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dc.contributor.authorDoki, Y.
dc.contributor.authorAjani, J. A.
dc.contributor.authorKato, K.
dc.contributor.authorXu, J.
dc.contributor.authorWyrwicz, L.
dc.contributor.authorMotoyama, S.
dc.contributor.authorOgata, T.
dc.contributor.authorKawakami, H.
dc.contributor.authorHsu, C. H.
dc.contributor.authorAdenis, A.
dc.contributor.authorEl Hajbi, F.
dc.contributor.authorDi Bartolomeo, M.
dc.contributor.authorBraghiroli, M. I.
dc.contributor.authorHoltved, E.
dc.contributor.authorOstoich, S. A.
dc.contributor.authorKim, H. R.
dc.contributor.authorUeno, M.
dc.contributor.authorMansoor, W.
dc.contributor.authorYang, W. C.
dc.contributor.authorLiu, T.
dc.contributor.authorBridgewater, J.
dc.contributor.authorMakino, T.
dc.contributor.authorXynos, I.
dc.contributor.authorLiu, X.
dc.contributor.authorLei, M.
dc.contributor.authorKondo, K.
dc.contributor.authorPatel, A.
dc.contributor.authorGricar, J.
dc.contributor.authorChau, I.
dc.contributor.authorKitagawa, Y.
dc.contributor.authorCheckMate 648 Trial, I.
dc.date.accessioned2022-02-22T11:44:41Z
dc.date.available2022-02-22T11:44:41Z
dc.date.issued2022en
dc.identifier.citationDoki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, et al. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. Vol. 386, New England Journal of Medicine. Massachusetts Medical Society; 2022. p. 449–62.en
dc.identifier.doi10.1056/NEJMoa2111380en
dc.identifier.urihttp://hdl.handle.net/10541/625073
dc.description.abstractBACKGROUND 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. opens in new tab.)en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1056/NEJMoa2111380en
dc.titleNivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinomaen
dc.typeArticleen
dc.identifier.journalNew England Journal of Medicineen
dc.description.noteen]


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