Dr. Norman Wolmark Receives Recognition for Leadership in Breast Cancer Clinical Trials
Three of BCRF’s long-time investigators were honored at SABCS during Wednesday’s sessions. Dr. Norman Wolmark of the National Surgical Adjuvant Breast and Bowel Project (NSABP) was selected as this year’s William L. McGuire Lecturer in recognition for his career as a leader in breast cancer clinical trials research. During his tenure as Executive Medical Director, then principal investigator of the NSABP, Dr. Wolmark directed and planned some of the most innovative surgical and adjuvant breast cancer trials that dramatically changed the treatment and and prevention strategies. In a lively lecture that was punctuated with humor and wit and a bit of good-natured sarcasm that Dr. Wolmark is well known for, he traced the history of some of the seminal clinical trials conducted through the NSABP and the impact they had on changing the standards of care.
Perhaps the most dramatic story to be told is the story of NSABP B-04 and B-06 clinical trials that began in the 1970’s. Both B-04 and B-06 were revolutionary in their randomized prospective clinical trial design and paved the way for a new standard in conservative breast cancer surgery and away from radical mastectomy, in which the affected breast, lymph nodes and chest wall were surgically removed. In addition to providing clear evidence that less surgery was just as effective at preventing recurrence for early stage disease, these studies were paradigm changing in our understanding that treatment failure was not a consequence of insufficient surgery, but to systemic disease that had already spread beyond the breast.
In spite of the strength of the evidence, Dr. Wolmark lamented the stark rise in patient-elected bilateral mastectomy in recent years, driven in large part by patient distrust of scientific evidence and fear that the cancer will come back.
Thirty years after the B-04 and B-06 studies, patients are again asking if there are alternatives to surgery for another early stage disease, ductal carcinoma in situ – DCIS. How to treat DCIS is controversial among some oncologists who believe most DCIS can be left alone or treated with anti-hormone drugs. Solving the question of whether surgery prevents future invasive breast cancer can only be achieved with prospective randomized trials.
“In the rush to do genomically-driven treatment trials, the clinical trials needed to answer the questions in DCIS are not getting done,” Wolmark noted.
Other notable advances that have come from NSABP clinical trials include the validation of sentinel lymph node biopsy that reduced the amount of surgery needed to determine if a cancer had spread to the lymph nodes – a marker for risk of metastasis; validation of the 21 gene recurrence score that in the process also optimized the use of tamoxifen and traztuzumab in combination with chemotherapy; and presurgical–or neoadjuvant clinical trials that have provided early clinical biomarkers of response to treatment.
BCRF Investigators honored with Brinker Awards for Scientific Distinction in Basic Science and Clinical Investigation
This year’s Brinker Awards were presented to BCRF investigators Dr. Myles Brown of Dana Farber Cancer Institute in the Basic Science category and Martine Piccart of Institut Jules Bordet in the Clinical Investigation category.
Dr. Brown is “a laboratory scientist with a true appreciation for clinical issues and a desire to translate his findings into meaningful clinical advances,” BCRF investigator Dr. Eric Winer of the Dana Farber Cancer Institute said in his introduction.
In his Brinker Award lecture, Dr. Brown described the inspiration for his career path: a young breast cancer patient who initially responded to a new drug called tamoxifen but later progressed and ultimately succumbed to her disease. To understand how this resistance emerged and persisted, Dr. Brown would go on to characterize the interaction of tamoxifen with the estrogen receptor. This ultimately provided key insights into the regulation of hormones that have laid the groundwork for the development of new targeted therapies. His talk highlighted the discoveries in this process and his ongoing work such as deciphering the role of mutations in the estrogen receptor gene (ESR1) in drug resistance and identifying potential therapeutic strategies to block this effect, including combining novel anti-hormone drugs with the new class of targeted therapies called CDK4/6 inhibitors currently in clinical trials in advanced estrogen receptor positive breast cancer. Read more about Dr. Brown’s BCRF research here.
Dr. Martine Piccart was recognized with the Brinker Award for Distinction in Clinical Investigation for her leadership in a wide range of clinical trials that have improved the standard of care in breast cancer around the world. A co-founder of the Breast International Group (BIG) – an organization of 56 academic breast cancer research groups, Dr. Piccart is a staunch advocate for international research and collaboration.
“Dr. Piccart is one of the greatest clinical trialists of our time whose leaderships has led to improved survival for early-stage breast cancer for patients around the globe,” BCRF grantee Dr. George Sledge of Stanford University said in his introduction.
In her Brinker Award lecture, Dr. Piccart used the experience of BIG clinical trials in HER2 positive breast cancer to demonstrate the layers of translational research that are needed to achieve real improvements in clinical care, including understanding the role of other factors, besides HER2, in disease progression. Activation of other growth signaling pathways and factors outside of the cell –in the tumor microenvironment–such as immune cells, are drivers of tumor heterogeneity that make each tumor unique. Identifying biomarkers of this heterogeneity can help doctors select the right drugs for each patient. Efforts by the Breast International Group are ongoing in that area utilizing new technologies and testing new therapeutic designs in tailoring treatment for this disease. These efforts provide a framework for trials in other types of breast cancer and an infrastructure for international collaboration. Read more about Dr. Piccart’s BCRF research here. Dr. Piccart is also the coordinator and lead investigator for the European component of the BCRF Evelyn H. Lauder Founder’s Fund.
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