Nivolumab  化疗现在是HER2阴性、既往未治疗、不可切除或复发性胃/胃食管交界癌（晚期胃癌）的标准治疗，但临床试验的长期随访数据有限。ATTRACTON-4是一个阶段3、在日本、韩国和台湾进行的双盲、安慰剂对照试验。患者被随机分配接受纳武单抗或安慰剂治疗，两者均结合医生选择的 SOX（口服 S-1 [替加氟-吉美嘧啶-奥替拉西钾]  奥沙利铂）或 CAPOX（卡培他滨  奥沙利铂）。我们报告了主要终点——集中评估的无进展生存期 (PFS) 和总生存期 (OS)——以及使用 3 年随访数据对存活患者进行 OS 的标志性分析。在截止日期（2021 年 5 月 10 日），纳武单抗化疗组中的 17/359 名患者和安慰剂化疗组中的 6/358 名患者正在继续研究治疗。纳武单抗化疗组的 PFS（集中评估）更长（中位 10.94 个月与 8.48 个月；风险比 [HR] 0.67，95% 置信区间 [CI] 0.55-0.82）。尽管两组之间的 OS 没有差异（中位数 17.45 个月与 17.15 个月；HR 0.89，95% CI 0.75-1.05），但 OS 的标志性分析（计算每个标志性时间点（每月）的 HR）在数值上有所改善随着时间的推移，在纳武单抗化疗组中。在纳武单抗化疗组中获得完全缓解的患者中，大约 80% 的患者在 3 岁时仍存活。纳武单抗  化疗没有观察到新的安全信号或主要的迟发型选择治疗相关不良事件。ATTRACTION-4的这项3年随访证实了纳武单抗  化疗对既往未经治疗的患者具有长期临床益处和可控的安全性晚期胃癌.NCT02746796.© 2024。作者。

Nivolumab + chemotherapy is now a standard of care for HER2-negative, previously untreated, unresectable or recurrent gastric/gastroesophageal junction cancer (advanced gastric cancer), but long-term follow-up data of clinical trials are limited.ATTRACTON-4 was a phase 3, double-blind, placebo-controlled trial in Japan, South Korea, and Taiwan. Patients were randomized to either nivolumab or placebo, both combined with the physician's choice of SOX (oral S-1 [tegafur-gimeracil-oteracil potassium] + oxaliplatin) or CAPOX (capecitabine + oxaliplatin). We report the primary endpoints-centrally assessed progression-free survival (PFS) and overall survival (OS)-and landmark analyses of OS among patients alive using 3-year follow-up data.At the cutoff date (May 10, 2021), 17/359 patients in the nivolumab + chemotherapy group and 6/358 in the placebo + chemotherapy group were continuing study treatment. PFS (centrally assessed) was longer in the nivolumab + chemotherapy group (median 10.94 vs. 8.48 months; hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.55-0.82). Although OS did not differ between the two groups (median 17.45 vs. 17.15 months; HR 0.89, 95% CI 0.75-1.05), the landmark analysis of OS, calculating HRs at each landmark time point (every month), was getting numerically better in the nivolumab + chemotherapy group over time. Approximately 80% of patients who achieved complete response in the nivolumab + chemotherapy group were alive at 3 years. No new safety signals or major late-onset select treatment-related adverse events were observed for nivolumab + chemotherapy.This 3-year follow-up of ATTRACTION-4 confirmed the long-term clinical benefit and manageable safety of nivolumab + chemotherapy in patients with previously untreated advanced gastric cancer.NCT02746796.© 2024. The Author(s).