Gynecology

Paclitaxel plus carboplatin was noninferior to paclitaxel plus cisplatin in extending overall survival in incurable metastatic or recurrent cervical cancer in a multicenter open-label randomized phase III clinical trial published online March 3 in Journal of Clinical Oncology.

Given that carboplatin induces less toxicity than does cisplatin, doesn’t require 24-hour hospitalization when administered, and doesn’t require monitored hydration to prevent nephrotoxicity as cisplatin does, the paclitaxel-plus-carboplatin therapy should be a standard treatment option for this patient population, said Dr. Ryo Kitagawa of NTT Medical Center, Tokyo, and associates.

Worldwide, cisplatin plus paclitaxel is considered the standard cytotoxic treatment for metastatic or recurrent cervical cancer. Carboplatin has been reported to be less effective in three studies, but the two agents have never been compared against each other in a phase III trial. Dr. Kitagawa and her associates performed such a comparison study in 253 women whose disease was not amenable to curative surgery or radiotherapy. These patients were randomly assigned to receive either paclitaxel plus carboplatin (126 patients) or standard paclitaxel plus cisplatin (127 patients) and were followed for a median of 18 months.

The carboplatin regimen, with a median overall survival of 17.5 months, proved to be noninferior to the cisplatin regimen, which had a median OS of 18.3 months. The carboplatin regimen also was either noninferior or superior to the cisplatin regimen for the secondary outcomes of progression-free survival (6.2 months vs. 6.9 months), complete response rate (7.1% vs. 3.9%), and complete or partial response rate (62.6% vs. 58.8%), the investigators said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.58.4391]).

The percentages of patients who completed the treatment protocol were nearly the same in both study groups (72% and 71%), and the patients who discontinued treatment because of adverse effects also was similar (9.5% and 11.8%). Quality of life was judged to be significantly better with the carboplatin regimen because the percentage of nonhospitalization time was much greater (61.9% vs 46.4%). The carboplatin regimen also induced markedly less grade 4 neutropenia, grade 3-4 febrile neutropenia, creatinine elevation, and nausea/vomiting, but thrombocytopenia and reversible neuropathy tended to be more frequent with carboplatin than with cisplatin.

Paclitaxel plus carboplatin was noninferior to paclitaxel plus cisplatin in extending overall survival in incurable metastatic or recurrent cervical cancer in a multicenter open-label randomized phase III clinical trial published online March 3 in Journal of Clinical Oncology.

Given that carboplatin induces less toxicity than does cisplatin, doesn’t require 24-hour hospitalization when administered, and doesn’t require monitored hydration to prevent nephrotoxicity as cisplatin does, the paclitaxel-plus-carboplatin therapy should be a standard treatment option for this patient population, said Dr. Ryo Kitagawa of NTT Medical Center, Tokyo, and associates.

Worldwide, cisplatin plus paclitaxel is considered the standard cytotoxic treatment for metastatic or recurrent cervical cancer. Carboplatin has been reported to be less effective in three studies, but the two agents have never been compared against each other in a phase III trial. Dr. Kitagawa and her associates performed such a comparison study in 253 women whose disease was not amenable to curative surgery or radiotherapy. These patients were randomly assigned to receive either paclitaxel plus carboplatin (126 patients) or standard paclitaxel plus cisplatin (127 patients) and were followed for a median of 18 months.

The carboplatin regimen, with a median overall survival of 17.5 months, proved to be noninferior to the cisplatin regimen, which had a median OS of 18.3 months. The carboplatin regimen also was either noninferior or superior to the cisplatin regimen for the secondary outcomes of progression-free survival (6.2 months vs. 6.9 months), complete response rate (7.1% vs. 3.9%), and complete or partial response rate (62.6% vs. 58.8%), the investigators said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.58.4391]).

The percentages of patients who completed the treatment protocol were nearly the same in both study groups (72% and 71%), and the patients who discontinued treatment because of adverse effects also was similar (9.5% and 11.8%). Quality of life was judged to be significantly better with the carboplatin regimen because the percentage of nonhospitalization time was much greater (61.9% vs 46.4%). The carboplatin regimen also induced markedly less grade 4 neutropenia, grade 3-4 febrile neutropenia, creatinine elevation, and nausea/vomiting, but thrombocytopenia and reversible neuropathy tended to be more frequent with carboplatin than with cisplatin.

Paclitaxel plus carboplatin was noninferior to paclitaxel plus cisplatin in extending overall survival in incurable metastatic or recurrent cervical cancer in a multicenter open-label randomized phase III clinical trial published online March 3 in Journal of Clinical Oncology.

Given that carboplatin induces less toxicity than does cisplatin, doesn’t require 24-hour hospitalization when administered, and doesn’t require monitored hydration to prevent nephrotoxicity as cisplatin does, the paclitaxel-plus-carboplatin therapy should be a standard treatment option for this patient population, said Dr. Ryo Kitagawa of NTT Medical Center, Tokyo, and associates.

Worldwide, cisplatin plus paclitaxel is considered the standard cytotoxic treatment for metastatic or recurrent cervical cancer. Carboplatin has been reported to be less effective in three studies, but the two agents have never been compared against each other in a phase III trial. Dr. Kitagawa and her associates performed such a comparison study in 253 women whose disease was not amenable to curative surgery or radiotherapy. These patients were randomly assigned to receive either paclitaxel plus carboplatin (126 patients) or standard paclitaxel plus cisplatin (127 patients) and were followed for a median of 18 months.

The carboplatin regimen, with a median overall survival of 17.5 months, proved to be noninferior to the cisplatin regimen, which had a median OS of 18.3 months. The carboplatin regimen also was either noninferior or superior to the cisplatin regimen for the secondary outcomes of progression-free survival (6.2 months vs. 6.9 months), complete response rate (7.1% vs. 3.9%), and complete or partial response rate (62.6% vs. 58.8%), the investigators said (J. Clin. Oncol. 2015 March 3 [doi:10.1200/JCO.2014.58.4391]).

The percentages of patients who completed the treatment protocol were nearly the same in both study groups (72% and 71%), and the patients who discontinued treatment because of adverse effects also was similar (9.5% and 11.8%). Quality of life was judged to be significantly better with the carboplatin regimen because the percentage of nonhospitalization time was much greater (61.9% vs 46.4%). The carboplatin regimen also induced markedly less grade 4 neutropenia, grade 3-4 febrile neutropenia, creatinine elevation, and nausea/vomiting, but thrombocytopenia and reversible neuropathy tended to be more frequent with carboplatin than with cisplatin.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to support proposed recommendations for use of the recently licensed 9-valent human papillomavirus vaccine.

At a meeting on Feb. 26, members of ACIP voted 14-0 with one abstention, to support the draft wording for HPV vaccination, which has been modified to account for the availability of the 9-valent HPV vaccine (Gardasil-9), licensed by the Food and Drug Administration in December 2014. The five additional high-risk HPV types – 31, 33, 45, 52, and 58 – included in the 9-valent vaccine are associated with about 20% of cervical cancers, and are not included in the quadrivalent vaccine (Gardasil) that was approved in 2006.

