Patient‐reported outcomes with cemiplimab monotherapy for first‐line treatment of advanced non–small cell lung cancer with PD‐L1 of ≥50%: The EMPOWER‐Lung 1 study

• Published in: Cancer 2023-01, Vol.129 (1), p.118-129
• Main Authors: Gümüş, Mahmut, Chen, Chieh‐I, Ivanescu, Cristina, Kilickap, Saadettin, Bondarenko, Igor, Özgüroğlu, Mustafa, Gogishvili, Miranda, Turk, Haci M., Cicin, Irfan, Harnett, James, Mastey, Vera, Naumann, Ulrike, Reaney, Matthew, Konidaris, Gerasimos, Sasane, Medha, Brady, Keri J. S., Li, Siyu, Gullo, Giuseppe, Rietschel, Petra, Sezer, Ahmet
• Format: Article
• Language: English
• Subjects: Adult; Alopecia; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Agents, Immunological - therapeutic use; Apoptosis; Appetite loss; B7-H1 Antigen; Body parts; Cancer therapies; Carcinoma, Non-Small-Cell Lung - drug therapy; Cell death; cemiplimab; Chemotherapy; Constipation; Cough; Diarrhea; Dyspnea; Empowerment; Global health; Humans; Immunotherapy; Lung; Lung cancer; Lung Neoplasms - drug therapy; Medical treatment; Monoclonal antibodies; Non-small cell lung carcinoma; non‐small cell lung cancer; Oncology; Original; ORIGINAL ARTICLES; Pain; Pain - etiology; Patient Reported Outcome Measures; patient‐reported outcomes; PD-L1 protein; Peripheral neuropathy; Platinum; Platinum - therapeutic use; Public health; Quality of Life; Respiration; Signs and symptoms; Small cell lung carcinoma; Survival; symptom burden; Targeted cancer therapy; Vomiting
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.34477

Background In the EMPOWER‐Lung 1 trial (ClinicalTrials.gov, NCT03088540), cemiplimab conferred longer survival than platinum‐doublet chemotherapy for advanced non–small cell lung cancer (NSCLC) with programmed cell death‐ligand 1 (PD‐L1) ≥50%. Patient‐reported outcomes were evaluated among trial participants. Methods Adults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum‐doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life‐Core 30 (QLQ‐C30) and Lung Cancer Module (QLQ‐LC13) questionnaires. Mixed‐model repeated measures analysis estimated overall change from baseline for PD‐L1 ≥50% and intention‐to‐treat populations. Kaplan–Meier analysis estimated time to definitive deterioration. Results In PD‐L1 ≥50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ‐C30 and QLQ‐LC13 scores showed moderate‐to‐high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32‐0.71) to 0.63 (95% CI, 0.41‐0.96). Cemiplimab showed lower risk of definitive deterioration for disease‐related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment‐related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p