OBG Management

“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”

ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)

Adenomyosis increasingly is a concern

Dr. Barbieri’s article on delay in diagnosis of endometriosis is timely and important. I agree that family history is very important, but often the mother had a hysterectomy at a relatively young age for heavy bleeding that was blamed on fibroids.

Adenomyosis seems to be increasing in prevalence and may be suggested by cystic changes in the endometrium on 3D ultrasonography. The patient often reports dark brown spotting before or after periods. The second day of the period is very heavy, and cramping may precede the period. Sometimes you can note punctate lesions on the cervix that cause a very friable cervix that is likely to bleed after the patient has coitus or a Pap smear. Adenomyosis may cause much of the troublesome bleeding seen after medroxyprogesterone acetate injection, insertion of a levonorgestrel-containing intrauterine device, etonogestrel implant placement, and even birth control pills, and it is often dismissed as dysfunctional uterine bleeding. The dark brown blood may represent blood exiting the crypts of the endometrium.

It is concerning that patients who are treated aggressively for adenomyosis in order to get pregnant seem to be at increased risk for retained placenta and decreased uterine tone in the third stage of labor. Certainly this makes intuitive sense if one surmises that the endometrium is abnormally deep into the myometrium, allowing for microscopic placental invasion and myometrial dysfunction.

Most troubling is the warning from the public health community regarding endocrine disruptors. Could BPA (bisphenol A) be contaminating our plastic water bottles and be causing an epidemic of younger-onset adenomyosis? It is certainly something worth studying.

John Lewis, MD
Waterbury, Connecticut

Endometriosis patients receive delayed diagnosis, ineffective treatments

Several points came to mind reading Dr. Barbieri’s article. First, with the surge in deep infiltrating endometriosis as reported in the literature, one has to ask about treating mild disease with hormones initially. Disease can and does progress with hormonal suppression, I assume because endometriosis makes its own estrogen. Yet when the surge is noticed, the recommendation, at least in Europe, is that we should look at pollution.

Second, I have to wonder why it is not reported that older women have endometriosis. I manage a 20,000-member education board for endometriosis patients and many of those seeking help are older and often already castrated. When I can find them access to advanced surgical skill, they are found to have active endometriosis.

The patients seeking more information (gaining 300 a week) have failed all that gynecology has to offer except expert surgical excision of their disease. In my view, gynecology in general has failed this patient population. I have worked with endometriosis patients for 32 years, and 75% of them have been dismissed as neurotic, with average time to diagnosis 9 years after symptoms appear.

It seems that the symptom profile found in endometriosis patients is not well known, and once the disease is diagnosed, the treatment options are ineffective.

Nancy Petersen, RN
Portland, Oregon

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”

ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)

Adenomyosis increasingly is a concern

Dr. Barbieri’s article on delay in diagnosis of endometriosis is timely and important. I agree that family history is very important, but often the mother had a hysterectomy at a relatively young age for heavy bleeding that was blamed on fibroids.

Adenomyosis seems to be increasing in prevalence and may be suggested by cystic changes in the endometrium on 3D ultrasonography. The patient often reports dark brown spotting before or after periods. The second day of the period is very heavy, and cramping may precede the period. Sometimes you can note punctate lesions on the cervix that cause a very friable cervix that is likely to bleed after the patient has coitus or a Pap smear. Adenomyosis may cause much of the troublesome bleeding seen after medroxyprogesterone acetate injection, insertion of a levonorgestrel-containing intrauterine device, etonogestrel implant placement, and even birth control pills, and it is often dismissed as dysfunctional uterine bleeding. The dark brown blood may represent blood exiting the crypts of the endometrium.

It is concerning that patients who are treated aggressively for adenomyosis in order to get pregnant seem to be at increased risk for retained placenta and decreased uterine tone in the third stage of labor. Certainly this makes intuitive sense if one surmises that the endometrium is abnormally deep into the myometrium, allowing for microscopic placental invasion and myometrial dysfunction.

Most troubling is the warning from the public health community regarding endocrine disruptors. Could BPA (bisphenol A) be contaminating our plastic water bottles and be causing an epidemic of younger-onset adenomyosis? It is certainly something worth studying.

John Lewis, MD
Waterbury, Connecticut

Endometriosis patients receive delayed diagnosis, ineffective treatments

Several points came to mind reading Dr. Barbieri’s article. First, with the surge in deep infiltrating endometriosis as reported in the literature, one has to ask about treating mild disease with hormones initially. Disease can and does progress with hormonal suppression, I assume because endometriosis makes its own estrogen. Yet when the surge is noticed, the recommendation, at least in Europe, is that we should look at pollution.

Second, I have to wonder why it is not reported that older women have endometriosis. I manage a 20,000-member education board for endometriosis patients and many of those seeking help are older and often already castrated. When I can find them access to advanced surgical skill, they are found to have active endometriosis.

The patients seeking more information (gaining 300 a week) have failed all that gynecology has to offer except expert surgical excision of their disease. In my view, gynecology in general has failed this patient population. I have worked with endometriosis patients for 32 years, and 75% of them have been dismissed as neurotic, with average time to diagnosis 9 years after symptoms appear.

