the largest HPV screening cohort nationally. The Roche-funded study was used to gain Food and Drug Administration approval for primary HPV screening in the United States. Less than 3% of enrolled women had received an HPV vaccine.

The women had HPV testing, in addition to liquid-based Pap testing and colposcopy, with follow-up out to 3 years in a subset. Genotyping was used to detect 16 high-risk types of HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, and 82), and the prevalence of each was benchmarked to that of HPV 16.

“We benchmarked to HPV 16 for a couple of reasons,” Dr. Huh explained. “One of which is that we now have two vaccines – the quadrivalent and the 9-valent vaccines – and we thought it would be interesting to see what happens to that ratio as we have had one for essentially 10 years and the other one transitions in. The other reason, of course, is that it’s a highly prevalent type and a type that’s seen in both vaccines.”

Results showed that the absolute prevalence of all 16 types combined was 11.5% in the entire cohort and 10.0% in the low-risk subset with normal Pap results. In age-stratified analyses, it was higher among women aged 21-24 years than among older women.

The prevalence ratio relative to HPV 16 for the most common viral types among those assessed ranged from 0.12 for HPV 33 to 0.57 for HPV 52.

“The ratios may not be relevant to you today, but they may become highly relevant 10, 20, or 30 years from now,” Dr. Huh commented, discussing HPV type 31, which had a ratio of 0.43, as an example. As coverage by the quadrivalent vaccine and hence protection against type 16 rises, “what we would expect over the next 10 years is that ratio to increase substantially, some theorize as much as fourfold. Then as you roll out the 9-valent vaccine, theoretically, that ratio should normalize back to 0.43, assuming again that the efficacy is equivalent for [type 31] and for type 16,” he explained. “So this is where it becomes very interesting, because if it doesn’t, there is something else going on in the population.”

The new data additionally allow good ability to track the phenomenon of viral type replacement, Dr. Huh said.

“But most importantly, what it allows us to do is to look at screening and the impact of the nonavalent vaccine on screening in the United States. If you all buy into primary HPV screening, the current algorithm uses type 16 and type 18. Well, if type 16 and type 18 go away and these ratios change, then we need to seriously revisit how we do primary HPV screening because the current algorithm is probably not the right algorithm to use,” he maintained.

CHICAGO – The 9-valent human papillomavirus (HPV) vaccine recently approved by the Food and Drug Administration has high efficacy for preventing disease caused by the vaccine-covered viral types and is well tolerated, according to end-of study data from a randomized trial.

The vaccine was on par with the quadrivalent vaccine when it came to protection against infection with the four original viral types covered by both vaccines. Additionally, for the five new viral types, it was associated with a 97% reduction in all cervical, vaginal, and vulvar intraepithelial neoplasia, a 100% reduction in cervical intraepithelial neoplasia 3, and a more than 90% reduction in related procedures and treatments, investigators reported at the Annual meeting of Society of Gynecologic Oncology. Meanwhile, it had a good safety profile.

Susan London/Frontline Medical News

“The consistency of the data is very reassuring,” said Dr. Elmar A. Joura of the Medical University of Vienna, General Hospital, and Comprehensive Cancer Center, also in Vienna.

Dr. Marcela delCarmen, session comoderator and a gynecologic oncologist at the Massachusetts General Hospital in Boston, asked, “You’ve presented data on the efficacy of the vaccine in the study population, but do you have any data on the effectiveness or the impact that the vaccine will have on the public health atmosphere of the general population?”

“First of all, we saw that the vaccine was doing exactly what was expected. These vaccines don’t have any therapeutic effect, so those women who have been infected at the time of vaccination, we did not observe a benefit during the course of the study. But from the previous study of the quadrivalent vaccine, we know [that] over the course of time, they also will get some benefit,” Dr. Joura replied.

“The second thing is, the vaccine really has the potential with this high effectiveness to change the screening practice in the long term. But what’s definitely needed is good coverage. And in many countries and also in this country, the coverage rates are far from optimal. Once you achieve a rate like in Australia or the United Kingdom, then the next step definitely is a change of screening algorithm,” such as a switch to primary HPV screening, he added.

There is a persistent medical need to develop new HPV vaccines, even though two highly effective vaccines have been on the market for some time, Dr. Joura maintained. “With HPV 16 and 18, you cover about 70% of invasive cervical cancer and about 50% of cervical precancer. Adding the next five most common most oncogenic HPV strains would give a coverage of 90% for both invasive and precancer, giving an additional benefit of 20% for invasive cancer and 35% for cervical precancer,” he elaborated.

In the Merck-sponsored phase IIb/III trial, the investigators randomized 14,215 women aged 16-26 to double-blind receipt of the quadrivalent vaccine (Gardasil, which covers viral types 6, 11, 16, and 18) or the 9-valent vaccine (Gardasil 9, which additionally covers viral types 31, 33, 45, 52, and 58). “It was not possible to have this trial placebo-controlled since two effective vaccines were available, so the controls were vaccinated with the quadrivalent HPV vaccine,” Dr. Joura explained. The women had follow-up with sample collection for up to 54 months.

Initial results showed that antibody titers for the original four viral types in the group given the 9-valent vaccine were noninferior to those in the group given the quadrivalent vaccine, and when compared against the historical placebo arm of the quadrivalent vaccine trial, there was dramatic and near full protection against type 16- and 18-related cervical, vaginal, and vulvar neoplasia. These findings led to approval of the vaccine late last year and a recent publication (N. Engl. J. Med. 2015;372:711-23).

The new, end-of-study data, capturing roughly an additional year of observation, showed that relative to the quadrivalent vaccine, the 9-valent vaccine provided good protection for the five new viral types among women negative for these types at baseline: Efficacy was 97.7% for protection against any neoplasia of the cervix, vagina, or vulva; 97.4% for protection against high-grade neoplasia; and 96.0% for protection against 6-month persistent infection.

“What is important for public health decisions is what is the effect on procedures and treatments,” Dr. Joura said. In fact, the 9-valent vaccine was highly efficacious for reducing external genital biopsies (92.3% risk reduction), cervical biopsy (97.7%), and loop electrosurgical excision procedure/conization (90.2%) related to the five new viral types covered.

The rate of vaccine-related adverse events was 92.2% with the 9-valent vaccine and 87.6% with the quadrivalent vaccine, with the difference mainly due to more injection site reactions with the former. There was two vaccine-related serious adverse events in the 9-valent group and one in the quadrivalent group.

Prevalence data will help assess trends, tailor screening

In a related study, investigators led by Dr. Warner K. Huh, a professor in the department of obstetrics and gynecology at the University of Alabama at Birmingham, determined the relative prevalence of HPV genotypes in the U.S. population.

Susan London/Frontline Medical News

“We are going to see a transition from the quadrivalent vaccine to the 9-valent vaccine, so information regarding genotypes in this country becomes extremely important,” he said. “There is very limited information in terms of the HPV prevalence for genotypes across the U.S. and more importantly, we almost have zero information on what that prevalence is in a low-risk population. To understand changes in the prevalence in this country, particularly with vaccination and then ultimately as it relates to screening, you are going to need to understand what that baseline data is.”

The investigators analyzed data from 46,751 women aged 21 years or older in the ATHENA study (Evaluation of the Cobas 4800 HPV Test for the Detection of High-Grade Cervical Disease), the largest HPV screening cohort nationally. The Roche-funded study was used to gain Food and Drug Administration approval for primary HPV screening in the United States. Less than 3% of enrolled women had received an HPV vaccine.

The women had HPV testing, in addition to liquid-based Pap testing and colposcopy, with follow-up out to 3 years in a subset. Genotyping was used to detect 16 high-risk types of HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, and 82), and the prevalence of each was benchmarked to that of HPV 16.

“We benchmarked to HPV 16 for a couple of reasons,” Dr. Huh explained. “One of which is that we now have two vaccines – the quadrivalent and the 9-valent vaccines – and we thought it would be interesting to see what happens to that ratio as we have had one for essentially 10 years and the other one transitions in. The other reason, of course, is that it’s a highly prevalent type and a type that’s seen in both vaccines.”

Results showed that the absolute prevalence of all 16 types combined was 11.5% in the entire cohort and 10.0% in the low-risk subset with normal Pap results. In age-stratified analyses, it was higher among women aged 21-24 years than among older women.

