Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Gastric Cancer. 2021 Jul;24(4):946-958. doi: 10.1007/s10120-021-01173-w. Epub 2021 Mar 20.
ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified.
The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression.
Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1-47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50-0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47-1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42).
Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.
ATTRACTION-2 研究表明，纳武利尤单抗可改善既往接受过≥2 种化疗方案治疗的晚期胃癌患者的总生存期（OS），与安慰剂相比。然而，纳武利尤单抗的长期疗效和治疗进展后（TBP）的结局尚不清楚。
收集了 3 年随访数据。进行了亚组分析，通过评估首次疾病进展后进展后的生存情况（PPS）来探索 TBP 的疗效。
共有 493 例患者被随机（2:1）接受纳武利尤单抗（n=330）或安慰剂（n=163）治疗。中位随访时间为 38.5 个月（范围 36.1-47.5），纳武利尤单抗组的 OS 明显长于安慰剂组（中位 5.3 个月 vs 4.1 个月；3 年生存率分别为 5.6%和 1.9%；风险比[HR]，0.62[95%置信区间（CI）0.50-0.75]，P<0.0001）。达到完全缓解或部分缓解的应答者（n=32）的中位 OS 为 26.7 个月，纳武利尤单抗组的 3 年生存率为 35.5%。总体而言，纳武利尤单抗组有 109 例患者和安慰剂组有 37 例患者接受了 TBP。纳武利尤单抗组的 PPS 长于安慰剂组（中位 5.8 个月 vs 4.5 个月；HR[95%CI]，0.69[0.47-1.01]，P=0.057）。相反，在非 TBP 患者中，两组的 PPS 相似（中位 2.3 个月 vs 2.2 个月；HR 0.90，P=0.42）。
在 3 年随访时证实了纳武利尤单抗的长期疗效，并提示纳武利尤单抗的 TBP 可带来生存获益。未来应确定选择适合纳武利尤单抗 TBP 的患者的生物标志物。
