| Added by | llasorsa |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma |
| Creator | Doki et al. |
| Author | Yuichiro Doki |
| Author | Jaffer A. Ajani |
| Author | Ken Kato |
| Author | Jianming Xu |
| Author | Lucjan Wyrwicz |
| Author | Satoru Motoyama |
| Author | Takashi Ogata |
| Author | Hisato Kawakami |
| Author | Chih-Hung Hsu |
| Author | Antoine Adenis |
| Author | Farid El Hajbi |
| Author | Maria Di Bartolomeo |
| Author | Maria I. Braghiroli |
| Author | Eva Holtved |
| Author | Sandra A. Ostoich |
| Author | Hye R. Kim |
| Author | Masaki Ueno |
| Author | Wasat Mansoor |
| Author | Wen-Chi Yang |
| Author | Tianshu Liu |
| Author | John Bridgewater |
| Author | Tomoki Makino |
| Author | Ioannis Xynos |
| Author | Xuan Liu |
| Author | Ming Lei |
| Author | Kaoru Kondo |
| Author | Apurva Patel |
| Author | Joseph Gricar |
| Author | Ian Chau |
| Author | Yuko Kitagawa |
| Abstract | 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<0.001) and in the overall population (median, 13.2 vs. 10.7 months; hazard ratio, 0.74; 99.1% CI, 0.58 to 0.96; P?=?0.002). Overall survival was also significantly longer with nivolumab plus ipilimumab than with chemotherapy among patients with tumor-cell PD-L1 expression of 1% or greater (median, 13.7 vs. 9.1 months; hazard ratio, 0.64; 98.6% CI, 0.46 to 0.90; P?=?0.001) and in the overall population (median, 12.7 vs. 10.7 months; hazard ratio, 0.78; 98.2% CI, 0.62 to 0.98; P?=?0.01). Among patients with tumor-cell PD-L1 expression of 1% or greater, a significant progression-free survival benefit was also seen with nivolumab plus chemotherapy over chemotherapy alone (hazard ratio for disease progression or death, 0.65; 98.5% CI, 0.46 to 0.92; P?=?0.002) but not with nivolumab plus ipilimumab as compared with chemotherapy. The incidence of treatment-related adverse events of grade 3 or 4 was 47% with nivolumab plus chemotherapy, 32% with nivolumab plus ipilimumab, and 36% with chemotherapy alone. CONCLUSIONS: Both first-line treatment with nivolumab plus chemotherapy and first-line treatment with nivolumab plus ipilimumab resulted in significantly longer overall survival than chemotherapy alone in patients with advanced esophageal squamous-cell carcinoma, with no new safety signals identified. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 648 ClinicalTrials.gov number, NCT03143153.). |
| Publication | The New England Journal of Medicine |
| Volume | 386 |
| Issue | 5 |
| Pages | 449-462 |
| Date | 2022-02-03 |
| Journal Abbr | N Engl J Med |
| Language | eng |
| DOI | 10.1056/NEJMoa2111380 |
| ISSN | 1533-4406 |
| Library Catalog | PubMed |
| Extra | PMID: 35108470 |
| Tags | Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, Carcinoma, Squamous Cell, Esophageal Neoplasms, Female, Humans, Ipilimumab, Male, Middle Aged, Nivolumab, Progression-Free Survival, Survival Analysis |
| Date Added | 2022/08/30 - 16:07:41 |
| Date Modified | 2024/10/10 - 16:52:18 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) Texte intégral (Attachment) |
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