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Dr. Jack West is a medical oncologist and thoracic oncology specialist, and Executive Director of Employer Services at the City of Hope Comprehensive Cancer Center in Duarte, CA.

Overcoming Obstacles in Lung Cancer Trial Participation
Mon, 02/04/2008 - 23:22
Author
Howard (Jack) West, MD, Associate Clinical Professor, Medical Oncology, Executive Director, Employer Services, Founder, President and CEO of GRACE

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.

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