It seems that the symptom profile found in endometriosis patients is not well known, and once the disease is diagnosed, the treatment options are ineffective.

Nancy Petersen, RN
Portland, Oregon

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“WHY ARE THERE DELAYS IN THE DIAGNOSIS OF ENDOMETRIOSIS?”

ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2017)

Adenomyosis increasingly is a concern

Dr. Barbieri’s article on delay in diagnosis of endometriosis is timely and important. I agree that family history is very important, but often the mother had a hysterectomy at a relatively young age for heavy bleeding that was blamed on fibroids.

Adenomyosis seems to be increasing in prevalence and may be suggested by cystic changes in the endometrium on 3D ultrasonography. The patient often reports dark brown spotting before or after periods. The second day of the period is very heavy, and cramping may precede the period. Sometimes you can note punctate lesions on the cervix that cause a very friable cervix that is likely to bleed after the patient has coitus or a Pap smear. Adenomyosis may cause much of the troublesome bleeding seen after medroxyprogesterone acetate injection, insertion of a levonorgestrel-containing intrauterine device, etonogestrel implant placement, and even birth control pills, and it is often dismissed as dysfunctional uterine bleeding. The dark brown blood may represent blood exiting the crypts of the endometrium.

It is concerning that patients who are treated aggressively for adenomyosis in order to get pregnant seem to be at increased risk for retained placenta and decreased uterine tone in the third stage of labor. Certainly this makes intuitive sense if one surmises that the endometrium is abnormally deep into the myometrium, allowing for microscopic placental invasion and myometrial dysfunction.

Most troubling is the warning from the public health community regarding endocrine disruptors. Could BPA (bisphenol A) be contaminating our plastic water bottles and be causing an epidemic of younger-onset adenomyosis? It is certainly something worth studying.

John Lewis, MD
Waterbury, Connecticut

Endometriosis patients receive delayed diagnosis, ineffective treatments

Several points came to mind reading Dr. Barbieri’s article. First, with the surge in deep infiltrating endometriosis as reported in the literature, one has to ask about treating mild disease with hormones initially. Disease can and does progress with hormonal suppression, I assume because endometriosis makes its own estrogen. Yet when the surge is noticed, the recommendation, at least in Europe, is that we should look at pollution.

Second, I have to wonder why it is not reported that older women have endometriosis. I manage a 20,000-member education board for endometriosis patients and many of those seeking help are older and often already castrated. When I can find them access to advanced surgical skill, they are found to have active endometriosis.

The patients seeking more information (gaining 300 a week) have failed all that gynecology has to offer except expert surgical excision of their disease. In my view, gynecology in general has failed this patient population. I have worked with endometriosis patients for 32 years, and 75% of them have been dismissed as neurotic, with average time to diagnosis 9 years after symptoms appear.

It seems that the symptom profile found in endometriosis patients is not well known, and once the disease is diagnosed, the treatment options are ineffective.

Nancy Petersen, RN
Portland, Oregon

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Up to 80% of women who are of reproductive age have uterine fibroids that cause heavy and prolonged bleeding.¹ Additional concerns include infertility and pain, says James Simon, MD, Clinical Professor at George Washington University in Washington, DC. Black women are more likely than white women to undergo hysterectomy for uterine fibroids. They also are more likely to experience severe or very severe symptoms from fibroids and report that these symptoms interfere with physical activities, relationships, and work.²

Current medical treatments include on- and off-label use of oral contraceptives, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on investigational oral GnRH antagonists and oral selective progesterone-receptor modulators (SPRMs) were presented at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.

Details of VENUS I

In the phase 3, randomized, controlled VENUS I trial, investigators assessed the efficacy and safety of ulipristal acetate (UPA), an SPRM, by race and body mass index (BMI) in premenopausal women (aged 18 to 50) with symptomatic uterine fibroids.¹

Simon and colleagues randomly assigned participants to UPA 5 mg, UPA 10 mg, or placebo once daily for 12 weeks, followed by a 12-week treatment-free follow-up period. UPA, at 5 and 10 mg, was significantly more efficacious than placebo in rate of and time to amenorrhea (P<.0001). The superiority was observed regardless of race and BMI. In addition, women taking UPA versus placebo reported significantly less impact on activities due to uterine fibroids. The study authors concluded that “UPA treatment provides effective control of bleeding and improvement in physical and social activities for women with symptomatic uterine fibroids, regardless of race and BMI.”¹

Establishing the ideal treatment period for UPA to avoid progesterone-associated endometrial changes (in this study it was 12 weeks of once-daily therapy) is a current goal, said Simon.

