PDF(Pubmed)
Abstract：
UNASSIGNED: IMpower210 (NCT02813785) explored the efficacy and safety of single-agent atezolizumab vs. docetaxel as second-line treatment for advanced non-small cell lung cancer (NSCLC) in East Asian patients.
UNASSIGNED: Key eligibility criteria for this phase III, open-label, randomized study included age ≥18 years; histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system (7th edition); Eastern Cooperative Oncology Group performance status of 0 or 1; and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab (1,200 mg) or docetaxel (75 mg/m2). The primary study endpoint was overall survival (OS) in the intention-to-treat (ITT) population with wild-type epidermal growth factor receptor expression (ITT EGFR-WT) and in the overall ITT population.
UNASSIGNED: Median OS in the ITT EGFR-WT population (n=467) was 12.3 [95% confidence interval (95% CI), 10.3-13.8] months in the atezolizumab arm (n=312) and 9.9 (95% CI, 7.8-13.9) months in the docetaxel arm [n=155; stratified hazard ratio (HR), 0.82; 95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5 (95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1 (95% CI, 8.4-14.2) months (n=377) with docetaxel treatment (n=188; stratified HR, 0.87; 95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel arm.
UNASSIGNED: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGFR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade 3/4 TRAEs.
UNASSIGNED: Key eligibility criteria for this phase III, open-label, randomized study included age ≥18 years; histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system (7th edition); Eastern Cooperative Oncology Group performance status of 0 or 1; and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab (1,200 mg) or docetaxel (75 mg/m2). The primary study endpoint was overall survival (OS) in the intention-to-treat (ITT) population with wild-type epidermal growth factor receptor expression (ITT EGFR-WT) and in the overall ITT population.
UNASSIGNED: Median OS in the ITT EGFR-WT population (n=467) was 12.3 [95% confidence interval (95% CI), 10.3-13.8] months in the atezolizumab arm (n=312) and 9.9 (95% CI, 7.8-13.9) months in the docetaxel arm [n=155; stratified hazard ratio (HR), 0.82; 95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5 (95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1 (95% CI, 8.4-14.2) months (n=377) with docetaxel treatment (n=188; stratified HR, 0.87; 95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel arm.
UNASSIGNED: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGFR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade 3/4 TRAEs.
摘要：
■IMpower210(NCT02813785)探讨了阿特珠单抗与单药的疗效和安全性。多西他赛作为东亚晚期非小细胞肺癌（NSCLC）的二线治疗。
■第三阶段的关键资格标准，开放标签，随机研究包括年龄≥18岁;根据国际癌症控制联盟/美国癌症分期联合委员会(第7版),组织学记录的晚期NSCLC;东部肿瘤协作组的表现状态为0或1;晚期或转移性NSCLC的铂类化疗后疾病进展.患者以2：1的比例随机分配接受阿特珠单抗（1,200mg）或多西他赛（75mg/m2）。主要研究终点是具有野生型表皮生长因子受体表达（ITTEGFR-WT）的意向治疗（ITT）人群和整体ITT人群的总生存期（OS）。
■ITTEGFR-WT人群中的中位OS（n=467）为12.3[95％置信区间（95％CI），阿特珠单抗组（n=312）的10.3-13.8个月和多西他赛组的9.9（95％CI，7.8-13.9）个月[n=155；分层风险比（HR），0.82；95%CI，0.66-1.03]。使用阿特珠单抗治疗的整个ITT人群的中位OS为12.5（95％CI，10.8-13.8）个月，使用多西他赛治疗的11.1（95％CI，8.4-14.2）个月（n=377）（n=188）；0.87；95%CI，0.71-1.08）。3/4级治疗相关不良事件（TRAEs）发生在阿特珠单抗组的18.4%患者和多西他赛组的50.0%患者中。
■IMpower210在ITTEGFR-WT或整体ITT人群中未达到OS的主要疗效终点。阿替珠单抗的耐受性高于多西他赛，3/4级TRAE的发生率较低。
■第三阶段的关键资格标准，开放标签，随机研究包括年龄≥18岁;根据国际癌症控制联盟/美国癌症分期联合委员会(第7版),组织学记录的晚期NSCLC;东部肿瘤协作组的表现状态为0或1;晚期或转移性NSCLC的铂类化疗后疾病进展.患者以2：1的比例随机分配接受阿特珠单抗（1,200mg）或多西他赛（75mg/m2）。主要研究终点是具有野生型表皮生长因子受体表达（ITTEGFR-WT）的意向治疗（ITT）人群和整体ITT人群的总生存期（OS）。
■ITTEGFR-WT人群中的中位OS（n=467）为12.3[95％置信区间（95％CI），阿特珠单抗组（n=312）的10.3-13.8个月和多西他赛组的9.9（95％CI，7.8-13.9）个月[n=155；分层风险比（HR），0.82；95%CI，0.66-1.03]。使用阿特珠单抗治疗的整个ITT人群的中位OS为12.5（95％CI，10.8-13.8）个月，使用多西他赛治疗的11.1（95％CI，8.4-14.2）个月（n=377）（n=188）；0.87；95%CI，0.71-1.08）。3/4级治疗相关不良事件（TRAEs）发生在阿特珠单抗组的18.4%患者和多西他赛组的50.0%患者中。
■IMpower210在ITTEGFR-WT或整体ITT人群中未达到OS的主要疗效终点。阿替珠单抗的耐受性高于多西他赛，3/4级TRAE的发生率较低。
