Quality of life with cemiplimab plus chemotherapy for first-line treatment of advanced non–small cell lung cancer: Patient-reported outcomes from phase 3 EMPOWER-Lung 3 |
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| Authors: | Tamta Makharadze MD Ruben G W Quek PhD Tamar Melkadze MD Miranda Gogishvili MD Cristina Ivanescu PhD Davit Giorgadze MD Mikhail Dvorkin MD Konstantin Penkov MD Konstantin Laktionov MD Gia Nemsadze MD Marina Nechaeva MD Irina Rozhkova MD Ewa Kalinka MD Christian Gessner MD Brizio Moreno-Jaime MD Rodolfo Passalacqua MD Gerasimos Konidaris MSc Petra Rietschel MD PhD Giuseppe Gullo MD |
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| Institution: | 1. LTD High Technology Hospital Med Center, Batumi, Georgia;2. Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA;3. Acad. F. Todua Medical Center, Tbilisi, Georgia;4. High Technology Medical Centre, University Clinic, Ltd, Tbilisi, Georgia;5. Patient Centered Endpoints, IQVIA, Amsterdam, Netherlands;6. David Tvildiani Medical University, Tbilisi, Georgia;7. State Budgetary Healthcare Institution of Omsk Region, Omsk, Russia;8. Private Medical Institution Euromedservice, St Petersburg, Russia;9. Federal State Budgetary Institution “N.N. Blokhin National Medical Research Center of Oncology” of the Ministry of Health of the Russian Federation, Moscow, Russia;10. The Institute of Clinical Oncology, Tbilisi, Georgia;11. Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Russia;12. State Budgetary Healthcare Institution of Kaluga Region, Kaluga, Russia;13. Polish Mother's Memorial Hospital Research Institute, ?ód?, Poland;14. POIS Leipzig GbR Steffi Geßner, Leipzig, Germany;15. Hospital Regional ISSSTE, Leon, Mexico;16. Istituti Ospitalieri Di Cremona, Cremona, Italy;17. Sanofi, Reading, UK |
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| Abstract: | Background EMPOWER-Lung 3, a randomized 2:1 phase 3 trial, showed clinically meaningful and statistically significant overall survival improvement with cemiplimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy for first-line treatment of advanced non–small cell lung cancer. This study evaluated patient-reported outcomes (PROs). Methods PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks) for the first six doses, and then at start of every three cycles, using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) and Quality of Life-Lung Cancer Module (QLQ-LC13) questionnaires. Prespecified analyses included a longitudinal mixed-effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis performed for global health status/quality of life (GHS/QoL) and all scales from the questionnaires. Between-arm TTD comparisons were made using a stratified log-rank test and proportional hazards model. Results A total of 312 patients were assigned to receive cemiplimab plus platinum-doublet chemotherapy and 154 to receive placebo plus chemotherapy; 391 (83.9%) were male and the median age was 63.0 years (range, 25–84). For pain symptoms (EORTC QLQ-C30), a statistically significant overall improvement from baseline (?4.98, 95% confidence interval CI] ?8.36 to ?1.60, p = .004) and a statistically significant delay in TTD (hazard ratio, 0.39; 95% CI, 0.26–0.60, p < .0001) favoring cemiplimab plus chemotherapy were observed. Statistically significant delays in TTD, all favoring cemiplimab plus chemotherapy, were also observed in functioning and symptom scales. A significant overall improvement from baseline in GHS/QoL was seen for cemiplimab plus chemotherapy compared with nonsignificant overall change from baseline for placebo plus chemotherapy (1.69, 95% CI, 0.20–3.19 vs. 1.08, 95% CI, –1.34 to 3.51; between arms, p = .673). No analyses yielded statistically significant PRO results favoring placebo plus chemotherapy for any QLQ-C30 or QLQ-LC13 scale. Conclusion Cemiplimab plus chemotherapy resulted in significant overall improvement in pain symptoms and delayed TTD in cancer-related and lung cancer–specific symptoms and functions. |
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| Keywords: | advanced non–small cell lung cancer cemiplimab non–small cell lung cancer patient-reported outcome quality of life |
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