Details of elagolix phase 2b study

Simon also presented data on another investigational drug, elagolix, an orally administered GnRH antagonist, which has an inhibiting effect on luteinizing hormone and follicle-stimulating hormone secretion. This in turn reduces production of estradiol and progesterone. Elagolix also is being studied for the treatment of endometriosis.³

In the uterine fibroids study, a 24-week, multicenter, double-blind, randomized controlled, parallel group trial, 567 premenopausal women aged 18 to 51 with heavy menstrual bleeding of >80 mL of blood loss were assigned to placebo or elagolix 300 mg twice per day or 600 mg once per day alone or in combination with add-back therapy (with estradiol/norethindrone acetate) to prevent bone loss and menopausal symptoms.⁴

Compared with placebo, women treated with elagolix with or without add-back therapy had significant reductions from baseline in mean menstrual blood loss. Women treated with elagolix also had significant increases in hemoglobin concentration from baseline to month 6 compared with placebo.⁴

Adverse effects were similar to menopause symptoms: bone loss, hot flashes, night sweats, headaches, and disturbed sleep, said Simon. With the add-back treatments, adverse effects were mitigated in a dose-dependent fashion, he pointed out, and were most likely tolerable compared with the heavy bleeding experienced by women at the start of the study.

Up to 80% of women who are of reproductive age have uterine fibroids that cause heavy and prolonged bleeding.¹ Additional concerns include infertility and pain, says James Simon, MD, Clinical Professor at George Washington University in Washington, DC. Black women are more likely than white women to undergo hysterectomy for uterine fibroids. They also are more likely to experience severe or very severe symptoms from fibroids and report that these symptoms interfere with physical activities, relationships, and work.²

Current medical treatments include on- and off-label use of oral contraceptives, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on investigational oral GnRH antagonists and oral selective progesterone-receptor modulators (SPRMs) were presented at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.

Details of VENUS I

In the phase 3, randomized, controlled VENUS I trial, investigators assessed the efficacy and safety of ulipristal acetate (UPA), an SPRM, by race and body mass index (BMI) in premenopausal women (aged 18 to 50) with symptomatic uterine fibroids.¹

Simon and colleagues randomly assigned participants to UPA 5 mg, UPA 10 mg, or placebo once daily for 12 weeks, followed by a 12-week treatment-free follow-up period. UPA, at 5 and 10 mg, was significantly more efficacious than placebo in rate of and time to amenorrhea (P<.0001). The superiority was observed regardless of race and BMI. In addition, women taking UPA versus placebo reported significantly less impact on activities due to uterine fibroids. The study authors concluded that “UPA treatment provides effective control of bleeding and improvement in physical and social activities for women with symptomatic uterine fibroids, regardless of race and BMI.”¹

Establishing the ideal treatment period for UPA to avoid progesterone-associated endometrial changes (in this study it was 12 weeks of once-daily therapy) is a current goal, said Simon.

Details of elagolix phase 2b study

Simon also presented data on another investigational drug, elagolix, an orally administered GnRH antagonist, which has an inhibiting effect on luteinizing hormone and follicle-stimulating hormone secretion. This in turn reduces production of estradiol and progesterone. Elagolix also is being studied for the treatment of endometriosis.³

In the uterine fibroids study, a 24-week, multicenter, double-blind, randomized controlled, parallel group trial, 567 premenopausal women aged 18 to 51 with heavy menstrual bleeding of >80 mL of blood loss were assigned to placebo or elagolix 300 mg twice per day or 600 mg once per day alone or in combination with add-back therapy (with estradiol/norethindrone acetate) to prevent bone loss and menopausal symptoms.⁴

Compared with placebo, women treated with elagolix with or without add-back therapy had significant reductions from baseline in mean menstrual blood loss. Women treated with elagolix also had significant increases in hemoglobin concentration from baseline to month 6 compared with placebo.⁴

Adverse effects were similar to menopause symptoms: bone loss, hot flashes, night sweats, headaches, and disturbed sleep, said Simon. With the add-back treatments, adverse effects were mitigated in a dose-dependent fashion, he pointed out, and were most likely tolerable compared with the heavy bleeding experienced by women at the start of the study.

Up to 80% of women who are of reproductive age have uterine fibroids that cause heavy and prolonged bleeding.¹ Additional concerns include infertility and pain, says James Simon, MD, Clinical Professor at George Washington University in Washington, DC. Black women are more likely than white women to undergo hysterectomy for uterine fibroids. They also are more likely to experience severe or very severe symptoms from fibroids and report that these symptoms interfere with physical activities, relationships, and work.²

Current medical treatments include on- and off-label use of oral contraceptives, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on investigational oral GnRH antagonists and oral selective progesterone-receptor modulators (SPRMs) were presented at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.

Details of VENUS I

In the phase 3, randomized, controlled VENUS I trial, investigators assessed the efficacy and safety of ulipristal acetate (UPA), an SPRM, by race and body mass index (BMI) in premenopausal women (aged 18 to 50) with symptomatic uterine fibroids.¹

Simon and colleagues randomly assigned participants to UPA 5 mg, UPA 10 mg, or placebo once daily for 12 weeks, followed by a 12-week treatment-free follow-up period. UPA, at 5 and 10 mg, was significantly more efficacious than placebo in rate of and time to amenorrhea (P<.0001). The superiority was observed regardless of race and BMI. In addition, women taking UPA versus placebo reported significantly less impact on activities due to uterine fibroids. The study authors concluded that “UPA treatment provides effective control of bleeding and improvement in physical and social activities for women with symptomatic uterine fibroids, regardless of race and BMI.”¹

Establishing the ideal treatment period for UPA to avoid progesterone-associated endometrial changes (in this study it was 12 weeks of once-daily therapy) is a current goal, said Simon.

