title: Efficacy and safety of crizotinib among Chinese EML4-ALK-positive, advanced-stage non-small cell lung cancer patients.
abstract: BACKGROUND
  We report the efficacy and safety of crizotinib treatment among Chinese patients with advanced-stage NSCLC.
  
  
  METHODS
  We 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).
  
  
  RESULTS
  Forty 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).
  
  
  CONCLUSIONS
  Crizotinib 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.
authors.affiliation: Department of Oncology, Kiang Wu Hospital, Estrada do Repouso, Macau, China, 999999.
authors.forename: Yabing
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Department of Oncology, Kiang Wu Hospital, Estrada do Repouso, Macau, China, 999999.
authors.forename: Guangli
authors.initials: G
authors.lastname: Xiao
authors.affiliation: Department of Oncology, Kiang Wu Hospital, Estrada do Repouso, Macau, China, 999999.
authors.forename: Xibin
authors.initials: X
authors.lastname: Qiu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan 2nd Road, Guangzhou, Guangdong, P.R. China, 510080.
authors.forename: Sheng
authors.initials: S
authors.lastname: Ye
authors.affiliation: Cancer Center of Sun Yat-sen University, State Key Laboratory of Oncology in Southern China, Department of Medical Oncology, No. 651 Dongfeng Road East, Guangzhou, Guangdong, P.R. China, 510060.
authors.forename: Tongyu
authors.initials: T
authors.lastname: Lin
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D002681:China; D000077547:Crizotinib; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000037:antagonists & inhibitors / Q000235:genetics*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: C522504:EML4-ALK fusion protein, human; D015514:Oncogene Proteins, Fusion; D047428:Protein Kinase Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D000077547:Crizotinib