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Patient-Reported Outcomes With Addition of Pembrolizumab vs Placebo to Pemetrexed/Platinum for Nonsquamous NSCLC


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As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, global health status/quality of life was maintained or improved with the addition of pembrolizumab vs placebo to pemetrexed/platinum therapy for previously untreated metastatic nonsquamous non–small cell lung cancer (NSCLC).

Marina C. Garassino, MD

Marina C. Garassino, MD

In the phase III double-blind KEYNOTE-189 trial, pembrolizumab plus pemetrexed/platinum was also associated with superior overall and progression-free survival as well as objective response rate vs placebo.

Study Details

In the trial, 607 patients without sensitizing EGFR or ALK alterations were randomly assigned 2:1 to receive 200 mg of pembrolizumab or placebo every 3 weeks for up to 2 years, with all patients receiving four cycles of pemetrexed (500 mg/m²) with investigator’s choice of carboplatin (5 mg/mL per min) or cisplatin (75 mg/m²) every 3 weeks for four cycles followed by maintenance pemetrexed every 3 weeks.  

In the patient-reported outcome analysis, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13) were administered at cycles 1 to 5, every three cycles thereafter during year 1, and every four cycles during years 2 to 3. The key patient-reported outcome endpoints were change from baseline to week 12 (during chemotherapy) and week 21 (following chemotherapy) in QLQ-C30 global health status/quality of life score and time to deterioration in cough, chest pain, or dyspnea.

Patient-Reported Outcomes

Median follow-up was 10.5 months. A total of 402 (99%) of 405 patients in the pembrolizumab group and 200 (99%) of 202 patients in the placebo group completed at least one patient-reported outcome assessment. Rates of compliance with QLQ-C30 were 89% of 402 patients vs 90% of 200 patients at baseline, 90% of 319 vs 89% of 149 at week 12, and 76% of 326 vs 64% of 143 at week 21.

“The addition of pembrolizumab to standard chemotherapy maintained global health status/quality of life, with improved global health status/quality of life scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed/platinum as first-line therapy for patients with metastatic nonsquamous non–small cell lung cancer.”
— Marina C. Garassino, MD, and colleagues

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At week 12, least-squares mean changes in global health status/quality of life scores were +1.0 point (95% confidence interval [CI] = −1.3 to +3.2) in the pembrolizumab group vs −2.6 points (95% CI = −5.8 to +0.5) in the placebo group (between-group difference = 3.6 points, 95% CI = −0.1 to +7.2, P = .053).

At week 21, least-squares mean changes in global health status/quality of life scores were +1.3 points (95% CI = −1.2 to +3.6) in the pembrolizumab group vs −4.0 points (95% CI = −7.7 to −0.3) in the placebo group (between-group difference = 5.3 points, 95% CI = +1.1 to +9.5, P = .014).

Median time to deterioration in cough, chest pain, or dyspnea was not reached (95% CI = 10.2 months to not reached) in the pembrolizumab group vs 7.0 months (95% CI = 4.8 months to not reached) in the placebo group (hazard ratio = 0.81, 95% CI = 0.60–1.09, P = .16).

The investigators concluded, “The addition of pembrolizumab to standard chemotherapy maintained global health status/quality of life, with improved global health status/quality of life scores at week 21 in the pembrolizumab plus chemotherapy group compared with the placebo plus chemotherapy group. These data further support use of pembrolizumab plus pemetrexed/platinum as first-line therapy for patients with metastatic nonsquamous non–small cell lung cancer.”

Dr. Garassino, of the Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by Merck Sharp & Dohme. For full disclosures of the study authors, visit thelancet.com.

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®.
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