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首页> 外文期刊>Cancer science. >Phase II study of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase‐rearranged metastatic non‐small‐cell lung cancer in Japan: ASCEND‐9
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Phase II study of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase‐rearranged metastatic non‐small‐cell lung cancer in Japan: ASCEND‐9

机译：ceritinib II期研究在日本接受alectinib治疗的间变性淋巴瘤激酶重新排列的转移性非小细胞肺癌患者：ASCEND-9

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Clinical experience of ceritinib in patients who progressed on alectinib is limited. In this prospective phase II study, we evaluated the activity of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase ( ALK )‐rearranged metastatic (stage IIIB/IV) non‐small‐cell lung cancer (NSCLC) in Japan. All patients were required to have ≥1 measurable lesion per RECIST, 1.1, and a World Health Organization Performance Status (WHO PS) of 0‐1. Prior crizotinib and/or up to 1 chemotherapy regimen was allowed. Primary endpoint was investigator‐assessed overall response rate (ORR) per RECIST 1.1. Ceritinib was given at a dose of 750 mg/day fasted. A total of 20 patients were enrolled from August 2015 to March 2017. All patients received prior alectinib (100%), 13 (65.0%) patients received prior platinum‐based chemotherapy, and 4 (20%) patients received prior crizotinib. Median duration of exposure and the follow‐up time with ceritinib were 3.7 months (range: 0.4‐15.1) and 11.6 months (range: 4.8‐23.0), respectively. Investigator‐assessed ORR was 25% (95% CI: 8.7‐49.1). Key secondary endpoints, all investigator assessed, included disease control rate (70.0%; 95% CI: 45.7‐88.1), time to response (median, 1.8 months; range: 1.8‐2.0), and duration of response (median, 6.3 months; 95% CI: 3.5‐9.2). Median progression‐free survival was 3.7 months (95% CI: 1.9‐5.3). The most common adverse events reported were diarrhea (85.0%), nausea (80.0%), and vomiting (65.0%). Based on our findings, ceritinib could be considered as one of the treatment options for patients with ALK ‐positive NSCLC who progressed on alectinib. (Trial registration no. NCT02450903).
机译：依立替尼治疗进展的患者中塞立替尼的临床经验有限。在这项前瞻性II期研究中，我们评估了在日本接受alectinib预处理的间变性淋巴瘤激酶（ALK）重排转移性（IIIB / IV期）非小细胞肺癌（NSCLC）患者中ceritinib的活性。根据RECIST，所有患者均应具有≥1个可测量的病变，并且世界卫生组织绩效状态（WHO PS）为0-1。允许事先使用克唑替尼和/或最多1种化疗方案。主要终点是根据RECIST 1.1由研究者评估的总体缓解率（ORR）。禁忌Ceritinib的剂量为每天750 mg。从2015年8月至2017年3月，共有20例患者入组。所有患者均接受过先前的艾来替尼（100％），13例（65.0％）接受过铂类化疗的患者，以及4例（20％）接受了克唑替尼的患者。 ceritinib的中位暴露时间和随访时间分别为3.7个月（范围：0.4-15.1）和11.6个月（范围：4.8-23.0）。研究者评估的ORR为25％（95％CI：8.7-49.1）。所有研究者均评估了主要的次要终点，包括疾病控制率（70.0％; 95％CI：45.7-88.1），响应时间（中位1.8个月;范围：1.8-2.0）和响应时间（中位6.3个月） ; 95％CI：3.5-9.2）。中位无进展生存期为3.7个月（95％CI：1.9-5.3）。报告的最常见不良事件为腹泻（85.0％），恶心（80.0％）和呕吐（65.0％）。根据我们的发现，塞来替尼可被视为治疗alectinib的ALK阳性NSCLC患者的一种治疗选择。 （注册号NCT02450903）。

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