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Study Exclusion Criteria Limits Real-World Benefit of Immunotherapy in Lung Cancer

Brandon Scalea
Published: Wednesday, Mar 06, 2019

Mohammad Jahanzeb, MD

Mohammad Jahanzeb, MD

Immunotherapy has emerged as a frontline option for patients with metastatic non–small cell lung cancer, but it is important to note that patients eligible for these trials account for a small portion of all patients with lung cancer, said Mohammad Jahanzeb, MD.

, Jahanzeb, professor of Clinical Medicine, Hematology/Oncology, Sylvester Comprehensive Cancer Center, at University of Miami Miller School of Medicine, shared the challenges of real-world eligibility for immunotherapy in lung cancer and beyond.

OncLive: What are some important exclusion criteria in clinical trials for immunotherapy?

Jahanzeb: Clinical trials have very strict criteria when we think of immunotherapy. Investigators specifically do not want to anger an immune system that is already angry. Naturally, [this includes] patients with autoimmune disease, those who have solid organ transplantation, and even those who have had bone marrow transplantation and have been immune suppressed, so they do not reject the graft or bone marrow. [All of] those patients would be excluded from these studies. With patients who have had pneumonitis in the past, you cannot afford to put them at risk for severe pneumonitis as a result of immunotherapy—this happens in 2% to 3% of patients, and so, these patients are also excluded.

This is not an exhaustive list, but patients with HIV, hepatitis, and psychiatric conditions or drug addictions would also be excluded [from trials]. We need patients to be compliant. At the end of the day, only about 4% of adult patients are treated on clinical trials in the United States as opposed to nearly 90% of pediatric patients who go on protocols.

Could you expand on age as an exclusion factor?

Age is a moving target. There was a time where everybody agreed that 65 [years] was the line between elderly and nonelderly; this may be because it corresponds with the Medicare eligibility age. Now, studies have gone up to 70 [years] or even older. Interestingly, when you look at patients older than 65 [years], efficacy with immunotherapy seems to be better. This is partly because you have more patients in that subset. The median age of patients with lung cancer is 68, so the majority would be what we consider elderly.

Are patients with driver mutations excluded from these trials?

Driver mutations are an interesting subset of patients because I believe—and now, data supports it—that carcinogen-induced cancers, which are caused by sunlight or smoking, are ugly tumors. They have a high tumor mutational burden. This means a sleeping immune system can wake up and more readily recognize these ugly features; it attacks them. Chemoimmunotherapy is much more effective there.
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Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Experts Weigh-In on Emerging Immune Checkpoint Inhibitors and Combination Strategies for Advanced NSCLCNov 30, 20191.5
Burst CME™ – Cancer Summaries and Commentaries: Update from Toronto: Advances in the Treatment of Lung CancersNov 30, 20190.5
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