Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer

Julien Mazieres, Dariusz Kowalski, Alexander Luft, David Vicente, Ali Tafreshi, Mahmut Gümüş, Konstantin Laktionov, Barbara Hermes, Irfan Cicin, Jerónimo Rodríguez-Cid, Jonathan Wilson, Terufumi Kato, Rodryg Ramlau, Silvia Novello, Sreekanth Reddy, Hans Georg Kopp, Bilal Piperdi, Xiaodong Li, Thomas Burke, Luis Paz-Ares

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

PURPOSE: In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC), with little impact on severe toxicity. We present patient-reported outcomes (PROs) from KEYNOTE-407. METHODS: Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13). Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in the QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13. Two-sided, nominal P values are provided. RESULTS: A total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively. GHS/QoL score improved for the pembrolizumab-combination group (least squares [LS] mean [95% CI] change from baseline: week 9, 1.8 [-0.9 to 4.4]; week 18, 4.3 [1.7 to 6.9]) and deteriorated in the placebo-combination group (week 9, -1.8 [-4.4 to 0.7]; week 18, -0.57 [-3.3 to 2.2]). Between-group differences were improved for the pembrolizumab-combination group (difference in LS mean scores: week 9, 3.6 [95% CI, 0.3 to 6.9], nominal P = .0337; week 18, 4.9 [1.4 to 8.3], nominal P = .0060). Median time to deterioration in cough, chest pain, or dyspnea was not reached in either group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06]; nominal P = .125). CONCLUSION: Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18. These results support use of pembrolizumab plus chemotherapy as first-line therapy for metastatic squamous NSCLC.

Original languageEnglish (US)
Pages (from-to)271-280
Number of pages10
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume38
Issue number3
DOIs
StatePublished - Jan 20 2020

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Mazieres, J., Kowalski, D., Luft, A., Vicente, D., Tafreshi, A., Gümüş, M., Laktionov, K., Hermes, B., Cicin, I., Rodríguez-Cid, J., Wilson, J., Kato, T., Ramlau, R., Novello, S., Reddy, S., Kopp, H. G., Piperdi, B., Li, X., Burke, T., & Paz-Ares, L. (2020). Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 38(3), 271-280. https://doi.org/10.1200/JCO.19.01348