EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer. (October 2022)

• Record Type: Journal Article
• Authors: Oaknin, Ana; Monk, Bradley J.; Vergote, Ignace; Cristina de Melo, Andreia; Kim, Yong-Man; Lisyanskaya, Alla S.; Samouëlian, Vanessa; Kim, Hee Seung; Gotovkin, Evgeniy A.; Damian, Fernanda; Chang, Chih-Long; Takahashi, Shunji; Li, Jingjin; Mathias, Melissa; Fury, Matthew G.; Ivanescu, Cristina; Reaney, Matthew; LaFontaine, Patrick R.; Lowy, Israel; Harnett, James; Chen, Chieh-I; Tewari, Krishnansu S.
• Is Part Of: European journal of cancer. Volume 174(2022)
• Page Start: 299
• Page End: 309
• Publication Date: 2022-10
• Subjects: Cemiplimab -- Chemotherapy -- Patient-reported outcomes -- Quality of life -- Functioning -- Symptoms; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2022.03.016
• Languages: English
• ISSNs: 0959-8049

Abstract

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. Graphical abstract: Image 1 Video 1 Video demonstrating the intraoperative manoeuvre of patellar reduction. Highlights: This study examined patient-reported outcomes for cervical cancer treatments. Patient-reported outcomes generally were stable/improved with cemiplimab and worsened with chemotherapy. Quality of life and physical functioning significantly favoured cemiplimab in patients with squamous cell carcinoma. Many other functioning and symptom scales also favoured cemiplimab versus chemotherapy.