ALK 重排阳性非小细胞肺癌且一般状况较差患者的生存分析：九州肺癌研究组 1401 研究的更新结果。
Survival Analysis for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status Treated with Alectinib: Updated Results of Lung Oncology Group in Kyushu 1401.
机构信息
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
出版信息
Oncologist. 2020 Apr;25(4):306-e618. doi: 10.1634/theoncologist.2019-0728. Epub 2019 Oct 30.
LESSONS LEARNED
Alectinib confers a pronounced survival benefit in patients with ALK rearrangement-positive non-small cell lung cancer and a poor performance status. Survival benefit of alectinib for patients with a poor performance status was consistent regardless of the presence of central nervous system metastases.
BACKGROUND
We previously reported a marked objective response rate (ORR) and safety for alectinib treatment in patients with ALK rearrangement-positive non-small cell lung cancer (NSCLC) and a poor performance status (PS) in the Lung Oncology Group in Kyushu (LOGiK) 1401 study. It remained unclear, however, whether alectinib might also confer a long-term survival benefit in such patients.
METHODS
Eighteen patients with ALK rearrangement-positive advanced NSCLC and a PS of 2, 3, or 4 (n = 12, 5, and 1, respectively) were enrolled in LOGiK1401 between September 2014 and December 2015 and received alectinib. We have now updated the survival data for the study.
RESULTS
The median follow-up time for all patients was 27.3 months. The median progression-free survival (PFS) was 16.2 months (95% confidence interval [CI], 7.1-30.8 months), and the median survival time (MST) and the 3-year overall survival rate were 30.3 months (95% CI, 11.5 months to not reached) and 43.8% (95% CI, 20.8-64.7%), respectively. This survival benefit was similarly manifest in patients with a PS of 2 (MST, 20.5 months) and those with a PS of ≥3 (MST, not reached). PFS did not differ between patients with or without central nervous system (CNS) metastases at baseline (median of 17.5 and 16.2 months, respectively, p = .886).
CONCLUSION
Alectinib showed a pronounced survival benefit for patients with ALK rearrangement-positive NSCLC and a poor PS regardless of the presence of CNS metastases, a patient population for which chemotherapy is not indicated.
经验教训
艾乐替尼为 ALK 重排阳性非小细胞肺癌和较差表现状态的患者带来显著的生存获益。对于表现状态较差的患者，无论是否存在中枢神经系统转移，艾乐替尼的生存获益都是一致的。
背景
我们之前在 LOGiK1401 研究中报告了艾乐替尼治疗 ALK 重排阳性非小细胞肺癌（NSCLC）和较差表现状态（PS）患者的显著客观缓解率（ORR）和安全性。然而，尚不清楚艾乐替尼是否也可能为这些患者带来长期生存获益。
方法
18 名 ALK 重排阳性晚期 NSCLC 且 PS 为 2、3 或 4 的患者（n=12、5 和 1）于 2014 年 9 月至 2015 年 12 月入组 LOGiK1401 并接受艾乐替尼治疗。我们现在更新了该研究的生存数据。
结果
所有患者的中位随访时间为 27.3 个月。中位无进展生存期（PFS）为 16.2 个月（95%置信区间[CI]，7.1-30.8 个月），中位总生存期（MST）和 3 年总生存率分别为 30.3 个月（95%CI，11.5 个月至未达到）和 43.8%（95%CI，20.8-64.7%）。这种生存获益在 PS 为 2 的患者（MST 为 20.5 个月）和 PS≥3 的患者（MST 未达到）中同样明显。基线时有或无中枢神经系统（CNS）转移的患者之间的 PFS 无差异（中位 PFS 分别为 17.5 和 16.2 个月，p=0.886）。
结论
对于 ALK 重排阳性 NSCLC 和较差 PS 的患者，艾乐替尼表现出显著的生存获益，无论是否存在 CNS 转移，这是一类不适合化疗的患者。
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