Details of elagolix phase 2b study

Simon also presented data on another investigational drug, elagolix, an orally administered GnRH antagonist, which has an inhibiting effect on luteinizing hormone and follicle-stimulating hormone secretion. This in turn reduces production of estradiol and progesterone. Elagolix also is being studied for the treatment of endometriosis.³

In the uterine fibroids study, a 24-week, multicenter, double-blind, randomized controlled, parallel group trial, 567 premenopausal women aged 18 to 51 with heavy menstrual bleeding of >80 mL of blood loss were assigned to placebo or elagolix 300 mg twice per day or 600 mg once per day alone or in combination with add-back therapy (with estradiol/norethindrone acetate) to prevent bone loss and menopausal symptoms.⁴

Compared with placebo, women treated with elagolix with or without add-back therapy had significant reductions from baseline in mean menstrual blood loss. Women treated with elagolix also had significant increases in hemoglobin concentration from baseline to month 6 compared with placebo.⁴

Adverse effects were similar to menopause symptoms: bone loss, hot flashes, night sweats, headaches, and disturbed sleep, said Simon. With the add-back treatments, adverse effects were mitigated in a dose-dependent fashion, he pointed out, and were most likely tolerable compared with the heavy bleeding experienced by women at the start of the study.

Visit the Society of Gynecologic Surgeons online: sgsonline.org

More videos from SGS:

• Approaches to isolating the uterine artery at its origin from the internal iliac artery
• Advanced techniques in cystectomy for mature cystic teratomas
• Novel classification of labial anatomy and evaluation in the treatment of labial agglutination
• Strategies for prophylactic oophoropexy
• Tips and tricks for open laparoscopy
• Complete colpectomy & colpocleisis: Model for simulation
• Natural orifice sacral colpopexy
• Alternative options for visualizing ureteral patency during intraoperative cystoscopy
• Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
• Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
• Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
• Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
• Laparoscopic cystectomy for large, bilateral ovarian dermoids
• Small bowel surgery for the benign gynecologist

Visit the Society of Gynecologic Surgeons online: sgsonline.org

More videos from SGS:

• Approaches to isolating the uterine artery at its origin from the internal iliac artery
• Advanced techniques in cystectomy for mature cystic teratomas
• Novel classification of labial anatomy and evaluation in the treatment of labial agglutination
• Strategies for prophylactic oophoropexy
• Tips and tricks for open laparoscopy
• Complete colpectomy & colpocleisis: Model for simulation
• Natural orifice sacral colpopexy
• Alternative options for visualizing ureteral patency during intraoperative cystoscopy
• Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
• Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
• Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
• Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
• Laparoscopic cystectomy for large, bilateral ovarian dermoids
• Small bowel surgery for the benign gynecologist

Visit the Society of Gynecologic Surgeons online: sgsonline.org

More videos from SGS:

• Approaches to isolating the uterine artery at its origin from the internal iliac artery
• Advanced techniques in cystectomy for mature cystic teratomas
• Novel classification of labial anatomy and evaluation in the treatment of labial agglutination
• Strategies for prophylactic oophoropexy
• Tips and tricks for open laparoscopy
• Complete colpectomy & colpocleisis: Model for simulation
• Natural orifice sacral colpopexy
• Alternative options for visualizing ureteral patency during intraoperative cystoscopy
• Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
• Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
• Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
• Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
• Laparoscopic cystectomy for large, bilateral ovarian dermoids
• Small bowel surgery for the benign gynecologist

PART 1

Robert E. Gutman, MD
FPMRS Program Director
MedStar Washington Hospital Center
Associate Professor
Departments of Urology and Obstetrics/Gynecology
Georgetown University
Washington, DC

Elizabeth R. Mueller, MD, MSME
Professor, Departments of Urology and Obstetrics/Gynecology
Loyola University Chicago Stritch School of Medicine
Loyola University Medical Center
Maywood, Illinois

Janet Bickel, MA
Leadership and Career Development Coach
Falls Church, Virginia

Kristin M. Jacobs, MD
Steering Committee Chair, AUGS-SGS Group of FPRN®
FPMRS Fellow, Division of Urogynecology and Reconstructive Pelvic Surgery
Brown University
Providence, Rhode Island

Lior Lowenstein, MD, MS, MHA
Clinical Associate Professor, Department of Obstetrics and Gynecology
Rambam Health Center Campus, Ruth and Bruce Rappaport Faculty of Medicine
Technion Israel Institute of Technology
Haifa, Israel

Drs. Gutman, Jacobs, and Lowenstein and Ms. Bickel report no financial relationships relevant to their articles. Dr. Mueller reports that she is an investigator for and is on the advisory board of Astellas Medical and Scientific Affairs.

