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artículo

Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Publicado por
Rha, SY, Oh, DY, Yañez, P, Bai, Y, Ryu, MH, Lee, J, Rivera, F, Alves, GV, Garrido, M, Shiu, KK, Fernández, MG, Li, J, Lowery, MA, Çil, T, Cruz, FM, Qin, S, Luo, S, Pan, H, Wainberg, ZA, Yin, L, Bordia, S, Bhagia, P, Wyrwicz, LS, KEYNOTE-859 investigators, Castro-Oliden, V

Publicado 2023

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Background: PD-1 inhibitors combined with chemotherapy have shown efficacy in gastric or gastro-esophageal junction cancer. We compared the efficacy and safety of pembrolizumab plus chemotherapy with placebo plus chemotherapy in participants with locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma. Methods: KEYNOTE-859 is a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial, done at 207 medical centres across 33 countries. Eligible participants were aged 18 years and older with previously untreated histologically or cytologically confirmed locally advanced or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) to receive pembrolizumab or placebo 200 mg, administered intravenously every 3...

artículo

Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study

Publicado por
Sun, JM, Shen, L, Shah, MA, Enzinger, P, Adenis, A, Doi, T, Kojima, T, Metges, JP, Li, Z, Kim, SB, Cho, BC, Mansoor, W, Li, SH, Sunpaweravong, P, Maqueda, MA, Goekkurt, E, Hara, H, Antunes, L, Fountzilas, C, Tsuji, A, Castro-Oliden, V, Liu Q, Shah S, Bhagia P, Kato K, KEYNOTE-590 Investigators.

Publicado 2021

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Background: First-line therapy for advanced oesophageal cancer is currently limited to fluoropyrimidine plus platinum-based chemotherapy. We aimed to evaluate the antitumour activity of pembrolizumab plus chemotherapy versus chemotherapy alone as first-line treatment in advanced oesophageal cancer and Siewert type 1 gastro-oesophageal junction cancer. Methods: We did a randomised, placebo-controlled, double-blind, phase 3 study across 168 medical centres in 26 countries. Patients aged 18 years or older with previously untreated, histologically or cytologically confirmed, locally advanced, unresectable or metastatic oesophageal cancer or Siewert type 1 gastro-oesophageal junction cancer (regardless of PD-L1 status), measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1, and Eastern Cooperative Oncology Group performance status of 0-1, were randomly assigned (1:1)...