EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer
Year: 2022
Type: article
Abstract: BACKGROUND: In a phase III, randomised, active-controlled study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9; R2810-ONC-1676; NCT03257267) and cemiplimab significantly improved survival versus investigator's choice of chemotherapy among patients with recurrent cervical cancer who had progressed on platinum-based therapy. Here we report patient-reported outcomes in this pivotal study. METHODS: Patients were randomised 1:1 to open-label cemiplimab (350 mg intravenously every 3 weeks) or investigator's choice of chemotherapy in 6-week cycles. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 during cycles 1-16. Least-squares mean changes from baseline in global health status (GHS)/quality of life (QoL) and physical functioning (PF) were secondary end-points in the statistical hierarchy. RESULTS: Of 608 patients (304/arm), 77.8% patients had squamous cell carcinoma and 22.2% patients had adenocarcinoma. Questionnaire completion rates were ∼90% throughout. In the squamous cell carcinoma population, overall between-group differences statistically significantly favoured cemiplimab in GHS/QoL (8.49; 95% confidence interval [CI]: 3.77-13.21; P = 0.0003) and PF (8.35; 95% CI: 4.08-12.62; P < 0.0001). Treatment differences favoured cemiplimab in both histologic populations by cycle 2. Overall changes from baseline in most functioning and symptom scales favoured cemiplimab, with clinically meaningful treatment differences in role functioning, appetite loss and pain in both populations. The sensitivity analyses, responder analyses and time to definitive deterioration favoured cemiplimab in both populations. CONCLUSIONS: Cemiplimab conferred favourable differences in GHS/QoL and PF compared with chemotherapy among patients with recurrent cervical cancer, with benefits in PF by cycle 2, and clinically meaningful differences favouring cemiplimab in role functioning, appetite loss, and pain.
Source: European Journal of Cancer
Authors: Ana Oaknin, Bradley J. Monk, Ignace Vergote, Andreia Cristina de Melo, Yong-Man Kim, Alla S. Lisyanskaya, Vanessa Samouëlian, Hee Seung Kim, Evgeniy A. Gotovkin, Fernanda Damian, Chih-Long Chang, Shunji Takahashi, Jingjin Li, Melissa Mathias, Matthew G. Fury, Cristina Ivanescu, Matthew Reaney, Patrick R. LaFontaine, Israel Lowy, James Harnett, Chieh-I Chen, Krishnansu S. Tewari
Institutions: Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Creighton University, University of Arizona, The US Oncology Network, Arizona Oncology, KU Leuven, Instituto Nacional de Câncer - INCA, Asan Medical Center, University of Ulsan, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Seoul National University, Hospital São Lucas da PUCRS, Pontifícia Universidade Católica do Rio Grande do Sul, Mackay Memorial Hospital, Mackay Medical University, The Cancer Institute Hospital, Japanese Foundation For Cancer Research, Regeneron (United States), IQVIA (United Kingdom), University of California, Irvine
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,800
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Regeneron Pharmaceuticals, Taiho Pharmaceutical, Les Laboratories Pierre Fabre, Clovis Oncology, Deciphera Pharmaceuticals, Mersana Therapeutics, Incyte, NuCana, Eisai, PharmaMar, Ono Pharmaceutical, Geistlich Pharma, Genentech, EMD Serono, Chugai Pharmaceutical, Daiichi Sankyo Europe
OpenAlex ID: W4288950951