Breast Cancer

The American Society of Clinical Oncology has issued updated guidelines on using breast tumor biomarker assays to help guide or influence decisions on systemic therapy in women with metastatic breast cancer, which were published online July 20 in the Journal of Clinical Oncology.

The quality of evidence for the recommendations ranges from insufficient to intermediate, and the “strength” of the recommendation was moderate for all of them.

When evaluating metastatic sites, it is important to note that the estrogen receptor (ER), progesterone receptor (PR), and/or human epidermal growth factor receptor 2 (HER2) status may have changed from the primary tumor, and these results could influence treatment. Thus, biopsy should be offered to patients with accessible, newly diagnosed metastases from primary breast cancer, to confirm disease status and test for ER, PR, and HER2 status, wrote Dr. Catherine Van Poznak of the University of Michigan Comprehensive Cancer Center in Ann Arbor, and colleagues, as one of the key recommendations (J. Clin. Oncol. 2015 July 20 [doi:10.1200/JCO.2015.61.1459]).

Patients should be also be told if discordances are detected, and that evidence is lacking to determine whether outcomes are better with treatment regimens based on receptor status in the metastases or the primary tumor.

If supported by the clinical scenario and patient goals for care, the ASCO Panel consensus is to preferentially use the biomarker status from the metastatic site rather than from the primary tumor, to direct therapy.

Decisions for initiating systemic therapy in this patient population should be based on clinical evaluation, judgment, as well as patient preferences. At present, there is no evidence that health outcomes will improve if treatment is initiated based solely on the results of biomarker assays that go beyond ER, PR, and HER2 status.

For patients who are already receiving systemic therapy, decisions for changing drugs or regimens, or discontinuing treatment should be based on clinical evaluation, clinician judgment of disease progression or response, and patient preference and input. There is no evidence at this time that changing therapy based solely on biomarker results beyond ER, PR, and HER2 improves health outcomes, quality of life, or cost effectiveness, they wrote. This recommendation applies for both tissue biomarkers and circulating tumor biomarkers.

The guidelines also recommend that carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 can be used as adjunctive assessments and can contribute to decisions regarding therapy. The data thus far, however, are insufficient to recommend their use alone for monitoring response to treatment. This recommendation, according to the researchers, is based on clinical experience and the informal consensus of the panel, since there are no studies that have been designed to evaluate the clinical utility of the markers.

It is also reasonable for clinicians to not use these markers as adjunctive assessments.

Outside of clinical trials, decisions for systemic therapy should be influenced by ER, PR, and HER2 status, as the clinical usefulness for other biomarkers has not yet been demonstrated. A number of other types of biomarkers are in active development, but there is insufficient evidence at this time showing that their use improves cancer outcomes, the panel said.

Biomarker distribution of ER, PR, and HER2 status may also differ across ethnic and racial backgrounds, and in addition to the biologic variability of these biomarkers, there is also evidence that disparities exist in the frequency of biomarker testing in certain populations.

The American Society of Clinical Oncology has issued updated guidelines on using breast tumor biomarker assays to help guide or influence decisions on systemic therapy in women with metastatic breast cancer, which were published online July 20 in the Journal of Clinical Oncology.

The quality of evidence for the recommendations ranges from insufficient to intermediate, and the “strength” of the recommendation was moderate for all of them.

When evaluating metastatic sites, it is important to note that the estrogen receptor (ER), progesterone receptor (PR), and/or human epidermal growth factor receptor 2 (HER2) status may have changed from the primary tumor, and these results could influence treatment. Thus, biopsy should be offered to patients with accessible, newly diagnosed metastases from primary breast cancer, to confirm disease status and test for ER, PR, and HER2 status, wrote Dr. Catherine Van Poznak of the University of Michigan Comprehensive Cancer Center in Ann Arbor, and colleagues, as one of the key recommendations (J. Clin. Oncol. 2015 July 20 [doi:10.1200/JCO.2015.61.1459]).

Patients should be also be told if discordances are detected, and that evidence is lacking to determine whether outcomes are better with treatment regimens based on receptor status in the metastases or the primary tumor.

If supported by the clinical scenario and patient goals for care, the ASCO Panel consensus is to preferentially use the biomarker status from the metastatic site rather than from the primary tumor, to direct therapy.

Decisions for initiating systemic therapy in this patient population should be based on clinical evaluation, judgment, as well as patient preferences. At present, there is no evidence that health outcomes will improve if treatment is initiated based solely on the results of biomarker assays that go beyond ER, PR, and HER2 status.

For patients who are already receiving systemic therapy, decisions for changing drugs or regimens, or discontinuing treatment should be based on clinical evaluation, clinician judgment of disease progression or response, and patient preference and input. There is no evidence at this time that changing therapy based solely on biomarker results beyond ER, PR, and HER2 improves health outcomes, quality of life, or cost effectiveness, they wrote. This recommendation applies for both tissue biomarkers and circulating tumor biomarkers.

The guidelines also recommend that carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 can be used as adjunctive assessments and can contribute to decisions regarding therapy. The data thus far, however, are insufficient to recommend their use alone for monitoring response to treatment. This recommendation, according to the researchers, is based on clinical experience and the informal consensus of the panel, since there are no studies that have been designed to evaluate the clinical utility of the markers.

It is also reasonable for clinicians to not use these markers as adjunctive assessments.

Outside of clinical trials, decisions for systemic therapy should be influenced by ER, PR, and HER2 status, as the clinical usefulness for other biomarkers has not yet been demonstrated. A number of other types of biomarkers are in active development, but there is insufficient evidence at this time showing that their use improves cancer outcomes, the panel said.

Biomarker distribution of ER, PR, and HER2 status may also differ across ethnic and racial backgrounds, and in addition to the biologic variability of these biomarkers, there is also evidence that disparities exist in the frequency of biomarker testing in certain populations.

The American Society of Clinical Oncology has issued updated guidelines on using breast tumor biomarker assays to help guide or influence decisions on systemic therapy in women with metastatic breast cancer, which were published online July 20 in the Journal of Clinical Oncology.

The quality of evidence for the recommendations ranges from insufficient to intermediate, and the “strength” of the recommendation was moderate for all of them.

When evaluating metastatic sites, it is important to note that the estrogen receptor (ER), progesterone receptor (PR), and/or human epidermal growth factor receptor 2 (HER2) status may have changed from the primary tumor, and these results could influence treatment. Thus, biopsy should be offered to patients with accessible, newly diagnosed metastases from primary breast cancer, to confirm disease status and test for ER, PR, and HER2 status, wrote Dr. Catherine Van Poznak of the University of Michigan Comprehensive Cancer Center in Ann Arbor, and colleagues, as one of the key recommendations (J. Clin. Oncol. 2015 July 20 [doi:10.1200/JCO.2015.61.1459]).

Patients should be also be told if discordances are detected, and that evidence is lacking to determine whether outcomes are better with treatment regimens based on receptor status in the metastases or the primary tumor.

