Hear how to engage patients in clinical trials and address barriers.
Many patients with SCLC have a high symptom burden, poor prognosis, adherence challenges due to treatment-related adverse events, stigmatization, and emotional distress. Clinical trials are taking place across the country for patients with all stages of small cell lung cancer. CANCER BUZZ spoke to David Waterhouse, MD, MPH, Medical Oncologist and Hematologist at the Dana-Farber Brigham Cancer Center, Milford Regional Medical Center in Milford, MA. Hear how to engage patients in clinical trials and address barriers.
Guests:
David Waterhouse, MD, MPH
Medical Oncologist and Hematologist
Dana-Farber Brigham Cancer Center
Milford Regional Medical Center
Milford, MA
“Eighty-five percent (85%) of cancer care is being done in the community, not at academic centers such as ours. And so, you have to be able to meet the patient where they are. I don’t think we do a very good job of that right now, as an oncologic community.”
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CANCER BUZZ: Welcome back to CANCER BUZZ TV. I'm your host, Summer Johnson. Historically, patients with small cell lung cancer have had limited treatment options, but in the past few years, the FDA has approved several treatments. This is a big development in cancer care, but patients with small cell Lung cancer still have barriers to getting treatment and participating in trials, not to mention the decline in screening and diagnosis.
So how do we engage more of these patients in clinical trials? We'll ask our guest today. David Waterhouse is a medical oncologist and hematologist at the Milford Regional Medical Center in Milford, Massachusetts. Thank you so much for speaking with us today, Dr. Waterhouse.
What criteria are used for patient eligibility for small cell lung cancer clinical trials?
David Waterhouse, MD, MPH: The eligibility for clinical trials are often dependent upon the intent of the trial and also the stage of the patient being treated. So in small cell, it's often limited to either limited disease or extensive disease. Although there have been a few clinical trials looking at a quote unquote “maintenance” type of strategy. Clinical trials criteria often look just like all the other clinical trials criteria. There'll be a comment about the stage of the disease and how that is to be defined.
There will be a section dedicated to performance status. All too often ECOG zero and one. There'll be tissue eligibility requirements for some of these studies. So whether you need biomarker testing or centralized testing, or you have to provide “x” number of slides for the scientific review. And then there's also exclusion criteria. The patients will have to have adequate bone marrow support, adequate renal function, adequate hepatic function.
The eligibility and ineligibility requirements often have been criticized because they are part of the root cause – why our trials don't look like the people we treat. Not all patients can meet that eligibility, but when we get out into practice, we still got to treat these people.
CANCER BUZZ: Why are clinical trials so important with this particular cancer?
David Waterhouse, MD, MPH: There is something a little bit unique about patients with small cell lung cancer. First of all, this is a disease that's seen largely in smokers. So you are still up against the, the barrier of this was a self-inflicted disease. So there is some remorse, there is some anger. There is almost a, a feeling like, well, I brought this upon myself, you know, there's not much I can do about it.
And you have to work with them to let them know it doesn't do them any good to look backwards. If we're going to make any progress, you got to look forward. The second thing is they do present sicker than your average lung cancer. This is a disease that comes on explosively. You are fine one minute and you are very sick the next. And that timeframe is usually measured in days and weeks, not months and years, so the patient is in a distressful point already.
They've had an explosive disease come on them, somebody in their family has Googled this and already saw the five year survival is abysmal. So that's already been shared, you know, by their cousin who's a, you know, physical therapist or something. And these patients start from behind the eight ball right at the beginning. And that is a challenge to put them on. If they are hospitalized, many institutions don't allow their trials inside the hospital, certainly in the community, and let's be honest, 80% or 85% of our care is being done in the community, not at academic centers such as ours.
So you have to be able to meet the patient where they are. And I don t think we do a very good job of that right now as an oncologic community, I would like us to do a better job and have been an advocate for decentralization of Trials.
CANCER BUZZ: Dr. Waterhouse, what are the opportunities to make small cell lung cancer trials more accessible to providers and patients in the community? Do you think we're missing those opportunities?
David Waterhouse, MD, MPH: I'll start with, are we missing opportunities? We definitely are missing opportunities. The first thing is we make the patient go to the trial. We have to find a way of bringing the trials to the patient. These are sick people. And to try and have to make them go to some large academic center, which may be hundreds of miles away when they're treating oncologists is close to home. We have to find a way of bringing the trials to the patients and to their providers.
The second thing we have to do is we have to make our eligibility criteria and ineligibility criteria more mirror the populations that we are treating. They are a sicker population And. So broadening the eligibility is another very important step. Another step is the trial design itself. All too often these patients have to be treated rapidly. And when you have a process that takes days, actually weeks to work a patient through it, you've missed the opportunity to enroll them.
So sometimes you know the patient is hospitalized and they need treatment right away. Well, the doc is just going to start the treatment. But now by starting a treatment, you've made them ineligible. So allowing for some initial therapy is another way, especially an extensive disease where we might be able to improve enrollment. Everyone wants a very clean, simple trial design.
Everything we do to complicate the trial means patients won't get on the study And. So I think that the people who are designing the trials really need to get down in the, in the weeds with those of us who are actually treating these patients to be more pragmatic in the design so that we can get every patient on a trial and we can make every doctor a trial list.
CANCER BUZZ: How do you engage in shared decision making when discussing treatment options like clinical trials?
David Waterhouse, MD, MPH: Well, every discussion with every patient ought to be shared decision making. Because at the end of the day, it's not us who has to take the chemotherapy or the treatment, it's going to be the patient. So that includes giving them all of their options, even if I may have my own bias what I want them to do, but I have to be a fair and balanced presenter to them about all the options that might be available to them. And that does include clinical trials when available. And if I don't have a clinical trials, I need to tell them where they could go to get a clinical trials.
If you, you listen to doctors all claim that they follow NCCN guidelines. And if you look at every NCCN guideline, it states that the best care for a patient is a clinical trials. I fully believe in that, and I will look for a trial for every one of my patients at every stage of their disease. And I do tell the patient that sometimes they will hear the word Guinea pig if they hear the word clinical trials.
And that gives them a very negative feeling. Other people will hear cutting edge, and I very point blank tell them, I hear cutting edge, but if you're hearing Guinea pig, we need to talk about it. And why I don't hear Guinea pig and why I hear cutting edge. So I ask him, when I said, clinical trials, what did you think? And that often it, it opens up a conversation with myself, the patient, often their family, because sometimes it's not what the fam the patient thinks.
It's also the people who influence the patient that become very important in the decision process.
CANCER BUZZ: Thank you, Dr. Waterhouse. If you'd like to learn more about our topic today, you can click on the resources in the show notes. This show is a resource of the Association of Community Cancer Centers developed for busy cancer professionals like you. On behalf of all of us here at CANCER BUZZ TV, thank you for watching. I'm Summer Johnson.
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