Photo: 3D4Medical / Science Source

PART 2

Geoffrey W. Cundiff, MD
Dr. Victor Gomel Professor and Head
Department of Obstetrics and Gynaecology
University of Bristish Columbia
Vancouver, British Columbia

Kimberly Kenton, MD,  MS
Professor, Obstetrics and Gynaecology and Urology
Divison Chief and Fellowship Program Director
Female Pelvis Medicine and Reconstructive Surgery
Medicial Director, Women's Integrated Pelvic Health Program
Northwestern Medicine/Northwestern University Feinberg School of Medicince
Chicago, Illinois

Denise M. Elser, MD
Urogynecologist
Women's Health Institute of Illinois
Oak Lawn, Illinois

Drs. Cundiff and Elser report no financial relationships relevant to their articles. Dr. Kenton reports that she receives grant or research support from Boston Scientific and the National Institutes of Health, and that she serves as an expert witness for the Butler Snow Law Firm/Ethicon.

Illustration: Science Picture Co/ Science Source

PART 1

Robert E. Gutman, MD
FPMRS Program Director
MedStar Washington Hospital Center
Associate Professor
Departments of Urology and Obstetrics/Gynecology
Georgetown University
Washington, DC

Elizabeth R. Mueller, MD, MSME
Professor, Departments of Urology and Obstetrics/Gynecology
Loyola University Chicago Stritch School of Medicine
Loyola University Medical Center
Maywood, Illinois

Janet Bickel, MA
Leadership and Career Development Coach
Falls Church, Virginia

Kristin M. Jacobs, MD
Steering Committee Chair, AUGS-SGS Group of FPRN®
FPMRS Fellow, Division of Urogynecology and Reconstructive Pelvic Surgery
Brown University
Providence, Rhode Island

Lior Lowenstein, MD, MS, MHA
Clinical Associate Professor, Department of Obstetrics and Gynecology
Rambam Health Center Campus, Ruth and Bruce Rappaport Faculty of Medicine
Technion Israel Institute of Technology
Haifa, Israel

Drs. Gutman, Jacobs, and Lowenstein and Ms. Bickel report no financial relationships relevant to their articles. Dr. Mueller reports that she is an investigator for and is on the advisory board of Astellas Medical and Scientific Affairs.

Photo: 3D4Medical / Science Source

PART 2

Geoffrey W. Cundiff, MD
Dr. Victor Gomel Professor and Head
Department of Obstetrics and Gynaecology
University of Bristish Columbia
Vancouver, British Columbia

Kimberly Kenton, MD,  MS
Professor, Obstetrics and Gynaecology and Urology
Divison Chief and Fellowship Program Director
Female Pelvis Medicine and Reconstructive Surgery
Medicial Director, Women's Integrated Pelvic Health Program
Northwestern Medicine/Northwestern University Feinberg School of Medicince
Chicago, Illinois

Denise M. Elser, MD
Urogynecologist
Women's Health Institute of Illinois
Oak Lawn, Illinois

Drs. Cundiff and Elser report no financial relationships relevant to their articles. Dr. Kenton reports that she receives grant or research support from Boston Scientific and the National Institutes of Health, and that she serves as an expert witness for the Butler Snow Law Firm/Ethicon.

Illustration: Science Picture Co/ Science Source

PART 1

Robert E. Gutman, MD
FPMRS Program Director
MedStar Washington Hospital Center
Associate Professor
Departments of Urology and Obstetrics/Gynecology
Georgetown University
Washington, DC

Elizabeth R. Mueller, MD, MSME
Professor, Departments of Urology and Obstetrics/Gynecology
Loyola University Chicago Stritch School of Medicine
Loyola University Medical Center
Maywood, Illinois

Janet Bickel, MA
Leadership and Career Development Coach
Falls Church, Virginia

Kristin M. Jacobs, MD
Steering Committee Chair, AUGS-SGS Group of FPRN®
FPMRS Fellow, Division of Urogynecology and Reconstructive Pelvic Surgery
Brown University
Providence, Rhode Island

Lior Lowenstein, MD, MS, MHA
Clinical Associate Professor, Department of Obstetrics and Gynecology
Rambam Health Center Campus, Ruth and Bruce Rappaport Faculty of Medicine
Technion Israel Institute of Technology
Haifa, Israel

Drs. Gutman, Jacobs, and Lowenstein and Ms. Bickel report no financial relationships relevant to their articles. Dr. Mueller reports that she is an investigator for and is on the advisory board of Astellas Medical and Scientific Affairs.

Photo: 3D4Medical / Science Source

PART 2

Geoffrey W. Cundiff, MD
Dr. Victor Gomel Professor and Head
Department of Obstetrics and Gynaecology
University of Bristish Columbia
Vancouver, British Columbia

Kimberly Kenton, MD,  MS
Professor, Obstetrics and Gynaecology and Urology
Divison Chief and Fellowship Program Director
Female Pelvis Medicine and Reconstructive Surgery
Medicial Director, Women's Integrated Pelvic Health Program
Northwestern Medicine/Northwestern University Feinberg School of Medicince
Chicago, Illinois

Denise M. Elser, MD
Urogynecologist
Women's Health Institute of Illinois
Oak Lawn, Illinois

Drs. Cundiff and Elser report no financial relationships relevant to their articles. Dr. Kenton reports that she receives grant or research support from Boston Scientific and the National Institutes of Health, and that she serves as an expert witness for the Butler Snow Law Firm/Ethicon.