If supported by the clinical scenario and patient goals for care, the ASCO Panel consensus is to preferentially use the biomarker status from the metastatic site rather than from the primary tumor, to direct therapy.

Decisions for initiating systemic therapy in this patient population should be based on clinical evaluation, judgment, as well as patient preferences. At present, there is no evidence that health outcomes will improve if treatment is initiated based solely on the results of biomarker assays that go beyond ER, PR, and HER2 status.

For patients who are already receiving systemic therapy, decisions for changing drugs or regimens, or discontinuing treatment should be based on clinical evaluation, clinician judgment of disease progression or response, and patient preference and input. There is no evidence at this time that changing therapy based solely on biomarker results beyond ER, PR, and HER2 improves health outcomes, quality of life, or cost effectiveness, they wrote. This recommendation applies for both tissue biomarkers and circulating tumor biomarkers.

The guidelines also recommend that carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 can be used as adjunctive assessments and can contribute to decisions regarding therapy. The data thus far, however, are insufficient to recommend their use alone for monitoring response to treatment. This recommendation, according to the researchers, is based on clinical experience and the informal consensus of the panel, since there are no studies that have been designed to evaluate the clinical utility of the markers.

It is also reasonable for clinicians to not use these markers as adjunctive assessments.

Outside of clinical trials, decisions for systemic therapy should be influenced by ER, PR, and HER2 status, as the clinical usefulness for other biomarkers has not yet been demonstrated. A number of other types of biomarkers are in active development, but there is insufficient evidence at this time showing that their use improves cancer outcomes, the panel said.

Biomarker distribution of ER, PR, and HER2 status may also differ across ethnic and racial backgrounds, and in addition to the biologic variability of these biomarkers, there is also evidence that disparities exist in the frequency of biomarker testing in certain populations.

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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.

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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.

“THE SGR IS ABOLISHED! WHAT COMES NEXT?”
LUCIA DIVENERE, MA (PRACTICE MANAGEMENT; JUNE 2015)

Do ACOG guidelines protect us from liability?
I read Ms. DiVenere’s June article with interest, but I found this point she quoted confusing: "The law protects physicians from liability from federal or state standards of care. No health care guideline or other standard developed under federal or state requirements associated with this law may be used as a standard of care or duty of care owed by a health care professional to a patient in a medical liability lawsuit."

I have 2 questions: How do you interpret the use of guidelines by the American College of Obstetricians and Gynecologists (ACOG), since they are developed independently by a specialty society rather than by federal or state “requirements”? Does this only pertain to liability lawsuits concerning billing of fees, or does it pertain to medical malpractice civil lawsuits?

In the Medicare Access and CHIP Reauthorization Act, I find this section that seems to contradict the protection¹:

What is the bottom line? No law can protect and provide immunity to a physician for true medical malpractice. This federal law says “no preemption.”
Arnold D. Wharton, MD
Tyler, Texas

Reference
1. Pub L No. 114–10. Medicare Access and CHIP Reauthorization Act of 2015. 114th Congress. Title 1—SGR repeal and Medicare Provider Payment Modernization. §106. Reducing administrative burden and other provisions. 129 STAT.143. http://www.gpo.gov/fdsys/pkg/PLAW-114publ10/pdf/PLAW-114publ10.pdf. Accessed June 10, 2015.

Ms. DiVenere responds
I thank Dr. Wharton for his interesting perspective. To answer the first questions, this section of the law only applies to guidelines and standards created by a federal or state entity, not to ACOG guidelines, and is intended to provide one area of protection from medical malpractice lawsuits. Interestingly, legislation has been introduced in the US House by Congressman Andy Barr (R-KY), with ACOG’s support, to create liability safe harbors for physicians who follow care guidelines developed by their relevant specialty society.  

As for the question about preemption, this section of the law allows stronger state laws to stand; this federal law would not preempt state laws. 

“HOW DO YOU DISMISS A PATIENT FROM YOUR PRACTICE’S CARE?”
JOSEPH S. SANFILIPPO, MD, MBA, AND STEVEN R. SMITH, JD (WHAT’S THE VERDICT?; JUNE 2015)

Statute of limitations still in effect; contact your insurer
While the end result to dismiss the patient was achieved, the statute of limitations for a possible malpractice suit had not fully run. I would suggest that the physician contact his/her insurer so that they can open a file and be alerted for a possible suit. Insurers generally require physicians to notify them of any potential suits.
Lynn Frame, MD, JD
Tulsa, Oklahoma

Dr. Sanfilippo and Mr. Smith respond
Our thanks to Dr. Frame for the good reminder that physicians should always remember the obligation to inform malpractice insurance carriers when a malpractice claim is being, or may be, filed. Insurance contracts vary somewhat regarding when notice must be given.

In the hypothetical case, there was an angry patient but no formal threat of legal action. Some lawyers take the sensible position that “when in doubt, notify.” Others are reluctant to “over notify” carriers. Our view is that this is one of the areas in which it may be beneficial for a physician to have an ongoing professional relationship with an attorney to allow for advice on when to provide insurance carrier notification.

“SURGICAL REMOVAL OF MALPOSITIONED IUDs”
BENJAMIN MARGOLIS, MD; MIREILLE D. TRUONG, MD; JULIA KEARNEY; SARAH SCHECHTER; JEANNIE KIM, MD; AND ARNOLD P. ADVINCULA, MD (VIDEO; JUNE 2015)

Videos show very useful techniques for malpositioned IUDs
I have placed somewhere in the ballpark of 2,000 intrauterine devices (IUDs) and have had 2 perforations that I am aware of (and probably many more malpositioned IUDs that I am unaware of). Some of those were likely the cause of a patient’s pain and were either removed or hysteroscopically repositioned. Dr. ­Advincula’s edited video from several cases demonstrates very useful techniques in the surgical management of these problems.
Philip Ivey, MD
Casa Grande, Arizona

The IUD might not stay where I put it
For the past several years I have performed the majority (more than 95%) of IUD insertions with ultrasound guidance and have been very thankful at times for the assistance of my sonographer. Despite my knowledge of accurate placement, there are still patients who return months or years later with a malpositioned IUD. I have come to realize that the uterus is a dynamic organ—not a piece of concrete. Just because I put the IUD in the right place does not ensure that it will stay there. Fortunately, I have not yet had a perforation into the abdominal cavity.

