National Consortium of Breast Centers - 25th Annual Meeting, 2015
Summary Impressions: Select Clinical Sessions
Rufus J. Mark, MD
Radiation Oncologist, Banner-University Medical Center Phoenix, AZ
Co-Editor, NCBC The Breast Center Bulletin
The American Cancer Society estimates that 231,840 American women will be diagnosed with breast cancer in 2015, and that 40,290 will die from the disease. To put these sobering numbers in perspective, about 4,000 American GIs died in 10 years in the recent Iraq War. So, despite the exciting progress we are experiencing in breast cancer, we still have a long way to go.
Daniel Kopans, MD, FACR, Professor of Radiology at Harvard Medical School, and founding Director of the Breast Imaging Division of Massachusetts General Hospital presented a comprehensive review of the results of Screening Mammography, and a worrisome trend of opposition to Mammogram Screening among certain media sources and medical journals.
At least 8 large randomized trials with long-term follow-up have demonstrated ~ 30-50% reduction in mortality with Mammogram Screening beginning at the age of 40. One trial with major flaws, the Canadian National Breast Cancer Screening Study (CNBSS), published 25 year follow-up data concluding that there was no survival benefit from Screening Mammography for women aged 40-59. The flaws of the CNBSS include the following.
|•||the use of old equipment|
|•||no Mammogram grids|
|•||straight lateral views only|
|•||no training of Mammogram Technologists|
|•||no breast imaging training of Radiologists|
|•||9 cm mammogram diagnosed tumors in the screened group vs. 2.1 cm tumors in the control arm|
|•||patient cross over from the control group to the screening group because women and breast cancer care givers knew the benefits of mammography.|
Notably, the flawed results of the CNBSS have been ignored by physicians and care givers in Canada. Women are advised to begin annual Mammogram Screening at age 40.
Remarkably and disturbingly, the CNBSS has received a great deal of attention in the media and major medical journals, including the New York Times and the New England Journal of Medicine. The flawed results of the CNBSS led the United States Preventive Services Task Force (USPSTF) to issue relaxed guidelines on Breast Screening. Specifically, the USPSTF recommends that screening begin at 50, and be done every other year. This is in stark contrast to the recommendations of multiple other organizations including, the American Cancer Society, American College of Radiology, American Congress of Obstetricians and Gynecologists, Society of Breast Imaging, and National Accreditation Program for Breast Centers, all of which recommend annual Screening Mammogram beginning at age 40. Dr. Kopans emphasized that breast cancer is an important issue for women in their 40s. About 50% of breast cancer deaths occur in women less than age 50 vs. 13% women older than 70.
Notably, and again disturbingly, the USPSTF panel does not include any professionals involved in taking care of breast cancer patients. There are no radiologists, surgical oncologists, radiation oncologists, or medical oncologists, serving on the USPSTF. Even more disturbingly,
Dr. Kopans and other notable figures have tried to refute the statements of the USPSTF and CNBSS momentum in the media and the New England Journal of Medicine, but have been ignored. The committee essentially ignored Laszlo Tabar MD’s landmark, two-county, population-based mammography screening program in Sweden, now with >30 year follow up, that clearly demonstrated a reduction in mortality due to mammography screening.
Dr. Kopans also addressed the issue of the media exaggerating the risk of Mammography causing cancer. There is no clinical evidence that annual Mammography in women starting at age 40 causes cancer. All of the statements and publications on this subject have been based on extrapolated models, not actual clinical data. In addition, none of these statements or publications take into account the ~30-50% reduction in breast cancer mortality from Screening Mammography which is far greater than the extrapolated Mammogram induced cancer risk, let alone mortality.
