Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Cancer Sci. 2021 Apr;112(4):1534-1544. doi: 10.1111/cas.14817. Epub 2021 Feb 9.
IMpower132 explored the safety and efficacy of atezolizumab plus pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small-cell lung cancer (NSCLC). Key eligibility criteria for the phase 3, open-label, IMpower132 study included age ≥18 y, histologically or cytologically confirmed advanced non-squamous NSCLC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status of 0/1, and no prior systemic treatment for stage IV NSCLC. Patients received atezolizumab (1200 mg) plus pemetrexed (500 mg/m ) and cisplatin (75 mg/m ) or carboplatin (area under the concentration curve, 6 mg/mL/min) (APP arm) or chemotherapy alone (PP arm). The co-primary study endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS) per RECIST 1.1 in the intention-to-treat population. A subgroup analysis was conducted in Japanese patients. In the Japanese subgroup (n = 101), median OS was 30.8 (95% CI, 24.3 to not estimable) mo in the APP arm (n = 48) and 22.2 (95% CI, 15.7-30.8) mo in the PP arm (n = 53; hazard ratio [HR], 0.63 [95% CI, 0.36-1.14]). PFS was 12.8 (95% CI, 8.6-16.6) mo in the APP arm vs 4.5 (95% CI, 4.1-6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21-0.58]). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 68.8% of APP arm patients and 44.2% of PP arm patients. Consistent with global study results, atezolizumab plus pemetrexed and platinum-based chemotherapy improved efficacy and was well tolerated in Japanese patients with advanced NSCLC despite a higher incidence of grade 3/4 TRAEs.
IMpower132 研究探索了阿特珠单抗联合培美曲塞和铂类化疗作为晚期非小细胞肺癌（NSCLC）一线治疗的安全性和有效性。这项开放标签、III 期、IMpower132 研究的主要入选标准包括：年龄≥18 岁；根据实体瘤反应评价标准 1.1（RECIST）确认为晚期非鳞状 NSCLC；东部肿瘤协作组（ECOG）体能状态为 0 或 1；无晚期 NSCLC 的既往系统治疗。患者接受阿特珠单抗（1200mg）联合培美曲塞（500mg/m ）和顺铂（75mg/m ）或卡铂（AUC 为 6mg/mL/min）（APP 组）或单纯化疗（PP 组）治疗。主要研究终点为在意向治疗人群中按 RECIST 1.1 评估的总生存期（OS）和研究者评估的无进展生存期（PFS）。在日本患者亚组中进行了一项亚组分析。在日本患者亚组（n=101）中，APP 组（n=48）的中位 OS 为 30.8 个月（95%CI，24.3-无法评估），PP 组（n=53）为 22.2 个月（95%CI，15.7-30.8）（HR，0.63[95%CI，0.36-1.14]）。APP 组的 PFS 为 12.8 个月（95%CI，8.6-16.6），PP 组为 4.5 个月（95%CI，4.1-6.7）（HR，0.33[95%CI，0.21-0.58]）。APP 组患者发生 3/4 级治疗相关不良事件（TRAEs）的比例为 68.8%，PP 组为 44.2%。与全球研究结果一致，尽管 3/4 级 TRAE 发生率较高，但阿特珠单抗联合培美曲塞和铂类化疗在晚期 NSCLC 日本患者中改善了疗效且具有良好的耐受性。