I really enjoyed the videos and advice, as always!
Elizabeth Street, MD
Marietta, Georgia

“EBOLA IN THE UNITED STATES: MANAGEMENT CONSIDERATIONS DURING PREGNANCY”
STEPHANIE L. BAKAYSA, MD, MPH; JEANNIE C. KELLY, MD; AND ERROL R. NORWITZ, MD, PHD
(JUNE 2015)

Improved care for pregnant women during Ebola crisis
The article on Ebola in pregnancy noted how little we actually know about the Ebola virus. The Ebola virus was first documented in 1976 in Sudan and the Democratic Republic of the Congo,¹ not in 1967 as the article stated. The Marburg virus outbreak occurred in 1967. Closely related, both viruses are filo viruses that cause hemorrhagic fever. A significant difference between the 2 is that the natural reservoir for the ­Marburg virus was identified. The outbreak in Marburg, Germany, which the virus is named for, was linked to African green monkeys imported from Uganda, East Africa.² Bats also have been identified as a reservoir for the Marburg virus.³ However, there is only speculation as to whether the natural reservoir for the Ebola virus is fruit bats. A 3-month research study following the 1995 outbreak of Ebola virus in Kikwit, Democratic Republic of the Congo, tested more than 3,000 vertebrate species and was still unable to identify a natural carrier for the virus.⁴

The Ebola virus was first documented nearly 40 years ago and yet we know so little about it. This demonstrates the ongoing disparity in funding and research devoted to disease conditions that most often affect only third-world nations.

Also, I’d like to point out that the article’s comment that pregnant patients are triaged “last” during the current Ebola virus outbreak may not be completely accurate. Yes, pregnant women have a significantly higher rate of mortality with Ebola viral infection. I spoke with a nurse (name and location withheld for confidentiality) who is currently the Clinical Lead at an Ebola Holding Unit for pregnant and lactating women in a West African nation. According to her, improved resources were quickly mobilized by nongovernment organizations and other foreign health care volunteers following the initial reports of disease, a factor that significantly increased access to care for pregnant women and improved outcomes. Erin Kiser, DNP, FNP-BC, WHNP-BC
Fayetteville, North Carolina

References
1. World Health Organization. Ebola virus disease. Fact sheet No. 103. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated April 2015. Accessed July 6, 2015.
2. World Health Organization. Marburg haemorrhagic fever. Fact sheet. http://www.who.int/mediacentre/factsheets/fs_marburg/en/. Published November 2012. Accessed July 8, 2015.
3. Towner JS, Pourrut X, Albariño CG, et al. Marburg virus infection detected in a common African bat. PLoS One. 2007;2(8):e764. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000764.
4. Leirs H, Mills JN, Krebs JW, et al. Search for the Ebola virus reservoir in Kikwit, Democratic Republic of the Congo: Reflections on a vertebrate collection. J Infect Dis. 1999;179(suppl 1):S155–S163.

“WHY IS OBSTETRICS AND GYNECOLOGY A POPULAR CAREER CHOICE FOR MEDICAL STUDENTS?”
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2015)

Had the chance to change my specialty, but didn’t
I trained in Mexico, where I was a board certified ObGyn and a maternal-fetal medicine specialist. When I came to the United States I had the opportunity to change my specialty, and I didn’t. As a “free agent” international medical graduate, I had to go through many hurdles. My gate to enter the American medical world was through a family practice residency. After a year, I realized my love was still obstetrics and gynecology. In 1996, I finished an ObGyn residency at Loma Linda University Medical Center in California, and have been board certified since 1998.

There are many things I like about this specialty. Mainly, it’s the diversity. A well-rounded ObGyn has to know internal medicine, pediatrics, and surgery and apply this knowledge to the pregnant patient—a feat somehow exclusive to ObGyns.

I have enjoyed a wonderful career and many rewards. I never stop thanking all those professors and colleagues who helped me develop the set of skills that I now possess.
Tomas A. Hernandez, MD 
Pasco, Washington

Not again!
I would not go into obstetrics and gynecology again because of many reasons:

I would like to say that ObGyn is a beautiful specialty, most likely the best of all medical specialties, if it was not for the attorneys’ greed and patients’ lack of understanding that we are not God. We are only doctors, working within a system that contributes to all of the above.
Manuel S. Mendizabal, MD
Miami, Florida

Are men discouraged from entering the ObGyn field?
Dr. Barbieri asks, “Why is obstetrics and gynecology a popular choice for medical students?” The unaddressed question is why is it unpopular for half of medical students? Ninety-three percent of resident graduates in the field are women, while women account for half of medical student graduates. Men rarely go into the specialty today. Perhaps job advertisements touting physician opportunities in “all female groups” discourage males. Perhaps hospitals’ “women’s health centers,” with “women taking care of women,” discourage males. Perhaps receptionists’ asking patients whether they prefer a male or female physician discourages male ObGyns. In the United States, two-thirds of outpatient office visits are made by women, and academic centers and hospitals focus on this demographic in their marketing. The business ends justify the unethical means.

The result of discouraging half your medical students from the field is a lower quality field. If male and female medical students are equally qualified for any field, and I believe this is true, then discouraging half the candidates from a field lowers the quality of the resulting field. This has been the product of all discrimination throughout the ages.
Joe Walsh, MD
Philadelphia, Pennsylvania

Dr. Barbieri responds
Drs. Hernandez and Mendizabal provide 2 divergent perspectives on our field. Dr. Hernandez cherishes the diversity of the clinical work in the field, and Dr. Mendizabal warns that night call and medical malpractice take a toll on a physician. Both perspectives are valid and important, and medical students entering the field should be alerted to these rewards and challenges.

I agree with Dr. Walsh that the majority of residents in obstetrics and gynecology are women. On ­December 31, 2013, of the 4,942 residents in obstetrics and gynecology in the United States, 82.5% were women.¹ In the fields of orthopedic surgery, neurosurgery, and urology, male residents dominate the resident complement, constituting 86.3%, 84.1%, and 77.3% of the residents, respectively.¹ It is interesting that the fields of obstetrics and gynecology, orthopedic surgery, neurosurgery, and urology are among the most competitive fields in the resident match. Based on personal observation, medical student clerkship directors and obstetrics and gynecology residency programs encourage both women and men to consider a career in obstetrics and gynecology and warmly welcome male applicants. Medical students select their preferred future specialty based on many factors. It is clear that in the past few years the medical students applying to obstetrics and gynecology are extremely capable, and I am confident that the future of women’s health is in the hands ofexcellent clinicians.

Reference
1. Brotherton SE, Etzel SI. Graduate medical education, 2013–2014. JAMA. 2014;312(22):2427–2445.

“IS IT TIME TO REVIVE ROTATIONAL FORCEPS?” WILLIAM H. BARTH JR, MD (EXAMINING THE EVIDENCE; MAY 2015)

Who will teach this dying art to a new generation?
The article on rotational forceps has what I consider one glaring defect—who will teach this dying art to a new generation?

Now retired, I was military-residency trained in the 1970s when you had to do your own regional and conduction anesthesia as well as operative forceps delivery—and that did not mean a silastic cup vacuum extractor, though we had just started using the Malstrom vacuum. Breech forceps, Kielland rotations, occipito-transverse forceps application—you name it and we did it as we had to keep our cesarean delivery rate down. All of us were well skilled in operative vaginal delivery.

