克唑替尼对于ALK阳性的晚期非小细胞肺癌患者进行一线治疗的疗效分析春雨国际.docx

Efficacy of crizotinib in first-line treatment of adults with ALK-positive advanced NSCLC 克唑替尼对于ALK阳性的晚期非小细胞肺癌患者进行一线治疗的疗效分析 近日，春雨国际医学部通过对文献的翻译，进一步阐释了克唑替尼对于ALK阳性的晚期非小细胞肺癌患者进行一线治疗的疗效。 1、Clinical efficacy The clinical efficacy of crizotinib in advanced ALK-positive NSCLC was initially demonstrated in phase I and II studies with an impressive ORR of 53–61% and median PFS of 8.5– 9.7 months. Later, the superiority of crizotinib over chemotherapy in second-line setting was validated in a phase III RCT. Two phase III RCTs, namely, PROFILE 1014 and PROFILE 1029 were conducted to evaluate the clinical efficacy and safety of first-line crizotinib. 临床疗效评价 克唑替尼治疗ALK阳性晚期非小细胞肺癌的临床疗效已经在1期2期实验中被证明，其客观缓解率为53%-61%，中位无进展生存期为8.5-9.7月。随后，作为二线药物克唑替尼与化疗相比，其优势在3期随机对照实验中被证明，以评估克唑替尼的临床疗效和安全性。 2. PFS benefit PROFILE 1014 (343 patients recruited globally) and PROFILE 1029 (207 patients recruited in East Asian, including 183 Chinese patients) were two prospective phase III RCTs to compare the efficacy and safety of crizotinib with standard chemotherapy in previously untreated advanced ALK-positive NSCLC. Both studies met their primary objectives of significantly prolonging PFS. In PROFILE 1014, crizotinib significantly prolonged PFS versus chemotherapy (median, 10.9 months vs. 7.0 months, hazard ratio (HR) 0.45, P 0.001). Besides, randomization was stratified according to the Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs. 2), Asian or non-Asian race, and presence or absence of brain metastases The PFS benefit with crizotinib was reported in most patient subgroups under analysis. Crizotinib also significantly improved ORR than che- motherapy (74% vs. 45%, P 0.001). The median duration of response was 11.3 months and 5.3 months in crizotinib and chemotherapy groups, respectively. Similar superior out- come of crizotinib over chemotherapy was also reported in PROFILE 1029. Crizotinib significantly prolonged PFS versus che- motherapy (median, 11.1 months vs. 6.8 mont