The prevalence ratio relative to HPV 16 for the most common viral types among those assessed ranged from 0.12 for HPV 33 to 0.57 for HPV 52.

“The ratios may not be relevant to you today, but they may become highly relevant 10, 20, or 30 years from now,” Dr. Huh commented, discussing HPV type 31, which had a ratio of 0.43, as an example. As coverage by the quadrivalent vaccine and hence protection against type 16 rises, “what we would expect over the next 10 years is that ratio to increase substantially, some theorize as much as fourfold. Then as you roll out the 9-valent vaccine, theoretically, that ratio should normalize back to 0.43, assuming again that the efficacy is equivalent for [type 31] and for type 16,” he explained. “So this is where it becomes very interesting, because if it doesn’t, there is something else going on in the population.”

The new data additionally allow good ability to track the phenomenon of viral type replacement, Dr. Huh said.

“But most importantly, what it allows us to do is to look at screening and the impact of the nonavalent vaccine on screening in the United States. If you all buy into primary HPV screening, the current algorithm uses type 16 and type 18. Well, if type 16 and type 18 go away and these ratios change, then we need to seriously revisit how we do primary HPV screening because the current algorithm is probably not the right algorithm to use,” he maintained.

CHICAGO – The 9-valent human papillomavirus (HPV) vaccine recently approved by the Food and Drug Administration has high efficacy for preventing disease caused by the vaccine-covered viral types and is well tolerated, according to end-of study data from a randomized trial.

The vaccine was on par with the quadrivalent vaccine when it came to protection against infection with the four original viral types covered by both vaccines. Additionally, for the five new viral types, it was associated with a 97% reduction in all cervical, vaginal, and vulvar intraepithelial neoplasia, a 100% reduction in cervical intraepithelial neoplasia 3, and a more than 90% reduction in related procedures and treatments, investigators reported at the Annual meeting of Society of Gynecologic Oncology. Meanwhile, it had a good safety profile.

Susan London/Frontline Medical News

“The consistency of the data is very reassuring,” said Dr. Elmar A. Joura of the Medical University of Vienna, General Hospital, and Comprehensive Cancer Center, also in Vienna.

Dr. Marcela delCarmen, session comoderator and a gynecologic oncologist at the Massachusetts General Hospital in Boston, asked, “You’ve presented data on the efficacy of the vaccine in the study population, but do you have any data on the effectiveness or the impact that the vaccine will have on the public health atmosphere of the general population?”

“First of all, we saw that the vaccine was doing exactly what was expected. These vaccines don’t have any therapeutic effect, so those women who have been infected at the time of vaccination, we did not observe a benefit during the course of the study. But from the previous study of the quadrivalent vaccine, we know [that] over the course of time, they also will get some benefit,” Dr. Joura replied.

“The second thing is, the vaccine really has the potential with this high effectiveness to change the screening practice in the long term. But what’s definitely needed is good coverage. And in many countries and also in this country, the coverage rates are far from optimal. Once you achieve a rate like in Australia or the United Kingdom, then the next step definitely is a change of screening algorithm,” such as a switch to primary HPV screening, he added.

There is a persistent medical need to develop new HPV vaccines, even though two highly effective vaccines have been on the market for some time, Dr. Joura maintained. “With HPV 16 and 18, you cover about 70% of invasive cervical cancer and about 50% of cervical precancer. Adding the next five most common most oncogenic HPV strains would give a coverage of 90% for both invasive and precancer, giving an additional benefit of 20% for invasive cancer and 35% for cervical precancer,” he elaborated.

In the Merck-sponsored phase IIb/III trial, the investigators randomized 14,215 women aged 16-26 to double-blind receipt of the quadrivalent vaccine (Gardasil, which covers viral types 6, 11, 16, and 18) or the 9-valent vaccine (Gardasil 9, which additionally covers viral types 31, 33, 45, 52, and 58). “It was not possible to have this trial placebo-controlled since two effective vaccines were available, so the controls were vaccinated with the quadrivalent HPV vaccine,” Dr. Joura explained. The women had follow-up with sample collection for up to 54 months.

Initial results showed that antibody titers for the original four viral types in the group given the 9-valent vaccine were noninferior to those in the group given the quadrivalent vaccine, and when compared against the historical placebo arm of the quadrivalent vaccine trial, there was dramatic and near full protection against type 16- and 18-related cervical, vaginal, and vulvar neoplasia. These findings led to approval of the vaccine late last year and a recent publication (N. Engl. J. Med. 2015;372:711-23).

The new, end-of-study data, capturing roughly an additional year of observation, showed that relative to the quadrivalent vaccine, the 9-valent vaccine provided good protection for the five new viral types among women negative for these types at baseline: Efficacy was 97.7% for protection against any neoplasia of the cervix, vagina, or vulva; 97.4% for protection against high-grade neoplasia; and 96.0% for protection against 6-month persistent infection.

“What is important for public health decisions is what is the effect on procedures and treatments,” Dr. Joura said. In fact, the 9-valent vaccine was highly efficacious for reducing external genital biopsies (92.3% risk reduction), cervical biopsy (97.7%), and loop electrosurgical excision procedure/conization (90.2%) related to the five new viral types covered.

The rate of vaccine-related adverse events was 92.2% with the 9-valent vaccine and 87.6% with the quadrivalent vaccine, with the difference mainly due to more injection site reactions with the former. There was two vaccine-related serious adverse events in the 9-valent group and one in the quadrivalent group.

Prevalence data will help assess trends, tailor screening

In a related study, investigators led by Dr. Warner K. Huh, a professor in the department of obstetrics and gynecology at the University of Alabama at Birmingham, determined the relative prevalence of HPV genotypes in the U.S. population.

Susan London/Frontline Medical News

“We are going to see a transition from the quadrivalent vaccine to the 9-valent vaccine, so information regarding genotypes in this country becomes extremely important,” he said. “There is very limited information in terms of the HPV prevalence for genotypes across the U.S. and more importantly, we almost have zero information on what that prevalence is in a low-risk population. To understand changes in the prevalence in this country, particularly with vaccination and then ultimately as it relates to screening, you are going to need to understand what that baseline data is.”

The investigators analyzed data from 46,751 women aged 21 years or older in the ATHENA study (Evaluation of the Cobas 4800 HPV Test for the Detection of High-Grade Cervical Disease), the largest HPV screening cohort nationally. The Roche-funded study was used to gain Food and Drug Administration approval for primary HPV screening in the United States. Less than 3% of enrolled women had received an HPV vaccine.

The women had HPV testing, in addition to liquid-based Pap testing and colposcopy, with follow-up out to 3 years in a subset. Genotyping was used to detect 16 high-risk types of HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, and 82), and the prevalence of each was benchmarked to that of HPV 16.

“We benchmarked to HPV 16 for a couple of reasons,” Dr. Huh explained. “One of which is that we now have two vaccines – the quadrivalent and the 9-valent vaccines – and we thought it would be interesting to see what happens to that ratio as we have had one for essentially 10 years and the other one transitions in. The other reason, of course, is that it’s a highly prevalent type and a type that’s seen in both vaccines.”

Results showed that the absolute prevalence of all 16 types combined was 11.5% in the entire cohort and 10.0% in the low-risk subset with normal Pap results. In age-stratified analyses, it was higher among women aged 21-24 years than among older women.

The prevalence ratio relative to HPV 16 for the most common viral types among those assessed ranged from 0.12 for HPV 33 to 0.57 for HPV 52.

“The ratios may not be relevant to you today, but they may become highly relevant 10, 20, or 30 years from now,” Dr. Huh commented, discussing HPV type 31, which had a ratio of 0.43, as an example. As coverage by the quadrivalent vaccine and hence protection against type 16 rises, “what we would expect over the next 10 years is that ratio to increase substantially, some theorize as much as fourfold. Then as you roll out the 9-valent vaccine, theoretically, that ratio should normalize back to 0.43, assuming again that the efficacy is equivalent for [type 31] and for type 16,” he explained. “So this is where it becomes very interesting, because if it doesn’t, there is something else going on in the population.”

The new data additionally allow good ability to track the phenomenon of viral type replacement, Dr. Huh said.

“But most importantly, what it allows us to do is to look at screening and the impact of the nonavalent vaccine on screening in the United States. If you all buy into primary HPV screening, the current algorithm uses type 16 and type 18. Well, if type 16 and type 18 go away and these ratios change, then we need to seriously revisit how we do primary HPV screening because the current algorithm is probably not the right algorithm to use,” he maintained.

ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

sworcester@frontlinemedcom.com

ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

sworcester@frontlinemedcom.com

ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

sworcester@frontlinemedcom.com

CHICAGO – Adding the anti-angiogenic agent bevacizumab to chemotherapy improves outcomes in women with platinum-sensitive recurrent epithelial ovarian cancer, the randomized Gynecologic Oncology Group 213 trial has shown.

Results reported at the annual meeting of the Society of Gynecologic Oncology showed that addition of bevacizumab reduced the risk of death (one of the trial’s co-primary endpoints) by a near-significant 17%, which amounted to 4.9 more months of life.

“Paclitaxel, carboplatin, and bevacizumab extended overall survival in patients with platinum-sensitive recurrent ovarian cancer, but narrowly missed that statistical upper limit of significance. The combination was associated with a significant improvement in progression-free survival as well as objective response,” commented lead investigator Dr. Robert L. Coleman, professor and vice chair of clinical research in the department of gynecologic oncology and reproductive medicine, University of Texas MD Anderson Cancer Center in Houston.

“Although toxicity was more commonly observed on the concomitant bevacizumab arm, no new safety signals were detected, and no negative impact on a patient-reported global functioning scale was observed,” he added.

Session attendee Dr. Brad Monk of the University of Arizona Cancer Center in Phoenix wondered if the overall survival results could be interpreted as positive in light of information gleaned since the trial’s inception.

“I think we all accept that 5 months is 5 months of overall survival. I accepted 8 years ago, when the study was developed, that [the statistical test used] was a two-sided test, looking for both superiority and inferiority,” he said. “But today we would never expect that bevacizumab would make survival worse. So if you were to apply a one-tailed test, the P value would go from .056 to .028, and then you would say it’s positive. I know that we can’t change the statistical design, but is this study really negative statistically? Is this a practice-changing study?”

“You are right, we have learned a lot,” Dr. Coleman agreed. “I think one of the most striking differences in this trial versus what our expectations were was the performance of the control arm,” wherein survival far exceeded the 22 months assumed in the trial’s planning; meanwhile, a progression-free survival benefit of bevacizumab was preserved. “I think that this is the strongest signal for that, and the fact that we were able to achieve that knowing that the environment has changed so much, to me, does feel like it is practice changing,” he said.

Two previous trials — CALYPSO (Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse) and OCEANS (Ovarian Cancer Study Comparing Efficacy and Safety of Chemotherapy and Anti-Angiogenic Therapy in Platinum-Sensitive Recurrent Disease) — tested variations on a chemotherapy backbone exclusively among platinum-sensitive patients, he noted, giving some background to the research. Neither found a significant survival benefit (Br J Cancer. 2012;107:588-91 and J Clin Oncol. 2012;30:2039-45).

Participants in the current trial were 674 women with ovarian cancer from the United States, Japan, and South Korea who had a complete response to primary therapy but experienced a recurrence at least 6 months later. They were randomized twice: first to receive secondary cytoreductive surgery or not, and then to receive carboplatin plus paclitaxel, with versus without concurrent and maintenance bevacizumab (Avastin). Genentech provided the agent and supported the National Cancer Institute/Cancer Therapy Evaluation Program for the trial.

In terms of adverse events of special interest, the bevacizumab group had significantly higher rates of grade 3 or worse thromboembolism (4% vs. 1%), infection (13% vs. 6%), hypertension (12% vs. less than 1%), proteinuria (8% vs. 0%), and joint pain (15% vs. 5%), reported Dr. Coleman, who disclosed that he had no conflicts of interest.

“However, arterial thrombosis, neutropenia, and febrile neutropenia were not different between the two arms. And in addition, while gastrointestinal events were more common in the experimental arm, the grade 3/4 events were no different, and no patient died as a result of this adverse event, “ he noted. Furthermore, the allergy (mainly carboplatin hypersensitivity) and grade 3 or worse neuropathy were essentially equally common across groups.

Median overall survival was 42.2 months with bevacizumab and 37.3 months without it (hazard ratio 0.83; P = .056). In subgroup analyses, benefit was similar of whether patients had undergone randomization for cytoreductive surgery, had a progression-free interval of more than 12 months, and had received bevacizumab before.

Progression-free survival was 13.8 months with bevacizumab and 10.4 months without it, a significant difference (hazard ratio 0.61; P less than .0001). The overall response rate was also better with the anti-angiogenic agent (79% vs. 59%, P less than .0001).

Patient-reported quality of life did not differ significantly between the two treatment groups, according to Dr. Coleman. Not surprisingly, those given bevacizumab were less likely to receive more of that agent or another anti-angiogenic agent as the next line of therapy after progression.

Data for the second co-primary endpoint, the overall survival impact of secondary cytoreductive surgery, are currently pending, he said.

CHICAGO – Adding the anti-angiogenic agent bevacizumab to chemotherapy improves outcomes in women with platinum-sensitive recurrent epithelial ovarian cancer, the randomized Gynecologic Oncology Group 213 trial has shown.

Results reported at the annual meeting of the Society of Gynecologic Oncology showed that addition of bevacizumab reduced the risk of death (one of the trial’s co-primary endpoints) by a near-significant 17%, which amounted to 4.9 more months of life.

“Paclitaxel, carboplatin, and bevacizumab extended overall survival in patients with platinum-sensitive recurrent ovarian cancer, but narrowly missed that statistical upper limit of significance. The combination was associated with a significant improvement in progression-free survival as well as objective response,” commented lead investigator Dr. Robert L. Coleman, professor and vice chair of clinical research in the department of gynecologic oncology and reproductive medicine, University of Texas MD Anderson Cancer Center in Houston.

“Although toxicity was more commonly observed on the concomitant bevacizumab arm, no new safety signals were detected, and no negative impact on a patient-reported global functioning scale was observed,” he added.

Session attendee Dr. Brad Monk of the University of Arizona Cancer Center in Phoenix wondered if the overall survival results could be interpreted as positive in light of information gleaned since the trial’s inception.

“I think we all accept that 5 months is 5 months of overall survival. I accepted 8 years ago, when the study was developed, that [the statistical test used] was a two-sided test, looking for both superiority and inferiority,” he said. “But today we would never expect that bevacizumab would make survival worse. So if you were to apply a one-tailed test, the P value would go from .056 to .028, and then you would say it’s positive. I know that we can’t change the statistical design, but is this study really negative statistically? Is this a practice-changing study?”

“You are right, we have learned a lot,” Dr. Coleman agreed. “I think one of the most striking differences in this trial versus what our expectations were was the performance of the control arm,” wherein survival far exceeded the 22 months assumed in the trial’s planning; meanwhile, a progression-free survival benefit of bevacizumab was preserved. “I think that this is the strongest signal for that, and the fact that we were able to achieve that knowing that the environment has changed so much, to me, does feel like it is practice changing,” he said.

Two previous trials — CALYPSO (Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse) and OCEANS (Ovarian Cancer Study Comparing Efficacy and Safety of Chemotherapy and Anti-Angiogenic Therapy in Platinum-Sensitive Recurrent Disease) — tested variations on a chemotherapy backbone exclusively among platinum-sensitive patients, he noted, giving some background to the research. Neither found a significant survival benefit (Br J Cancer. 2012;107:588-91 and J Clin Oncol. 2012;30:2039-45).

Participants in the current trial were 674 women with ovarian cancer from the United States, Japan, and South Korea who had a complete response to primary therapy but experienced a recurrence at least 6 months later. They were randomized twice: first to receive secondary cytoreductive surgery or not, and then to receive carboplatin plus paclitaxel, with versus without concurrent and maintenance bevacizumab (Avastin). Genentech provided the agent and supported the National Cancer Institute/Cancer Therapy Evaluation Program for the trial.

In terms of adverse events of special interest, the bevacizumab group had significantly higher rates of grade 3 or worse thromboembolism (4% vs. 1%), infection (13% vs. 6%), hypertension (12% vs. less than 1%), proteinuria (8% vs. 0%), and joint pain (15% vs. 5%), reported Dr. Coleman, who disclosed that he had no conflicts of interest.

