Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Japan.
Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.
Atezolizumab, an anti-programmed death-ligand 1 (PD-L1) agent, is effective and well tolerated in patients with pretreated advanced non-small-cell lung cancer (NSCLC). We assessed its efficacy and safety in Japanese patients through subgroup analyses of the phase 3 OAK study (NCT02008227).
Key eligibility criteria of this randomized, controlled, open-label, international study include locally advanced/metastatic NSCLC, ≥ 1 prior platinum-based chemotherapy, age ≥ 18 years, measurable disease (Response Evaluation Criteria in Solid Tumors v1.1), and Eastern Cooperative Oncology Group performance status 0 or 1. Atezolizumab 1200 mg or docetaxel 75 mg/m was provided intravenously every 3 weeks. Co-primary end points were overall survival (OS) in the intention-to-treat (ITT) population and those with ≥ 1% PD-L1 expression on tumor cells (TC) or tumor-infiltrating immune cells (IC; TC1/2/3 or IC1/2/3).
Sixty-four ITT patients were Japanese; 19 had TC1/2/3 or IC1/2/3 status. In Japanese ITT patients, median OS in the atezolizumab arm (n = 36) was longer than the docetaxel arm (n = 28; 21.3 months [95% confidence interval (CI), 11.0-not estimable (NE)] versus 17.0 months [95% CI, 12.5-NE], respectively; hazard ratio 0.80 [95% CI, 0.41-1.57]). In the TC1/2/3 or IC1/2/3 population, median OS was 21.3 months (95% CI, 15.0-NE) and NE in the atezolizumab (n = 11) and docetaxel (n = 8) groups, respectively (hazard ratio, 0.81 [95% CI, 0.22-3.05]). Atezolizumab was generally well tolerated, with no treatment-related deaths.
Atezolizumab was effective and well tolerated in pretreated Japanese patients with NSCLC. Results are consistent with the primary analysis of OAK.
阿特珠单抗是一种抗程序性死亡配体 1（PD-L1）的药物，在治疗既往接受过治疗的晚期非小细胞肺癌（NSCLC）患者中具有疗效和良好的耐受性。我们通过 OAK 研究（NCT02008227）的亚组分析评估了其在日本患者中的疗效和安全性。
这项随机、对照、开放标签、国际性研究的关键入选标准包括局部晚期/转移性 NSCLC、≥1 次既往铂类化疗、年龄≥18 岁、可测量疾病（实体瘤疗效评价标准 1.1）和东部肿瘤协作组体能状态 0 或 1。阿特珠单抗 1200mg 或多西他赛 75mg/m2 每 3 周静脉输注一次。主要终点是在意向治疗（ITT）人群和肿瘤细胞（TC）或肿瘤浸润免疫细胞（IC；TC1/2/3 或 IC1/2/3）上表达≥1%PD-L1 的患者中的总生存期（OS）。
64 名 ITT 患者为日本人；19 名患者具有 TC1/2/3 或 IC1/2/3 状态。在日本 ITT 患者中，阿特珠单抗组（n=36）的中位 OS 长于多西他赛组（n=28；21.3 个月[95%置信区间（CI），11.0-NE]与 17.0 个月[95%CI，12.5-NE]，分别；风险比 0.80[95%CI，0.41-1.57]）。在 TC1/2/3 或 IC1/2/3 人群中，阿特珠单抗组（n=11）和多西他赛组（n=8）的中位 OS 分别为 21.3 个月（95%CI，15.0-NE）和 NE（风险比，0.81[95%CI，0.22-3.05]）。阿特珠单抗总体耐受性良好，无治疗相关死亡。
阿特珠单抗在既往治疗的日本 NSCLC 患者中具有疗效和良好的耐受性。结果与 OAK 的主要分析一致。