When I stopped practicing obstetrics, the fresh-out-of-residency people coming into our practice couldn’t do a low forceps delivery. If there is to be a reteaching of rotational forceps, they’d better catch us old codgers fast before we die off (I am 72) and grant us malpractice relief (I no longer have insurance). This is an art, not a science, and can’t be taught from a book or a computer model. Set up a crash course to teach this dying art, pay us well, and perhaps we will be able to pass this skill along. Otherwise it will be gone forever.

I have always said that forceps are like a shoehorn—used correctly, they make things so much easier.
Robert Frischer, MD

Wichita Falls, Texas

“IS SUPPLEMENTAL ULTRASONO­G-RAPHY A VALUABLE ADDITION TO BREAST CANCER SCREENING FOR WOMEN WITH DENSE BREASTS?”
MARK D. PEARLMAN, MD (EXAMINING THE EVIDENCE; MARCH 2015)

Why I now recommend 3D ultrasonography to my high-risk patients
In 2012, I attended a medical staff meeting where Dr. Ruby Chang spoke about a newly available modality at our hospital: 3D ultrasonography. Her slideshow included some impressive images of cancers that were not seen on mammogram but were unmistakable on sonography.

I decided to have a 3D ultrasound for myself in order to tell my patients what it was like. I also have “heterogeneously dense breasts” on mammogram. For the previous 10 years, my annual screening mammograms had all been negative. The 3D ultrasound showed an 8-mm cancer in my left breast—not palpable to me. A subsequent mammogram was still negative for cancer.

Luckily, the breast cancer was Stage 1 at surgery, and I did not need chemotherapy or radiation, opting for skin- and nipple-sparing double mastectomy. I had a double mastectomy because I believed that I could no longer trust screening mammo­graphy for a timely diagnosis.

To this day, I explain breast density to all of my higher-risk patients who have either heterogeneously or extremely dense breasts. I tell them that their mammograms may miss a cancer and that there is another test that might help detect cancer early. It’s a good thing to have another way to evaluate the breast, especially when our patients are being sent letters about their “dense breasts.” (The majority of my patients do not understand what this means.)

I realize that data may show that this modality isn’t the perfect solution and may lead to more testing and procedures, but in my case, it was worth it!

Strangely, to this day, I have not had one patient who had breast cancer diagnosed in this way.

It’s a shame that insurance companies don’t cover even partial cost for eligible patients.
Bettina Zatuchni, MD
Pleasanton, California

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.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Regional nodal irradiation added to whole-breast or thoracic wall irradiation in an unselected patient population reduces breast cancer recurrence rates and improves disease-free and distant disease-free survival, but has little or no effect on overall survival, results of two large, long-term, randomized clinical trials show.

In the MA.20 trial, there was no significant difference in overall survival at 10-year follow-up between women with early breast cancer treated with breast-conserving surgery, adjuvant systemic therapy, and whole-breast irradiation with or without regional nodal irradiation.

Women who received nodal irradiation had significantly better disease-free survival, but at the cost of higher rates of pneumonitis and lymphedema, report Dr. Timothy J. Whelan from the Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton, Ont., and his colleagues in the July 23 issue of the New England Journal of Medicine (doi:10.1056/NEJMoa1415340).

In the EORTC 22922/10925 study, investigators in the European Organization for Research and Treatment of Cancer randomly assigned women with a centrally or medially located primary tumor irrespective of axillary involvement, or an externally located tumor with axillary involvement, to receive either whole-breast or thoracic wall irradiation alone, or with the addition of regional nodal irradiation.

As in the Canadian study, the investigators found no difference in overall survival at 10 years between women who received nodal irradiation and those who did not. Similarly, the EORTC investigators found that rates of disease-free survival and distant disease-free survival were better among women who received nodal irradiation. The nodal irradiation group also had a significantly lower rate of breast cancer–specific death. The European investigators, however, felt that “the acute side effects of regional nodal irradiation were modest.” The study, by Dr. Philip M. Poortmans of Radboud University in Nijmegen, the Netherlands, also appears in the New England Journal of Medicine (2015 July 23 [doi:10.1056/NEJMoa1415369]).

“The trials by Whelan et al. and Poortmans et al. show the possibilities and the limits of more extensive regional treatment of breast cancer in an unselected population and frame the discussion for the next generation of individualized treatment programs, built largely on genomic characterization of tumor biology,” write Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston and Dr. Monica Morrow of the Memorial Sloan Kettering Cancer in New York, in an accompanying editorial.

MA.20

From March 2000 through February 2007, Dr. Whelan and colleagues in the MA.20 trial enrolled 1,832 women with node-positive or high-risk node-negative cancer treated with breast-conserving surgery and adjuvant systemic therapy. The women were randomly assigned, 916 in each group, to undergo either whole-breast irradiation plus regional nodal irradiation (including internal mammary, supraclavicular, and axillary lymph node), or whole-breast irradiation alone (controls).

At 10-year follow-up, overall survival rates were similar, at 82.8% in the nodal irradiation group and 81.8% in the control group (hazard ratio, 0.91, P =.38). However, as noted before, the rate of disease-free survival was 82% in the nodal irradiation group, compared with 77% in the control group (HR, 0.76, P = .01).

When they looked at adverse effects of the additional radiation, however, the investigators found that rates of grade 2 or greater acute pneumonitis were 1.2% among nodal irradiation patients, compared with just 0.2% of controls (P = .001). Lymphedema rates were also nearly twice as high among nodally irradiated patients (8.4% vs. 4.5%, respectively, P = .001).

The authors concluded that the addition of regional nodal irradiation to whole-breast irradiation after breast-conserving surgery in women with node-positive or high-risk node-negative breast cancer did not improve overall survival but did reduce breast-cancer recurrence. “Our findings indicate the importance of basing treatment decisions on a careful discussion of the potential benefits and risks with each patient,” they wrote.

EORTC 22922/10925

In this trial, a total of 4004 women were randomized from 1996 through 2004. The patients had either centrally or medially located primary tumors, irrespective of axillary involvement, or an externally located tumor with axillary involvement.

Most of the women (76.1%) had breast-conserving surgery. Of those who underwent radical mastectomy 73.4% of the patients in both the nodal irradiation and control groups underwent chest wall irradiation.

All but 1% of patients with node-positive disease received adjuvant systemic therapy, as did 66.3% of patients with node-negative disease.

At 10 years, overall survival was not significantly different between the two groups, at 82.3% in the nodal irradiation group and 80.7% in the control group (HR, 0.87; P = 0.06).

As in the Canadian trial, the rate of disease-free survival was significantly better among patients who received nodal-irradiation, at 72.1% vs. 69.1% (HR for disease progression or death, 0.89; P = .04).

Regional nodal irradiation was also associated with significantly better distant disease-free survival (78.0% vs. 75.0%; HR, 0.86; P = .02), and breast cancer mortality (12.5% vs.14.4%; HR, 0.82; P = .02).