Concern has been raised about radiation exposure from Screening Mammography and potential future cancer risk. It is important to remember that we are all unavoidably exposed to background radiation dose from the earth and space in our daily lives. The radiation exposure dose from a Screening Mammogram is 0.4 mSV. This is the same dose we get from background exposure in our daily lives every 7 weeks. At altitude, the radiation exposure is higher because of less protection from the ozone layer. The annual effective radiation exposure dose to airline pilots and flight attendants has been calculated at 3.07 mSV. This is about 10 times the exposure of annual Screening Mammography. No increase in cancer diagnosis has ever been reported in these occupations. In addition, people who live at higher altitudes in Denver Colorado, the Andes, the Alps, and Tibet, have never been reported to have a higher incidence of cancer.
Gary Levine, MD, Medical Director of Memorial Care Breast Centers at several sites in Southern California, and Sarah Friedewald, MD, Medical Director of the Lynn Sage Comprehensive Breast Center at Northwestern Memorial, among others, gave presentations on the results of Screening Mammogram 3-D Tomosynthesis. In one notable study, the Oslo Tomosynthesis Trial reviewed 12,631 women who underwent 2D-Mammogram and then 2-D + 3-D Tomosynthesis. There was a 27% increase in cancer detection, 40% increase in invasive cancer detection, and 15% decrease in false positives in the 3-D Tomosynthesis group. These results have been confirmed in many other studies. In the Italian STORM Trial, 7,292 women underwent 2-D Mammogram and then 2-D + 3-D Tomosynthesis. Results included 34% increase in invasive cancer detection. Dr. Friedewald reviewed the results of a 13 Institution Cooperative Study, in which 454,850 women were studied. A total of 281,187 2-D studies were done and 173,663 2D + 3D Tomosynthesis examinations were performed. The reported results included 29% increase in cancer detection, 41% increase in invasive cancer detection, and 15% decrease in recalls. Women with dense breasts gain particular benefit from 3-D Screening. 3-D Tomosynthesis is well on the way to becoming the standard of care for Breast Cancer Screening.
Melvin Silverstein, MD, FACS, Director of Hoag Breast Cancer Program in Newport Beach, CA reviewed the subject of breast conservation radiation therapy, with particular emphasis on the results of Intra-Operative Radiation Therapy (IORT). In the early 1980s, 6 randomized trials enrolling more than 6,000 patients were published demonstrating that mastectomy offered no advantage over lumpectomy + External Radiation Therapy (XRT) to the whole breast, with regard to overall survival, disease free survival, and local-regional recurrence. The New England Journal of Medicine, in a 20-year update of these trials, reached the same conclusion. In a 1992 consensus statement, the National Cancer Institute reported that breast conservation therapy with XRT was the preferred method of treatment for women with Stage I/II breast cancer because it achieved the same survival as mastectomy while preserving the breast. In interviews conducted by the National Cancer Institute, 90% of women rated their cosmetic results as very good. When asked if they could make the choice again about breast conservation XRT, 98% of women said that they would undergo XRT again.
These original XRT protocols generally called for 6 weeks of daily XRT. Starting in the late 1990s, trials exploring more rapid radiation delivery to the partial breast (Accelerated Partial Breast Irradiation) in 1 week began. Most of these APBI trials used High Dose Rate (HDR) technique. Now, long-term results up to 15 years have shown that 1 week APBI achieves the same cancer control and cosmetic outcomes as 6 week XRT. Two randomized trials in Europe showed no difference between APBI with HDR vs. XRT with respect to local breast cancer recurrence and cosmesis. Most recently, IORT given in 1 day at the time of surgery has been investigated in the ELIOT and TARGIT Trials. In the ELIOT Trial, 1,305 patients with tumors < 2.5 cm were randomized to 6 weeks of XRT vs. IORT. With 5 year follow-up, patients who underwent XRT experienced 0.4% local recurrence vs. 4.4% with IORT (p=0.0002). Overall survival was the same. In the TARGIT Trial, 3,451 patients were randomized. With a median follow-up of 29 months, the 5 year calculated actuarial local recurrence was 1.3% with XRT vs. 3.3% with IORT (p=0.042). In conclusion, the ELIOT and TARGIT Trials have shown excellent local tumor control with 1 day IORT. With up to 5 year follow-up, there has been minimal increase in local recurrence with 1 day of IORT vs. 6 weeks of XRT, but longer-term follow up would be required for general acceptance. In addition, there are few centers in the United States offering IORT, although the number is growing.