“However, arterial thrombosis, neutropenia, and febrile neutropenia were not different between the two arms. And in addition, while gastrointestinal events were more common in the experimental arm, the grade 3/4 events were no different, and no patient died as a result of this adverse event, “ he noted. Furthermore, the allergy (mainly carboplatin hypersensitivity) and grade 3 or worse neuropathy were essentially equally common across groups.

Median overall survival was 42.2 months with bevacizumab and 37.3 months without it (hazard ratio 0.83; P = .056). In subgroup analyses, benefit was similar of whether patients had undergone randomization for cytoreductive surgery, had a progression-free interval of more than 12 months, and had received bevacizumab before.

Progression-free survival was 13.8 months with bevacizumab and 10.4 months without it, a significant difference (hazard ratio 0.61; P less than .0001). The overall response rate was also better with the anti-angiogenic agent (79% vs. 59%, P less than .0001).

Patient-reported quality of life did not differ significantly between the two treatment groups, according to Dr. Coleman. Not surprisingly, those given bevacizumab were less likely to receive more of that agent or another anti-angiogenic agent as the next line of therapy after progression.

Data for the second co-primary endpoint, the overall survival impact of secondary cytoreductive surgery, are currently pending, he said.

CHICAGO – Adding the anti-angiogenic agent bevacizumab to chemotherapy improves outcomes in women with platinum-sensitive recurrent epithelial ovarian cancer, the randomized Gynecologic Oncology Group 213 trial has shown.

Results reported at the annual meeting of the Society of Gynecologic Oncology showed that addition of bevacizumab reduced the risk of death (one of the trial’s co-primary endpoints) by a near-significant 17%, which amounted to 4.9 more months of life.

“Paclitaxel, carboplatin, and bevacizumab extended overall survival in patients with platinum-sensitive recurrent ovarian cancer, but narrowly missed that statistical upper limit of significance. The combination was associated with a significant improvement in progression-free survival as well as objective response,” commented lead investigator Dr. Robert L. Coleman, professor and vice chair of clinical research in the department of gynecologic oncology and reproductive medicine, University of Texas MD Anderson Cancer Center in Houston.

“Although toxicity was more commonly observed on the concomitant bevacizumab arm, no new safety signals were detected, and no negative impact on a patient-reported global functioning scale was observed,” he added.

Session attendee Dr. Brad Monk of the University of Arizona Cancer Center in Phoenix wondered if the overall survival results could be interpreted as positive in light of information gleaned since the trial’s inception.

“I think we all accept that 5 months is 5 months of overall survival. I accepted 8 years ago, when the study was developed, that [the statistical test used] was a two-sided test, looking for both superiority and inferiority,” he said. “But today we would never expect that bevacizumab would make survival worse. So if you were to apply a one-tailed test, the P value would go from .056 to .028, and then you would say it’s positive. I know that we can’t change the statistical design, but is this study really negative statistically? Is this a practice-changing study?”

“You are right, we have learned a lot,” Dr. Coleman agreed. “I think one of the most striking differences in this trial versus what our expectations were was the performance of the control arm,” wherein survival far exceeded the 22 months assumed in the trial’s planning; meanwhile, a progression-free survival benefit of bevacizumab was preserved. “I think that this is the strongest signal for that, and the fact that we were able to achieve that knowing that the environment has changed so much, to me, does feel like it is practice changing,” he said.

Two previous trials — CALYPSO (Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse) and OCEANS (Ovarian Cancer Study Comparing Efficacy and Safety of Chemotherapy and Anti-Angiogenic Therapy in Platinum-Sensitive Recurrent Disease) — tested variations on a chemotherapy backbone exclusively among platinum-sensitive patients, he noted, giving some background to the research. Neither found a significant survival benefit (Br J Cancer. 2012;107:588-91 and J Clin Oncol. 2012;30:2039-45).

Participants in the current trial were 674 women with ovarian cancer from the United States, Japan, and South Korea who had a complete response to primary therapy but experienced a recurrence at least 6 months later. They were randomized twice: first to receive secondary cytoreductive surgery or not, and then to receive carboplatin plus paclitaxel, with versus without concurrent and maintenance bevacizumab (Avastin). Genentech provided the agent and supported the National Cancer Institute/Cancer Therapy Evaluation Program for the trial.

In terms of adverse events of special interest, the bevacizumab group had significantly higher rates of grade 3 or worse thromboembolism (4% vs. 1%), infection (13% vs. 6%), hypertension (12% vs. less than 1%), proteinuria (8% vs. 0%), and joint pain (15% vs. 5%), reported Dr. Coleman, who disclosed that he had no conflicts of interest.

“However, arterial thrombosis, neutropenia, and febrile neutropenia were not different between the two arms. And in addition, while gastrointestinal events were more common in the experimental arm, the grade 3/4 events were no different, and no patient died as a result of this adverse event, “ he noted. Furthermore, the allergy (mainly carboplatin hypersensitivity) and grade 3 or worse neuropathy were essentially equally common across groups.

Median overall survival was 42.2 months with bevacizumab and 37.3 months without it (hazard ratio 0.83; P = .056). In subgroup analyses, benefit was similar of whether patients had undergone randomization for cytoreductive surgery, had a progression-free interval of more than 12 months, and had received bevacizumab before.

Progression-free survival was 13.8 months with bevacizumab and 10.4 months without it, a significant difference (hazard ratio 0.61; P less than .0001). The overall response rate was also better with the anti-angiogenic agent (79% vs. 59%, P less than .0001).

Patient-reported quality of life did not differ significantly between the two treatment groups, according to Dr. Coleman. Not surprisingly, those given bevacizumab were less likely to receive more of that agent or another anti-angiogenic agent as the next line of therapy after progression.

Data for the second co-primary endpoint, the overall survival impact of secondary cytoreductive surgery, are currently pending, he said.

CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).

The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.

Susan London/Frontline Medical News

“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.

“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”

The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”

Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.

“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.

The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.

Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.

On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).

Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.

In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.

The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).

CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).

The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.

Susan London/Frontline Medical News

“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.

“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”

The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”

Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.

“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.

The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.

Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.

On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).

Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.

In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.

The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).

CHICAGO – Delaying debulking until patients have had some chemotherapy is a safer strategy for women with advanced ovarian cancer, according to interim results of the randomized phase III SCORPION trial (Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm).

The odds of complications such as sepsis, organ failure, and death in the perioperative period were 19.3 times higher among women who underwent primary debulking than among counterparts who underwent neoadjuvant chemotherapy followed by interval debulking, Dr. Anna Fagotti reported at the annual meeting of the Society of Gynecologic Oncology.

Susan London/Frontline Medical News

“Primary debulking surgery is associated with a statistically significantly higher risk of major perioperative morbidity with respect to interval debulking surgery in high–tumor load advanced epithelial ovarian cancer patients,” she said.

“Most of these complications, however, are grade 3, with a higher incidence than reported from retrospective analyses in the literature. The reported mortality rate [with primary debulking] … is in line with the literature data,” added Dr. Fagotti of the University of Perugia, Terni, Italy. “Our survival data will definitely clarify whether such a severe complication rate is acceptable in terms of cost-effectiveness.”

The trial also offers a cautionary note about study methodology in this setting, she said. Specifically, “any neoadjuvant chemotherapy clinical study that is based on instrumental or clinical evaluation only, excluding staging laparoscopy, might include very heterogeneous populations, thus leading to substantial biases.”

Giving some background to the research, Dr. Fagotti noted that case series have shown a survival advantage for women with advanced ovarian cancer who undergo primary debulking with optimal or no residual tumor, albeit at the cost of more extensive surgery. But randomized trials have shown similar survival and fewer complications with the interval debulking approach.

“We know also that many limits can be ascribed to these studies, so, as a consequence, there are gray-zone patients in whom the best primary treatment option is not clear yet,” she commented.

The 110 patients studied in SCORPION had suspected advanced ovarian cancer with a FIGO (International Federation of Gynecology and Obstetrics) stage of IIIc or IV, and had an intraoperative staging laparoscopy score of 8-12. They were randomized evenly to primary debulking followed by adjuvant chemotherapy or to neoadjuvant chemotherapy followed by interval debulking.

Three patients in the latter arm had progression during their chemotherapy and were therefore unable to proceed to their planned surgery, Dr. Fagotti reported.

