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Gregory J. Riely, MD, PhD

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Quality-of-Life Data Support Pembrolizumab’s Role in Early-Stage NSCLC

By: Celeste L. Dixon
Posted: Monday, July 15, 2024

More KEYNOTE-671 data—specifically, on patient-reported quality of life—support the neoadjuvant regimen of the PD-1 inhibitor pembrolizumab plus cisplatin-based chemotherapy as a new standard of care in the preoperative treatment of patients with resectable, early-stage (stage II, IIIA, or IIIB [N2]) non–small cell lung cancer (NSCLC). These data join the positive efficacy and safety results from the phase III trial, noted Marina Chiara Garassino, MD, of University of Chicago Medicine & Biological Sciences, and colleagues, who presented their results during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8012).

Adding perioperative pembrolizumab maintained health-related quality of life in both the neoadjuvant and adjuvant settings vs neoadjuvant chemotherapy and surgery alone, the team stressed. The 397 patients in KEYNOTE-671’s experimental arm had pembrolizumab and chemotherapy before surgery and pembrolizumab after surgery, whereas the 400 patients in the comparator arm had placebo and chemotherapy before surgery and placebo afterwards. Previously reported results showed that the patients in the pembrolizumab arm had significant improvements in event-free survival, overall survival, pathologic complete response, and major pathologic response vs those in the placebo arm.

“There were no significant differences from baseline in the neoadjuvant or adjuvant phase for any patient-reported outcome score,” noted the authors. Patients completed the European Organisation for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 items (QLQ-C30) and QLQ-LC13 (the EORTC’s modular supplement for use in lung cancer clinical trials) at baseline; at the last scheduled presurgery visit; at adjuvant cycles 1 through 4, 7, 10, and 13; and at each visit after treatment.

Score changes were evaluated from baseline to neoadjuvant week 11 and adjuvant week 10, which were the latest times of ≥ 60% completion and ≥ 80% compliance, explained Dr. Garassino and co-investigators. Scores evaluated specifically were QLQ-C30 global health status/quality of life, physical functioning, role functioning, dyspnea, and QLC-LC13 cough and chest pain in all treated patients who completed at least one patient-reported outcome assessment.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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