Claudine Isaacs, MD, Co-Director of the Fisher Center of Familial Cancer Research and Lombardi Cancer Center at Georgetown University gave an update on the explosion of discovery surrounding genetic testing and treatment of cancer. Multi-Gene Panel Testing has led to the identification of an increasingly bewildering number of multiple genes involved in the subsequent development of cancer. These now include, BRCA 1 and 2, p53, PTEN, CDH1, PALB2, EPCAM, MLH1, MSH2, MSH6, PMS2, PTEN, STK11, TP53, ATM, CHEK2, BARD1, BRIP1, FANCC, NBN, RAD51C, RAD51D, and XRCC2. These genes and mutations therein have in turn led to the identification of the risk of the development of cancers of the breast, ovary, prostate, pancreas, colon, rectum, stomach, gallbladder, biliary duct, soft tissues, brain, kidney and uterus. Such discovery has led to fear by some who say that we do not know what to do with such knowledge, and that we will cause fear in patients. The answer to this concern should be that ultimately knowledge is power. These discoveries have already led to identification of people who have these genetic risks who then should be screened more aggressively for cancers. In addition, treatments can now be recommended for people who are at exceptionally high risk. These include bilateral mastectomy and bilateral oophorectomy for BRCA 1 and 2 patients. We are at the dawn of a new frontier in medicine. We now have a vaccine (Gardisil) which can prevent ~90% of all cervix cancers. We have an antibody (Rituxan) which is effective in treating CD-20 antigen positive lymphomas. Imagine a day when we may give vaccine cocktails which can prevent many cancers, and give antibodies to treat many more. I am a Radiation Oncologist. I can now dream of a day when we will no longer need surgery, radiation, and chemotherapy to treat cancer.
Important breast cancer developments in 2014 in surgery, radiology, radiation oncology, and medical oncology were presented by a panel of experts in each field. They offered the following insights.
In surgery, Jay Harness, MD, FACS, from the Center for Cancer Prevention and Treatment St. Joseph Hospital, Orange, CA, reported that nipple sparing mastectomy has been proven in more than 300 publications to be a safe oncologic procedure. In consensus statements issued by multiple professional societies, including the American College of Surgery, American Society of Therapeutic Radiation Oncology, and American Society of Clinical Oncology, supported a standard of no ink at the surgical margin as adequate in breast cancer surgery. Finally, Dr. Harness stated that he believes IORT is a reasonable option for appropriate candidates with early stage breast cancer.
In radiology, Jay Parikh, MD, FACR, FACP, from MD Anderson Hospital, stated that 2D-3D Tomosynthesis and Ultrasound Screening are becoming the standard of care for Breast Cancer Screening.
In radiation oncology, Julia White, MD, from Ohio State University, reported a number of developments. The 12-Gene Recurrence Score for low risk Ductal Carcinoma In Situ predicts for an 8% recurrence risk of invasive cancer with local excision alone at 10 year follow-up. In the Norwegian Tumor Registry Study, the 10 year overall survival after lumpectomy + XRT achieved significantly better results than modified radical mastectomy in N1 positive patients. The results of a randomized trial in which 520 patients were randomized to 1 week of Accelerated Partial Breast Irradiation with non-invasive Intensity Modulated Radiation Therapy (IMRT) vs. 6 weeks of XRT were presented at the San Antonio Breast Cancer 2014 Conference. At 5 year follow-up, there was no significant difference in local recurrence or cosmesis.
