Is a Fixed 2-Year Duration of Pembrolizumab Treatment Safe in Advanced NSCLC?

By: Vanessa A. Carter, BS
Posted: Tuesday, August 6, 2024

Benjamin Besse, MD, PhD, of Paris-Saclay University, Orsay, France, and Gustave Roussy Cancer Campus, Villejuif, and colleagues conducted the ATHENA study to determine the optimal duration of treatment with the PD-1 inhibitor pembrolizumab as well as real-life prognostic factors among patients with non–small cell lung cancer (NSCLC). Published in The Lancet Regional Health Europe, the results of this retrospective cohort study suggest that although halting pembrolizumab therapy after 2 years may be safe in this patient population, causality cannot be confirmed because of confounding and selection bias.

“For the first time, a history of diabetes, beta-blocker usage, and prior prescription of painkillers are associated with a higher risk of death in this population,” concluded the investigators. “Additionally, for the first time, the volume of patients treated with pembrolizumab at a center was associated with survival, with treatment in low-volume centers being associated with a higher risk of death.”

This study identified 43,359 patients from the French National Health Insurance database with lung cancer who received first-line pembrolizumab for advanced disease. Hospital, pharmacy delivery, and outpatient care reports were used to extract treatment and patient information. A Cox model weighted by inverse of propensity score was used to estimate the treatment duration’s hazard ratio (HR), and a Cox model selected by least absolute shrinkage and selection operator (LASSO) was used to identify prognostic factors.

The median follow-up was 25.9 months. The median overall survival was 15.7 months. The study authors found that age; hospital category; inpatient hospitalization; chemoimmunotherapy; male sex; and history of diabetes, painkiller, and beta-blocker prescription were all independently associated with survival (all P < .001); diuretic prescription (P = .004) also appeared to be associated with survival. Participants who received pembrolizumab beyond 2-years had a median treatment duration of 33.2 months. Of note, this was not associated with a better overall survival than a fixed 2-year treatment (HR = 0.97).

Disclosure: For full disclosures of the study authors, visit thelancet.com.

The Lancet Regional Health Europe