The rate of pulmonary fibrosis at 10 years was higher among patients in the nodal irradiation group (4.4% vs. 1.7%, P < .001). Rates of cardiac fibrosis and cardiac disease were also numerically but not significantly higher among patients who received nodal irradiation. There were no other significant differences between the groups in other late toxic effects or performance status, the authors reported.

“Our data do not apply to patients with lateral node-negative cancers, which is the largest patient subgroup in industrialized countries,” they noted.

The MA.20 study was supported by grants from the Canadian Cancer Society Research Institute, NCIC Clinical Trials Group, Canadian Breast Cancer Research Initiative, U.S. National Cancer Institute, and the Cancer Council of Victoria, New South Wales, Queensland, and South Australia. Dr. Whelan reported receiving fees for serving on an advisory board from Genomic Health and testing reagents for another study from NanoString Technologies. The EORTC study was supported by the EORTC and national health agencies. Dr. Poortmans reported no conflicts of interest. Dr. Burstein reported no conflicts of interest. Dr. Morrow reported personal fees from Genomic Health outside the submitted work.

Regional nodal irradiation added to whole-breast or thoracic wall irradiation in an unselected patient population reduces breast cancer recurrence rates and improves disease-free and distant disease-free survival, but has little or no effect on overall survival, results of two large, long-term, randomized clinical trials show.

In the MA.20 trial, there was no significant difference in overall survival at 10-year follow-up between women with early breast cancer treated with breast-conserving surgery, adjuvant systemic therapy, and whole-breast irradiation with or without regional nodal irradiation.

Women who received nodal irradiation had significantly better disease-free survival, but at the cost of higher rates of pneumonitis and lymphedema, report Dr. Timothy J. Whelan from the Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton, Ont., and his colleagues in the July 23 issue of the New England Journal of Medicine (doi:10.1056/NEJMoa1415340).

In the EORTC 22922/10925 study, investigators in the European Organization for Research and Treatment of Cancer randomly assigned women with a centrally or medially located primary tumor irrespective of axillary involvement, or an externally located tumor with axillary involvement, to receive either whole-breast or thoracic wall irradiation alone, or with the addition of regional nodal irradiation.

As in the Canadian study, the investigators found no difference in overall survival at 10 years between women who received nodal irradiation and those who did not. Similarly, the EORTC investigators found that rates of disease-free survival and distant disease-free survival were better among women who received nodal irradiation. The nodal irradiation group also had a significantly lower rate of breast cancer–specific death. The European investigators, however, felt that “the acute side effects of regional nodal irradiation were modest.” The study, by Dr. Philip M. Poortmans of Radboud University in Nijmegen, the Netherlands, also appears in the New England Journal of Medicine (2015 July 23 [doi:10.1056/NEJMoa1415369]).

“The trials by Whelan et al. and Poortmans et al. show the possibilities and the limits of more extensive regional treatment of breast cancer in an unselected population and frame the discussion for the next generation of individualized treatment programs, built largely on genomic characterization of tumor biology,” write Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston and Dr. Monica Morrow of the Memorial Sloan Kettering Cancer in New York, in an accompanying editorial.

MA.20

From March 2000 through February 2007, Dr. Whelan and colleagues in the MA.20 trial enrolled 1,832 women with node-positive or high-risk node-negative cancer treated with breast-conserving surgery and adjuvant systemic therapy. The women were randomly assigned, 916 in each group, to undergo either whole-breast irradiation plus regional nodal irradiation (including internal mammary, supraclavicular, and axillary lymph node), or whole-breast irradiation alone (controls).

At 10-year follow-up, overall survival rates were similar, at 82.8% in the nodal irradiation group and 81.8% in the control group (hazard ratio, 0.91, P =.38). However, as noted before, the rate of disease-free survival was 82% in the nodal irradiation group, compared with 77% in the control group (HR, 0.76, P = .01).

When they looked at adverse effects of the additional radiation, however, the investigators found that rates of grade 2 or greater acute pneumonitis were 1.2% among nodal irradiation patients, compared with just 0.2% of controls (P = .001). Lymphedema rates were also nearly twice as high among nodally irradiated patients (8.4% vs. 4.5%, respectively, P = .001).

The authors concluded that the addition of regional nodal irradiation to whole-breast irradiation after breast-conserving surgery in women with node-positive or high-risk node-negative breast cancer did not improve overall survival but did reduce breast-cancer recurrence. “Our findings indicate the importance of basing treatment decisions on a careful discussion of the potential benefits and risks with each patient,” they wrote.

EORTC 22922/10925

In this trial, a total of 4004 women were randomized from 1996 through 2004. The patients had either centrally or medially located primary tumors, irrespective of axillary involvement, or an externally located tumor with axillary involvement.

Most of the women (76.1%) had breast-conserving surgery. Of those who underwent radical mastectomy 73.4% of the patients in both the nodal irradiation and control groups underwent chest wall irradiation.

All but 1% of patients with node-positive disease received adjuvant systemic therapy, as did 66.3% of patients with node-negative disease.

At 10 years, overall survival was not significantly different between the two groups, at 82.3% in the nodal irradiation group and 80.7% in the control group (HR, 0.87; P = 0.06).

As in the Canadian trial, the rate of disease-free survival was significantly better among patients who received nodal-irradiation, at 72.1% vs. 69.1% (HR for disease progression or death, 0.89; P = .04).

Regional nodal irradiation was also associated with significantly better distant disease-free survival (78.0% vs. 75.0%; HR, 0.86; P = .02), and breast cancer mortality (12.5% vs.14.4%; HR, 0.82; P = .02).

The rate of pulmonary fibrosis at 10 years was higher among patients in the nodal irradiation group (4.4% vs. 1.7%, P < .001). Rates of cardiac fibrosis and cardiac disease were also numerically but not significantly higher among patients who received nodal irradiation. There were no other significant differences between the groups in other late toxic effects or performance status, the authors reported.

“Our data do not apply to patients with lateral node-negative cancers, which is the largest patient subgroup in industrialized countries,” they noted.

The MA.20 study was supported by grants from the Canadian Cancer Society Research Institute, NCIC Clinical Trials Group, Canadian Breast Cancer Research Initiative, U.S. National Cancer Institute, and the Cancer Council of Victoria, New South Wales, Queensland, and South Australia. Dr. Whelan reported receiving fees for serving on an advisory board from Genomic Health and testing reagents for another study from NanoString Technologies. The EORTC study was supported by the EORTC and national health agencies. Dr. Poortmans reported no conflicts of interest. Dr. Burstein reported no conflicts of interest. Dr. Morrow reported personal fees from Genomic Health outside the submitted work.

Regional nodal irradiation added to whole-breast or thoracic wall irradiation in an unselected patient population reduces breast cancer recurrence rates and improves disease-free and distant disease-free survival, but has little or no effect on overall survival, results of two large, long-term, randomized clinical trials show.