In medical oncology, Nadine Tung, MD from Harvard Medical School reported a number of advances. NSABP-31 reported 10 year follow-up in a study of Her2/neu positive patients where Adriamycin + Cytoxan + Taxol + Herceptin gained 84% overall survival vs. 75% with the same regimen without Herceptin (JCO, 2014; 32: 3744). The result was statistically significant (p < 0.001). The CLEOPATRA Trial studied Her2/neu positive patients, in which Taxol + Trastuzumab + Pertuzumab was found to be superior to Taxol + Trastuzumab, with median survival of 57 months vs. 41 months (ESMO, 2014). In another important trial, neoadjuvant Taxol + Trastuzumab + Pertuzumab achieved 46% pathologic complete response rate vs. 29% Taxol + Trastuzumab alone (Lancet Oncol, 2012; 13: 25). In Triple Negative Breast Cancer (TNBC), the CALGB-40603 Trial reported that Carbolplatin containing regimens gained 54% pathologic complete response rate vs. 41% without (JCO, 2015; 33: 13). The result was statistically significant (p=0.0029). Long-term follow-up data on survival are pending. In another TNBC study, the TNT Trial, Carboplatin was compared to Taxol. There was no significant difference in response rate, progression free survival, or overall survival. However, in BRCA 1 and 2 positive patients, there was a 68% response rated in the Carboplatin group vs. 33% without (SABC, 2014). The difference was statistically significant (p=0.03). Finally, in a possible window into the future, Tumor Infiltrating Lymphocytes were found to predict response rate, disease free survival, and overall survival in TNBC (JCO, 2014; 32: 2935).
Harold Freeman, MD, a Surgical Oncologist, established the first Patient Navigation Program at Harlem Hospital Center in New York City in 1990. Initially, the program was funded through an American Cancer Society Grant designed to insure that breast cancer patients’ diagnoses and subsequent treatments were not delayed. In addition, the Grant funded low cost screening and community outreach. The results were impressive, the most important being a marked improvement in survival. In 1986, the 5 year survival of breast cancer patients diagnosed at Harlem Hospital was only 39%. By 2000, 10 years after institution of Patient Navigation, the 5 year survival had improved to 70%. The evolving functions of Navigators include coordination of patient care from screening to diagnosis and treatment, finding aid for funding for transportation, nutrition, and treatment, and enhancing communication and care coordination between care givers.
Dr. Freeman’s Program sparked a national movement, with similar Navigation Programs organized through the American Cancer Society, the National Cancer Institute, Medicare, and many other private organizations as well as hospitals and pharmaceutical companies. The results of Dr. Freeman’s Patient Navigation Program have been validated in many other studies. Following institution of a Patient Navigation Program at Lincoln Medical and Mental Health Center in New York City, patient no-show appointments decreased from 67% to 10%, time from initial consult to medical procedures decreased from 10 weeks to 2 weeks, and detection of early cancers increased by 50%. Other published benefits of Navigation include decreased time from an abnormal finding to diagnosis in breast, cervix, and prostate cancers as well as increased early cancer detection and improved survival. Today, Navigation Programs have expanded services, incorporating financial aid, transportation, nutritional support, coordination of patient care between physicians and ancillary services, improved communication between patients and physicians, and enhancement of patient compliance with treatment and follow-up. The National Consortium of Breast Centers initiated the navigation program in 2009 with a beta test and it has grown every year. This very successful program has recently been expanded to include all certified professionals as well as lay people.
As a result of the overwhelming success of Patient Navigation Programs, President Bush signed into law the Patient Navigator, Outreach and Chronic Disease Prevention Act in 2005. The law authorized $2.9 million in Federal Grants to hire and train Patient Navigators. The American College of Surgeon’s Commission on Cancer added Patient Navigation as a mandatory standard for Cancer Program Accreditation by 2015. The National Accreditation Program for Breast Centers [NAPBC] includes navigation as one of its standards as well. Funding for Navigation is now available through multiple organizations including the National Cancer Institute, Centers for Medicare and Medicaid Services, American Cancer Society, Susan Komen Foundation, Avon Foundation, Pfizer Foundation, and Amgen Foundation.
Patient Navigation Programs have had a major impact in saving lives and improving quality of care. However, challenges remain. Following evidence based medicine and in turn, complying with the National Comprehensive Cancer Network Guidelines, has not been consistently applied in programs across the United States. Medicare is currently studying the idea of mandating that physicians and hospitals follow NCCN guidelines in order to be reimbursed.
