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作者：SCI天天读
SCI
23 April 2024
Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer
（The New England journal of medicine；IF：158.5）
Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Ochi Lohmann T, Xu T, Cardona A, Ruf T, Noe J, Solomon BJ; ALINA Investigators. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Apr 11;390(14):1265-1276. doi: 10.1056/NEJMoa2310532. PMID: 38598794.
Dr. Wu can be contacted at wuyilong@gdph.org.cn or at the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, 106 Zhongshan Er Lu, 510080 Guangzhou, China. Dr. Solomon can be contacted at bensolomon@petermac.org or at the Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan St., Melbourne, VIC 3000, Australia.
Background 背景
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.
铂类化疗是可切除ALK阳性非小细胞肺癌（NSCLC）患者的推荐辅助治疗。与化疗相比，阿来替尼辅助治疗对于切除术后ALK阳性NSCLC患者的疗效和安全性尚缺乏相关数据。
Methods 方法
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.
我们开展了一项全球性、三期、开放标签、随机试验，该试验将完全切除术后ALK阳性 IB期（肿瘤≥4 cm）、II期或IIIA期NSCLC患者（根据美国癌症联合委员会和国际癌症控制联盟的《癌症分期手册》第七版进行分类）以1:1比例随机分成两组，分别口服阿来替尼（每天两次，每次600 mg）24个月或静脉注射铂类化疗4个周期（每个周期21天）。主要终点是无瘤生存期，在II期或IIIA期患者中进行分级检验，之后在意向性治疗人群中进行检验。其他终点包括中枢神经系统（CNS）无瘤生存期、总生存期和安全性。
Results 结果
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.
共计257例患者被随机分配接受阿来替尼（130例）或化疗（127例）。在II期或IIIA期疾病患者中，阿来替尼组的2年无病生存率为93.8%，化疗组为63.0%（疾病复发或死亡的风险比，0.24；95%置信区间[CI]，0.13~0.45；P<0.001）；在意向性治疗人群中，两组的2年无病生存率分别为93.6%和63.7%（风险比，0.24；95% CI，0.13~0.43；P<0.001）。与化疗相比，阿来替尼在CNS无病生存率方面与有临床意义的益处相关（CNS疾病复发或死亡的风险比，0.22；95% CI，0.08~0.58）。总生存率数据尚不成熟。本试验中没有非预期的安全性结果。
Conclusions 结论
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.).
在切除术后ALK阳性IB期、II期或IIIA期NSCLC患者中，与铂类化疗相比，阿来替尼辅助治疗显著提高无病生存率。（由罗氏公司资助；ALINA在ClinicalTrials.gov注册号为NCT03456076）。
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