©xrender/ Thinkstock.com

The age groups, as proposed by ACIP’s HPV work group, are the same as currently recommended for HPV vaccination: females and males aged 11 or 12 years (but the series can be started at age 9 years); and females aged 13-26 years and males aged 13-21 years, who have not been vaccinated or have not completed the three-dose series. The statement that males aged 22-26 years may be vaccinated, as currently recommended, also is included.

For males over 15 years, this would be off-label use since the 9-valent vaccine is licensed in males aged 9-15 years, but immunogenicity data in males aged 16-26 years has been presented to ACIP and has been submitted to the FDA, Dr. Lauri Markowitz of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), said at the meeting.

The draft also adds to the previous recommendation that females can be vaccinated with the bivalent vaccine, the quadrivalent vaccine (as long as it available), or the 9-valent vaccine; and males can be vaccinated with the quadrivalent vaccine (as long as it is available) or the 9-valent vaccine.

Other proposed modifications include wording regarding interchangeability of the vaccines, which no longer includes the statement that ACIP recommends that females complete the HPV vaccination series with the same vaccine product, whenever possible.

Instead, it states that when providers do not know which vaccine the female patient received previously, or does not have it available, “or are in settings transitioning” to the 9-valent vaccine, “for protection against HPV 16 and 18, any HPV vaccine product may be used to continue or complete the series for females.” For males, the statement now says that the quadrivalent or the 9-valent vaccine “may be used to continue or complete the series.” (Previously, it said that only the quadrivalent vaccine was licensed in males.)

Dr. Markowitz said that no change in HPV vaccination during pregnancy has been proposed and that a new pregnancy registry for the 9-valent vaccine has been created. (HPV vaccination is not recommended during pregnancy.)

The HPV work group also is considering use of the 9-valent vaccine in people who have completed the HPV vaccination series, which will be presented at the next ACIP meeting in June 2015.

Gardasil 9 was licensed in December 2014, for females aged 9-26 years, and males aged 9-15 years for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. When it was licensed, the FDA said that the 9-valent vaccine has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.

A representative of the manufacturer, Merck Sharpe & Dohme, said at the meeting that the 9-valent vaccine is commercially available and that the company is confident that there will be an adequate supply of both the 9-valent and the quadrivalent vaccine.

The bivalent HPV vaccine, Cervarix, was licensed in 2009 for females only and protects against HPV types 16 and 18. More than 98% of the HPV vaccine used in the United States has been with the quadrivalent vaccine, according to Dr. Markowitz.

emechcatie@frontlinemedcom.com

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to support proposed recommendations for use of the recently licensed 9-valent human papillomavirus vaccine.

At a meeting on Feb. 26, members of ACIP voted 14-0 with one abstention, to support the draft wording for HPV vaccination, which has been modified to account for the availability of the 9-valent HPV vaccine (Gardasil-9), licensed by the Food and Drug Administration in December 2014. The five additional high-risk HPV types – 31, 33, 45, 52, and 58 – included in the 9-valent vaccine are associated with about 20% of cervical cancers, and are not included in the quadrivalent vaccine (Gardasil) that was approved in 2006.

©xrender/ Thinkstock.com

The age groups, as proposed by ACIP’s HPV work group, are the same as currently recommended for HPV vaccination: females and males aged 11 or 12 years (but the series can be started at age 9 years); and females aged 13-26 years and males aged 13-21 years, who have not been vaccinated or have not completed the three-dose series. The statement that males aged 22-26 years may be vaccinated, as currently recommended, also is included.

For males over 15 years, this would be off-label use since the 9-valent vaccine is licensed in males aged 9-15 years, but immunogenicity data in males aged 16-26 years has been presented to ACIP and has been submitted to the FDA, Dr. Lauri Markowitz of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), said at the meeting.

The draft also adds to the previous recommendation that females can be vaccinated with the bivalent vaccine, the quadrivalent vaccine (as long as it available), or the 9-valent vaccine; and males can be vaccinated with the quadrivalent vaccine (as long as it is available) or the 9-valent vaccine.

Other proposed modifications include wording regarding interchangeability of the vaccines, which no longer includes the statement that ACIP recommends that females complete the HPV vaccination series with the same vaccine product, whenever possible.

Instead, it states that when providers do not know which vaccine the female patient received previously, or does not have it available, “or are in settings transitioning” to the 9-valent vaccine, “for protection against HPV 16 and 18, any HPV vaccine product may be used to continue or complete the series for females.” For males, the statement now says that the quadrivalent or the 9-valent vaccine “may be used to continue or complete the series.” (Previously, it said that only the quadrivalent vaccine was licensed in males.)

Dr. Markowitz said that no change in HPV vaccination during pregnancy has been proposed and that a new pregnancy registry for the 9-valent vaccine has been created. (HPV vaccination is not recommended during pregnancy.)

The HPV work group also is considering use of the 9-valent vaccine in people who have completed the HPV vaccination series, which will be presented at the next ACIP meeting in June 2015.

Gardasil 9 was licensed in December 2014, for females aged 9-26 years, and males aged 9-15 years for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. When it was licensed, the FDA said that the 9-valent vaccine has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.

A representative of the manufacturer, Merck Sharpe & Dohme, said at the meeting that the 9-valent vaccine is commercially available and that the company is confident that there will be an adequate supply of both the 9-valent and the quadrivalent vaccine.

The bivalent HPV vaccine, Cervarix, was licensed in 2009 for females only and protects against HPV types 16 and 18. More than 98% of the HPV vaccine used in the United States has been with the quadrivalent vaccine, according to Dr. Markowitz.

emechcatie@frontlinemedcom.com

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to support proposed recommendations for use of the recently licensed 9-valent human papillomavirus vaccine.

At a meeting on Feb. 26, members of ACIP voted 14-0 with one abstention, to support the draft wording for HPV vaccination, which has been modified to account for the availability of the 9-valent HPV vaccine (Gardasil-9), licensed by the Food and Drug Administration in December 2014. The five additional high-risk HPV types – 31, 33, 45, 52, and 58 – included in the 9-valent vaccine are associated with about 20% of cervical cancers, and are not included in the quadrivalent vaccine (Gardasil) that was approved in 2006.

©xrender/ Thinkstock.com

The age groups, as proposed by ACIP’s HPV work group, are the same as currently recommended for HPV vaccination: females and males aged 11 or 12 years (but the series can be started at age 9 years); and females aged 13-26 years and males aged 13-21 years, who have not been vaccinated or have not completed the three-dose series. The statement that males aged 22-26 years may be vaccinated, as currently recommended, also is included.

For males over 15 years, this would be off-label use since the 9-valent vaccine is licensed in males aged 9-15 years, but immunogenicity data in males aged 16-26 years has been presented to ACIP and has been submitted to the FDA, Dr. Lauri Markowitz of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), said at the meeting.

The draft also adds to the previous recommendation that females can be vaccinated with the bivalent vaccine, the quadrivalent vaccine (as long as it available), or the 9-valent vaccine; and males can be vaccinated with the quadrivalent vaccine (as long as it is available) or the 9-valent vaccine.

Other proposed modifications include wording regarding interchangeability of the vaccines, which no longer includes the statement that ACIP recommends that females complete the HPV vaccination series with the same vaccine product, whenever possible.

