PURPOSE/OBJECTIVE(S): In clinical trials, crizotinib has shown robust response rates and greater efficacy than chemotherapy in patients with anaplastic lymphoma kinase-positive (ALK+) advanced nonesmall cell lung cancer (NSCLC). Crizotinib has been available as a targeted therapy for ALK+ NSCLC in Europe (EU) since 2012, but information on its use and outcomes in real-world settings to date has been limited primarily to populations in the US. Therefore, the objective of this study was to assess treatment patterns and outcomes in ALK+ advanced NSCLC patients in an EU population treated with crizotinib in regular clinical practice.
MATERIALS/METHODS: A retrospective medical record review was conducted in selected EU countries for adults (18 years of age) with ALK+ NSCLC treated with crizotinib as first- or later-line therapy for metastatic disease between October 1, 2012 and July 1, 2015. Crizotinib-related clinical trial enrollees were excluded. Applicable IRB approvals were obtained. Physicians and research staff at participating sites abstracted the study data. All data were de-identified, anonymized, and pooled across countries. Descriptive analyses were conducted to assess crizotinib-related treatment patterns and overall response rate (ORR). Progression-free survival (PFS) and overall survival (OS) were descriptively analyzed via the Kaplan-Meier method.
RESULTS: A total of 303 patient records were identified for inclusion: United Kingdom (nZ127), Germany (nZ75), Belgium (nZ63), the Netherlands (nZ20), and Denmark (nZ18). Mean (SD) age was 59.9 (10.4) years, and a majority were male (60%), current or former smoker (61%), and staged with metastatic disease upon initial diagnosis (89%). Approximately one-third of patients (34%, nZ104) initiated crizotinib as first-line therapy for metastatic NSCLC. Median duration of crizotinib treatment was 7 months and 53% of patients were deceased upon record abstraction. Disease progression was the most frequently reported (77%) reason for crizotinib discontinuation; 7 patients (2%) died while on crizotinib therapy. Clinical outcomes are presented in the table.
CONCLUSION: ORR (65.7%) and OS (median: 20.4 months) for crizotinib recipients in the settings studied here align with previous trials. PFS among second-line crizotinib recipients was also consistent with trials. For first-line recipients, however, PFS was somewhat shorter compared with crizotinib trials. Our findings indicate that crizotinib outcomes observed in ALK+ NSCLC patients in clinical studies may translate to regular clinical practice.
