The widespread use of immune checkpoint inhibitors has led to significant benefits in younger patients with advanced lung cancer; however, older patients have not experienced similar survival benefits, according to research from Yale Cancer Center. The study was published in JAMA Oncology.1
Teja Voruganti, MD, PhD
“There has been a great deal of excitement in the cancer community regarding the potential of immune checkpoint inhibitors to improve survival in patients with lung cancer,” said Teja Voruganti, MD, PhD, first author of the study. “The initial clinical trials that led to [U.S. Food and Drug Administration (FDA)] approval for these treatments suggested impressive benefits. Now that these medications have been used in clinical practice for several years, it is critical to assess the survival benefits for patients in routine clinical practice, outside of the clinical trial setting.”
Building on Prior Work
Earlier studies by senior author Cary Gross, MD, Professor of Medicine and of Epidemiology at Yale, and his team demonstrated that patients enrolled in initial clinical trials that led to FDA approval of immune checkpoint inhibitors are often younger and healthier than patients with cancer in real-world clinical practice.
Cary Gross, MD
“It is unclear whether the substantial benefits we see in premarketing trials of cancer therapies in fact bear out when the treatments are used in everyday practice,” Dr. Gross said. “That’s what patients care about—they’re not just asking, ‘What did the initial study show?’ They want to know, ‘What happens when people like me take this treatment?’”
Differing Survival Outcomes
For the new study, the authors analyzed a large database of patients with advanced-stage lung cancer who were diagnosed from 2011 through 2019. They found that by the end of the study period, there was no difference in the use of immune checkpoint inhibitors between patients aged 55 and younger and those aged 75 and older; fewer than half of the patients in each group were receiving immune checkpoint inhibitors. However, the effect on survival outcomes differed dramatically; after immune checkpoint inhibitors were approved in 2015, survival increased from 11.5 months to 16 months among younger patients in 2019. In older patients, however, the median survival increased from 9.1 months to 10.2 months over the same period. This is below the 2- to 3-month threshold for clinical benefit that ASCO has defined as a clinically meaningful survival improvement for lung cancer.
“The use of immune checkpoint inhibitors has been touted as a ‘game changer’ in the treatment of lung cancer, but our findings show that the impact on older adults may not actually be clinically meaningful,” Dr. Gross added. “This is a wake-up call for patients, researchers, and policymakers: We need to determine which cancer treatments are effective in older patients, rather than relying on assumptions. These are life and death questions—we need evidence.”
Disclosure: Dr. Voruganti reported no conflicts of interest. Dr. Gross has received grants from Johnson & Johnson and AstraZeneca. For full disclosure information for the study authors, visit jamanetwork.com.
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