Instead, it states that when providers do not know which vaccine the female patient received previously, or does not have it available, “or are in settings transitioning” to the 9-valent vaccine, “for protection against HPV 16 and 18, any HPV vaccine product may be used to continue or complete the series for females.” For males, the statement now says that the quadrivalent or the 9-valent vaccine “may be used to continue or complete the series.” (Previously, it said that only the quadrivalent vaccine was licensed in males.)

Dr. Markowitz said that no change in HPV vaccination during pregnancy has been proposed and that a new pregnancy registry for the 9-valent vaccine has been created. (HPV vaccination is not recommended during pregnancy.)

The HPV work group also is considering use of the 9-valent vaccine in people who have completed the HPV vaccination series, which will be presented at the next ACIP meeting in June 2015.

Gardasil 9 was licensed in December 2014, for females aged 9-26 years, and males aged 9-15 years for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. When it was licensed, the FDA said that the 9-valent vaccine has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.

A representative of the manufacturer, Merck Sharpe & Dohme, said at the meeting that the 9-valent vaccine is commercially available and that the company is confident that there will be an adequate supply of both the 9-valent and the quadrivalent vaccine.

The bivalent HPV vaccine, Cervarix, was licensed in 2009 for females only and protects against HPV types 16 and 18. More than 98% of the HPV vaccine used in the United States has been with the quadrivalent vaccine, according to Dr. Markowitz.

emechcatie@frontlinemedcom.com

The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.

But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.

“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).

Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.

The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.

Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.

For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.

Age was the strongest risk factor for uterine cancer and other abnormalities.

Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.

The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.

The researchers reported having no financial disclosures.

The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.

But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.

“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).

Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.

The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.

Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.

For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.

Age was the strongest risk factor for uterine cancer and other abnormalities.

Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.

The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.

The researchers reported having no financial disclosures.

The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.

But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.

“Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).

Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.

The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.

Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.

For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.

Age was the strongest risk factor for uterine cancer and other abnormalities.

Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.

The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.

The researchers reported having no financial disclosures.

The immunogenicity and efficacy of the recently approved 9-valent human papillomavirus vaccine were similar to that of the currently approved and recommended quadrivalent HPV vaccine, in an international study of over 14,000 women.

The study, published in the New England Journal of Medicine on Feb. 19, was the basis of the approval of the 9-valent vaccine in December 2014. The quadrivalent HPV vaccine is marketed as Gardasil and the 9-valent vaccine will be marketed as Gardasil-9.

The 9-valent vaccine covers the four HPV types (6, 11, 16, and 18) included in the quadrivalent vaccine; HPV-16 and HPV-18 are associated with about 70% of cervical cancers. The 9-valent vaccine, which includes five other oncogenic HPV types (31, 33, 45, 52, and 58), “offers the potential to increase overall prevention of cervical cancer ... to approximately 90%,” Dr. E. A. Joura of the department of gynecology and obstetrics at the Medical University of Vienna and associates said (N. Engl. J. Med. 2015;372:711-23 [doi:10.1056/NEJMoa1405044]).

Steve Mann_ThinkStock

In the Broad Spectrum HPV Vaccine Study, 14,215 women were randomized to receive the three recommended doses of the quadrivalent HPV vaccine or the 9-valent HPV vaccine and were followed with tests that included Pap tests, and swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue at baseline and periodically up to 4.5 years. Antibody responses to HPV types 6, 11, 16, and 18 (the types included in both vaccines) were similar in the two groups.

In both groups, the rate of high-grade cervical, vulvar, or vaginal disease associated with HPV types in the vaccines and those not in the vaccines was 14 cases per 1,000 person-years. In a subgroup of patients not infected with HPV at baseline, rates were 2.4% among those who received the 9-valent vaccine vs. 4.2% of those who received the quadrivalent vaccine.

The rate of high-grade cervical, vulvar, or vaginal disease associated with the five additional HPV types included in the 9-valent disease was 0.1 cases per 1,000 person-years, compared with 1.6 cases per 1,000 person-years among those who received the quadrivalent vaccine, a 97% reduced risk associated with the new vaccine.

As anticipated, injection-site reactions were more common among those who received the 9-valent vaccine (91% vs. 85%); most cases were mild to moderate. Other adverse events included dizziness, reported in about 3% in both groups.

The authors concluded that the study results showed that the 9-valent vaccine “prevented cervical, vulvar, and vaginal disease and persistent infection associated with HPV-31, 33, 45, 52, and 58,” and that the incidence of disease associated with HPV-6, 11, 16, and 18 were similar in the two groups. “The effect of vaccination on the burden of cancer remains to be determined,” they added.

The study was funded by Merck, manufacturer of the Gardasil vaccines. Dr. Joura disclosed having received advisory board and lecture fees from Merck and Sanofi Pasteur MSD, and grant support from Merck and GlaxoSmithKline. Other author disclosures included ties to Merck, GlaxoSmithKline, Gen-Probe Hologic, Becton Dickinson, and others. Other authors are Merck employees.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to vote on proposed recommendations regarding the use of the 9-valent vaccine at a meeting on Feb. 26.

emechcatie@frontlinemedcom.com

The immunogenicity and efficacy of the recently approved 9-valent human papillomavirus vaccine were similar to that of the currently approved and recommended quadrivalent HPV vaccine, in an international study of over 14,000 women.

The study, published in the New England Journal of Medicine on Feb. 19, was the basis of the approval of the 9-valent vaccine in December 2014. The quadrivalent HPV vaccine is marketed as Gardasil and the 9-valent vaccine will be marketed as Gardasil-9.

The 9-valent vaccine covers the four HPV types (6, 11, 16, and 18) included in the quadrivalent vaccine; HPV-16 and HPV-18 are associated with about 70% of cervical cancers. The 9-valent vaccine, which includes five other oncogenic HPV types (31, 33, 45, 52, and 58), “offers the potential to increase overall prevention of cervical cancer ... to approximately 90%,” Dr. E. A. Joura of the department of gynecology and obstetrics at the Medical University of Vienna and associates said (N. Engl. J. Med. 2015;372:711-23 [doi:10.1056/NEJMoa1405044]).

Steve Mann_ThinkStock

In the Broad Spectrum HPV Vaccine Study, 14,215 women were randomized to receive the three recommended doses of the quadrivalent HPV vaccine or the 9-valent HPV vaccine and were followed with tests that included Pap tests, and swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue at baseline and periodically up to 4.5 years. Antibody responses to HPV types 6, 11, 16, and 18 (the types included in both vaccines) were similar in the two groups.

In both groups, the rate of high-grade cervical, vulvar, or vaginal disease associated with HPV types in the vaccines and those not in the vaccines was 14 cases per 1,000 person-years. In a subgroup of patients not infected with HPV at baseline, rates were 2.4% among those who received the 9-valent vaccine vs. 4.2% of those who received the quadrivalent vaccine.

The rate of high-grade cervical, vulvar, or vaginal disease associated with the five additional HPV types included in the 9-valent disease was 0.1 cases per 1,000 person-years, compared with 1.6 cases per 1,000 person-years among those who received the quadrivalent vaccine, a 97% reduced risk associated with the new vaccine.

