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首页> 外文期刊>Lung Cancer: Targets and Therapy >Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase ( ALK )-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies
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Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase ( ALK )-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies

机译：在II期NP28673和NP28761研究中接受壁鞘蛋白（ALK）阳性非小细胞肺癌（NSCLC）患者的患者的时间

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Introduction: Alectinib is a highly selective and potent ALK inhibitor, approved for the treatment of patients with metastatic ALK + NSCLC based on results from the Phase II global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies. Methods: This exploratory analysis of two Phase II studies of alectinib (NP28673/NP28761) investigated time to systemic response (TTR) and time to central nervous system (CNS) response (TTCR) in patients with previously treated advanced anaplastic lymphoma kinase fusion gene-positive ( ALK +) non-small-cell lung cancer. Patients (n=225) received 600 mg oral alectinib twice daily and had scans every 6/8 weeks (NP28673/NP28761). Results: For NP28673 and NP28761, respectively: median follow-up was 21.3 months/17.0 months; most responders (72.6%/82.9%) responded by the first disease assessment; median TTR was 8 weeks (95% confidence interval [CI]: 8.00–8.14)/6 weeks (95% CI: 5.86–6.14); median TTCR in responders with measurable baseline CNS disease was 8 weeks (95% CI: 7.86–10.29)/6 weeks (95% CI: 5.71–not evaluable). Similar results were observed regardless of measurable/non-measurable disease. Discussion: These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS.
机译：介绍：alectinib是一种高度选择性和有效的ALK抑制剂，批准根据II期全球NP28673（NCT01801111）和北美NP28761（NCT01871805）研究的结果治疗转移性ALK + NSCLC患者。方法：对肺结泡（NP28673 / NP28761）的两阶段II研究的探索性分析研究了以前治疗先前治疗的先前治疗先进的促进淋巴瘤激酶融合基因 - 的患者中枢神经系统（TTR）和中枢神经系统（CNS）反应（TTCR）的时间阳性（Alk +）非小细胞肺癌。患者（n = 225）每天两次接受600毫克口服肺结泡，每6/8周扫描（NP28673 / NP28761）。结果：对于NP28673和NP28761分别：中位随访时间为21.3个月/ 17.0个月;大多数响应者（72.6％/ 82.9％）由第一疾病评估作出反应;中位数TTR为8周（95％置信区间[CI]：8.00-8.14）/ 6周（95％CI：5.86-6.14）;可衡量基线CNS病患者的反应者中位TTCR为8周（95％CI：7.86-10.29）/ 6周（95％CI：5.71-NOT评估）。无论可测量/不可衡量的疾病如何，都观察到类似的结果。讨论：这些数据表明，莱切韦在全世界和CNS中达到患者的快速反应。

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