Defining Standard of Care in Oncology -- Neither Straightforward nor Simple

Maurie Markman, MD


May 07, 2020

This transcript has been edited for clarity.

Hello. I'm Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I want to briefly discuss a very important and complex topic that is increasingly relevant in the world of clinical oncology: the difficulty of defining a standard of care given the increasing rate of approvals for new antineoplastic agents.

The practicing oncologist reading a paper in a high-impact journal today may say, "This sounds like a great strategy in this particular patient"; however, tomorrow there may be a different high-impact paper looking at another strategy in a very similar setting. It becomes difficult to choose.

The approvals of new agents and combination regimens are very important advances. But clearly it is not the responsibility of the US Food and Drug Administration to make sure that every time they approve a new agent, [they also determine] the standard of care; the initial trial design for the approval might include a standard of care from several years ago.

The cancer I am most interested in relative to my clinical research is ovarian cancer. We went for a period of 20 years where the frontline therapy was the same: a platinum agent (generally carboplatin) and paclitaxel. Bevacizumab was added after a number of trials looked at it over a number of years.

But today we see poly(adenosine diphosphate–ribose) polymerase (PARP) inhibitors being examined. We see PARP inhibitors plus an antiangiogenic agent. We see BRCA mutation–positive patients and patients who are defined as potentially eligible for treatment based upon homologous recombination deficiency platforms, which are additional diagnostic strategies. I expect that we're going to see new approvals coming in this area.

Again, the question for the practicing oncologist seeing a patient with newly diagnosed ovarian cancer is, what is the optimal strategy among these different agents? Will there be trials that compare one strategy to another or even several strategies to each other?

I suggest that this falls into the category of pragmatic clinical trials—randomized trials that test interventions in real-world clinical practice settings.

But who will encourage these trials to be conducted? Who will pay for these trials? A variety of groups could encourage such work, including the American Society of Clinical Oncology—who take the lead in the area of patients and their interactions with their treating oncologist—and the American Cancer Society. Even the National Cancer Institute could play a role in encouraging such trials. Finally, and very importantly, insurers responsible for paying patients' bills could get together and say, "We will pay for the price of this trial to help define the optimal therapy in a given clinical setting."

How do you define optimal patient management—the standard of care—when very exciting strategies are entering the scene on an almost daily basis? This is a very important question for which there is no simple answer. It's important for us in the oncology community to be aware that this question will likely only become increasingly relevant in the future.

Maurie Markman, MD, is president of medicine and science at Cancer Treatment Centers of America in Philadelphia. He has more than 20 years of experience in cancer treatment and gynecologic oncology research.

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