Patient-Reported Outcomes With Immunotherapy vs Chemotherapy in Advanced NSCLC

Key Points

  • In patients with advanced NSCLC, pembrolizumab was associated with a statistically significant improvement in quality-of-life score compared with chemotherapy.
  • Pembrolizumab was associated with a prolonged time to deterioration in the composite measure of cough, chest pain, and dyspnea.

Pembrolizumab (Keytruda) treatment was associated with improved or maintained health-related quality of life vs platinum-based chemotherapy in the phase III KEYNOTE-024 trial in advanced programmed cell death ligand 1 (PD-L1)–positive non–small cell lung cancer (NSCLC). These findings were reported by Brahmer et al in The Lancet Oncology.

Study Details

In the open-label trial, 305 previously untreated patients with PD-L1 tumor proportion score ≥ 50% were randomized to receive pembrolizumab (n = 154) or platinum-based chemotherapy (n = 151). Pembrolizumab was associated with significantly improved progression-free survival.

In the current study, patient-reported outcomes were assessed at day 1 of cycles 1 to 3, every 9 weeks thereafter, at the treatment discontinuation visit, and at the 30-day safety assessment visit using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 items (QLQ-C30) and the EORTC Quality-of-Life Questionnaire Lung Cancer 13 items (QLQ-LC13). The primary exploratory patient-reported outcome endpoints were change at week 15 in the QLQ-C30 global health status/quality-of-life score and time to deterioration of the composite of cough, chest pain, and dyspnea in the QLQ-LC13. Time to deterioration was defined as the time to first onset of a ≥ 10-point decrease from baseline in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥ 10-point decrease from baseline in any of the three symptoms.

Improved Patient-Reported Outcomes

Patient-reported outcomes compliance was > 90% at baseline and approximately 80% at week 15 for both groups. The least-squares mean baseline to week 15 change in QLQ-C30 global health status/quality-of-life score was 6.9 in the pembrolizumab group vs −0.9 in the chemotherapy group (difference = 7.8, P = .0020). As noted by the authors, although improvements of ≥ 10 points on this measure have been viewed as clinically meaningful, differences as low as 4 points have been reported to represent minimally important differences in NSCLC trials. Deterioration in the QLQ-LC13 composite endpoint was observed in 31% vs 39% of patients. The median time to deterioration was not reached in the pembrolizumab group vs 5.0 months in the chemotherapy group (hazard ratio = 0.66, P = .029).

The investigators concluded: “Pembrolizumab improves or maintains health-related [quality of life] compared with that for chemotherapy, and might represent a new first-line standard of care for PD-L1-expressing, advanced NSCLC.”

The study was funded by Merck & Co.

Julie Brahmer, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, is the corresponding author of The Lancet Oncology article. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


Advertisement

Advertisement



Advertisement