1. DiGiulio, Sarah

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Delivering the William L. Memorial Lecture at the San Antonio Breast Cancer Symposium last month, Norman Wolmark, MD, Chair of the National Surgical Adjuvant Breast and Bowel Project (NSABP), aired his bias from the start of his talk, "The Contribution of NSABP Clinical Trials to the Management of Early Breast Cancer."

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"We are passionate in the belief that the randomized, prospective, clinical trial is the methodology to move the state of the art forward in an unbiased, disinterested manner. We are passionate in the belief that the randomized, prospective, clinical trial will deliver us from the age of tyranny, the age of authoritarianism, when an individual could ascend their proprietorial pulpit armed with a retrospective case series based on personal charisma and the institution they represented could influence the way a disease is treated for decades-and in the case of breast cancer for three quarters of the century," he said.


"The randomized prospective, clinical trial was a methodology by which we could challenge what our mentors insisted on and taught us was absolutely required. It used the scientific method," he added.


Wolmark continued the lecture highlighting key contributions of the NSABP breast cancer clinical trials. But, those NSABP hallmarks serve as a warning, he concluded-during a time when social media discussions proliferate and genomic-based treatment approaches pose new challenges to following traditional clinical trial designs-that the randomized, prospective, clinical trial still is the methodology to move the state of the art of breast cancer research forward.


Wolmark, who is also a member of OT's editorial board, elaborated on the key points of his lecture during an interview after the session.


1. What are the key points about the research and role of NSABP for breast cancer researchers and breast cancer care providers to remember today?

"Randomized, prospective clinical trials-certainly for early breast cancer-have really defined the standard of care.


"The whole retreat from radical mastectomy was driven by scientific endpoints in well-controlled clinical trials that were funded by the National Cancer Institute. And those initial clinical trials gave us a far better understanding and perspective of the biology of the disease and how it behaves. They really provided the catalyst for the subsequent trials, which further retreat from operative intervention, advance breast preservation, and so forth.


"For sentinel node resection, [those trials] provided the rationale that convinced surgeons that if they're going to increase cure rates that they wouldn't do it based on nuances in operative technique-that they would do it using systemic chemotherapy.


"The NSABP did many trials with chemotherapy that had progressive increases in the overall survivorship with breast cancer.


"And then the great transition that occurred with B-31/N9831, which was published in 2005, where we're targeting a specific well-defined molecular discriminant namely HER2-and that really changed that segment of the disease from a dire prognosis to one that had a very good prognosis."


2. You also offered a few warnings during your talk...

"The worrisome factor today is social media being such an integral part of how people, particularly those individuals who are under 50 years of age, make decisions.


"We see that that there's an increase in the use of mastectomy and prophylactic bilateral mastectomy, which is not something that we [breast cancer researchers] recommend, particularly for tumors that can be treated with a breast-preserving operation because the risk of the contralateral breast does not warrant its removal. And yet there are many women under 50 who adopt this as their primary approach. And it mostly conflicts with the data that we have for the randomized trials."


And regarding the era of genomic medicine...

"We're starting to deal with smaller and smaller [patient] subsets. We're getting into a frontier where everyone is going to have a case series to say, 'I've targeted this particular molecular discriminant and I've done an early phase molecular-based trial and look at the data that I'm getting.'


"This sort of brings us back to the frontier where a surgeon would say I have a variation on this procedure and look how good my results are. And the smaller the subset of course, the greater the insecurity and the greater the likelihood for misguided enthusiasm."


3. And lastly, you are well-respected as an energetic lecturer-do you have any words of wisdom or advice on how you prepare an engaging talk?

"I really don't... Do I have a formula? No, I really don't. It's something that I just do. And whether I do it well or not depends on the response of the audience. Sometimes you connect with the audience, sometimes you don't.


"You'll need to tell me if I connected!"


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