On average, women in the interval debulking group had less extensive surgery than peers in the primary debulking group. In particular, they were significantly less likely to undergo pelvic and/or abdominal peritonectomy (58% vs. 100%), bowel resection (19% vs. 100%), diaphragmatic peritonectomy or resection (38% vs. 100%), partial hepatectomy (0% vs. 18%), and splenectomy (4% vs. 53%). Overall, they were nearly half as likely to have any upper abdominal procedure (58% vs. 100%).

Ninety percent of all patients had optimal cytoreduction to residual disease of 1 cm or less, with no significant difference between groups, Dr. Fagotti said.

In terms of surgical measures, the interval debulking group had a median operative time that was about a third shorter and median blood loss and hospital stays about half those with primary debulking.

The interval debulking group was significantly less likely to experience any major postoperative complication (6% vs. 53%, P = .001). Notably, they had lower rates of pleural effusion (2% vs. 31%), sepsis (0% vs. 7%), pulmonary thromboembolism (0% vs. 6%), reoperation with organ resection (0% vs. 4%), multiorgan failure (0% vs. 2%), and surgery-related death (0% vs. 4%).

CHICAGO– Quality of life at baseline and during treatment is an important prognostic factor in women with ovarian cancer, confirms an analysis reported at the annual meeting of the Society of Gynecologic Oncology.

Patients’ baseline quality of life score was independently associated with both progression-free and overall survival among 1,152 women participating in the Gynecologic Oncology Group (GOG) 218 trial, a randomized phase III trial comparing chemotherapy with versus without bevacizumab (Avastin), reported Dr. Neil T. Phippen of Walter Reed National Military Medical Center, Bethesda, Md.

Quality of life was assessed at six time points with FACT-O TOI (the Functional Assessment of Cancer Therapy–Ovarian Trial Outcome Index), on which possible scores range from 0-104 and higher scores indicate better quality of life. Women were included in analyses if they had completed the questionnaire at two or more time points.

Patients whose FACT-O TOI scores improved during treatment had a 4- to 5-month longer progression-free survival and a 20- to 25-month longer overall survival than counterparts whose scores worsened.

“Coupled with previously published data establishing quality of life as an independent predictor of survival across cancer sites, our results underscore the importance of quality of life surveillance in phase III clinical trials and support the inclusion of quality of life as an important component of composite clinical trial endpoints currently under development,” Dr. Phippen commented.

“Considering the independent prognostic value of the baseline FACT-O TOI score and the trend in the FACT-O TOI, methods to improve compliance with this evaluation metric are needed,” he maintained.

Patient-reported quality of life has been shown to be independently prognostic in at least five other cancers, according to Dr. Phippen. In advanced ovarian cancer, baseline FACT-O score (J. Clin. Oncol. 2005;23:5605-12) and the physical well-being scale of this score (Gynecol. Oncol. 2012;124:379-82) have previously been linked to overall survival.

In the new study, multivariate analysis that included potential confounders (age, performance status, stage, suboptimal debulking, and history of stroke or MI) showed that each 1-point decrease in baseline FACT-O TOI score was associated with significantly worse progression-free survival (hazard ratio, 1.005) and overall survival (HR, 1.0008), reported Dr. Phippen, who disclosed that he had no relevant conflicts of interest.

Additionally, within the group with lowest-quartile FACT-O TOI scores (indicating poorest quality of life), relative to peers who had a worsening of scores during treatment, women who had an improvement had significantly better progression-free survival (12.7 vs. 8.6 months) and overall survival (40.8 vs. 16 months).

Similarly, within the group having scores in higher quartiles, women who had an improvement in score during treatment again had significantly better progression-free survival (16.7 vs. 11.1 months) and overall survival (54.4 vs. 33.6 months).

CHICAGO– Quality of life at baseline and during treatment is an important prognostic factor in women with ovarian cancer, confirms an analysis reported at the annual meeting of the Society of Gynecologic Oncology.

Patients’ baseline quality of life score was independently associated with both progression-free and overall survival among 1,152 women participating in the Gynecologic Oncology Group (GOG) 218 trial, a randomized phase III trial comparing chemotherapy with versus without bevacizumab (Avastin), reported Dr. Neil T. Phippen of Walter Reed National Military Medical Center, Bethesda, Md.

Quality of life was assessed at six time points with FACT-O TOI (the Functional Assessment of Cancer Therapy–Ovarian Trial Outcome Index), on which possible scores range from 0-104 and higher scores indicate better quality of life. Women were included in analyses if they had completed the questionnaire at two or more time points.

Patients whose FACT-O TOI scores improved during treatment had a 4- to 5-month longer progression-free survival and a 20- to 25-month longer overall survival than counterparts whose scores worsened.

“Coupled with previously published data establishing quality of life as an independent predictor of survival across cancer sites, our results underscore the importance of quality of life surveillance in phase III clinical trials and support the inclusion of quality of life as an important component of composite clinical trial endpoints currently under development,” Dr. Phippen commented.

“Considering the independent prognostic value of the baseline FACT-O TOI score and the trend in the FACT-O TOI, methods to improve compliance with this evaluation metric are needed,” he maintained.

Patient-reported quality of life has been shown to be independently prognostic in at least five other cancers, according to Dr. Phippen. In advanced ovarian cancer, baseline FACT-O score (J. Clin. Oncol. 2005;23:5605-12) and the physical well-being scale of this score (Gynecol. Oncol. 2012;124:379-82) have previously been linked to overall survival.

In the new study, multivariate analysis that included potential confounders (age, performance status, stage, suboptimal debulking, and history of stroke or MI) showed that each 1-point decrease in baseline FACT-O TOI score was associated with significantly worse progression-free survival (hazard ratio, 1.005) and overall survival (HR, 1.0008), reported Dr. Phippen, who disclosed that he had no relevant conflicts of interest.

Additionally, within the group with lowest-quartile FACT-O TOI scores (indicating poorest quality of life), relative to peers who had a worsening of scores during treatment, women who had an improvement had significantly better progression-free survival (12.7 vs. 8.6 months) and overall survival (40.8 vs. 16 months).

Similarly, within the group having scores in higher quartiles, women who had an improvement in score during treatment again had significantly better progression-free survival (16.7 vs. 11.1 months) and overall survival (54.4 vs. 33.6 months).

CHICAGO– Quality of life at baseline and during treatment is an important prognostic factor in women with ovarian cancer, confirms an analysis reported at the annual meeting of the Society of Gynecologic Oncology.

Patients’ baseline quality of life score was independently associated with both progression-free and overall survival among 1,152 women participating in the Gynecologic Oncology Group (GOG) 218 trial, a randomized phase III trial comparing chemotherapy with versus without bevacizumab (Avastin), reported Dr. Neil T. Phippen of Walter Reed National Military Medical Center, Bethesda, Md.

Quality of life was assessed at six time points with FACT-O TOI (the Functional Assessment of Cancer Therapy–Ovarian Trial Outcome Index), on which possible scores range from 0-104 and higher scores indicate better quality of life. Women were included in analyses if they had completed the questionnaire at two or more time points.

Patients whose FACT-O TOI scores improved during treatment had a 4- to 5-month longer progression-free survival and a 20- to 25-month longer overall survival than counterparts whose scores worsened.

“Coupled with previously published data establishing quality of life as an independent predictor of survival across cancer sites, our results underscore the importance of quality of life surveillance in phase III clinical trials and support the inclusion of quality of life as an important component of composite clinical trial endpoints currently under development,” Dr. Phippen commented.

“Considering the independent prognostic value of the baseline FACT-O TOI score and the trend in the FACT-O TOI, methods to improve compliance with this evaluation metric are needed,” he maintained.

Patient-reported quality of life has been shown to be independently prognostic in at least five other cancers, according to Dr. Phippen. In advanced ovarian cancer, baseline FACT-O score (J. Clin. Oncol. 2005;23:5605-12) and the physical well-being scale of this score (Gynecol. Oncol. 2012;124:379-82) have previously been linked to overall survival.

In the new study, multivariate analysis that included potential confounders (age, performance status, stage, suboptimal debulking, and history of stroke or MI) showed that each 1-point decrease in baseline FACT-O TOI score was associated with significantly worse progression-free survival (hazard ratio, 1.005) and overall survival (HR, 1.0008), reported Dr. Phippen, who disclosed that he had no relevant conflicts of interest.

Additionally, within the group with lowest-quartile FACT-O TOI scores (indicating poorest quality of life), relative to peers who had a worsening of scores during treatment, women who had an improvement had significantly better progression-free survival (12.7 vs. 8.6 months) and overall survival (40.8 vs. 16 months).