The preceding paragraphs serve as testimony to the progress that has been made in breast cancer over the past 25 years. Mammography and other imaging techniques, breast conservation surgery and radiation, chemotherapy, patient navigation, and now genetic mapping have saved millions of lives and breasts over this time. Organizations like the NCBC through education of health care providers and influencing legislation, have had a major impact on these results. Significant progress has been made in the war against breast cancer. Through improvements in breast imaging and patient navigation, more cancers are being detected at an earlier stage. Improvements in surgery, radiation treatment, and chemotherapy have led to improved survival and breast preservation. More lives are being saved and more breasts are being preserved. The rapid revolution in gene panels and tailored genetic treatment are the dawn of a new frontier. Vaccines to prevent breast cancer are no longer a far off dream. Together, through our collective efforts, we are in a position to make these noble goals happen faster. Let us not relax. The more effort we make today, the more lives we can save, and the more breasts we can preserve! One day we may even have vaccines to prevent breast cancer altogether. We are all dedicated professionals who are committed to a common goal. Our perseverance facilitates progress.
For more information, contact Rufus J. Mark, M.D at email@example.com
This article was submitted prior to the recent updated USPSTF recommendations.
Moving Forward Together - NCBC & ASBD Relationship
As Presidents of the National Consortium of Breast Centers (NCBC) and the American Society of Breast Disease (ASBD), it is our privilege to officially announce the integration of our two organizations. With over 65 years of combined experience, we bring together two organizations with essentially identical missions: the advancement of the interdisciplinary team approach to breast care with the goal of positively impacting quality while being sensitive to evidence-based, value-based care. While similar in mission and vision, our organizations offer unique expertise and together they will yield one stronger and more vibrant organization. We will exist as the National Consortium of Breast Centers, however the ASBD name, identity and moniker will continue to be valued and will appear in most organizational communications.
ASBD members will immediately become members in full standing of the NCBC through 2015. The Wiley Breast Journal will continue to be delivered to the ASBD membership, in a digital format.
Membership will renew on an annual basis. The renewal for all members will be identified as NCBC membership and the yearly membership rate is just $150, or $275 with the digital Wiley Journal.
Four members of the existing ASBD board have joined the NCBC Board of Directors and an ASBD Clinical Track Planning Committee will be tasked with developing (in conjunction with the overall conference planning committee) the Clinical Track for our Annual Symposium in 2016 and moving forward. We have many exciting projects underway at NCBC including our International Program, an expanded Navigation Program featuring the nation’s only Navigator Certification and a project underway to expand and improve our National Quality Measures for Breast Centers (NQMBC) program.
Our 25th Annual Interdisciplinary Breast Center Conference took place in Las Vegas, NV March 14-18, 2015. The exciting program that included several combined ASBD/NCBC Clinical Tracks was very well received.
In the coming months we will continue to periodically update the membership on this new promising relationship.
In summary, with over 65 years of combined experience, we bring together two organizations with essentially identical missions: the advancement of the interdisciplinary team approach to breast care with the goal of positively impacting quality while being sensitive to evidence-based, value-based care. While similar in mission and vision, our organizations offer unique expertise and together they will yield one stronger and more vibrant organization.
Looking To A Bright Future Together,
This NCBC award is given annually to an individual who has had a significant impact on the general area of breast health and specifically the concept and development of breast centers. The areas of achievement considered appropriate for this award include clinical research, product development and implementation, professional and patient education, patient and breast center advocacy, and advancement of patient care.
The recipient of this year’s 2015 Impact Award was Daniel B. Kopans, MD, FACR, Professor of Radiology, Harvard Medical School and Senior Radiologist, Breast Imaging Division, Dept. of Radiology, Massachusetts General Hospital. Dr. Kopans was presented the award during the 25th annual breast center conference in plenary session by Gary Levine, MD, President of the National Consortium of Breast Centers.