Illustration: Science Picture Co/ Science Source

“HOW AND WHEN UMBILICAL CORD GAS ANALYSIS CAN JUSTIFY YOUR OBSTETRIC MANAGEMENT”

MICHAEL G. ROSS, MD, MPH (MARCH 2017)

Cord gas analysis can be beneficial but has drawbacks

In his article, Dr. Ross makes a few statements I would like to challenge. He gives a list of indications for cord gas analysis, even with a vigorous newborn. I would suggest that doing so is not only unnecessary, but could get the delivering provider in trouble. Normal gases with a vigorous infant are not actionable, and neither are abnormal gases with a vigorous infant. The latter situation could, however, lower the bar for a lawsuit if any neurologic pathology is diagnosed in the child.

At our hospital, blood gas assessments generate charges of $90 for each arterial and venous sample. The author states that gases are helpful for staff education. If that is the purposeof measuring the gases when Apgar scores are normal, then the bill for the gases should be sent to the staff, not the patient or insurance company.

The precise reason for doing cord gases is to prove you are a good doctor. If the Apgar scores are low, a healthy set of gases shows that your interventions were timely and appropriate. Normal gases prevent lawsuits in this situation.

Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Ross responds

I appreciate the comments of Dr. Walsh, who suggests that we should not obtain cord gases in vigorous infants due, in part, to the hospital charges. There are several reasons for the indications detailed in the article. Although normal Apgar scores would appear to negate the potential for severe metabolic acidosis, Apgar scoring accuracy has been challenged in medical legal cases. Furthermore, there may be newborn complications (eg, pre-existing hypoxic injury, intraventricular bleed) that may not be recognized immediately, yet hypoxemia and acidosis may be alleged to have contributed to the outcome. The actual cost of running a blood gas sample is far less than the $90 hospital charges. Nevertheless, if hospital charge is a concern, I recommend that the physician obtain a cord gas sample immediately following the delivery and determine whether to run the sample after the 5-minute Apgar score is obtained.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“HOW AND WHEN UMBILICAL CORD GAS ANALYSIS CAN JUSTIFY YOUR OBSTETRIC MANAGEMENT”

MICHAEL G. ROSS, MD, MPH (MARCH 2017)

Cord gas analysis can be beneficial but has drawbacks

In his article, Dr. Ross makes a few statements I would like to challenge. He gives a list of indications for cord gas analysis, even with a vigorous newborn. I would suggest that doing so is not only unnecessary, but could get the delivering provider in trouble. Normal gases with a vigorous infant are not actionable, and neither are abnormal gases with a vigorous infant. The latter situation could, however, lower the bar for a lawsuit if any neurologic pathology is diagnosed in the child.

At our hospital, blood gas assessments generate charges of $90 for each arterial and venous sample. The author states that gases are helpful for staff education. If that is the purposeof measuring the gases when Apgar scores are normal, then the bill for the gases should be sent to the staff, not the patient or insurance company.

The precise reason for doing cord gases is to prove you are a good doctor. If the Apgar scores are low, a healthy set of gases shows that your interventions were timely and appropriate. Normal gases prevent lawsuits in this situation.

Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Ross responds

I appreciate the comments of Dr. Walsh, who suggests that we should not obtain cord gases in vigorous infants due, in part, to the hospital charges. There are several reasons for the indications detailed in the article. Although normal Apgar scores would appear to negate the potential for severe metabolic acidosis, Apgar scoring accuracy has been challenged in medical legal cases. Furthermore, there may be newborn complications (eg, pre-existing hypoxic injury, intraventricular bleed) that may not be recognized immediately, yet hypoxemia and acidosis may be alleged to have contributed to the outcome. The actual cost of running a blood gas sample is far less than the $90 hospital charges. Nevertheless, if hospital charge is a concern, I recommend that the physician obtain a cord gas sample immediately following the delivery and determine whether to run the sample after the 5-minute Apgar score is obtained.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“HOW AND WHEN UMBILICAL CORD GAS ANALYSIS CAN JUSTIFY YOUR OBSTETRIC MANAGEMENT”

MICHAEL G. ROSS, MD, MPH (MARCH 2017)

Cord gas analysis can be beneficial but has drawbacks

In his article, Dr. Ross makes a few statements I would like to challenge. He gives a list of indications for cord gas analysis, even with a vigorous newborn. I would suggest that doing so is not only unnecessary, but could get the delivering provider in trouble. Normal gases with a vigorous infant are not actionable, and neither are abnormal gases with a vigorous infant. The latter situation could, however, lower the bar for a lawsuit if any neurologic pathology is diagnosed in the child.

At our hospital, blood gas assessments generate charges of $90 for each arterial and venous sample. The author states that gases are helpful for staff education. If that is the purposeof measuring the gases when Apgar scores are normal, then the bill for the gases should be sent to the staff, not the patient or insurance company.