As anticipated, injection-site reactions were more common among those who received the 9-valent vaccine (91% vs. 85%); most cases were mild to moderate. Other adverse events included dizziness, reported in about 3% in both groups.

The authors concluded that the study results showed that the 9-valent vaccine “prevented cervical, vulvar, and vaginal disease and persistent infection associated with HPV-31, 33, 45, 52, and 58,” and that the incidence of disease associated with HPV-6, 11, 16, and 18 were similar in the two groups. “The effect of vaccination on the burden of cancer remains to be determined,” they added.

The study was funded by Merck, manufacturer of the Gardasil vaccines. Dr. Joura disclosed having received advisory board and lecture fees from Merck and Sanofi Pasteur MSD, and grant support from Merck and GlaxoSmithKline. Other author disclosures included ties to Merck, GlaxoSmithKline, Gen-Probe Hologic, Becton Dickinson, and others. Other authors are Merck employees.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to vote on proposed recommendations regarding the use of the 9-valent vaccine at a meeting on Feb. 26.

emechcatie@frontlinemedcom.com

The immunogenicity and efficacy of the recently approved 9-valent human papillomavirus vaccine were similar to that of the currently approved and recommended quadrivalent HPV vaccine, in an international study of over 14,000 women.

The study, published in the New England Journal of Medicine on Feb. 19, was the basis of the approval of the 9-valent vaccine in December 2014. The quadrivalent HPV vaccine is marketed as Gardasil and the 9-valent vaccine will be marketed as Gardasil-9.

The 9-valent vaccine covers the four HPV types (6, 11, 16, and 18) included in the quadrivalent vaccine; HPV-16 and HPV-18 are associated with about 70% of cervical cancers. The 9-valent vaccine, which includes five other oncogenic HPV types (31, 33, 45, 52, and 58), “offers the potential to increase overall prevention of cervical cancer ... to approximately 90%,” Dr. E. A. Joura of the department of gynecology and obstetrics at the Medical University of Vienna and associates said (N. Engl. J. Med. 2015;372:711-23 [doi:10.1056/NEJMoa1405044]).

Steve Mann_ThinkStock

In the Broad Spectrum HPV Vaccine Study, 14,215 women were randomized to receive the three recommended doses of the quadrivalent HPV vaccine or the 9-valent HPV vaccine and were followed with tests that included Pap tests, and swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue at baseline and periodically up to 4.5 years. Antibody responses to HPV types 6, 11, 16, and 18 (the types included in both vaccines) were similar in the two groups.

In both groups, the rate of high-grade cervical, vulvar, or vaginal disease associated with HPV types in the vaccines and those not in the vaccines was 14 cases per 1,000 person-years. In a subgroup of patients not infected with HPV at baseline, rates were 2.4% among those who received the 9-valent vaccine vs. 4.2% of those who received the quadrivalent vaccine.

The rate of high-grade cervical, vulvar, or vaginal disease associated with the five additional HPV types included in the 9-valent disease was 0.1 cases per 1,000 person-years, compared with 1.6 cases per 1,000 person-years among those who received the quadrivalent vaccine, a 97% reduced risk associated with the new vaccine.

As anticipated, injection-site reactions were more common among those who received the 9-valent vaccine (91% vs. 85%); most cases were mild to moderate. Other adverse events included dizziness, reported in about 3% in both groups.

The authors concluded that the study results showed that the 9-valent vaccine “prevented cervical, vulvar, and vaginal disease and persistent infection associated with HPV-31, 33, 45, 52, and 58,” and that the incidence of disease associated with HPV-6, 11, 16, and 18 were similar in the two groups. “The effect of vaccination on the burden of cancer remains to be determined,” they added.

The study was funded by Merck, manufacturer of the Gardasil vaccines. Dr. Joura disclosed having received advisory board and lecture fees from Merck and Sanofi Pasteur MSD, and grant support from Merck and GlaxoSmithKline. Other author disclosures included ties to Merck, GlaxoSmithKline, Gen-Probe Hologic, Becton Dickinson, and others. Other authors are Merck employees.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to vote on proposed recommendations regarding the use of the 9-valent vaccine at a meeting on Feb. 26.

emechcatie@frontlinemedcom.com

PARIS – Although survival remains relatively poor, the options for the management of metastatic, recurrent, or persistent cervical cancer have increased in recent years, with bevacizumab-enhanced, platinum-based, combination chemotherapy becoming the “new standard” for many women according to medical oncologist Isabelle Ray-Coquard.

Speaking at a recent international conference on anticancer treatment, Dr. Ray-Coquard of Centre Léon Bérard in Lyon, France, noted that there are several questions that the medical oncologists must address before prescribing treatment. These are: Would the patient benefit from chemotherapy and if so, should a single-agent or a combination be used? Is the patient a candidate for a new or novel agent? Or would palliative care be the best option? How can patients best be selected for treatment?

“We have some strong data to support the use of cisplatin first line,” she observed. “Cisplatin is probably the first actor in the management of cervix cancer.” Response rates using single-agent cisplatin have ranged from 18% to 25% in women with recurrent and advanced carcinoma of the cervix.

“The question is what is the best partner for cisplatin?” Dr. Ray-Coquard asked. She highlighted several studies showing the activity of other cytotoxic chemotherapies as single agents, with the highest responses seen with paclitaxel (Taxol, at 19% of patients), followed by vinorelbine (Navelbine, 18%), irinotecan (Campto, 17%), topotecan (Hycamtin, 16%), docetaxel (Taxotere, 13%), and the lowest with gemcitabine (Gemzar, 8%).

Both paclitaxel and topotecan have been studied in combination with cisplatin vs. cisplatin alone and been shown to confer survival benefits. In the Gynecologic Oncology Group (GOG) 169 study (J. Clin. Oncol. 2004;22:3113-9), for example, paclitaxel plus cisplatin was associated with a significant (P < .001) increase in progression-free survival (PFS) of 4.8 vs. 2.8 months, although overall survival (OS) was not statistically different (9.7 vs. 8.8 months). Dr. Ray-Coquard noted, however, that paclitaxel had been given to women randomized to cisplatin at relapse, which might have clouded the OS benefit.

Similar benefits were seen when topotecan and cisplatin were combined and compared against single agent cisplatin in the GOG 179 study (J. Clin. Oncol. 2005;23:4626-33), with median PFS of 4.6 vs 2.9 months (P = .014) and median OS of 9.4 and 6.5 months (P = .017).

The toxicity of combining chemotherapies is important, and looking at the combination of topotecan and cisplatin vs. cisplatin alone in the GOG 179 study, Dr. Ray-Coquard noted that grade 3 & 4 side effects such as neutropenia, thrombocytopenia, nausea, and vomiting occurred much more frequently.

Data from the GOG 204 study (J. Clin. Oncol. 2009;27:4649-55) suggested that both paclitaxel and topotecan were good partners for cisplatin, with perhaps an advantage for paclitaxel. The latter combination can be inconvenient for patients, however, as it requires infusion of paclitaxel over 24 hours and hydration is required to prevent renal toxicity associated with the cisplatin. The combination is also quite toxic and hasn’t been shown to significantly relieve pain or to improve quality of life.