Similarly, within the group having scores in higher quartiles, women who had an improvement in score during treatment again had significantly better progression-free survival (16.7 vs. 11.1 months) and overall survival (54.4 vs. 33.6 months).

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

WASHINGTON– Despite ethical issues raised by mitochondrial replacement therapy and uncertainties about the potential risks, women with serious mitochondrial diseases appear willing to accept these unknowns for the chance to prevent transmission of the diseases to their biological children.

Mitochondrial replacement therapy (MRT), which was recently granted approval in the United Kingdom, involves removing the nuclear DNA from the egg or fertilized egg of a woman with mitochondrial abnormalities and inserting it into a donor egg with normal mitochondria, after the nuclear DNA of the donor egg has been removed.

An MRT technique that entails removing the mitochondrial DNA from the intended mother’s egg is being evaluated at two centers in the United States, the University of Oregon, Eugene, where it has been performed in macaque monkeys, and the New York Stem Cell Foundation.

Courtesy Wikimedia Commons/Archaeogenetics/Creative Commons License

The technique, also known as mitochondrial donation, mitochondrial transfer, or mitochondrial DNA replacement, has generated significant controversy, with critics warning that it will lead to “germline enhancements,” eugenics, and designer babies.

But at a 2-day meeting sponsored by the Institute of Medicine (IOM), researchers presented survey data showing that for women who are carriers of these mutations, the ethical concerns are secondary.

In a survey of 92 women who were known carriers of a mitochondrial DNA mutation or were at risk of carrying a mutation, there was universal concern about transmitting mitochondrial DNA mutations to their children, and “overwhelming support and widespread interest” in the clinical use of MRT, particularly among women considering having children at the time of the survey, according to Dr. Michio Hirano, professor of neurology at Columbia University, which collaborates with the New York Stem Cell Foundation on this research.

Almost 80% of the women said they had considered not having children because of the transmission risk and almost three-quarters of those who already had children said they would have considered not having children if they had known they carried the mutation.

Carrying a mutation “has a profound effect on what these women think about their progeny and the risk of transmitting disease,” said Dr. Hirano, who is codirector of the North American Mitochondrial Disease Consortium.

Almost all of the 21 women who were considering having children at the time of the survey said that having a biological child was “very” or “somewhat” important to them, and almost all said they would be interested in the option of MRT. Dr. Hirano, noted that preimplantation genetic diagnosis (PGD), an option often raised as an alternative to MRT, is not always reliable.

Kirah Fasano, a 32-year-old with chronic progressive external ophthalmoplegia, who spoke at the IOM meeting, said that because of her type of mitochondrial disease, PGD was not an option, and after several failed attempts with in-vitro fertilization using her own eggs, she and her husband opted for an egg donor.

She now has a healthy baby, but MRT “is exactly what we would have been looking for,” she said. “I would do it today if it were available,” even after hearing the potential downsides of the technology, she added.

Heather Ward, who has MELAS (mitochondrial encephalopathy, lactic acidosis, and strokelike episodes) and whose daughter was diagnosed with the disease at 18 months, acknowledged that children do bear risk with new techniques such as MRT. But she said that risk must be weighed against the benefits of potentially preventing neurodegenerative mitochondrial diseases in those children.

“It’s very important, if we have the option, to be able to give mothers with MELAS the option to have healthy children. We have the technology. We need to study it,” she said. “And I think it’s a huge disservice to women who have this disease to not give them that option.”

But another meeting participant, Marcy Darnovsky, Ph.D., said that there are two applications of these technologies – human reproductive cloning and human germline modification – which “are so dangerous from a safety and a social standpoint, that they should be taken off the table.”

These genetic techniques should not be evaluated as a medical treatment, where the medical risks are weighed against the medical benefits, because they do not provide a medical benefit but “a very real social benefit,” the ability to have a genetically related child, said Dr. Darnofsky, executive director of the Center for Genetics and Society, in Berkeley, Calif. While the desire of parents should be taken seriously, “they don’t trump everything else,” she added.

Other topics discussed during the meeting included whether egg and sperm donors view themselves as parents, the importance of a direct genetic connection to one’s child, and the concept of procreative liberty. The participants also discussed the unknown risks of manipulating the mitochondria, how to follow-up with children born as a result of MRT, and the risks to young egg donors paid to donate.

The IOM, which is studying the ethical and social policy considerations associated with mitochondrial replacement therapy at the request of the Food and Drug Administration, will hold several more public meetings before issuing a consensus report in early 2016. The regulation of human cells used in therapies that involve the transfer of genetic material “by means other than the union of gamete nuclei” is regulated by the FDA.

emechcatie@frontlinemedcom.com

WASHINGTON– Despite ethical issues raised by mitochondrial replacement therapy and uncertainties about the potential risks, women with serious mitochondrial diseases appear willing to accept these unknowns for the chance to prevent transmission of the diseases to their biological children.

Mitochondrial replacement therapy (MRT), which was recently granted approval in the United Kingdom, involves removing the nuclear DNA from the egg or fertilized egg of a woman with mitochondrial abnormalities and inserting it into a donor egg with normal mitochondria, after the nuclear DNA of the donor egg has been removed.

An MRT technique that entails removing the mitochondrial DNA from the intended mother’s egg is being evaluated at two centers in the United States, the University of Oregon, Eugene, where it has been performed in macaque monkeys, and the New York Stem Cell Foundation.

Courtesy Wikimedia Commons/Archaeogenetics/Creative Commons License

The technique, also known as mitochondrial donation, mitochondrial transfer, or mitochondrial DNA replacement, has generated significant controversy, with critics warning that it will lead to “germline enhancements,” eugenics, and designer babies.

But at a 2-day meeting sponsored by the Institute of Medicine (IOM), researchers presented survey data showing that for women who are carriers of these mutations, the ethical concerns are secondary.

In a survey of 92 women who were known carriers of a mitochondrial DNA mutation or were at risk of carrying a mutation, there was universal concern about transmitting mitochondrial DNA mutations to their children, and “overwhelming support and widespread interest” in the clinical use of MRT, particularly among women considering having children at the time of the survey, according to Dr. Michio Hirano, professor of neurology at Columbia University, which collaborates with the New York Stem Cell Foundation on this research.

Almost 80% of the women said they had considered not having children because of the transmission risk and almost three-quarters of those who already had children said they would have considered not having children if they had known they carried the mutation.

Carrying a mutation “has a profound effect on what these women think about their progeny and the risk of transmitting disease,” said Dr. Hirano, who is codirector of the North American Mitochondrial Disease Consortium.

Almost all of the 21 women who were considering having children at the time of the survey said that having a biological child was “very” or “somewhat” important to them, and almost all said they would be interested in the option of MRT. Dr. Hirano, noted that preimplantation genetic diagnosis (PGD), an option often raised as an alternative to MRT, is not always reliable.

Kirah Fasano, a 32-year-old with chronic progressive external ophthalmoplegia, who spoke at the IOM meeting, said that because of her type of mitochondrial disease, PGD was not an option, and after several failed attempts with in-vitro fertilization using her own eggs, she and her husband opted for an egg donor.

She now has a healthy baby, but MRT “is exactly what we would have been looking for,” she said. “I would do it today if it were available,” even after hearing the potential downsides of the technology, she added.

Heather Ward, who has MELAS (mitochondrial encephalopathy, lactic acidosis, and strokelike episodes) and whose daughter was diagnosed with the disease at 18 months, acknowledged that children do bear risk with new techniques such as MRT. But she said that risk must be weighed against the benefits of potentially preventing neurodegenerative mitochondrial diseases in those children.

“It’s very important, if we have the option, to be able to give mothers with MELAS the option to have healthy children. We have the technology. We need to study it,” she said. “And I think it’s a huge disservice to women who have this disease to not give them that option.”

But another meeting participant, Marcy Darnovsky, Ph.D., said that there are two applications of these technologies – human reproductive cloning and human germline modification – which “are so dangerous from a safety and a social standpoint, that they should be taken off the table.”

These genetic techniques should not be evaluated as a medical treatment, where the medical risks are weighed against the medical benefits, because they do not provide a medical benefit but “a very real social benefit,” the ability to have a genetically related child, said Dr. Darnofsky, executive director of the Center for Genetics and Society, in Berkeley, Calif. While the desire of parents should be taken seriously, “they don’t trump everything else,” she added.

