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EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical 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
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
Vall d'Hebron Barcelona Hospital Campus
Source :
Scientia
Publication Year :
2022
Publisher :
Elsevier BV, 2022.

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.

Subjects

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]

Details

ISSN :
09598049
Volume :
174
Database :
OpenAIRE
Journal :
European Journal of Cancer
Accession number :
edsair.doi.dedup.....e7902ba76c90b86f4278bb8b41600848
Full Text :
https://doi.org/10.1016/j.ejca.2022.03.016