Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma
| Autor: | Yuichiro, Doki, Jaffer A, Ajani, Ken, Kato, Jianming, Xu, Lucjan, Wyrwicz, Satoru, Motoyama, Takashi, Ogata, Hisato, Kawakami, Chih-Hung, Hsu, Antoine, Adenis, Farid, El Hajbi, Maria, Di Bartolomeo, Maria I, Braghiroli, Eva, Holtved, Sandra A, Ostoich, Hye R, Kim, Masaki, Ueno, Wasat, Mansoor, Wen-Chi, Yang, Tianshu, Liu, John, Bridgewater, Tomoki, Makino, Ioannis, Xynos, Xuan, Liu, Ming, Lei, Kaoru, Kondo, Apurva, Patel, Joseph, Gricar, Ian, Chau, Yuko, Kitagawa, Rachna T, Shroff |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Adult
Aged 80 and over Male Immune Checkpoint Inhibitors/administration & dosage Esophageal Neoplasms Antineoplastic Combined Chemotherapy Protocols/adverse effects B7-H1 Antigen/antagonists & inhibitors General Medicine Middle Aged Ipilimumab Survival Analysis B7-H1 Antigen Progression-Free Survival Nivolumab/administration & dosage Nivolumab Carcinoma Squamous Cell/drug therapy Antineoplastic Combined Chemotherapy Protocols Carcinoma Squamous Cell Humans Female Ipilimumab/administration & dosage Esophageal Neoplasms/drug therapy Immune Checkpoint Inhibitors Aged |
| Zdroj: | Doki, Y, Ajani, J A, Kato, K, Xu, J, Wyrwicz, L, Motoyama, S, Ogata, T, Kawakami, H, Hsu, C H, Adenis, A, El Hajbi, F, Di Bartolomeo, M, Braghiroli, M I, Holtved, E, Ostoich, S A, Kim, H R, Ueno, M, Mansoor, W, Yang, W C, Liu, T, Bridgewater, J, Makino, T, Xynos, I, Liu, X, Lei, M, Kondo, K, Patel, A, Gricar, J, Chau, I, Kitagawa, Y & CheckMate 648 Trial Investigators 2022, ' Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma ', The New England Journal of Medicine, vol. 386, no. 5, pp. 449-462 . https://doi.org/10.1056/NEJMoa2111380 |
| ISSN: | 1533-4406 |
| DOI: | 10.1056/NEJMoa2111380 |
| Popis: | BACKGROUND: First-line chemotherapy for advanced esophageal squamous-cell carcinoma results in poor outcomes. The monoclonal antibody nivolumab has shown an overall survival benefit over chemotherapy in previously treated patients with advanced esophageal squamous-cell carcinoma. METHODS: In this open-label, phase 3 trial, we randomly assigned adults with previously untreated, unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma in a 1:1:1 ratio to receive nivolumab plus chemotherapy, nivolumab plus the monoclonal antibody ipilimumab, or chemotherapy. The primary end points were overall survival and progression-free survival, as determined by blinded independent central review. Hierarchical testing was performed first in patients with tumor-cell programmed death ligand 1 (PD-L1) expression of 1% or greater and then in the overall population (all randomly assigned patients). RESULTS: A total of 970 patients underwent randomization. At a 13-month minimum follow-up, overall survival was significantly longer with nivolumab plus chemotherapy than with chemotherapy alone, both among patients with tumor-cell PD-L1 expression of 1% or greater (median, 15.4 vs. 9.1 months; hazard ratio, 0.54; 99.5% confidence interval [CI], 0.37 to 0.80; P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|