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.

IF 5.1 Q1 ONCOLOGY

Lung Cancer: Targets and Therapy Pub Date : 2019-11-13 eCollection Date: 2019-01-01 DOI:10.2147/LCTT.S209231

Shirish Gadgeel, Alice T Shaw, Fabrice Barlesi, Lucio Crino, James Ch Yang, Anne-Marie Dingemans, Dong-Wan Kim, Filippo de Marinis, Mathias Schulz, Shiyao Liu, Ravindra Gupta, Vlatka Smoljanovic, Sai-Hong Ignatius Ou

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Abstract

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.

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在 NP28673 和 NP28761 II 期研究中接受阿来替尼治疗的晚期无性淋巴瘤激酶 (ALK) 阳性非小细胞肺癌 (NSCLC) 患者的应答时间。

简介阿来替尼是一种高选择性、强效的ALK抑制剂，根据全球NP28673（NCT01801111）和北美NP28761（NCT01871805）II期研究的结果，被批准用于治疗转移性ALK+ NSCLC患者：这项对阿来替尼（NP28673/NP28761）两项II期研究的探索性分析调查了既往接受过治疗的晚期无性淋巴瘤激酶融合基因阳性（ALK+）非小细胞肺癌患者的全身反应时间（TTR）和中枢神经系统（CNS）反应时间（TTCR）。患者（n=225）口服600毫克阿来替尼，每天两次，每6/8周扫描一次（NP28673/NP28761）：结果：NP28673和NP28761的中位随访时间分别为21.3个月/17.0个月；大多数应答者（72.6%/82.9%）在首次疾病评估时应答；中位TTR为8周（95%置信区间[CI]：8.00-8.14）/6 周（95% 置信区间：5.86-6.14）；基线中枢神经系统疾病可测量的应答者的中位 TTCR 为 8 周（95% 置信区间：7.86-10.29）/6 周（95% 置信区间：5.71-无法评估）。讨论：这些数据表明，阿来替尼治疗中枢神经系统疾病的疗效非常好：这些数据表明，阿来替尼对患者的全身和中枢神经系统均可产生快速反应。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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