Abstract

IntroductionWe report the efficacy and safety of crizotinib treatment among Chinese patients with advanced-stage NSCLC.MethodsWe retrospectively analyzed patients with EML4-ALK positive advanced NSCLC who were treated with crizotinib from May 2012 to Aug 2013. Baseline clinical parameters, treatment protocol, response to therapy and survival were noted. The primary goal was to evaluate the efficacy of crizotinib in patients who were previously treated patients or who had poor ECOG performance status (PS).ResultsForty patients were evaluable for safety and efficacy. Median age was 43 years, 100% had adenocarcinoma and stage IV disease, and 42.5% were female. Six patients received frontline treatment with crizotinib, 17 patients had 1 prior treatment, and 17 patients had more than 2 lines of prior treatment. Patients received a median of 5 cycles of treatment (range 1–15 cycles). After the first cycle, 92.5% (37/40) patients archived partial remission (PR). At the end of the follow-up period, the overall PR rate was 70% (28/40), and progression of disease (PD) occurred in 30% of patients (12/40). The median PFS was 28 weeks (95% CI 15.4 to 40.5 weeks), and median OS was 40 weeks (95% CI 38.6 to 49.3 weeks). The most frequent treatment-related AEs were vomiting (47.5%), vision disorder (27.5%) and increased ALT/AST (42%); most toxicities were Grade 1/2. Observed treatment-related Grade 3/4 AEs included increased ALT/AST (10%) and vomiting (5%). The EML4-ALK fusion rate and number of prior chemotherapy cycles did not appear to significantly affect the efficacy of crizotinib. However, PS 0–2 patients had improved PFS (50 weeks vs. 24 weeks, p = 0.015).ConclusionsCrizotinib was safe, well-tolerated, and effective in Chinese patients with pre-treated ALK-rearranged NSCLC. QOL was improved and PS appears to have an effect on the efficacy of crizotinib, but prior treatment and ALK fusion rate do not.

Highlights

  • We report the efficacy and safety of crizotinib treatment among Chinese patients with advanced-stage non-small cell lung cancer (NSCLC)

  • Quality of life (QOL) was improved and performance status (PS) appears to have an effect on the efficacy of crizotinib, but prior treatment and ALK fusion rate do not

  • We prospectively reviewed clinical outcomes of Chinese NSCLC patients treated with crizotinib in our center and generated further efficacy and safety data in these patients

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Summary

Introduction

More than 50% of patients with non-small cell lung cancer (NSCLC) and known oncogene mutations are candidates for personalized or targeted therapy. ALK is a recently identified tyrosine kinase target in NSCLC [1]. The ALK fusion gene has been found in approximately 5% of Caucasian NSCLC patients and occurs in 3.3–6.1% of Chinese patients [2,3,4]. Crizotinib is an oral tyrosine kinase inhibitor that targets ALK, MET and ROS1. In the recently published PROFILE 1007 study, 159 previously treated patients were randomized to receive crizotinib or chemotherapy with pemetrexed or docetaxel until disease progression. We prospectively reviewed clinical outcomes of Chinese NSCLC patients treated with crizotinib in our center and generated further efficacy and safety data in these patients

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