On Patient Care and Equipoise as SWOG Meets in San Francisco

I am heading to San Francisco where I will take part in the SWOG Semi-Annual Meeting. To those who might be unfamiliar with us, SWOG is a group funded by the National Cancer Institute and is part of the National Clinical Trials Network (NCTN). We run clinical trials across disease sites and scenarios, from prevention to treatment to survivorship and palliative care. SWOG members travel from all across the country twice a year to meet, learn, teach, and plan—all of this in the most interactive way possible, in as inclusive a way that we can imagine. Thanks to the leadership in our Patient Advocacy group (shout out to Wendy Lawton and Rick Bangs!), this includes patient advocates, who are embedded more and more into aspects of trial design at the earliest point.

The goal is to launch clinical trials across the country, and once that happens, to ensure they successfully accrue. We spend a lot of time trying to improve accrual—from making sure our investigators open as many trials as possible, supporting them once that happens, and then, to ensure patients are made aware of them in as “non-scientific lingo” as possible. Yet, I have come to recognize (though not the first time) that we as clinicians can sometimes be our own barriers to accrual.

I recall one instance when I was in a Tumor Board. A 70-year-old patient with breast cancer was presented: 1.0cm Grade 2 tumor with one of five positive lymph nodes, hormone-receptor positive, HER2-neu negative. We discussed treatment, and I still remember the spirited debate that followed. Some felt chemotherapy was a “no-brainer” while others felt very strongly that endocrine therapy was sufficient, arguing that chemotherapy would add very little. At the time we had the TAILORx trial open, one that was prospectively evaluating the use of the 21-Gene Recurrence Score. One of my colleagues had suggested talking to her about this trial.

I thought it was a great idea. In fact, it was more than a great idea—it was the most appropriate option. The situation this patient found herself in was clinical equipoise, where we, as clinicians, are unsure whether treatment (or which type of treatment) provides benefit. In these situations, there is no good evidence to guide decisions. In reality, we make recommendations based on what we believe to be in the best interests of our particular patient, drawing from our own particular experience with patients in a similar situation.

I expected that everyone attending this Tumor Board would be on board with the option to offer her the trial, but that wasn’t the case. Some felt it would be “not in the interests of the trial” to put someone on “at her age,” and others thought it would be “unjust if she had to take chemotherapy.”  Others felt it was fine to put her on trial because “if she didn’t like her treatment assignment, she could always withdraw.”

A few of us listened to this conversation, with each provider speaking from the perspective of what they truly felt was in the best interest of this patient. Ultimately, one of our most seasoned providers spoke up. “If we, as a group, feel we know the answer,” he asked, “why are we doing a trial?”

This stopped everyone. “The point,” he continued, “is to go beyond anecdotes, to actually provide an evidence basis, isn’t it? In order to do that, we can’t cherry pick the patients we place on trials, just like we cannot make any one patient do a trial rather than standard of care.” With that, consensus was reached. Ultimately, the patient was offered the trial and agreed to participate.

Clinical trials are the pathway to better—better treatments, better outcomes, and a future without cancer. It’s not enough that trials are designed to answer important questions, or that the options for trials are available for our patients. We, as investigators, need to believe in them and be willing to offer them to all patients that are eligible. Too often, we (myself included) make determinations that patients are best served off a clinical trial, even though they are eligible. I think we have to be cognizant of our own biases, in practice and when it comes to trials. If we hope to make expeditious progress, we have to believe there are questions we must answer, together.