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SCI 7 October 2018
BACKGROUND 背景 Enhancing tumor-specific T-cell immunity by inhibiting programmed death ligand 1 (PD-L1) programmed death 1 (PD-1) signaling has shown promise in the treatment of extensive-stage small-cell lung cancer. Combining checkpoint inhibition with cytotoxic chemotherapy may have a synergistic effect and improve efficacy. 通过抑制程序性死亡配体1(PD-L1)程序性死亡1(PD-1)信号传导增强肿瘤特异性T细胞免疫在广泛期小细胞肺癌的治疗中显示出前景。检查点抑制与细胞毒性化疗相结合可能具有协同效应并提高疗效。 METHODS 方法 We conducted this double-blind, placebo-controlled, phase 3 trial to evaluate atezolizumab plus carboplatin and etoposide in patients with extensive-stage small-cell lung cancer who had not previously received treatment. Patients were randomly assigned in a 1:1 ratio to receive carboplatin and etoposide with either atezolizumab or placebo for four 21-day cycles (induction phase), followed by a maintenance phase during which they received either atezolizumab or placebo (according to the previous random assignment) until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors, version 1.1, or no additional clinical benefit. The two primary end points were investigator-assessed progression free survival and overall survival in the intention-to- treat population. 我们进行了这项双盲，安慰剂对照的3期试验，以评估atezolizumab加卡铂和依托泊苷对既往未接受过治疗的广泛期小细胞肺癌患者的影响。患者以1：1的比例随机分配接受卡铂和依托泊苷联合atezolizumab或安慰剂治疗4个21天周期（诱导期），然后是维持期，在此期间他们接受了atezolizumab或安慰剂（在此期间他们接受atezolizumab单抗或安慰剂(根据先前的随机分配)直到它们具有不可接受的毒性作用，根据实体瘤反应评价标准，版本1.1，或没有额外的临床益处的疾病进展。两个主要终点是研究者评估的无进展生存率和治疗意向人群的总生存率。 A total of 201 patients were randomly assigned to the atezolizumab group, and 202 patients to the placebo group. At a median follow-up of 13.9 months, the median overall survival was 12.3 months in the atezolizumab group and 10.3 months in the placebo group (hazard ratio for death, 0.70; 95% confidence interval [CI], 0.54 to 0.91; P = 0.007). The median progression-free survival was 5.2 months and 4.3 months, respectively (hazard ratio for disease progression or death, 0.77; 95% CI, 0.62 to 0.96; P = 0.02). The safety profile of atezolizumab plus carboplatin and etoposide was consistent with the previously reported safety profile of the individual agents, with no new findings observed. 共有201名患者被随机分配到atezolizumab组，202名患者被安排到安慰剂组。 在中位随访13.9个月时，atezolizumab组的中位总生存期为12.3个月，安慰剂组为10.3个月（死亡风险比为0.70; 95％置信区间[CI]，0.54至0.91; P =0.007）。中位无进展生存期分别为5.2个月和4.3个月（疾病进展或死亡的风险比，0.77; 95％CI，0.62至0.96; P = 0.02）。atezolizumab加卡铂和依托泊苷的安全性与先前报道的各药物的安全性一致，没有观察到新的发现。 The addition of atezolizumab to chemotherapy in the first-line treatment of extensive- stage small-cell lung cancer resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. 在广泛期小细胞肺癌的一线治疗中，在化疗中加入atezolizumab，与单独化疗相比，可显著延长总体生存期和无进展生存期。 喜欢SCI天天读的理由 陪您一起学习SCI医学论文 每天5分钟，让自己的英语牛逼起来 特殊福利让您惊喜连连 |
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来自： rodneyzhang > 《肿瘤》
