GRACE :: Lung Cancer

Overcoming Obstacles in Lung Cancer Trial Participation

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Many of us who work in the field of lung cancer, whether as doctor, patient, friend, or family member, bemoan that lung cancer is too often viewed as a black sheep among cancers – little attention and too few resources. But one of the key ways in which lung cancer has lagged behind has been in terms of clinical trials participation, and this is something that we can control, and our underperformance (on both the physician and patient side) has hurt the field.

The field of oncology is used to seeing trials with thousands of patients with breast cancer and colon cancer, to name two other common cancers, and the pace of clinical research in those fields has led to major momentum and rapid advances. The field of lung cancer has certainly had advances too, but the question is how far we’re falling behind our potential, with 200,000 new cases in the US alone, and with pharmaceutical companies recognizing the size of that market and falling over each other to get their new drugs used in lung cancer. Despite these factors, the pace of progress in the field is maddeningly slow, in large part because of the slow pace of clinical trial completion that drives our development of new diagnostic and prognostic tools, and of course also new treatments.

Lung cancer patients make up a far smaller percentage of the clinical trial populations in the US (9% of male patients on cancer trials are on a lung cancer study, and 4.6% of women) than they do overall US cancer patients (14% and 12.6% of cancers in men and women, respectively) (abstract here). Even more acute is the under-representation of older and sicker patients, as well as minorities. In many countries, minority patients do poorly compared with Caucasians. As we learn more about relevant differences among different racial/ethnic groups based on genetic differences in how cancer behaves or treatments work in patient subsets, it becomes increasingly clear that we need to include diverse populations in our lung cancer trials.

There’s no doubt that there are multiple causes for low trial participation. Historically, there have been times when there were not interesting clinical trials. Now there is a broad range of interesting trials, but certainly access is a problem. Others have done work suggesting that lung cancer patients may feel more hopelessness about changing their plight than people with other cancers (abstract here). People may see the offer of a clinical trial as a “last resort” and be less inclined to pursue clinical research because of that. And even among highly proactive and educated participants on OncTalk, 73% of the 107 respondents here who participated on a recent online poll said they would not participate in a placebo-controlled trial that included standard of care treatment (with placebo) on the control arm. I realize that people would prefer the new agent, but we can only determine the value of a new treatment if we compare it properly to a standard treatment arm.

I’m certainly interested in people feeling the “guinea pig syndrome” in trying new treatments, but I think that while some people fear the new, for many people the objection to a trial is in not getting the new approach. Regardless, at the present time some of our problems controlled by investigators/physicians who write protocols that are too restrictive and “cherry picking”, or they don’t prioritize trial options when speaking with patients. Other obstacles are controlled by patients reluctant to try anything “investigational”, or else unwilling to accept being randomized to a treatment and not receiving the non-standard treatment they have decided is critically important.

But we all need to do better if we’re going to move the field forward and improve our survival results in the next five years compared to the last five years. Clinical trials, including randomized ones and even placebo-controlled ones, are an important driver of the evolution of our understanding of cancer and its best treatment.


3 Responses to Overcoming Obstacles in Lung Cancer Trial Participation

  • Karen says:

    My husband participated in clincial trails, we were trying to find a new drug, a cure maybe?, it gave us hope. Dana-Farber and Jimmy Fund where so supportive of this, they have many clinical studies for SCLC, even for ED disease. I can honestly say that the care Eric received during this trail was exceptional, he was monitored 24/7, the nurses were the best at what they do, it was truly amazing the care and monitoring he received. I think the sad thing is like Eric, his cancer was so aggressive, he had to stop and go right to chemo they knew might hold the cancer at bay…people with this disease don’t have any or many good months to try these sometimes. He was 35 and strong and willing to do it, and was able to tolerate it better than topotecan…
    It made Eric say more than once, maybe just maybe I helped the future of this disease alittle bit, He was happy to do it, and it gave us hope that we were going to find the wonder drug!
    I pray that soon someone will find the mix.

  • myrtle says:

    I remain a bit confused about clinical trials. When I was diagnosed, that was one of the first things I asked about, but was told by my local Onc and MD Anderson where I had gone for a second opinion, that I was not an appropriate candidate. By the time I was able to do some research on my own, I found out that I was not eligible for most trials because by then I had previous treatment. I still continue to look because I have been treated with almost everything approved, but cannot find anything that I am eligible for or that does not sound like a different cocktail of what I have already had. I know that things have changed a bit from when I was diagnosed in 2005 and maybe if my diagnosis was today, there would be more options presented up front. I still do not know how someone with multiple prior treatments can get into anything meaningful.
    Myrtle

  • Dr. West says:

    Myrtle,

    You’re right that trials for previously treated patients are pretty hard to come by. I think it would be helpful to have more studies with liberal eligibility criteria. Frankly, many drug companies would love to see their drugs used as first or second line treatments, not approved as 4th or 5th line therapy, because the pool of patients who are candidates for such late treatment is so small compare with the larger first line population. So trials that allow heavily pretreated patients are often a lower priority. But my trials in never-smokers or BAC, one with sutent and another with nexavar as single agents, don’t restrict based on prior therapies. I try to practice what I preach. But there’s a long way to go in getting more relaxed entry criteria for clinical trials.

    Karen,

    Thanks for bringing up a couple of the important advantages of participating in clinical trials, when they’re available options. They can bring additional hope, and they do lead to progress in the field. Some fortunate patients on the original trials with drugs like iressa and tarceva were the first ones to get a major benefit with these agents, and their participation led to our growing understanding of these agents and their approval (subsequently reversed for iressa) and widespread use for lung cancer patients.

    -Dr. West

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