The precise reason for doing cord gases is to prove you are a good doctor. If the Apgar scores are low, a healthy set of gases shows that your interventions were timely and appropriate. Normal gases prevent lawsuits in this situation.

Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Ross responds

I appreciate the comments of Dr. Walsh, who suggests that we should not obtain cord gases in vigorous infants due, in part, to the hospital charges. There are several reasons for the indications detailed in the article. Although normal Apgar scores would appear to negate the potential for severe metabolic acidosis, Apgar scoring accuracy has been challenged in medical legal cases. Furthermore, there may be newborn complications (eg, pre-existing hypoxic injury, intraventricular bleed) that may not be recognized immediately, yet hypoxemia and acidosis may be alleged to have contributed to the outcome. The actual cost of running a blood gas sample is far less than the $90 hospital charges. Nevertheless, if hospital charge is a concern, I recommend that the physician obtain a cord gas sample immediately following the delivery and determine whether to run the sample after the 5-minute Apgar score is obtained.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Reader inquires about coding for McCall culdoplasty

It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?

Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina

Melanie Witt responds

Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.

As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.

If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Reader inquires about coding for McCall culdoplasty

It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?

Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina

Melanie Witt responds

Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.

As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.

If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Reader inquires about coding for McCall culdoplasty

It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?

Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina

Melanie Witt responds

Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.

As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.

If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”

ANDREW M. KAUNITZ, MD (MARCH 2017)

Refutes concept of overdiagnosis of breast cancer

I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?

The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!

John T. Armstrong, MD
Napa, California

Dr. Kaunitz responds

I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.

My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.¹

Share your thoughts!  Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”

ANDREW M. KAUNITZ, MD (MARCH 2017)

Refutes concept of overdiagnosis of breast cancer

I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?

The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!

John T. Armstrong, MD
Napa, California

Dr. Kaunitz responds

I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.

My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.¹

Share your thoughts!  Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”

ANDREW M. KAUNITZ, MD (MARCH 2017)

Refutes concept of overdiagnosis of breast cancer

I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?

The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!

John T. Armstrong, MD
Napa, California

Dr. Kaunitz responds

I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.

My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.¹

Share your thoughts!  Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The objective of the study by Janda and colleagues (known as the “LACE” trial) was to evaluate the equivalency of total laparoscopic hysterectomy (TLH) with staging versus the standard procedure, which is total abdominal hysterectomy (TAH) with staging, for surgical management of women with presumed low-risk, early-stage endometrial cancer.

Related Article:
2016 Update on cancer

Details of the study

This nonblinded, randomized controlled multicenter equivalency trial included 760 women from Australia, New Zealand, and Hong Kong undergoing surgical management of presumed stage I uterine endometrioid adenocarcinoma. All surgeries were performed or supervised by trained gynecologic oncologists. Pelvic lymph node sampling was required but omission was permitted for: morbid obesity, low risk of metastasis based on frozen section results, medically unfit status, or institutional guidelines prohibiting the procedure. Patients were excluded for preoperative nonendometrioid histology, suspected ultimate FIGO stage II–IV based on preoperative imaging, or uterine size greater than 10 weeks’ gestation.

The primary outcome was disease-free survival, defined as the time from surgery to the date of first recurrence, which included disease progression, development of a new primary malignancy, or death. Secondary outcomes included disease recurrence, patterns of recurrence, and overall survival. A 7% difference in disease-free survival at 4.5 years postoperatively was prespecified and determined based on previously published literature.^1–4

By Kaplan-Meier estimates, disease-free survival at 4.5 years was 81.3% in the TAH group and 81.6% in the TLH group, a 0.3% difference. In addition, there were no differences noted in secondary outcomes, further supporting equivalency of the surgical modalities. The only significantly different surgical findings included decreased operative time in the TAH group and decreased lymph node dissection completion in the TLH group.

Related Article:
Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?

Study strengths and weaknesses

The largest previous trial of more than 2,000 patients examining the method of surgical management was the Gynecologic Oncology Group’s (GOG) noninferiority LAP2 trial.³ This trial has been used widely to promote a minimally invasive approach, but did not actually reach the prespecified statistical goals. The LACE trial, however, successfully reached its statistical targets and is now the largest randomized trial supporting an equivalence in oncologic outcomes.

It is important to recognize the limitations of the LACE trial in the current medical environment. The study population was a very specific group of low-risk women without high-risk histologic subtypes or even moderately enlarged uteri; many institutions would consider offering a minimally invasive approach to these women. In addition, this study did not include robotic minimally invasive surgery, which in many regions of the country is rapidly becoming accepted as the first choice procedure over traditional laparoscopy.⁵ Furthermore, the FIRES trial and others^6–8 have demonstrated that utilizing a minimally invasive approach that includes sentinel lymph node identification and removal may be as diagnostic as a full dissection, adding considerations to surgical modality selection.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The objective of the study by Janda and colleagues (known as the “LACE” trial) was to evaluate the equivalency of total laparoscopic hysterectomy (TLH) with staging versus the standard procedure, which is total abdominal hysterectomy (TAH) with staging, for surgical management of women with presumed low-risk, early-stage endometrial cancer.