Other topics discussed during the meeting included whether egg and sperm donors view themselves as parents, the importance of a direct genetic connection to one’s child, and the concept of procreative liberty. The participants also discussed the unknown risks of manipulating the mitochondria, how to follow-up with children born as a result of MRT, and the risks to young egg donors paid to donate.

The IOM, which is studying the ethical and social policy considerations associated with mitochondrial replacement therapy at the request of the Food and Drug Administration, will hold several more public meetings before issuing a consensus report in early 2016. The regulation of human cells used in therapies that involve the transfer of genetic material “by means other than the union of gamete nuclei” is regulated by the FDA.

emechcatie@frontlinemedcom.com

WASHINGTON– Despite ethical issues raised by mitochondrial replacement therapy and uncertainties about the potential risks, women with serious mitochondrial diseases appear willing to accept these unknowns for the chance to prevent transmission of the diseases to their biological children.

Mitochondrial replacement therapy (MRT), which was recently granted approval in the United Kingdom, involves removing the nuclear DNA from the egg or fertilized egg of a woman with mitochondrial abnormalities and inserting it into a donor egg with normal mitochondria, after the nuclear DNA of the donor egg has been removed.

An MRT technique that entails removing the mitochondrial DNA from the intended mother’s egg is being evaluated at two centers in the United States, the University of Oregon, Eugene, where it has been performed in macaque monkeys, and the New York Stem Cell Foundation.

Courtesy Wikimedia Commons/Archaeogenetics/Creative Commons License

The technique, also known as mitochondrial donation, mitochondrial transfer, or mitochondrial DNA replacement, has generated significant controversy, with critics warning that it will lead to “germline enhancements,” eugenics, and designer babies.

But at a 2-day meeting sponsored by the Institute of Medicine (IOM), researchers presented survey data showing that for women who are carriers of these mutations, the ethical concerns are secondary.

In a survey of 92 women who were known carriers of a mitochondrial DNA mutation or were at risk of carrying a mutation, there was universal concern about transmitting mitochondrial DNA mutations to their children, and “overwhelming support and widespread interest” in the clinical use of MRT, particularly among women considering having children at the time of the survey, according to Dr. Michio Hirano, professor of neurology at Columbia University, which collaborates with the New York Stem Cell Foundation on this research.

Almost 80% of the women said they had considered not having children because of the transmission risk and almost three-quarters of those who already had children said they would have considered not having children if they had known they carried the mutation.

Carrying a mutation “has a profound effect on what these women think about their progeny and the risk of transmitting disease,” said Dr. Hirano, who is codirector of the North American Mitochondrial Disease Consortium.

Almost all of the 21 women who were considering having children at the time of the survey said that having a biological child was “very” or “somewhat” important to them, and almost all said they would be interested in the option of MRT. Dr. Hirano, noted that preimplantation genetic diagnosis (PGD), an option often raised as an alternative to MRT, is not always reliable.

Kirah Fasano, a 32-year-old with chronic progressive external ophthalmoplegia, who spoke at the IOM meeting, said that because of her type of mitochondrial disease, PGD was not an option, and after several failed attempts with in-vitro fertilization using her own eggs, she and her husband opted for an egg donor.

She now has a healthy baby, but MRT “is exactly what we would have been looking for,” she said. “I would do it today if it were available,” even after hearing the potential downsides of the technology, she added.

Heather Ward, who has MELAS (mitochondrial encephalopathy, lactic acidosis, and strokelike episodes) and whose daughter was diagnosed with the disease at 18 months, acknowledged that children do bear risk with new techniques such as MRT. But she said that risk must be weighed against the benefits of potentially preventing neurodegenerative mitochondrial diseases in those children.

“It’s very important, if we have the option, to be able to give mothers with MELAS the option to have healthy children. We have the technology. We need to study it,” she said. “And I think it’s a huge disservice to women who have this disease to not give them that option.”

But another meeting participant, Marcy Darnovsky, Ph.D., said that there are two applications of these technologies – human reproductive cloning and human germline modification – which “are so dangerous from a safety and a social standpoint, that they should be taken off the table.”

These genetic techniques should not be evaluated as a medical treatment, where the medical risks are weighed against the medical benefits, because they do not provide a medical benefit but “a very real social benefit,” the ability to have a genetically related child, said Dr. Darnofsky, executive director of the Center for Genetics and Society, in Berkeley, Calif. While the desire of parents should be taken seriously, “they don’t trump everything else,” she added.

Other topics discussed during the meeting included whether egg and sperm donors view themselves as parents, the importance of a direct genetic connection to one’s child, and the concept of procreative liberty. The participants also discussed the unknown risks of manipulating the mitochondria, how to follow-up with children born as a result of MRT, and the risks to young egg donors paid to donate.

The IOM, which is studying the ethical and social policy considerations associated with mitochondrial replacement therapy at the request of the Food and Drug Administration, will hold several more public meetings before issuing a consensus report in early 2016. The regulation of human cells used in therapies that involve the transfer of genetic material “by means other than the union of gamete nuclei” is regulated by the FDA.

emechcatie@frontlinemedcom.com

CHICAGO – Women whose ovarian cancers harbor a BRCA mutation or have a similar genomic signature are most likely to benefit from the investigational agent rucaparib, suggest interim results of a phase II trial reported at the annual meeting of the Society of Gynecologic Oncology.

Investigators assessed activity of this novel oral PARP (poly-ADP-ribose) inhibitor in ARIEL2, A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The study was sponsored by Clovis Oncology, manufacturer of rucaparib.

They also tested a biomarker of homologous recombination deficiency (HRD), which confers susceptibility to PARP inhibitors and is commonly seen in BRCA-mutated tumors, said Dr. Elizabeth Swisher, medical director of the breast and ovarian cancer prevention program at the Seattle Cancer Care Alliance and a professor at the University of Washington, Seattle.

Tumors were genomically profiled with next-generation sequencing, which picks up the loss of heterozygosity caused by HRD, whether specifically due to a BRCA mutation or to other molecular aberrations that give tumors a similar genomic signature.

Results in the first 121 evaluable patients showed that 25% had tumors with a BRCA mutation (a percentage capped in the study) and 42% had tumors that lacked such mutation but nonetheless had a BRCA-like signature, while 33% had tumors negative for the biomarker, Dr. Swisher reported.

The response rate to rucaparib according to RECIST (Response Evaluation Criteria In Solid Tumors) was 43% among 61 evaluable patients overall. But it varied significantly by HRD biomarker status: It was 65% in those with BRCA-mutated tumors and 40% in those with a BRCA-like signature, but only 8% in those with tumors negative for the biomarker (P less than .001).

The most common treatment-related adverse events were nausea, fatigue, and transient elevation of liver function tests. None of the patients stopped treatment because of toxicity.

“Rucaparib is active and well tolerated in high-grade ovarian cancer,” summarized Dr. Swisher.

“Comprehensive genomic analysis of the tumor based on a next-generation sequencing platform can prospectively identify ovarian cancer patients who respond to rucaparib, and it identifies both relevant BRCA mutations and a BRCA-like signature in one test,” she said. “The BRCA-like signature could have utility in other cancer types beyond ovarian cancer, potentially.”

She noted that ARIEL2 has recently been expanded to be a registration study for the treatment of patients with ovarian cancer who have had failure of three prior therapies, regardless of BRCA mutational status, and remains open for enrollment.

Investigators with the ARIEL program are refining the HRD biomarker, according to Dr. Swisher. “We will look at different cutoffs to see if we can get an even better cutoff for defining the BRCA-like cases. That biomarker will be locked down and tested prospectively in ARIEL3, which is the pivotal phase III, randomized, placebo-controlled study – recurrent, maintenance, platinum sensitive – that hopefully will be a registration study,” she elaborated.

Dr. Swisher disclosed that she had no relevant conflicts of interest. The trial was sponsored by Clovis Oncology.

CHICAGO – Women whose ovarian cancers harbor a BRCA mutation or have a similar genomic signature are most likely to benefit from the investigational agent rucaparib, suggest interim results of a phase II trial reported at the annual meeting of the Society of Gynecologic Oncology.

Investigators assessed activity of this novel oral PARP (poly-ADP-ribose) inhibitor in ARIEL2, A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The study was sponsored by Clovis Oncology, manufacturer of rucaparib.

