The immune checkpoint inhibitor pembrolizumab was associated with clinically meaningful improvements in health-related quality of life (QOL) compared with platinum-based chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) treated on the KEYNOTE-024 trial, according to results (abstract PR04.01) presented at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer, held December 4–7 in Vienna.
In the KEYNOTE-024 study, pembrolizumab showed significantly improved progression-free survival compared with platinum-based chemotherapy as a first-line therapy for patients with advanced NSCLC with programmed death ligand 1 (PD-L1) expression on 50% or greater of tumor cells and no sensitizing EGFR or ALK aberrations. Additionally, pembrolizumab significantly improved overall survival.
“Combined with the superior progression-free survival and overall survival, as well as a manageable safety profile, pembrolizumab may be a new standard of care in the first-line treatment of advanced NSCLC in patients with PD-L1 expression scores of at least 50%,” said Julie R. Brahmer, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, during a press conference.
Brahmer presented results from a prespecified patient-reported outcomes analysis of the trial. The analysis included 305 patients who had been randomly assigned to pembrolizumab or investigator-choice platinum-doublet chemotherapy plus optional pemetrexed maintenance. Patients were administered the EORTC QLQ-C30 and the QLQ-LC13 at cycles 1–3 and every 9 weeks thereafter. The key endpoints were change from baseline to week 15 in QLQ-C30 global health status/QOL score and time to deterioration in the QLQ-LC13 composite of cough, chest pain, and dyspnea. The final analysis included data from 299 patients.
According to Brahmer, there was a general improvement in global health status in those patients who were treated with pembrolizumab and a stabilization of global health status in patients treated with chemotherapy. The mean difference between these two arms was about 7.8 points (nominal 2-sided P = .002). The proportion of improved global health status/QOL score at week 15, defined as a 10-point or greater change from baseline, was 40.0% for patients taking pembrolizumab and 26.5% for those in the chemotherapy group.
“Based on this, we conclude that pembrolizumab has a clinically meaningful improvement in health-related QOL compared with standard chemotherapy,” said Brahmer. “Some people might argue that a 7-point difference might not be clinically significant, but when you have patients treated with disease such as NSCLC where you have a lot of symptoms, a smaller change may be clinically significant and this is supported by some publications that say at least a 4-point difference could be considered as clinically significant.”
Fewer patients in the pembrolizumab arm saw their cough, dyspnea, or chest pain symptoms deteriorate (30% vs 39%), and time to deterioration in these symptoms was significantly prolonged with pembrolizumab (hazard ratio, 0.66; 95% CI, 0.44–0.97).