本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2310532

摘要内容如下：

背景

对于可切除的ALK阳性非小细胞肺癌（NSCLC）患者，以铂为基础的化疗是推荐的辅助治疗。在切除的ALK阳性NSCLC患者中，辅助阿列替尼与化疗相比的疗效和安全性数据缺乏。

方法

我们进行了一项全球性、3期、开放标签、随机试验，在该试验中，完全切除的、ALK阳性的Ib期NSCLC（肿瘤≥4cm）、II期或IIIA（根据美国癌症联合委员会和国际癌症控制联盟的第七版癌症分期手册分类）以1:1的比例随机分配接受24个月的口服阿列替尼（600 mg，每日两次）或四个21天周期的静脉铂类化疗。主要终点是无病生存率，在II期或IIIa期疾病患者中进行分层测试，然后在意向治疗人群中进行测试。其他终点包括中枢神经系统（CNS）无病生存率、总生存率和安全性。

结果

共有257名患者被随机分配接受阿列替尼（130名患者）或化疗（127名患者）。在II期或IIIa期疾病患者中，阿列替尼组和化疗组2年存活和无病患者的百分比分别为93.8%和63.0%（疾病复发或死亡的风险比为0.24；95%置信区间[CI]，0.13至0.45；P<0.001），在意向治疗人群中分别为93.6%和63.7%（风险比为0.24；95%可信区间为0.13~0.43；P<0.001）。与化疗相比，阿列替尼在CNS无病生存率方面具有临床意义的益处（CNS疾病复发或死亡的风险比为0.22；95%置信区间，0.08至0.58）。总生存率的数据尚不成熟。未观察到意外的安全性发现。

结论

在切除的IB、II或IIIa期ALK阳性NSCLC患者中，与以铂为基础的化疗相比，辅助阿列替尼显著提高了无病生存率。（由F.Hoffmann-La Roche资助；Alina ClinicalTrials.gov编号，NCT03456076。）

英文原文如下：

Abstracts

BACKGROUND  Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking.

METHODS  We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA (as classified according to the seventh edition of the Cancer Staging Manual of the American Joint Committee on Cancer and Union for International Cancer Control) were randomly assigned in a 1:1 ratio to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was disease-free survival, tested hierarchically among patients with stage II or IIIA disease and then in the intention-to-treat population. Other end points included central nervous system (CNS) disease-free survival, overall survival, and safety.

RESULTS  In total, 257 patients were randomly assigned to receive alectinib (130 patients) or chemotherapy (127 patients). The percentage of patients alive and disease-free at 2 years was 93.8% in the alectinib group and 63.0% in the chemotherapy group among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.45; P<0.001) and 93.6% and 63.7%, respectively, in the intention-to-treat population (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). Data for overall survival were immature. No unexpected safety findings were observed.

CONCLUSIONS  Among patients with resected ALK-positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. (Funded by F. Hoffmann-La Roche; ALINA ClinicalTrials.gov number, NCT03456076.).

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