背景:在数据 CheckMate 577 (NCT02743494)中，尼鲁单抗(NIVO)治疗在无病生存期(DFS)中显示出显著和临床意义的改善（相对安慰剂组）。在接受新辅助 CRT 并有残留病理疾病的切除 (R0) II/III 期食管癌或胃食管交界癌 EC/GEJC 患者中耐受性良好。尼鲁单抗(NIVO)组相对安慰剂（PBO）组中位无病生存期 DFS 加倍(分别为 22.4 和 11 个月;HR 0.69;96.4%可信区间 0.56 - -0.86;P = 0.0003)。严重的治疗相关不良事件(TRAEs)和导致停药的 TRAEs 报告了< 10%的接受 NIVO 治疗患者和 3%的安慰剂对照 PBO 患者。

Background: In CheckMate 577 (NCT02743494), NIVO demonstrated a significant and clinically meaningful improvement in disease-free survival (DFS; primary endpoint) vs placebo (PBO) and was well tolerated in patients (pts) with resected (R0) stage II/III EC/GEJC who received neoadjuvant CRT and had residual pathologic disease. Median DFS doubled with NIVO vs PBO (22.4 vs 11.0 months; HR 0.69; 96.4% CI 0.56–0.86; P = 0.0003). Serious treatment-related adverse events (TRAEs) and TRAEs leading to discontinuation were reported for < 10% of pts with NIVO and 3% with PBO.

方法:患者以随机 2:1 分组为:NIVO 240 mg 或 PBO Q2W 组，共 16 周，此后接受 NIVO 480 mg 或 PBO Q4W 治疗。本文提供了来自 CheckMate 577 所显示的额外疗效、安全性和生活质量(QoL)数据。

Methods: Pts were randomized 2:1 to NIVO 240 mg or PBO Q2W for 16 weeks, followed by NIVO 480 mg or PBO Q4W. Here, we present additional efficacy, safety, and quality-of-life (QoL) data from CheckMate 577.

结果:将 794 例患者随机分组(NIVO：532,PBO：262)。NIVO 组和 PBO 组的远端复发分别为29%和 39%，局部复发为 12%和 17%。NIVO 组和 PBO 组的中位无远处转移生存期分别为 28.3 个月和 17.6 个月(HR 0.74;95%可信区间 0.60 - -0.92)。中位无进展生存期 2 (PFS2;从随机分组到后续系统治疗后进展、开始第二次后续系统治疗或死亡(以较早者为准)的时间未达到 NIVO 组相对 PBO 组的 32.1 个月 (HR 0.77;95%可信区间 0.60-0.99)。具有潜在免疫病原学的 TRAEs(选择 TRAEs;表中列出了为 NIVO 报告的 sTRAEs)。FACT-ECS 和 FACT-G7 的结果显示，NIVO 和 PBO 治疗期间生活质量较基线改善的趋势相似，治疗后仍保持受益。

Results: 794 pts were randomized (NIVO, 532; PBO, 262). Distant recurrence was reported for 29% vs 39% and locoregional recurrence for 12% vs 17% of pts in the NIVO vs PBO groups, respectively. Median distant metastasis-free survival was 28.3 vs 17.6 months with NIVO vs PBO (HR 0.74; 95% CI 0.60–0.92). Median progression-free survival 2 (PFS2; time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death, whichever is earlier) was not reached with NIVO vs 32.1 months with PBO (HR 0.77; 95% CI 0.60–0.99). TRAEs with potential immunologic etiology (select TRAEs; sTRAEs) reported for NIVO are presented in the table. Results for the FACT-ECS and FACT-G7 showed similar trends for QoL improvement from baseline for NIVO and PBO during treatment and maintained benefit post-treatment.

a：Most sTRAEs were grade 1 or 2. Grade 3–4 sTRAEs occurred in ≤ 1% of pts and there were no grade 5 sTRAEs. bEvents without a stop date or where stop date was death date were considered unresolved; events without worsening from baseline were excluded.

结论:NIVO 辅助治疗具有临床意义的疗效、可接受的安全性和维持的生活质量，进一步支持其作为接受新辅助 CRT 并残留病理疾病的切除 EC/GEJC 患者的新治疗护理标准。

Conclusions: Adjuvant NIVO demonstrated clinically meaningful efficacy, an acceptable safety profile, and maintained QoL, providing further support for its use as a new standard of care for pts with resected EC/GEJC who received neoadjuvant CRT with residual pathologic disease.