In the MA.20 trial, there was no significant difference in overall survival at 10-year follow-up between women with early breast cancer treated with breast-conserving surgery, adjuvant systemic therapy, and whole-breast irradiation with or without regional nodal irradiation.

Women who received nodal irradiation had significantly better disease-free survival, but at the cost of higher rates of pneumonitis and lymphedema, report Dr. Timothy J. Whelan from the Juravinski Cancer Centre at Hamilton Health Sciences in Hamilton, Ont., and his colleagues in the July 23 issue of the New England Journal of Medicine (doi:10.1056/NEJMoa1415340).

In the EORTC 22922/10925 study, investigators in the European Organization for Research and Treatment of Cancer randomly assigned women with a centrally or medially located primary tumor irrespective of axillary involvement, or an externally located tumor with axillary involvement, to receive either whole-breast or thoracic wall irradiation alone, or with the addition of regional nodal irradiation.

As in the Canadian study, the investigators found no difference in overall survival at 10 years between women who received nodal irradiation and those who did not. Similarly, the EORTC investigators found that rates of disease-free survival and distant disease-free survival were better among women who received nodal irradiation. The nodal irradiation group also had a significantly lower rate of breast cancer–specific death. The European investigators, however, felt that “the acute side effects of regional nodal irradiation were modest.” The study, by Dr. Philip M. Poortmans of Radboud University in Nijmegen, the Netherlands, also appears in the New England Journal of Medicine (2015 July 23 [doi:10.1056/NEJMoa1415369]).

“The trials by Whelan et al. and Poortmans et al. show the possibilities and the limits of more extensive regional treatment of breast cancer in an unselected population and frame the discussion for the next generation of individualized treatment programs, built largely on genomic characterization of tumor biology,” write Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston and Dr. Monica Morrow of the Memorial Sloan Kettering Cancer in New York, in an accompanying editorial.

MA.20

From March 2000 through February 2007, Dr. Whelan and colleagues in the MA.20 trial enrolled 1,832 women with node-positive or high-risk node-negative cancer treated with breast-conserving surgery and adjuvant systemic therapy. The women were randomly assigned, 916 in each group, to undergo either whole-breast irradiation plus regional nodal irradiation (including internal mammary, supraclavicular, and axillary lymph node), or whole-breast irradiation alone (controls).

At 10-year follow-up, overall survival rates were similar, at 82.8% in the nodal irradiation group and 81.8% in the control group (hazard ratio, 0.91, P =.38). However, as noted before, the rate of disease-free survival was 82% in the nodal irradiation group, compared with 77% in the control group (HR, 0.76, P = .01).

When they looked at adverse effects of the additional radiation, however, the investigators found that rates of grade 2 or greater acute pneumonitis were 1.2% among nodal irradiation patients, compared with just 0.2% of controls (P = .001). Lymphedema rates were also nearly twice as high among nodally irradiated patients (8.4% vs. 4.5%, respectively, P = .001).

The authors concluded that the addition of regional nodal irradiation to whole-breast irradiation after breast-conserving surgery in women with node-positive or high-risk node-negative breast cancer did not improve overall survival but did reduce breast-cancer recurrence. “Our findings indicate the importance of basing treatment decisions on a careful discussion of the potential benefits and risks with each patient,” they wrote.

EORTC 22922/10925

In this trial, a total of 4004 women were randomized from 1996 through 2004. The patients had either centrally or medially located primary tumors, irrespective of axillary involvement, or an externally located tumor with axillary involvement.

Most of the women (76.1%) had breast-conserving surgery. Of those who underwent radical mastectomy 73.4% of the patients in both the nodal irradiation and control groups underwent chest wall irradiation.

All but 1% of patients with node-positive disease received adjuvant systemic therapy, as did 66.3% of patients with node-negative disease.

At 10 years, overall survival was not significantly different between the two groups, at 82.3% in the nodal irradiation group and 80.7% in the control group (HR, 0.87; P = 0.06).

As in the Canadian trial, the rate of disease-free survival was significantly better among patients who received nodal-irradiation, at 72.1% vs. 69.1% (HR for disease progression or death, 0.89; P = .04).

Regional nodal irradiation was also associated with significantly better distant disease-free survival (78.0% vs. 75.0%; HR, 0.86; P = .02), and breast cancer mortality (12.5% vs.14.4%; HR, 0.82; P = .02).

The rate of pulmonary fibrosis at 10 years was higher among patients in the nodal irradiation group (4.4% vs. 1.7%, P < .001). Rates of cardiac fibrosis and cardiac disease were also numerically but not significantly higher among patients who received nodal irradiation. There were no other significant differences between the groups in other late toxic effects or performance status, the authors reported.

“Our data do not apply to patients with lateral node-negative cancers, which is the largest patient subgroup in industrialized countries,” they noted.

The MA.20 study was supported by grants from the Canadian Cancer Society Research Institute, NCIC Clinical Trials Group, Canadian Breast Cancer Research Initiative, U.S. National Cancer Institute, and the Cancer Council of Victoria, New South Wales, Queensland, and South Australia. Dr. Whelan reported receiving fees for serving on an advisory board from Genomic Health and testing reagents for another study from NanoString Technologies. The EORTC study was supported by the EORTC and national health agencies. Dr. Poortmans reported no conflicts of interest. Dr. Burstein reported no conflicts of interest. Dr. Morrow reported personal fees from Genomic Health outside the submitted work.

Breast cancer is the most frequently diagnosed cancer in women, with an estimated 231,840 new cases representing 14.0% of all new cancer cases in the United States in 2015.¹ Early screening and modern techniques of imaging and diagnosis have led to a significant improvement in detecting early-stage breast cancers and to a decrease in the incidence of metastatic breast cancer (MBC).² About 20%-30% of patients who are initially diagnosed with an early-stage, nonmetastatic breast cancer will subsequently develop a distant metastatic disease. Between 6%-10% of the new breast cancer cases present initially as stage IV, referred to as de novo MBC.

Click on the PDF icon at the top of this introduction to read the full article.

Breast cancer is the most frequently diagnosed cancer in women, with an estimated 231,840 new cases representing 14.0% of all new cancer cases in the United States in 2015.¹ Early screening and modern techniques of imaging and diagnosis have led to a significant improvement in detecting early-stage breast cancers and to a decrease in the incidence of metastatic breast cancer (MBC).² About 20%-30% of patients who are initially diagnosed with an early-stage, nonmetastatic breast cancer will subsequently develop a distant metastatic disease. Between 6%-10% of the new breast cancer cases present initially as stage IV, referred to as de novo MBC.

Click on the PDF icon at the top of this introduction to read the full article.

