Repositorio
Institucional

Janjigian, Yelena Y.

Shitara, Kohei

Ajani, Jaffer A.

Moehler, Markus

Garrido, Marcelo

Gallardo, Carlos

Shen, Lin

Yamaguchi, Kensei

Wyrwicz, Lucjan

Skoczylas, Tomasz

Bragagnoli, Arinilda Campos

Liu, Tianshu

Tehfe, Mustapha

Elimova, Elena

Bruges, Ricardo

Zander, Thomas

de Azevedo, Sergio

Kowalyszyn, Ruben

Pazo-Cid, Roberto

Schenker, Michael

Cleary, James M.

Yanez, Patricio

Feeney, Kynan

Karamouzis, Michalis, V

Poulart, Valerie

Lei, Ming

Xiao, Hong

Kondo, Kaoru

Li, Mingshun

Nivolumab plus chemotherapy or ipilimumab in gastro-oesophageal cancer

NATURE PORTFOLIO

NATURE

en

Standard first-line chemotherapy results in disease progression and death within one year in most patients with human epidermal growth factor receptor 2 (HER2)-negative gastro-oesophageal adenocarcinoma(1-4). Nivolumab plus chemotherapy demonstrated superior overall survival versus chemotherapy at 12-month follow-up in gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in the randomized, global CheckMate 649 phase 3 trial(5) (programmed death ligand-1 (PD-L1) combined positive score >= 5 and all randomized patients). On the basis of these results, nivolumab plus chemotherapy is now approved as a first-line treatment for these patients in many countries(6). Nivolumab and the cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor ipilimumab have distinct but complementary mechanisms of action that contribute to the restoration of anti-tumour T-cell function and induction of de novo anti-tumour T-cell responses, respectively(7-)(11). Treatment combining 1 mg kg(-1) nivolumab with 3 mg kg(-1) ipilimumab demonstrated clinically meaningful anti-tumour activity with a manageable safety profile in heavily pre-treated patients with advanced gastro-oesophageal cancer(12). Here we report both long-term follow-up results comparing nivolumab plus chemotherapyversus chemotherapy alone and the first results comparing nivolumab plus ipilimumab versus chemotherapy alone from CheckMate 649. After the 24.0-month minimum follow-up, nivolumab plus chemotherapy continued to demonstrate improvement in overall survival versus chemotherapy alone in patients with PD-L1 combined positive >= 5 score (hazard ratio 0.70, 95% confidence interval 0.61, 0.81) and all randomized patients (hazard ratio 0.79, 95% confidence interval 0.71, 0.88). Overall survival in patients with PD-L1 combined positive score >= 5 for nivolumab plus ipilimumab versus chemotherapy alone did not meet the prespecified boundary for significance. No new safety signals were identified. Our results support the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastro-oesophageal adenocarcinoma.

artículo original

10.1038/s41586-022-04508-4

PDF

OPEN-LABEL

COMBINATION THERAPY

SOLID TUMORS

JUNCTION

CAPECITABINE

CISPLATIN

Ciencias Multidisciplinarias

ETIQUETA ABIERTA

TERAPIA COMBINADA

TUMORES SÓLIDOS

JUNCIÓN

CAPECITABINA

CISPLATINO

Oncología

Medicina General e Interna

Farmacología y Farmacia

Nivolumab plus chemotherapy or ipilimumab in gastro-oesophageal cancer

942

artículo original

version publicada

CC BY 4.0

CC BY 4.0

acceso abierto

acceso abierto

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