Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study
Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study
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DOI：
10.1016/j.cllc.2018.01.004
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发表时间：
2018-07-01
影响因子：
3.6
通讯作者：
Kubo, Toshio
中科院分区：
文献类型：
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作者：
Hida, Toyoaki;Kaji, Reiko;Kubo, Toshio
阿替唑珠单抗治疗晚期/转移性非小细胞肺癌(NSCLC)有效且耐受性良好。我们通过3期OAK研究的子分析，在相同环境下对的日本非小细胞肺癌患者检验了阿替唑单抗的有效性和安全性。与多西紫杉醇相比，阿替唑珠单抗可提高总存活率，且耐受性良好，因此为日本患者提供了一种潜在的非小细胞肺癌治疗方法。简介：抗程序性死亡配体1(PD-L1)药物阿替唑珠单抗对经过治疗的晚期非小细胞肺癌(NSCLC)患者有效且耐受性良好。我们通过3期OAK研究(NCT02008227)的亚组分析来评估其在日本患者中的有效性和安全性。患者和方法：这项随机、对照、开放标签的国际研究的关键资格标准包括：局部晚期/转移性非小细胞肺癌，有过铂类化疗的患者=1，年龄=18岁，可测量的疾病(实体肿瘤的反应评估标准v1.1)，东方合作肿瘤组表现状态为0或1。每3周静脉注射阿替唑单抗1200 mg或多西紫杉醇75 mg/m(2)。共同的主要终点是意向治疗(ITT)人群中的总生存期(OS)和肿瘤细胞(TC)或肿瘤浸润性免疫细胞(IC；Tc1/2/3或IC1/2/3)上PD-L1表达=1%的患者。结果：64例ITT患者为日本人，19例为Tc1/2/3或IC1/2/3状态。在日本ITT患者中，阿替唑单抗组(n=36)的中位OS比多西他赛组(n=28)长，分别为21.3个月[95%可信区间(CI)，11.0不可估测(NE)]和17.0个月[95%CI，12.5-NE]；风险比0.80[95%CI，0.41-1.57]。在Tc1/2/3或IC1/2/3人群中，阿替唑单抗组(n=11)和多西紫杉醇组(n=8)的中位OS分别为21.3个月(95%CI，15.0-NE)和NE(危险比，0.81[95%CI，0.22-3.05])。泰唑珠单抗总体耐受性良好，没有与治疗相关的死亡。结论：阿替唑单抗治疗日本非小细胞肺癌患者疗效好，耐受性好。结果与橡木的初步分析结果一致。(C)2018年提交人(S)。由爱思唯尔公司出版。
Atezolizumab is effective and well tolerated in pretreated advanced/metastatic non-small-cell lung cancer (NSCLC). We examined atezolizumab's efficacy and safety in 64 Japanese patients with NSCLC in the same setting via a subanalysis of the phase 3 OAK study. Atezolizumab improved overall survival versus docetaxel and was generally well tolerated, thus offering a potential NSCLC treatment for Japanese patients.Introduction: Atezolizumab, an antieprogrammed 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). Patients and Methods: 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(2) 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). Results: 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. Conclusion: Atezolizumab was effective and well tolerated in pretreated Japanese patients with NSCLC. Results are consistent with the primary analysis of OAK. (C) 2018 The Author(s). Published by Elsevier Inc.