Related Article:
2016 Update on cancer

Details of the study

This nonblinded, randomized controlled multicenter equivalency trial included 760 women from Australia, New Zealand, and Hong Kong undergoing surgical management of presumed stage I uterine endometrioid adenocarcinoma. All surgeries were performed or supervised by trained gynecologic oncologists. Pelvic lymph node sampling was required but omission was permitted for: morbid obesity, low risk of metastasis based on frozen section results, medically unfit status, or institutional guidelines prohibiting the procedure. Patients were excluded for preoperative nonendometrioid histology, suspected ultimate FIGO stage II–IV based on preoperative imaging, or uterine size greater than 10 weeks’ gestation.

The primary outcome was disease-free survival, defined as the time from surgery to the date of first recurrence, which included disease progression, development of a new primary malignancy, or death. Secondary outcomes included disease recurrence, patterns of recurrence, and overall survival. A 7% difference in disease-free survival at 4.5 years postoperatively was prespecified and determined based on previously published literature.^1–4

By Kaplan-Meier estimates, disease-free survival at 4.5 years was 81.3% in the TAH group and 81.6% in the TLH group, a 0.3% difference. In addition, there were no differences noted in secondary outcomes, further supporting equivalency of the surgical modalities. The only significantly different surgical findings included decreased operative time in the TAH group and decreased lymph node dissection completion in the TLH group.

Related Article:
Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?

Study strengths and weaknesses

The largest previous trial of more than 2,000 patients examining the method of surgical management was the Gynecologic Oncology Group’s (GOG) noninferiority LAP2 trial.³ This trial has been used widely to promote a minimally invasive approach, but did not actually reach the prespecified statistical goals. The LACE trial, however, successfully reached its statistical targets and is now the largest randomized trial supporting an equivalence in oncologic outcomes.

It is important to recognize the limitations of the LACE trial in the current medical environment. The study population was a very specific group of low-risk women without high-risk histologic subtypes or even moderately enlarged uteri; many institutions would consider offering a minimally invasive approach to these women. In addition, this study did not include robotic minimally invasive surgery, which in many regions of the country is rapidly becoming accepted as the first choice procedure over traditional laparoscopy.⁵ Furthermore, the FIRES trial and others^6–8 have demonstrated that utilizing a minimally invasive approach that includes sentinel lymph node identification and removal may be as diagnostic as a full dissection, adding considerations to surgical modality selection.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The objective of the study by Janda and colleagues (known as the “LACE” trial) was to evaluate the equivalency of total laparoscopic hysterectomy (TLH) with staging versus the standard procedure, which is total abdominal hysterectomy (TAH) with staging, for surgical management of women with presumed low-risk, early-stage endometrial cancer.

Related Article:
2016 Update on cancer

Details of the study

This nonblinded, randomized controlled multicenter equivalency trial included 760 women from Australia, New Zealand, and Hong Kong undergoing surgical management of presumed stage I uterine endometrioid adenocarcinoma. All surgeries were performed or supervised by trained gynecologic oncologists. Pelvic lymph node sampling was required but omission was permitted for: morbid obesity, low risk of metastasis based on frozen section results, medically unfit status, or institutional guidelines prohibiting the procedure. Patients were excluded for preoperative nonendometrioid histology, suspected ultimate FIGO stage II–IV based on preoperative imaging, or uterine size greater than 10 weeks’ gestation.

The primary outcome was disease-free survival, defined as the time from surgery to the date of first recurrence, which included disease progression, development of a new primary malignancy, or death. Secondary outcomes included disease recurrence, patterns of recurrence, and overall survival. A 7% difference in disease-free survival at 4.5 years postoperatively was prespecified and determined based on previously published literature.^1–4

By Kaplan-Meier estimates, disease-free survival at 4.5 years was 81.3% in the TAH group and 81.6% in the TLH group, a 0.3% difference. In addition, there were no differences noted in secondary outcomes, further supporting equivalency of the surgical modalities. The only significantly different surgical findings included decreased operative time in the TAH group and decreased lymph node dissection completion in the TLH group.

Related Article:
Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?

Study strengths and weaknesses

The largest previous trial of more than 2,000 patients examining the method of surgical management was the Gynecologic Oncology Group’s (GOG) noninferiority LAP2 trial.³ This trial has been used widely to promote a minimally invasive approach, but did not actually reach the prespecified statistical goals. The LACE trial, however, successfully reached its statistical targets and is now the largest randomized trial supporting an equivalence in oncologic outcomes.

It is important to recognize the limitations of the LACE trial in the current medical environment. The study population was a very specific group of low-risk women without high-risk histologic subtypes or even moderately enlarged uteri; many institutions would consider offering a minimally invasive approach to these women. In addition, this study did not include robotic minimally invasive surgery, which in many regions of the country is rapidly becoming accepted as the first choice procedure over traditional laparoscopy.⁵ Furthermore, the FIRES trial and others^6–8 have demonstrated that utilizing a minimally invasive approach that includes sentinel lymph node identification and removal may be as diagnostic as a full dissection, adding considerations to surgical modality selection.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.