EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer

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

doi:10.1016/j.ejca.2022.03.016

EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer

Eur J Cancer. 2022 Oct:174:299-309. doi: 10.1016/j.ejca.2022.03.016. Epub 2022 Jul 31.

Authors

Ana Oaknin¹, Bradley J Monk², Ignace Vergote³, Andreia Cristina de Melo⁴, Yong-Man Kim⁵, Alla S Lisyanskaya⁶, Vanessa Samouëlian⁷, Hee Seung Kim⁸, Evgeniy A Gotovkin⁹, Fernanda Damian¹⁰, Chih-Long Chang¹¹, Shunji Takahashi¹², Jingjin Li¹³, Melissa Mathias¹³, Matthew G Fury¹³, Cristina Ivanescu¹⁴, Matthew Reaney¹⁵, Patrick R LaFontaine¹⁶, Israel Lowy¹³, James Harnett¹³, Chieh-I Chen¹³, Krishnansu S Tewari¹⁷

Affiliations

¹ Gynaecologic Cancer Programme, Vall D'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall D'Hebron, Vall D'Hebron Barcelona Hospital Campus, Barcelona, Spain. Electronic address: [email protected].
² Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona, Creighton University, Phoenix, AZ, USA.
³ Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, University Hospitals, KU Leuven, Leuven, Belgium.
⁴ Division of Clinical Research and Technological Development, Hospital Do Câncer II, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.
⁵ Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
⁶ St Petersburg State Budgetary Institution of Healthcare, St Petersburg, Russia.
⁷ Gynecologic Oncology Division, Department of Obstetrics and Gynecology, Centre Hospitalier de L'Université de Montréal (CHUM), Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM) and Université de Montréal, Montreal, Canada.
⁸ Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea.
⁹ State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary, Ivanovo, Russia.
¹⁰ Centro de Pesquisa Em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande Do Sul, Porto Alegre, Brazil.
¹¹ Department of Obstetrics and Gynecology, Mackay Memorial Hospital and Department of Medicine, Mackay Medical College, Taipei, Taiwan.
¹² Department of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
¹³ Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
¹⁴ IQVIA, Amsterdam, Netherlands.
¹⁵ IQVIA, London, UK.
¹⁶ Sanofi, Cambridge, MA, USA.
¹⁷ Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, University of California, Irvine, CA, USA.

PMID: 35922251
DOI: 10.1016/j.ejca.2022.03.016

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.

Keywords: Cemiplimab; Chemotherapy; Functioning; Patient-reported outcomes; Quality of life; Symptoms.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Carcinoma, Squamous Cell* / drug therapy
Female
Humans
Neoplasm Recurrence, Local / drug therapy
Neoplasm Recurrence, Local / etiology
Pain / drug therapy
Patient Reported Outcome Measures
Quality of Life
Uterine Cervical Neoplasms* / drug therapy

Substances

Antibodies, Monoclonal, Humanized
cemiplimab

Associated data

ClinicalTrials.gov/NCT03257267