Phase II trial findings (Gynecol. Oncol. 2012;125:307-11) suggest that carboplatin might be an effective and less toxic alternative to cisplatin in combination with paclitaxel. There may also be a slight advantage of using carboplatin in patients who have already received prior platinum therapy but not in those who have not received cisplatin before.

“If we want to increase the overall survival, we need to also explore new compounds,” Dr. Ray-Coquard said. Drugs targeting the human epidermal growth factor receptor (HER) and angiogenesis have been tested, with lapatinib (Tykerb) and pazopanib (Votrient) found to be too toxic to use in combination but perhaps have an effect on survival when used alone. Cediranib (tentative trade name Recentin) in combination with paclitaxel and cisplatin also improved PFS in a phase II trial.

The best evidence in support of using targeted therapy to date is for bevacizumab. Using bevacizumab in combination with platinum-based combination chemotherapy is supported by the positive findings of the GOG 240 study (N. Engl. J. Med. 2014;370:734-43). This trial tested two hypotheses: first, if a nonplatinum chemotherapy doublet of paclitaxel and topotecan (Hycamtin) would be better than a platinum-based couplet (cisplatin plus paclitaxel); second if receiving additional antiangiogenic therapy with bevacizumab (Avastin) would confer any benefit over these combined chemotherapy regimens.

The results showed that combining topotecan with paclitaxel was not superior to cisplatin plus paclitaxel. When bevacizumab was combined with chemotherapy, however, there were PFS and OS benefits. Bevacizumab conferred an almost 4-month gain in OS, Dr. Ray-Coquard said.

Several factors including age, performance status, and previous treatment and toxicities need to be considered when selecting this or other treatment, she explained in an interview.

Women who have a very poor (≥ 2) performance status or who are symptomatic may not be suitable for the bevacizumab-enhanced therapy, as they may not be able to tolerate the toxicities associated with this regimen.

Notable toxicities reported with the regimen in the GOG 240 study included gastrointestinal fistula and perforation, neutropenia, including febrile neutropenia, hypertension, thrombosis and an increased risk for bleeding in the GI tract.

Understandably, care needs to be taken when considering this regimen for women who may have residual toxicity from other treatments, such as enteritis or cystitis caused by radiotherapy, and those with bowel, bladder, or vaginal involvement.

Women with vaginal bleeding or renal impairment may also not be able to tolerate combined antiangiogenic and chemotherapeutic treatment very well, and women with uncontrolled hypertension might not be good candidates.

Perhaps some of these women could still receive platinum-based chemotherapy without the bevacizumab, but, unfortunately, there will still be women for whom best supportive or palliative care may be the only option, Dr. Ray-Coquard said.

Dr. Ray-Coquard has served on advisory boards convened by Roche and AstraZeneca.

PARIS – Although survival remains relatively poor, the options for the management of metastatic, recurrent, or persistent cervical cancer have increased in recent years, with bevacizumab-enhanced, platinum-based, combination chemotherapy becoming the “new standard” for many women according to medical oncologist Isabelle Ray-Coquard.

Speaking at a recent international conference on anticancer treatment, Dr. Ray-Coquard of Centre Léon Bérard in Lyon, France, noted that there are several questions that the medical oncologists must address before prescribing treatment. These are: Would the patient benefit from chemotherapy and if so, should a single-agent or a combination be used? Is the patient a candidate for a new or novel agent? Or would palliative care be the best option? How can patients best be selected for treatment?

“We have some strong data to support the use of cisplatin first line,” she observed. “Cisplatin is probably the first actor in the management of cervix cancer.” Response rates using single-agent cisplatin have ranged from 18% to 25% in women with recurrent and advanced carcinoma of the cervix.

“The question is what is the best partner for cisplatin?” Dr. Ray-Coquard asked. She highlighted several studies showing the activity of other cytotoxic chemotherapies as single agents, with the highest responses seen with paclitaxel (Taxol, at 19% of patients), followed by vinorelbine (Navelbine, 18%), irinotecan (Campto, 17%), topotecan (Hycamtin, 16%), docetaxel (Taxotere, 13%), and the lowest with gemcitabine (Gemzar, 8%).

Both paclitaxel and topotecan have been studied in combination with cisplatin vs. cisplatin alone and been shown to confer survival benefits. In the Gynecologic Oncology Group (GOG) 169 study (J. Clin. Oncol. 2004;22:3113-9), for example, paclitaxel plus cisplatin was associated with a significant (P < .001) increase in progression-free survival (PFS) of 4.8 vs. 2.8 months, although overall survival (OS) was not statistically different (9.7 vs. 8.8 months). Dr. Ray-Coquard noted, however, that paclitaxel had been given to women randomized to cisplatin at relapse, which might have clouded the OS benefit.

Similar benefits were seen when topotecan and cisplatin were combined and compared against single agent cisplatin in the GOG 179 study (J. Clin. Oncol. 2005;23:4626-33), with median PFS of 4.6 vs 2.9 months (P = .014) and median OS of 9.4 and 6.5 months (P = .017).

The toxicity of combining chemotherapies is important, and looking at the combination of topotecan and cisplatin vs. cisplatin alone in the GOG 179 study, Dr. Ray-Coquard noted that grade 3 & 4 side effects such as neutropenia, thrombocytopenia, nausea, and vomiting occurred much more frequently.

Data from the GOG 204 study (J. Clin. Oncol. 2009;27:4649-55) suggested that both paclitaxel and topotecan were good partners for cisplatin, with perhaps an advantage for paclitaxel. The latter combination can be inconvenient for patients, however, as it requires infusion of paclitaxel over 24 hours and hydration is required to prevent renal toxicity associated with the cisplatin. The combination is also quite toxic and hasn’t been shown to significantly relieve pain or to improve quality of life.

Phase II trial findings (Gynecol. Oncol. 2012;125:307-11) suggest that carboplatin might be an effective and less toxic alternative to cisplatin in combination with paclitaxel. There may also be a slight advantage of using carboplatin in patients who have already received prior platinum therapy but not in those who have not received cisplatin before.

“If we want to increase the overall survival, we need to also explore new compounds,” Dr. Ray-Coquard said. Drugs targeting the human epidermal growth factor receptor (HER) and angiogenesis have been tested, with lapatinib (Tykerb) and pazopanib (Votrient) found to be too toxic to use in combination but perhaps have an effect on survival when used alone. Cediranib (tentative trade name Recentin) in combination with paclitaxel and cisplatin also improved PFS in a phase II trial.

The best evidence in support of using targeted therapy to date is for bevacizumab. Using bevacizumab in combination with platinum-based combination chemotherapy is supported by the positive findings of the GOG 240 study (N. Engl. J. Med. 2014;370:734-43). This trial tested two hypotheses: first, if a nonplatinum chemotherapy doublet of paclitaxel and topotecan (Hycamtin) would be better than a platinum-based couplet (cisplatin plus paclitaxel); second if receiving additional antiangiogenic therapy with bevacizumab (Avastin) would confer any benefit over these combined chemotherapy regimens.

The results showed that combining topotecan with paclitaxel was not superior to cisplatin plus paclitaxel. When bevacizumab was combined with chemotherapy, however, there were PFS and OS benefits. Bevacizumab conferred an almost 4-month gain in OS, Dr. Ray-Coquard said.

