Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Department of Respiratory Medicine, Juntendo University, Tokyo, Japan.
Cancer Sci. 2023 Jun;114(6):2560-2568. doi: 10.1111/cas.15777. Epub 2023 Apr 2.
Alectinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), is the recommended first-line treatment for ALK-positive non-small-cell lung cancer (NSCLC) in Japan. Lorlatinib was approved as a subsequent therapeutic option after progression while receiving ALK TKI treatment. However, data on the use of lorlatinib in the second- or third-line setting after alectinib failure are limited in Japanese patients. This retrospective real-world observational study investigated the clinical effectiveness of lorlatinib in second- or later-line settings after alectinib failure in Japanese patients. Clinical and demographic data collected in the Japan Medical Data Vision (MDV) database between December 2015 and March 2021 were used. Patients diagnosed with lung cancer who received lorlatinib following alectinib failure after the November 2018 marketing approval of lorlatinib in Japan were included. Of 1954 patients treated with alectinib, 221 were identified from the MDV database as receiving lorlatinib after November 2018. The median age of these patients was 62 years. Second-line lorlatinib treatment was reported for 154 patients (70%); third- or later-line lorlatinib treatment was reported for 67 patients (30%). The median duration of treatment (DOT) for all lorlatinib-treated patients was 161 days (95% confidence interval [CI], 126-248), and 83 patients (37.6%) continued treatment after data cut-off (March 31, 2021). Median DOTs of 147 days (95% CI, 113-242) and 244 days (95% CI, 109 to not reached) were reported with second-line and third- or later-line treatment, respectively. Consistent with clinical trial data, this real-world observational study supports data suggesting the effectiveness of lorlatinib after alectinib failure in Japanese patients.
阿来替尼是一种间变性淋巴瘤激酶（ALK）酪氨酸激酶抑制剂（TKI），是日本推荐的ALK 阳性非小细胞肺癌（NSCLC）的一线治疗药物。劳拉替尼在接受 ALK TKI 治疗进展后被批准为后续治疗选择。然而，在日本患者中，阿来替尼失败后二线或三线使用劳拉替尼的数据有限。这项回顾性真实世界观察性研究调查了阿来替尼失败后二线或更后线使用劳拉替尼在日本患者中的临床疗效。研究使用了 2015 年 12 月至 2021 年 3 月期间在日本医疗数据视野（MDV）数据库中收集的临床和人口统计学数据。该研究纳入了在日本劳拉替尼于 2018 年 11 月获准上市后，阿来替尼治疗后失败的患者，随后接受劳拉替尼治疗的肺癌患者。在接受阿来替尼治疗的 1954 名患者中，从 MDV 数据库中确定了 221 名患者在日本 2018 年 11 月后接受了劳拉替尼治疗。这些患者的中位年龄为 62 岁。154 名患者（70%）接受二线劳拉替尼治疗，67 名患者（30%）接受三线或更后线劳拉替尼治疗。所有接受劳拉替尼治疗的患者中位治疗持续时间（DOT）为 161 天（95%置信区间[CI]，126-248），截至数据截止日期（2021 年 3 月 31 日），有 83 名患者（37.6%）继续接受治疗。二线和三线或更后线治疗的中位 DOT 分别为 147 天（95%CI，113-242）和 244 天（95%CI，109 至未达到）。与临床试验数据一致，这项真实世界观察性研究支持阿来替尼失败后日本患者使用劳拉替尼有效的数据。
