Details

Autor(en) / Beteiligte

• Makharadze, Tamta
• Quek, Ruben G. W.
• Melkadze, Tamar
• Gogishvili, Miranda
• Ivanescu, Cristina
• Giorgadze, Davit
• Dvorkin, Mikhail
• Penkov, Konstantin
• Laktionov, Konstantin
• Nemsadze, Gia
• Nechaeva, Marina
• Rozhkova, Irina
• Kalinka, Ewa
• Gessner, Christian
• Moreno‐Jaime, Brizio
• Passalacqua, Rodolfo
• Konidaris, Gerasimos
• Rietschel, Petra
• Gullo, Giuseppe

Titel

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

Ist Teil von

• Cancer, 2023-07, Vol.129 (14), p.2256-2265

Ort / Verlag

United States: Wiley Subscription Services, Inc

Erscheinungsjahr

2023

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. Cemiplimab plus chemotherapy significantly improves pain in advanced lung cancer patients; significant delay in other symptom and function deterioration is also achieved. These results further support positive benefit‐risk profile of cemiplimab plus chemotherapy.