背景:在數據 CheckMate 577 (NCT02743494)中，尼魯單抗(NIVO)治療在無病生存期(DFS)中顯示出顯著和臨床意義的改善（相對安慰劑組）。在接受新輔助 CRT 並有殘留病理疾病的切除 (R0) II/III 期食管癌或胃食管交界癌 EC/GEJC 患者中耐受性良好。尼魯單抗(NIVO)組相對安慰劑（PBO）組中位無病生存期 DFS 加倍(分別為 22.4 和 11 個月;HR 0.69;96.4%可信區間 0.56 - -0.86;P = 0.0003)。嚴重的治療相關不良事件(TRAEs)和導致停藥的 TRAEs 報告了< 10%的接受 NIVO 治療患者和 3%的安慰劑對照 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:患者以隨機 2:1 分組為:NIVO 240 mg 或 PBO Q2W 組，共 16 周，此後接受 NIVO 480 mg 或 PBO Q4W 治療。本文提供了來自 CheckMate 577 所顯示的額外療效、安全性和生活質量(QoL)數據。

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.

結果:將 794 例患者隨機分組(NIVO：532,PBO：262)。NIVO 組和 PBO 組的遠端複發分別為29%和 39%，局部複發為 12%和 17%。NIVO 組和 PBO 組的中位無遠處轉移生存期分別為 28.3 個月和 17.6 個月(HR 0.74;95%可信區間 0.60 - -0.92)。中位無進展生存期 2 (PFS2;從隨機分組到後續係統治療後進展、開始第二次後續係統治療或死亡(以較早者為準)的時間未達到 NIVO 組相對 PBO 組的 32.1 個月 (HR 0.77;95%可信區間 0.60-0.99)。具有潛在免疫病原學的 TRAEs(選擇 TRAEs;表中列出了為 NIVO 報告的 sTRAEs)。FACT-ECS 和 FACT-G7 的結果顯示，NIVO 和 PBO 治療期間生活質量較基線改善的趨勢相似，治療後仍保持受益。

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.

結論:NIVO 輔助治療具有臨床意義的療效、可接受的安全性和維持的生活質量，進一步支持其作為接受新輔助 CRT 並殘留病理疾病的切除 EC/GEJC 患者的新治療護理標準。

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.