CheckMate 577: A randomized, double-blind, phase 3 study of nivolumab (Nivo) or placebo in patients (Pts) with resected lower esophageal (E) or gastroesophageal junction (GEJ) cancer.
CheckMate 577: A randomized, double-blind, phase 3 study of nivolumab (Nivo) or placebo in patients (Pts) with resected lower esophageal (E) or gastroesophageal junction (GEJ) cancer.
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CheckMate 577：一项针对食管下段 (E) 或胃食管交界处 (GEJ) 癌切除患者 (Pts) 进行的纳武单抗 (Nivo) 或安慰剂的随机、双盲 3 期研究。
DOI：
10.1200/jco.2017.35.4_suppl.tps212
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发表时间：
2017
影响因子：
45.3
通讯作者：
M. Moehler
中科院分区：
文献类型：
--
作者：
R. Kelly;A. Lockhart;D. Jonker;B. Melichar;T. André;I. Chau;S. Clarke;J. Cleary;Y. Doki;F. Franke;Y. Kitagawa;C. Mariette;P. Montenegro;E. Roca;M. Ciprotti;M. Moehler
TPS212背景：放化疗(CRT)后手术切除是目前治疗E/GEJ癌的标准治疗方案，3年和5年生存率在30%到40%之间。目前，手术切除后尚无有效的辅助剂。程序性死亡-1(PD-1)配体1/2(PD-L1/L2)的表达与E/GEJ癌的预后不良有关，提示抑制PD-1可能会改善预后。NIVO是一种针对PD-1的全人IgG4单抗，在多种肿瘤类型和一些患者的长期反应中显示出生存益处。NIVO单一疗法治疗化疗难治的胃/E/GEJ癌的1/2期研究显示，在PD-L1+和PD-L1-肿瘤患者中，肿瘤消退，中位总生存期(OS)为5个月，12个月OS率为36%(Janjigian Y等)。J·克莱恩·奥科尔。2016；34：Suppl；摘要4010)。这项多国、双盲、3期试验将评估尼沃作为一种辅助治疗再发性心脏病患者的疗效。
TPS212Background: Chemoradiotherapy (CRT) followed by surgical resection is a current standard of care (SOC) for pts with E/GEJ cancer, with 3- and 5-year survival rates ranging from 30% to 40%. Currently, no effective adjuvant SOC is available following resection. Expression of programmed death-1 (PD-1) ligands 1/2 (PD-L1/L2) has been associated with a poor prognosis in E/GEJ cancer, suggesting that PD-1 inhibition may improve outcomes. Nivo is a fully human IgG4 monoclonal antibody that targets PD-1, with demonstrated survival benefit in multiple tumor types and long-term responses in some patients. A phase 1/2 study of nivo monotherapy in chemotherapy-refractory pts with gastric/E/GEJ cancer demonstrated tumor regression, a median overall survival (OS) of 5 months, and a 12-month OS rate of 36% in pts with PD-L1+ and PD-L1- tumors (Janjigian Y, et al. J Clin Oncol. 2016;34:suppl; abstract 4010). This multinational, double-blind, phase 3 trial will evaluate nivo as an adjuvant therapy for pts with resec...