Several factors including age, performance status, and previous treatment and toxicities need to be considered when selecting this or other treatment, she explained in an interview.

Women who have a very poor (≥ 2) performance status or who are symptomatic may not be suitable for the bevacizumab-enhanced therapy, as they may not be able to tolerate the toxicities associated with this regimen.

Notable toxicities reported with the regimen in the GOG 240 study included gastrointestinal fistula and perforation, neutropenia, including febrile neutropenia, hypertension, thrombosis and an increased risk for bleeding in the GI tract.

Understandably, care needs to be taken when considering this regimen for women who may have residual toxicity from other treatments, such as enteritis or cystitis caused by radiotherapy, and those with bowel, bladder, or vaginal involvement.

Women with vaginal bleeding or renal impairment may also not be able to tolerate combined antiangiogenic and chemotherapeutic treatment very well, and women with uncontrolled hypertension might not be good candidates.

Perhaps some of these women could still receive platinum-based chemotherapy without the bevacizumab, but, unfortunately, there will still be women for whom best supportive or palliative care may be the only option, Dr. Ray-Coquard said.

Dr. Ray-Coquard has served on advisory boards convened by Roche and AstraZeneca.

PARIS – Although survival remains relatively poor, the options for the management of metastatic, recurrent, or persistent cervical cancer have increased in recent years, with bevacizumab-enhanced, platinum-based, combination chemotherapy becoming the “new standard” for many women according to medical oncologist Isabelle Ray-Coquard.

Speaking at a recent international conference on anticancer treatment, Dr. Ray-Coquard of Centre Léon Bérard in Lyon, France, noted that there are several questions that the medical oncologists must address before prescribing treatment. These are: Would the patient benefit from chemotherapy and if so, should a single-agent or a combination be used? Is the patient a candidate for a new or novel agent? Or would palliative care be the best option? How can patients best be selected for treatment?

“We have some strong data to support the use of cisplatin first line,” she observed. “Cisplatin is probably the first actor in the management of cervix cancer.” Response rates using single-agent cisplatin have ranged from 18% to 25% in women with recurrent and advanced carcinoma of the cervix.

“The question is what is the best partner for cisplatin?” Dr. Ray-Coquard asked. She highlighted several studies showing the activity of other cytotoxic chemotherapies as single agents, with the highest responses seen with paclitaxel (Taxol, at 19% of patients), followed by vinorelbine (Navelbine, 18%), irinotecan (Campto, 17%), topotecan (Hycamtin, 16%), docetaxel (Taxotere, 13%), and the lowest with gemcitabine (Gemzar, 8%).

Both paclitaxel and topotecan have been studied in combination with cisplatin vs. cisplatin alone and been shown to confer survival benefits. In the Gynecologic Oncology Group (GOG) 169 study (J. Clin. Oncol. 2004;22:3113-9), for example, paclitaxel plus cisplatin was associated with a significant (P < .001) increase in progression-free survival (PFS) of 4.8 vs. 2.8 months, although overall survival (OS) was not statistically different (9.7 vs. 8.8 months). Dr. Ray-Coquard noted, however, that paclitaxel had been given to women randomized to cisplatin at relapse, which might have clouded the OS benefit.

Similar benefits were seen when topotecan and cisplatin were combined and compared against single agent cisplatin in the GOG 179 study (J. Clin. Oncol. 2005;23:4626-33), with median PFS of 4.6 vs 2.9 months (P = .014) and median OS of 9.4 and 6.5 months (P = .017).

The toxicity of combining chemotherapies is important, and looking at the combination of topotecan and cisplatin vs. cisplatin alone in the GOG 179 study, Dr. Ray-Coquard noted that grade 3 & 4 side effects such as neutropenia, thrombocytopenia, nausea, and vomiting occurred much more frequently.

Data from the GOG 204 study (J. Clin. Oncol. 2009;27:4649-55) suggested that both paclitaxel and topotecan were good partners for cisplatin, with perhaps an advantage for paclitaxel. The latter combination can be inconvenient for patients, however, as it requires infusion of paclitaxel over 24 hours and hydration is required to prevent renal toxicity associated with the cisplatin. The combination is also quite toxic and hasn’t been shown to significantly relieve pain or to improve quality of life.

Phase II trial findings (Gynecol. Oncol. 2012;125:307-11) suggest that carboplatin might be an effective and less toxic alternative to cisplatin in combination with paclitaxel. There may also be a slight advantage of using carboplatin in patients who have already received prior platinum therapy but not in those who have not received cisplatin before.

“If we want to increase the overall survival, we need to also explore new compounds,” Dr. Ray-Coquard said. Drugs targeting the human epidermal growth factor receptor (HER) and angiogenesis have been tested, with lapatinib (Tykerb) and pazopanib (Votrient) found to be too toxic to use in combination but perhaps have an effect on survival when used alone. Cediranib (tentative trade name Recentin) in combination with paclitaxel and cisplatin also improved PFS in a phase II trial.

The best evidence in support of using targeted therapy to date is for bevacizumab. Using bevacizumab in combination with platinum-based combination chemotherapy is supported by the positive findings of the GOG 240 study (N. Engl. J. Med. 2014;370:734-43). This trial tested two hypotheses: first, if a nonplatinum chemotherapy doublet of paclitaxel and topotecan (Hycamtin) would be better than a platinum-based couplet (cisplatin plus paclitaxel); second if receiving additional antiangiogenic therapy with bevacizumab (Avastin) would confer any benefit over these combined chemotherapy regimens.

The results showed that combining topotecan with paclitaxel was not superior to cisplatin plus paclitaxel. When bevacizumab was combined with chemotherapy, however, there were PFS and OS benefits. Bevacizumab conferred an almost 4-month gain in OS, Dr. Ray-Coquard said.

Several factors including age, performance status, and previous treatment and toxicities need to be considered when selecting this or other treatment, she explained in an interview.

Women who have a very poor (≥ 2) performance status or who are symptomatic may not be suitable for the bevacizumab-enhanced therapy, as they may not be able to tolerate the toxicities associated with this regimen.

Notable toxicities reported with the regimen in the GOG 240 study included gastrointestinal fistula and perforation, neutropenia, including febrile neutropenia, hypertension, thrombosis and an increased risk for bleeding in the GI tract.

Understandably, care needs to be taken when considering this regimen for women who may have residual toxicity from other treatments, such as enteritis or cystitis caused by radiotherapy, and those with bowel, bladder, or vaginal involvement.

Women with vaginal bleeding or renal impairment may also not be able to tolerate combined antiangiogenic and chemotherapeutic treatment very well, and women with uncontrolled hypertension might not be good candidates.

Perhaps some of these women could still receive platinum-based chemotherapy without the bevacizumab, but, unfortunately, there will still be women for whom best supportive or palliative care may be the only option, Dr. Ray-Coquard said.

Dr. Ray-Coquard has served on advisory boards convened by Roche and AstraZeneca.

Results of a recent survey of provider and patient attitudes toward and behaviors surrounding cervical cancer screening indicate there is much confusion, among both practitioners and patients, about the optimal screening interval for cervical cancer. Only 48% of women understood that HPV can cause cervical cancer.