Breast cancer is the most frequently diagnosed cancer in women, with an estimated 231,840 new cases representing 14.0% of all new cancer cases in the United States in 2015.¹ Early screening and modern techniques of imaging and diagnosis have led to a significant improvement in detecting early-stage breast cancers and to a decrease in the incidence of metastatic breast cancer (MBC).² About 20%-30% of patients who are initially diagnosed with an early-stage, nonmetastatic breast cancer will subsequently develop a distant metastatic disease. Between 6%-10% of the new breast cancer cases present initially as stage IV, referred to as de novo MBC.

Click on the PDF icon at the top of this introduction to read the full article.

Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

klennon@frontlinemedicalnews.com

Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

klennon@frontlinemedicalnews.com

Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.

The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.

The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.

“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.

Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).

This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.

klennon@frontlinemedicalnews.com

In regions where more women undergo screening mammography, the detection of small cancers increases but mortality doesn’t change significantly, compared with regions where fewer women have the screening, according to a report published July 6 in JAMA Internal Medicine.

The finding indicates that screening mammography leads to “widespread overdiagnosis,” identifying many small, indolent, or regressive breast tumors that otherwise would not have become clinically apparent, reported Charles Harding, a data scientist and statistical analyst in Seattle, and his associates.

Ideally, screening mammography should result in increased detection of small (less advanced) cancers, decreased detection of large (more advanced) cancers, and reduced breast cancer–specific mortality. To examine whether this is what actually happens, Mr. Harding and his colleagues analyzed mammography rates among 16,120,349 women over age 40 residing in 547 counties across the country during a 1-year period, where the frequency of screening ranged from 39% to 78%.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

They correlated these findings with breast cancer incidence and mortality data in those regions for the ensuing 10 years. They identified 53,207 incident cases of breast cancer for their primary analysis.

There was a clear correlation between the number of users of screening mammography and breast cancer incidence. A 10% increase in screening was associated with a 16% mean increase in breast cancer incidence (relative risk, 1.16), or an absolute increase of 35-49 cases per 100,000. However, there was no significant change in breast cancer mortality (RR, 1.01).

When the data were stratified according to tumor size, the researchers found that the increase in breast cancer was confined to small tumors only (2 cm or less).

Moreover, “although it has been hoped that screening would allow breast-conserving surgical procedures to replace more extensive mastectomies, we saw no evidence supporting this change,” the investigators wrote (JAMA Intern. Med. 2015 July 6 [doi:10.1001/jamainternmed.2015.3043]).

Future research should focus on whether all women undergoing screening mammography have the same risk of overdiagnosis, or if overdiagnosis is more likely to occur in certain groups, Mr. Harding and his associates added.

Mr. Harding reported receiving funding from Exergen Corporation for this work. Another study author, Francesco Pompei, Ph.D., is founder and chief executive officer of Exergen. Exergen is a designer and manufacturer of medical and other devices. No other financial disclosures were reported.

In regions where more women undergo screening mammography, the detection of small cancers increases but mortality doesn’t change significantly, compared with regions where fewer women have the screening, according to a report published July 6 in JAMA Internal Medicine.

The finding indicates that screening mammography leads to “widespread overdiagnosis,” identifying many small, indolent, or regressive breast tumors that otherwise would not have become clinically apparent, reported Charles Harding, a data scientist and statistical analyst in Seattle, and his associates.

Ideally, screening mammography should result in increased detection of small (less advanced) cancers, decreased detection of large (more advanced) cancers, and reduced breast cancer–specific mortality. To examine whether this is what actually happens, Mr. Harding and his colleagues analyzed mammography rates among 16,120,349 women over age 40 residing in 547 counties across the country during a 1-year period, where the frequency of screening ranged from 39% to 78%.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

They correlated these findings with breast cancer incidence and mortality data in those regions for the ensuing 10 years. They identified 53,207 incident cases of breast cancer for their primary analysis.

There was a clear correlation between the number of users of screening mammography and breast cancer incidence. A 10% increase in screening was associated with a 16% mean increase in breast cancer incidence (relative risk, 1.16), or an absolute increase of 35-49 cases per 100,000. However, there was no significant change in breast cancer mortality (RR, 1.01).

When the data were stratified according to tumor size, the researchers found that the increase in breast cancer was confined to small tumors only (2 cm or less).

Moreover, “although it has been hoped that screening would allow breast-conserving surgical procedures to replace more extensive mastectomies, we saw no evidence supporting this change,” the investigators wrote (JAMA Intern. Med. 2015 July 6 [doi:10.1001/jamainternmed.2015.3043]).

Future research should focus on whether all women undergoing screening mammography have the same risk of overdiagnosis, or if overdiagnosis is more likely to occur in certain groups, Mr. Harding and his associates added.

Mr. Harding reported receiving funding from Exergen Corporation for this work. Another study author, Francesco Pompei, Ph.D., is founder and chief executive officer of Exergen. Exergen is a designer and manufacturer of medical and other devices. No other financial disclosures were reported.

In regions where more women undergo screening mammography, the detection of small cancers increases but mortality doesn’t change significantly, compared with regions where fewer women have the screening, according to a report published July 6 in JAMA Internal Medicine.

The finding indicates that screening mammography leads to “widespread overdiagnosis,” identifying many small, indolent, or regressive breast tumors that otherwise would not have become clinically apparent, reported Charles Harding, a data scientist and statistical analyst in Seattle, and his associates.

Ideally, screening mammography should result in increased detection of small (less advanced) cancers, decreased detection of large (more advanced) cancers, and reduced breast cancer–specific mortality. To examine whether this is what actually happens, Mr. Harding and his colleagues analyzed mammography rates among 16,120,349 women over age 40 residing in 547 counties across the country during a 1-year period, where the frequency of screening ranged from 39% to 78%.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

They correlated these findings with breast cancer incidence and mortality data in those regions for the ensuing 10 years. They identified 53,207 incident cases of breast cancer for their primary analysis.

There was a clear correlation between the number of users of screening mammography and breast cancer incidence. A 10% increase in screening was associated with a 16% mean increase in breast cancer incidence (relative risk, 1.16), or an absolute increase of 35-49 cases per 100,000. However, there was no significant change in breast cancer mortality (RR, 1.01).

When the data were stratified according to tumor size, the researchers found that the increase in breast cancer was confined to small tumors only (2 cm or less).

Moreover, “although it has been hoped that screening would allow breast-conserving surgical procedures to replace more extensive mastectomies, we saw no evidence supporting this change,” the investigators wrote (JAMA Intern. Med. 2015 July 6 [doi:10.1001/jamainternmed.2015.3043]).

Future research should focus on whether all women undergoing screening mammography have the same risk of overdiagnosis, or if overdiagnosis is more likely to occur in certain groups, Mr. Harding and his associates added.

Mr. Harding reported receiving funding from Exergen Corporation for this work. Another study author, Francesco Pompei, Ph.D., is founder and chief executive officer of Exergen. Exergen is a designer and manufacturer of medical and other devices. No other financial disclosures were reported.

