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[大学生论坛]:初治中使用阿特朱单抗搭配化疗治疗广泛期小细胞肺癌

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韬略 发表于 2019-1-4 10:14:59 | 显示全部楼层 |阅读模式
First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer
初治中使用阿特朱单抗搭配化疗治疗广泛期小细胞肺癌
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)信号传导来增强肿瘤特异性T细胞免疫已经在治疗广泛期小细胞肺癌中前景广阔。将检查点抑制与细胞毒性化学疗法相结合可能具有协同效应以及改善功效。
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.
我们进行了双盲与安慰剂对照的3期试验,以评估阿特朱单抗搭配卡铂和依托泊苷对尚未接受治疗的患有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搭配阿特朱单抗或安慰剂治疗4个21天周期(诱导期),然后是维持期,在此期间他们接受了阿特朱单抗或安慰剂(根据之前的随机分配),直到依据实体肿瘤标准1.1版的评估反馈发现不可逆的毒性作用,或没有额外的临床益处。两个主要终点是意向治疗人群的经研究者评估的无进展生存期与总生存期。
Results
结果
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阿特朱单抗组,202名患者分配到安慰剂组。在中位跟踪的第13.9个月里,阿特朱单抗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)。阿特朱单抗搭配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。
Conclusions
结论
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初治中,在化疗中加入阿特朱单抗可使总生存期和无进展生存期明显长于单独化疗。
作者:
Leora Horn, M.D., Aaron S. Mansfield, M.D., Aleksandra Szczęsna, M.D., Libor Havel, M.D., Maciej Krzakowski, M.D., Ph.D., Maximilian J. Hochmair, M.D., Florian Huemer, M.D., György Losonczy, M.D., Ph.D., Melissa L. Johnson, M.D., Makoto Nishio, M.D., Ph.D., Martin Reck, M.D., Tony Mok, M.D.

期刊名称:New England Journal of Medicine
发布时间:2018-12-06
N Engl J Med 2018; 379:2220-2229|December 6, 2018|DOI: 10.1056/NEJMoa1809064

15级翻译英语 柳韬略 3141201036

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