Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Gastric Cancer. 2019 Mar;22(2):344-354. doi: 10.1007/s10120-018-0899-6. Epub 2018 Dec 1.
Nivolumab, an anti-programmed death-1 agent, showed survival benefits in Asian patients, including Japanese, with gastric/gastro-esophageal junction (G/GEJ) cancer. We report the analysis of the Japanese subpopulation from ATTRACTION-2 that evaluated nivolumab versus placebo in unresectable advanced or recurrent G/GEJ cancer after ≥ 2 chemotherapy regimens.
Data from the Japanese subpopulation in the randomized, double-blind, placebo-controlled, phase 3 trial were analyzed (data cutoff, February 25, 2017). Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).
Among the overall study population of 493 patients, 226 (nivolumab 152; placebo 74) were enrolled from 28 sites in Japan. In the Japanese subset, median OS was longer with nivolumab versus placebo (5.4 months, 95% CI 4.6-7.4 versus 3.6 months, 95% CI 2.8-5.0). The risk of death was lower in the nivolumab versus placebo group (hazard ratio 0.58, 95% CI 0.42-0.78; p = 0.0002). Incidences of serious adverse events were 23% (35/152) and 25% (18/72) in the nivolumab and placebo groups, respectively. In the Japanese ITT population, 22% of nivolumab-treated and 28% of placebo-treated patients received prior ramucirumab treatment. Overall, clinical activity of nivolumab was observed regardless of prior ramucirumab use. In the nivolumab group, ORR and PFS were numerically higher in patients with prior ramucirumab use than in those without.
In the Japanese subpopulation, patients receiving nivolumab had longer OS, similar to the overall population, with a manageable safety profile. The interaction between nivolumab and ramucirumab will be clarified in ongoing clinical trials.
抗程序性死亡-1 药物纳武利尤单抗在亚洲患者（包括日本人）中的胃癌/胃食管结合部（G/GEJ）癌中显示出生存获益。我们报告了在接受至少 2 种化疗方案后不可切除的晚期或复发性 G/GEJ 癌患者中，评价纳武利尤单抗对比安慰剂的 ATTRACTION-2 日本亚组人群的分析结果。
对随机、双盲、安慰剂对照、3 期试验的日本亚组人群的数据进行了分析（数据截止日期：2017 年 2 月 25 日）。主要终点为总生存期（OS）；次要终点包括无进展生存期（PFS）和客观缓解率（ORR）。
在 493 例患者的总体研究人群中，28 个日本中心共纳入 226 例（纳武利尤单抗 152 例，安慰剂 74 例）。在日本亚组中，纳武利尤单抗组的中位 OS 长于安慰剂组（5.4 个月，95%CI 4.6-7.4 比 3.6 个月，95%CI 2.8-5.0）。纳武利尤单抗组的死亡风险低于安慰剂组（风险比 0.58，95%CI 0.42-0.78；p=0.0002）。纳武利尤单抗组和安慰剂组的严重不良事件发生率分别为 23%（35/152）和 25%（18/72）。在日本意向治疗人群中，22%的纳武利尤单抗治疗患者和 28%的安慰剂治疗患者曾接受雷莫芦单抗治疗。总的来说，无论是否曾接受雷莫芦单抗治疗，纳武利尤单抗均表现出临床活性。在纳武利尤单抗组中，曾接受雷莫芦单抗治疗的患者的 ORR 和 PFS 均高于未接受雷莫芦单抗治疗的患者。
在日本亚组中，接受纳武利尤单抗治疗的患者的 OS 更长，与总体人群相似，安全性特征可管理。纳武利尤单抗与雷莫芦单抗之间的相互作用将在正在进行的临床试验中得到明确。
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