Dr. Kopans is a Professor of Radiology at Harvard Medical School and founder of the Breast Imaging Division at the Massachusetts General Hospital. Dr. Kopans was among the first to recognize the value of Ultrasound, CT, and MRI in breast evaluation and developed the first "Breast Imaging" Division in the U.S. He helped to develop the subspecialty now known as Breast Imaging. Dr. Kopans is a leading clinician, researcher and teacher in the field. He is a Gold Medal recipient from the Society of Breast Imaging. Dr. Kopans has 40 years of clinical experience in all aspects of breast evaluation including mammography, ultrasound, CT and MRI.
In addition, he has been principal investigator on numerous research projects and is the author of over 250 peer reviewed publications. His textbook on Breast Imaging is one of the leading references in the field.
Dr. Kopans developed the springhook wire localization system and the methods for positioning it that permitted radiologists to aggressively, but safely, diagnose small breast cancers with a minimum of trauma and cosmetic change to the breast. This helped to permit the expansion of screening mammography.
Dr. Kopans is the inventor of the latest advance in Breast Imaging known as Digital Breast Tomosynthesis which is replacing conventional mammography with more three-dimensional information that reduces recall rates while increasing the detection of small cancers.
The organized reporting system that he developed at the Massachusetts General Hospital formed the basis of the American College of Radiology Breast Imaging Reporting and Data System (BIRADS).
Dr. Kopans has been a leading advocate for annual breast cancer screening. Due to his many years of experience and knowledge, he has been able to provide the framework of scientific evidence that has supported annual screening for women beginning at the age of 40. Dr. Kopan’s leadership played a major role in reversing the 1993 NCI decision to start screening at age 50. His continued scientific analyses have helped to sustain access for women despite efforts by others to curtail screening. As such, he is frequently requested as an expert in refuting the USPSTF breast imaging standards that negatively impact the age and schedule for screening mammography.
Gary M. Levine, MD
Memorial Care Breast Centers
Long Beach Memorial, Orange Coast Memorial and Saddleback Memorial Medical Centers
Associate Clinical Professor USC Keck School of Medicine Los Angeles, CA
The Inspiration Award is given each year to an individual who embodies more than just a highly qualified clinician. We try to identify individuals who have contributed to the field of breast care and through their deeds and actions have demonstrated their commitment to women with breast cancer. They are looked upon as mentors or examples of how to do it "right." They make our own work seem much more worthwhile and meaningful.
This year we are not recognizing an individual but rather a service generated and matured over the years through the NCBC. This year we awarded the Inspiration Award to Navigation! Navigation teaches individuals to have medical, social and emotional competence as well as the wisdom and education to know when to use each skill.
We identified three individuals who have played pivotal roles in the genesis, maturation and future of navigation. We identified Judy Kneece, RN, OCN for her long term efforts in teaching navigation and providing comprehensive education In this field. We honored Colleen Johnson, RN, NP, CN-BP who has worked within NCBC for many years developing the certification program and teaching navigation to individuals from across the country. We also honored Melissa Hopkins, RN, BA, CN-BN who is the current leader in navigation for NCBC and will take this program to its future development.
We are proud to announce that NCBC has recently teamed up with Dr. Harold Freeman, the “father’ of navigation, to expand the NCBC navigation opportunities.
We were happy to honor these three individuals.
Cary S. Kaufman MD, FACS
Associate Clinical Professor of Surgery
Bellingham Breast Center
Bellingham, WA 98225
Inspiration Award Recipients 2005 to 2014
2014: Lazlo Tabar, MD, FACR (Hon)
2013: Benjamin O. Anderson, MD
2012: Steven Schorr
2011: John W. Cumming
2010: J.B. Askew MD, Jr. and Phillip G. Sutton, MD, FACS
2009: Teresita Macarol, RT(R)(M)(QM), CBPN-IC
2008: Barbara Rabinowitz, PhD, MSW, RN
2007: Blake Cady, MD, FACS, MSHA
2006: Deb Wiggins, BA
2005: Olivia Newton John