They also tested a biomarker of homologous recombination deficiency (HRD), which confers susceptibility to PARP inhibitors and is commonly seen in BRCA-mutated tumors, said Dr. Elizabeth Swisher, medical director of the breast and ovarian cancer prevention program at the Seattle Cancer Care Alliance and a professor at the University of Washington, Seattle.

Tumors were genomically profiled with next-generation sequencing, which picks up the loss of heterozygosity caused by HRD, whether specifically due to a BRCA mutation or to other molecular aberrations that give tumors a similar genomic signature.

Results in the first 121 evaluable patients showed that 25% had tumors with a BRCA mutation (a percentage capped in the study) and 42% had tumors that lacked such mutation but nonetheless had a BRCA-like signature, while 33% had tumors negative for the biomarker, Dr. Swisher reported.

The response rate to rucaparib according to RECIST (Response Evaluation Criteria In Solid Tumors) was 43% among 61 evaluable patients overall. But it varied significantly by HRD biomarker status: It was 65% in those with BRCA-mutated tumors and 40% in those with a BRCA-like signature, but only 8% in those with tumors negative for the biomarker (P less than .001).

The most common treatment-related adverse events were nausea, fatigue, and transient elevation of liver function tests. None of the patients stopped treatment because of toxicity.

“Rucaparib is active and well tolerated in high-grade ovarian cancer,” summarized Dr. Swisher.

“Comprehensive genomic analysis of the tumor based on a next-generation sequencing platform can prospectively identify ovarian cancer patients who respond to rucaparib, and it identifies both relevant BRCA mutations and a BRCA-like signature in one test,” she said. “The BRCA-like signature could have utility in other cancer types beyond ovarian cancer, potentially.”

She noted that ARIEL2 has recently been expanded to be a registration study for the treatment of patients with ovarian cancer who have had failure of three prior therapies, regardless of BRCA mutational status, and remains open for enrollment.

Investigators with the ARIEL program are refining the HRD biomarker, according to Dr. Swisher. “We will look at different cutoffs to see if we can get an even better cutoff for defining the BRCA-like cases. That biomarker will be locked down and tested prospectively in ARIEL3, which is the pivotal phase III, randomized, placebo-controlled study – recurrent, maintenance, platinum sensitive – that hopefully will be a registration study,” she elaborated.

Dr. Swisher disclosed that she had no relevant conflicts of interest. The trial was sponsored by Clovis Oncology.

CHICAGO – Women whose ovarian cancers harbor a BRCA mutation or have a similar genomic signature are most likely to benefit from the investigational agent rucaparib, suggest interim results of a phase II trial reported at the annual meeting of the Society of Gynecologic Oncology.

Investigators assessed activity of this novel oral PARP (poly-ADP-ribose) inhibitor in ARIEL2, A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The study was sponsored by Clovis Oncology, manufacturer of rucaparib.

They also tested a biomarker of homologous recombination deficiency (HRD), which confers susceptibility to PARP inhibitors and is commonly seen in BRCA-mutated tumors, said Dr. Elizabeth Swisher, medical director of the breast and ovarian cancer prevention program at the Seattle Cancer Care Alliance and a professor at the University of Washington, Seattle.

Tumors were genomically profiled with next-generation sequencing, which picks up the loss of heterozygosity caused by HRD, whether specifically due to a BRCA mutation or to other molecular aberrations that give tumors a similar genomic signature.

Results in the first 121 evaluable patients showed that 25% had tumors with a BRCA mutation (a percentage capped in the study) and 42% had tumors that lacked such mutation but nonetheless had a BRCA-like signature, while 33% had tumors negative for the biomarker, Dr. Swisher reported.

The response rate to rucaparib according to RECIST (Response Evaluation Criteria In Solid Tumors) was 43% among 61 evaluable patients overall. But it varied significantly by HRD biomarker status: It was 65% in those with BRCA-mutated tumors and 40% in those with a BRCA-like signature, but only 8% in those with tumors negative for the biomarker (P less than .001).

The most common treatment-related adverse events were nausea, fatigue, and transient elevation of liver function tests. None of the patients stopped treatment because of toxicity.

“Rucaparib is active and well tolerated in high-grade ovarian cancer,” summarized Dr. Swisher.

“Comprehensive genomic analysis of the tumor based on a next-generation sequencing platform can prospectively identify ovarian cancer patients who respond to rucaparib, and it identifies both relevant BRCA mutations and a BRCA-like signature in one test,” she said. “The BRCA-like signature could have utility in other cancer types beyond ovarian cancer, potentially.”

She noted that ARIEL2 has recently been expanded to be a registration study for the treatment of patients with ovarian cancer who have had failure of three prior therapies, regardless of BRCA mutational status, and remains open for enrollment.

Investigators with the ARIEL program are refining the HRD biomarker, according to Dr. Swisher. “We will look at different cutoffs to see if we can get an even better cutoff for defining the BRCA-like cases. That biomarker will be locked down and tested prospectively in ARIEL3, which is the pivotal phase III, randomized, placebo-controlled study – recurrent, maintenance, platinum sensitive – that hopefully will be a registration study,” she elaborated.

Dr. Swisher disclosed that she had no relevant conflicts of interest. The trial was sponsored by Clovis Oncology.

CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.

The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.

Susan London/Frontline Medical News

“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.

“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”

Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”

The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.

In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.

The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.

Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.

On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.

In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.

The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.

The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.

CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.

The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.

Susan London/Frontline Medical News

“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.

“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”

Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”

The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.

In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.

The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.

Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.

On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.

In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.

The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.

The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.

CHICAGO – A preoperative risk model accurately identifies women with endometrial cancer who are unlikely to have lymph node metastases, finds a prospective cohort study reported at the annual Meeting of the Society of Gynecologic Oncology.

The model – which uses favorable MRI features, endometrioid histology on biopsy, and a cancer antigen 125 (CA125) level of 35 U/mL or lower to define a low-risk group – had a negative predictive value of 97% when tested in 529 Asian women.

Susan London/Frontline Medical News

“Using [our model], we can reliably identify patients with a low risk for lymph node metastasis before surgery,” said Dr. Sokbom Kang, director of the division of gynecologic oncology at the National Cancer Center, Goyang, Korea.

“In the clinic, our preoperative risk assessment may be useful in patient counseling. By sharing this risk information with our patients, we may improve their decision-making process about their surgery,” he added. “Not only does it help patient counseling and surgical planning, but it also may be useful in patient selection for future surgical trials.”

Some guidelines have stopped recommending routine lymphadenectomy in patients with endometrial cancer, according to Dr. Kang. “However, some experts still endorse this procedure, even in low-risk patients. Their argument is, low-risk patients cannot be accurately identified because preoperative tests are inaccurate.”

The risk model was developed by the Korean Gynecologic Oncology group (J. Clin. Oncol. 2012;30:1329-34) and has since been validated in smaller single-nationality cohorts.

In the new study, known as PALME (Preoperative Risk Assessment for Lymph Node Metastasis in Endometrial Cancer), it was tested among consecutive women from 25 hospitals in Korea, Japan, and China who had a histologic diagnosis of endometrial cancer. Those with squamous cell carcinoma or sarcoma histologies were excluded.

The women underwent MRI and CA125 testing in the 4 weeks before surgery. They had surgical staging with pelvic lymphadenectomy, and para-aortic lymphadenectomy was recommended. The median number of nodes removed was 23.

Results showed that the model classified 51% of the patients as having a low risk of lymph node metastases, reported Dr. Kang, who disclosed that he had no relevant conflicts of interest.

On the basis of surgical findings, the model had a negative predictive value of 97%, corresponding to a false-negative predictive rate of just 3%, which was in line with earlier results seen in the smaller validation studies.

In a receiver operating characteristic curve analysis, the model had a summarized sensitivity of 91% and a summarized specificity of 54%.

The performance was similar when tumor grade was substituted for CA125 level, except that specificity decreased significantly. “The lower specificity means fewer patients will benefit from our selective lymphadenectomy strategy, so it impairs the cost-effectiveness of our strategy,” Dr. Kang said.

The model performed similarly as well as a model using features of the primary tumor drawn from the final pathology report. “This proves our preoperative risk assessment has similar accuracy to the postoperative risk assessment for identifying a low risk of lymph node metastasis,” he concluded.

ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.

ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.

ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.