The survey, of 2000 women and 750 providers, was conducted by the National Association of Nurse Practitioners in Women’s Health and Healthy Women.

This special audiocast is an interview with James S. Simon, MD, panel member for the survey release event in Washington, DC.

Listen to hear the survey results and Dr. Simon discuss:
• The roots of the highlighted confusion around cervical cancer screening among women and practitioners
• How often he screens patients for cervical cancer and what tests he employs
• His patient counseling strategy regarding HPV and other sexually transmitted infections

Dr. James A. Simon reports having served (within the last year) or currently serving as a consultant to or on the advisory boards of: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Amgen Inc. (Thousand Oaks, CA), Amneal Pharmaceuticals (Bridgewater, NJ), Apotex, Inc. (Toronto, Canada), Ascend Therapeutics (Herndon, VA), Dr. Reddy Laboratories, Ltd. (Hyderabad, India), Everett Laboratories, Inc. (West Orange, NJ), Lupin Pharmaceuticals, (Baltimore, MD), Merck & Co., Inc. (Whitehouse Station, NJ), Novartis Pharmaceuticals Corporation (East Hanover, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), Pfizer Inc. (New York, NY), Shionogi Inc. (Florham Park, NJ), Shippan Point Advisors LLC (Upper Saddle River, NJ), Sprout Pharmaceuticals (Raleigh, NC), and TherapeuticsMD (Boca Raton, FL).

He reports having received grant/research support in the last year or currently from: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Agile Therapeutics (Princeton, NJ), Bayer Healthcare LLC., (Tarrytown, NY), New England Research Institute, Inc. (Watertown, MA), Novo Nordisk (Bagsvrerd, Denmark), Palatin Technologies (Cranbury, NJ), and Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and TherapeuticsMD (Boca Raton, FL).

He also reports having served or currently serving on the speakers' bureaus of: Amgen Inc. (Thousand Oaks, CA), Eisai, Inc. (Woodcliff Lake, NJ), Merck (Whitehouse Station, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), and Shionogi Inc. (Florham Park, NJ).

Results of a recent survey of provider and patient attitudes toward and behaviors surrounding cervical cancer screening indicate there is much confusion, among both practitioners and patients, about the optimal screening interval for cervical cancer. Only 48% of women understood that HPV can cause cervical cancer.

The survey, of 2000 women and 750 providers, was conducted by the National Association of Nurse Practitioners in Women’s Health and Healthy Women.

This special audiocast is an interview with James S. Simon, MD, panel member for the survey release event in Washington, DC.

Listen to hear the survey results and Dr. Simon discuss:
• The roots of the highlighted confusion around cervical cancer screening among women and practitioners
• How often he screens patients for cervical cancer and what tests he employs
• His patient counseling strategy regarding HPV and other sexually transmitted infections

Dr. James A. Simon reports having served (within the last year) or currently serving as a consultant to or on the advisory boards of: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Amgen Inc. (Thousand Oaks, CA), Amneal Pharmaceuticals (Bridgewater, NJ), Apotex, Inc. (Toronto, Canada), Ascend Therapeutics (Herndon, VA), Dr. Reddy Laboratories, Ltd. (Hyderabad, India), Everett Laboratories, Inc. (West Orange, NJ), Lupin Pharmaceuticals, (Baltimore, MD), Merck & Co., Inc. (Whitehouse Station, NJ), Novartis Pharmaceuticals Corporation (East Hanover, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), Pfizer Inc. (New York, NY), Shionogi Inc. (Florham Park, NJ), Shippan Point Advisors LLC (Upper Saddle River, NJ), Sprout Pharmaceuticals (Raleigh, NC), and TherapeuticsMD (Boca Raton, FL).

He reports having received grant/research support in the last year or currently from: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Agile Therapeutics (Princeton, NJ), Bayer Healthcare LLC., (Tarrytown, NY), New England Research Institute, Inc. (Watertown, MA), Novo Nordisk (Bagsvrerd, Denmark), Palatin Technologies (Cranbury, NJ), and Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and TherapeuticsMD (Boca Raton, FL).

He also reports having served or currently serving on the speakers' bureaus of: Amgen Inc. (Thousand Oaks, CA), Eisai, Inc. (Woodcliff Lake, NJ), Merck (Whitehouse Station, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), and Shionogi Inc. (Florham Park, NJ).

Results of a recent survey of provider and patient attitudes toward and behaviors surrounding cervical cancer screening indicate there is much confusion, among both practitioners and patients, about the optimal screening interval for cervical cancer. Only 48% of women understood that HPV can cause cervical cancer.

The survey, of 2000 women and 750 providers, was conducted by the National Association of Nurse Practitioners in Women’s Health and Healthy Women.

This special audiocast is an interview with James S. Simon, MD, panel member for the survey release event in Washington, DC.

Listen to hear the survey results and Dr. Simon discuss:
• The roots of the highlighted confusion around cervical cancer screening among women and practitioners
• How often he screens patients for cervical cancer and what tests he employs
• His patient counseling strategy regarding HPV and other sexually transmitted infections

Dr. James A. Simon reports having served (within the last year) or currently serving as a consultant to or on the advisory boards of: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Amgen Inc. (Thousand Oaks, CA), Amneal Pharmaceuticals (Bridgewater, NJ), Apotex, Inc. (Toronto, Canada), Ascend Therapeutics (Herndon, VA), Dr. Reddy Laboratories, Ltd. (Hyderabad, India), Everett Laboratories, Inc. (West Orange, NJ), Lupin Pharmaceuticals, (Baltimore, MD), Merck & Co., Inc. (Whitehouse Station, NJ), Novartis Pharmaceuticals Corporation (East Hanover, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), Pfizer Inc. (New York, NY), Shionogi Inc. (Florham Park, NJ), Shippan Point Advisors LLC (Upper Saddle River, NJ), Sprout Pharmaceuticals (Raleigh, NC), and TherapeuticsMD (Boca Raton, FL).

He reports having received grant/research support in the last year or currently from: AbbVie, Inc. (North Chicago, IL), Actavis, PLC. (Dublin, Ireland), Agile Therapeutics (Princeton, NJ), Bayer Healthcare LLC., (Tarrytown, NY), New England Research Institute, Inc. (Watertown, MA), Novo Nordisk (Bagsvrerd, Denmark), Palatin Technologies (Cranbury, NJ), and Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), and TherapeuticsMD (Boca Raton, FL).

He also reports having served or currently serving on the speakers' bureaus of: Amgen Inc. (Thousand Oaks, CA), Eisai, Inc. (Woodcliff Lake, NJ), Merck (Whitehouse Station, NJ), Noven Pharmaceuticals, Inc. (New York, NY), Novo Nordisk (Bagsvrerd, Denmark), and Shionogi Inc. (Florham Park, NJ).

An estimated 14.1 million new cancer cases and 8.2 million cancer deaths occurred in 2012, although incidences of certain cancers, such as lung cancer, are increasing rapidly in less developed countries, according to GLOBOCAN 2012, a research project produced by the International Agency for Research on Cancer (IARC) to determine worldwide estimates of cancer incidence and mortality.