Breast cancer is no longer the monolithic disease it once was. And now, depending on the type of breast cancer a patient has, appropriate treatment is getting easier. According to the Annual Report to the Nation on the Status of Cancer, 1975-2011, released by the National Cancer Institute (NCI) in Bethesda, Maryland, there are data on the national incidence of the 4 major molecular subtypes of breast cancer by age, race and ethnicity, socioeconomic level, and other factors for the first time.

Related: Advances in Targeted Therapy for Breast Cancer

Although the subtypes—which relate to the hormone receptor (HR) status and expression of the HER₂ gene—were already known prior to the report, incidence was not. But beginning in 2010, cancer registries have been required to report both HR and HER₂ status for breast cancer cases. Being able to divide the data in previously unavailable ways will help researchers more accurately stratify breast cancer by risk, NCI says.

The least aggressive breast cancer subtype, HR+/HER₂- was the most prevalent, at 73% of all breast cancer cases. Rates were highest among non-Hispanic whites living in low-poverty areas.

Related: Timely Assessment of Cancer Symptoms

“Triple-negative” breast cancer, HR-/HER₂-, made up 13% of all cases and had the worst prognosis. Non-Hispanic blacks had the highest rates of triple-negative breast cancer, as well as the highest rates of late-stage disease and poorly/undifferentiated pathology.

The HR+/HER₂+ breast cancer, which accounted for 10% of all cases, was more common in Idaho, Tennessee, and Pennsylvania. No states were statistically different from the national rates for HR-/HER₂+, which accounted for 5% of all cases. Triple-negative rates were lower in the northwestern U.S. and higher in the southeastern U.S.

Related: Can Endocrine Therapy Adherence Be Improved?

The data can also be used to help women better understand health implications based on their breast cancer subtype. In one study cited by NCI, slightly more than half of the women reported their correct estrogen status, HER₂ status, and stage of cancer. Only about 1 in 5 reported the correct grade. However, women who understood the basis for their treatment, the researchers found, were generally more satisfied with treatment.

Sources
National Cancer Institute. New analysis of breast cancer subtypes could lead to better risk stratification; Annual Report to the Nation shows that mortality and incidence for most cancers continue to decline [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975-2011. Bethesda, MD: National Cancer Institute; 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975 -2011: questions and answers [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.

Breast cancer is no longer the monolithic disease it once was. And now, depending on the type of breast cancer a patient has, appropriate treatment is getting easier. According to the Annual Report to the Nation on the Status of Cancer, 1975-2011, released by the National Cancer Institute (NCI) in Bethesda, Maryland, there are data on the national incidence of the 4 major molecular subtypes of breast cancer by age, race and ethnicity, socioeconomic level, and other factors for the first time.

Related: Advances in Targeted Therapy for Breast Cancer

Although the subtypes—which relate to the hormone receptor (HR) status and expression of the HER₂ gene—were already known prior to the report, incidence was not. But beginning in 2010, cancer registries have been required to report both HR and HER₂ status for breast cancer cases. Being able to divide the data in previously unavailable ways will help researchers more accurately stratify breast cancer by risk, NCI says.

The least aggressive breast cancer subtype, HR+/HER₂- was the most prevalent, at 73% of all breast cancer cases. Rates were highest among non-Hispanic whites living in low-poverty areas.

Related: Timely Assessment of Cancer Symptoms

“Triple-negative” breast cancer, HR-/HER₂-, made up 13% of all cases and had the worst prognosis. Non-Hispanic blacks had the highest rates of triple-negative breast cancer, as well as the highest rates of late-stage disease and poorly/undifferentiated pathology.

The HR+/HER₂+ breast cancer, which accounted for 10% of all cases, was more common in Idaho, Tennessee, and Pennsylvania. No states were statistically different from the national rates for HR-/HER₂+, which accounted for 5% of all cases. Triple-negative rates were lower in the northwestern U.S. and higher in the southeastern U.S.

Related: Can Endocrine Therapy Adherence Be Improved?

The data can also be used to help women better understand health implications based on their breast cancer subtype. In one study cited by NCI, slightly more than half of the women reported their correct estrogen status, HER₂ status, and stage of cancer. Only about 1 in 5 reported the correct grade. However, women who understood the basis for their treatment, the researchers found, were generally more satisfied with treatment.

Sources
National Cancer Institute. New analysis of breast cancer subtypes could lead to better risk stratification; Annual Report to the Nation shows that mortality and incidence for most cancers continue to decline [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975-2011. Bethesda, MD: National Cancer Institute; 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975 -2011: questions and answers [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.

Breast cancer is no longer the monolithic disease it once was. And now, depending on the type of breast cancer a patient has, appropriate treatment is getting easier. According to the Annual Report to the Nation on the Status of Cancer, 1975-2011, released by the National Cancer Institute (NCI) in Bethesda, Maryland, there are data on the national incidence of the 4 major molecular subtypes of breast cancer by age, race and ethnicity, socioeconomic level, and other factors for the first time.

Related: Advances in Targeted Therapy for Breast Cancer

Although the subtypes—which relate to the hormone receptor (HR) status and expression of the HER₂ gene—were already known prior to the report, incidence was not. But beginning in 2010, cancer registries have been required to report both HR and HER₂ status for breast cancer cases. Being able to divide the data in previously unavailable ways will help researchers more accurately stratify breast cancer by risk, NCI says.

The least aggressive breast cancer subtype, HR+/HER₂- was the most prevalent, at 73% of all breast cancer cases. Rates were highest among non-Hispanic whites living in low-poverty areas.

Related: Timely Assessment of Cancer Symptoms

“Triple-negative” breast cancer, HR-/HER₂-, made up 13% of all cases and had the worst prognosis. Non-Hispanic blacks had the highest rates of triple-negative breast cancer, as well as the highest rates of late-stage disease and poorly/undifferentiated pathology.

The HR+/HER₂+ breast cancer, which accounted for 10% of all cases, was more common in Idaho, Tennessee, and Pennsylvania. No states were statistically different from the national rates for HR-/HER₂+, which accounted for 5% of all cases. Triple-negative rates were lower in the northwestern U.S. and higher in the southeastern U.S.

Related: Can Endocrine Therapy Adherence Be Improved?

The data can also be used to help women better understand health implications based on their breast cancer subtype. In one study cited by NCI, slightly more than half of the women reported their correct estrogen status, HER₂ status, and stage of cancer. Only about 1 in 5 reported the correct grade. However, women who understood the basis for their treatment, the researchers found, were generally more satisfied with treatment.

Sources
National Cancer Institute. New analysis of breast cancer subtypes could lead to better risk stratification; Annual Report to the Nation shows that mortality and incidence for most cancers continue to decline [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975-2011. Bethesda, MD: National Cancer Institute; 2015.

National Cancer Institute. Annual Report to the Nation on the Status of Cancer, 1975 -2011: questions and answers [press release]. Bethesda, MD: National Cancer Institute; March 30, 2015.