1. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer
- Author
-
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, Institut Català de la Salut, [Oaknin A] Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Monk BJ] Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona, Creighton University, Phoenix, AZ, USA. [Vergote I] Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, University Hospitals, KU Leuven, Leuven, Belgium. [Cristina de Melo A] Division of Clinical Research and Technological Development, Hospital Do Câncer II, Brazilian National Cancer Institute, Rio de Janeiro, Brazil. [Kim YM] Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, South Korea. [Lisyanskaya AS] St Petersburg State Budgetary Institution of Healthcare, St Petersburg, Russia, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Quality of life ,Cancer Research ,Pacients - Satisfacció ,Pain ,Uterine Cervical Neoplasms ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Antibodies, Monoclonal, Humanized ,Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Female::Uterine Neoplasms::Uterine Cervical Neoplasms [DISEASES] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Quimioteràpia combinada ,Coll uterí - Càncer - Tractament ,Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Chemotherapy ,Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires::Health Care Surveys::Patient Reported Outcome Measures [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Patient Reported Outcome Measures ,Functioning ,OUTCOMES ,Science & Technology ,Patient-reported outcomes ,técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios::encuestas sobre atención a la salud::medidas de resultados percibidos por los pacientes [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,EORTC QLQ-C30 ,Cemiplimab ,Oncology ,Symptoms ,Carcinoma, Squamous Cell ,Quality of Life ,SURVIVAL ,Female ,Neoplasm Recurrence, Local ,Life Sciences & Biomedicine ,neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino [ENFERMEDADES] - Abstract
Chemotherapy; Quality of life; Symptoms Quimioterapia; Calidad de vida; Síntomas Quimioteràpia; Qualitat de vida; Símptomes 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. This work was supported by Regeneron Pharmaceuticals, Inc., and Sanofi.
- Published
- 2022
- Full Text
- View/download PDF