Interestingly, less developed countries account for only 57% of cases and 65% of cancer deaths worldwide, despite their share of the population surveyed being significantly larger than that of more developed countries.

Lung cancer is the leading cause of cancer death among males in both more and less developed countries, and among females in more developed countries. Breast cancer remains the leading cause of cancer death among females in less developed countries, although this may change as breast cancer testing becomes more commonplace and more countries adapt Western lifestyle habits, the researchers noted.

Read the full article here: CA Cancer J. Clin. 2015;000:000-000 (doi:10.3322/caac.21262).

An estimated 14.1 million new cancer cases and 8.2 million cancer deaths occurred in 2012, although incidences of certain cancers, such as lung cancer, are increasing rapidly in less developed countries, according to GLOBOCAN 2012, a research project produced by the International Agency for Research on Cancer (IARC) to determine worldwide estimates of cancer incidence and mortality.

Interestingly, less developed countries account for only 57% of cases and 65% of cancer deaths worldwide, despite their share of the population surveyed being significantly larger than that of more developed countries.

Lung cancer is the leading cause of cancer death among males in both more and less developed countries, and among females in more developed countries. Breast cancer remains the leading cause of cancer death among females in less developed countries, although this may change as breast cancer testing becomes more commonplace and more countries adapt Western lifestyle habits, the researchers noted.

Read the full article here: CA Cancer J. Clin. 2015;000:000-000 (doi:10.3322/caac.21262).

An estimated 14.1 million new cancer cases and 8.2 million cancer deaths occurred in 2012, although incidences of certain cancers, such as lung cancer, are increasing rapidly in less developed countries, according to GLOBOCAN 2012, a research project produced by the International Agency for Research on Cancer (IARC) to determine worldwide estimates of cancer incidence and mortality.

Interestingly, less developed countries account for only 57% of cases and 65% of cancer deaths worldwide, despite their share of the population surveyed being significantly larger than that of more developed countries.

Lung cancer is the leading cause of cancer death among males in both more and less developed countries, and among females in more developed countries. Breast cancer remains the leading cause of cancer death among females in less developed countries, although this may change as breast cancer testing becomes more commonplace and more countries adapt Western lifestyle habits, the researchers noted.

Read the full article here: CA Cancer J. Clin. 2015;000:000-000 (doi:10.3322/caac.21262).

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.

High-risk human papillomavirus testing is acceptable as a primary approach to cervical cancer screening in women aged 25 years and older, according to interim clinical guidance from an expert panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology.

Based on several large studies published since 2011 when screening guidelines were last updated, the panel concluded that a negative high-risk HPV (hrHPV) test provides greater reassurance of low cervical intraepithelial neoplasia grade 3–positive (CIN3+) risk than does a negative cytology result, and that “because of equivalent or superior effectiveness, primary hrHPV screening can be considered as an alternative to current U.S. cytology-based cervical cancer screening methods.”

The guidance was simultaneously published on Jan. 8 in Gynecologic Oncology (2015 [doi:10.1016/j.ygyno.2014.12.022]), the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology (2015;125:330-7 [doi:10.1097/AOG.0000000000000669]).

xrender/ Thinkstock.com

The 13-member panel was convened when an application was submitted to the U.S. Food and Drug Administration for a currently marketed HPV test to be labeled for the indication of primary cervical cancer screening; that application was approved in April 2013.

The panel included representatives from the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology.

Cytology alone and cotesting remain the screening options specifically recommended in existing major guidelines. The interim guidance does not supplant those guidelines, but provides clinicians with an additional screening tool, Dr. Warner K. Huh of the University of Alabama at Birmingham, and his colleagues reported.

“The scientific evidence clearly demonstrates that primary HPV testing outperforms cytology or Pap as a screening test. This has been confirmed from numerous European and Canadian studies as well as the ATHENA trial. There are going to be fewer false negatives with HPV, and arguably, we have been using a less sensitive test for screening for a while now,” Dr. Huh said in a statement, adding that “pap smears miss a fair number of adenocarcinomas.”

The ATHENA HPV trial is a longitudinal study of the HPV test sponsored by Roche Diagnostics, and the end-of-study results, which were used along with other study data and expert opinion in the guidance panel’s deliberations, were published in Gynecologic Oncology 2014 [doi:10.1016/j.ygyno.2014.11.076].

Previously approved labeling for HPV tests included triage of equivocal cytology and as an adjunct to cytology in women aged 30 years and older – two uses that are “widely recommended by numerous stakeholder societies and organizations, as well as the U.S. Preventive Services Task Force,” the authors noted, adding that hrHPV testing was also approved for identifying specific high-risk types of HPV for triage in select settings.

Primary hrHPV testing was not indicated “in most clinical settings,” mainly due to substantial concerns about the specificity of primary hrHPV screening and the potential harms, the lack of a well-defined and evaluated strategy to manage hrHPV-positive women, and inadequate information to define appropriate screening intervals for those who test negative, the panel wrote.

But since that time, several large studies have been published strengthening the evidence in support of primary hrHPV screening. The new studies “consistently demonstrate an improved sensitivity of primary hrHPV screening for detecting cervical cancer precursor lesions, compared with cytology alone,” the panel wrote.

Based on this evidence, the expert panel also concluded that:

• Triage of hrHPV-positive women using a combination of genotyping for HPV-16 and -18, and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.

• Rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.

• Primary hrHPV screening should not be initiated before age 25.

The panel called primary hrHPV screening “an important scientific and clinical advance in cervical cancer screening because it offers better reassurance of low cancer risk, compared with cytology-only screening conducted at the same interval.”

More data on triage options should be available soon and could lead to updated triage recommendations, the panel noted.

“Primary hrHPV screening at 25-29 years of age may lead to increased CIN 3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation,” the panel wrote. “While there continue to be numerous practical and research questions, primary hrHPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the United States. However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened.”

In fact, most women who have cervical cancer have not been screened or have not been adequately screened, according to Dr. Andrew Menzin, associate chief of gynecologic oncology at North Shore LIJ Health System, and professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y.

“That’s still the challenge, and I expect that having the opportunity to use a primary HPV test will facilitate enhanced screening,” he said in an interview.

Dr. Menzin said that use and acceptance of cotesting has been widespread, and predicts that the 3-year minimum testing interval for primary hrHPV testing recommended by the guidance panel could serve to ease some of the discomfort that many clinicians felt as guidelines expanded screening intervals from 1 year to 3 years, and then to 5 years with cotesting, thereby promoting acceptance of primary hrHPV testing.

“The information provided in the interim guidance speaks to a trend in the advancement of cervical cancer screening of allowing technological advances to be coupled with ongoing evolution in our knowledge of the natural history of disease and to focus on tests that have high accuracy and important predictive value,” he said. “The inclusion of the hrHPV test as an additional primary screening tool in the cervical cancer screening armamentarium will also help to evolve the triage of testing to focus on patients at greatest risk while minimizing the burden of testing and evaluation on those who are low risk, thereby optimizing care delivery.”

The panel’s work was funded by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Dr. Huh is on the scientific advisory board of Merck. Dr. Menzin said he had no financial disclosures.