Dr Janice Mehnert Discusses Including Patients With Comorbidities in Cancer Clinical Trials

Janice Mehnert, MD, Head of the Phase I Developmental Therapeutics Program at Rutgers Cancer Institute of New Jersey, and the Head of the Melanoma Research Team, explains the importance of including patients with comorbidities in clinical trials and what could be done to promote it.

You’ve written about the importance of including patients with comorbidities in clinical trials. Can you discuss what can be done to promote this?

Absolutely. … The reason clinical trials are so stringent in the beginning is because there’s a duty to your patient and there’s a duty to the study. … Obviously you’ve got to keep the patient safe. If the patient has no cardiovascular, or kidney, or liver reserve to withstand a side effect, and they sustain a side effect that they can’t recover from, you’ve done nobody any good. The flip side is when patients are enrolled in clinical trials, and there are a lot of side effects that are maybe not related to the medication but are related their disease, sometimes it’s very difficult to tease that out. If you enroll patients with too many medical problems and there are lots of side effects reported, you don’t know if it the disease or the drug causing it, so you can’t properly study the drug. So, there’s a lot of very good reasons to have strict eligibility criteria for clinical trials.

But once you get into an arena where you have a reasonable handle on the safety profile of the medication and you’re starting to see it approved in multiple places that’s the time to say, “OK, do I really need to have this perfect measured kidney function to enroll this patient?” Do I really need to exclude somebody who has a history of hepatitis C, perfect liver function and a tiny, tiny viral load that’s detectable in blood work? Do you I need to exclude that patient that had a very small brain metastasis that was treated and stable? I think the answer to many of these questions is, “no.” I think we can be more inclusive, and there’s a task force developed by the American Society of Clinical Oncology that has addressed these questions in a larger forum. Hopefully, we’ll start to see some change.

Certainly, in melanoma we’ve seen change in the brain metastasis space. We’ve had a paper in the New England Journal of Medicine looking at immunotherapy in patients who’d had brain lesions written by my colleague Dr Hussein Tawbi. We have had trials ongoing with targeted therapy for a number of years now. Certainly, we are recognizing this is not a population we should exclude from clinical trials. We’ve addressed the fact that patients have extra-cranial disease, and the intra-cranial disease remains such an Achilles heel. We have to start studying that area.