P3.02a-019 Real World Utilization and Outcomes of ALK-Positive Crizotinib Treated Metastatic NSCLC Patients in US Community Oncology Practice: Topic: ALK Clinical

Abstract

It is estimated that 3-5% of non-small cell lung cancers (NSCLC) are ALK-positive. Crizotinib was the first approved ALK inhibitor for metastatic NSCLC, demonstrating efficacy in clinical trial settings. However, there is less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice. Objectives of this study consisted of describing demographic and disease characteristics, treatment patterns, and outcomes in US community practice. This was a retrospective, observational study of adult crizotinib-treated ALK-positive patients with metastatic NSCLC who received treatment between 9/1/2011 and 10/31/2014, with follow up through 12/31/15. Data were obtained via programmatic queries of the US Oncology Network/McKesson Specialty Health electronic health record database, supplemented with chart abstraction. Patients in clinical trials or diagnosed with other primary cancers were excluded. Descriptive statistics were calculated overall and by line of therapy (LOT), performance status, and brain metastases. Overall survival (OS) and time to treatment failure (TTF) were estimated from crizotinib initiation using the Kaplan Meier (KM) method. We identified 70,300 NSCLC patients, of which n=199 ALK-positive crizotinib treated patients met eligibility criteria during the study period. Crizotinib was prescribed as first line (1L) in n= 123 (61.8%) and second line or greater (≥2L) in n= 76 (38.2%). The majority (88.9%) had confirmed adenocarcinoma histology and 32.1% had brain metastases at initial diagnosis. Median age at crizotinib initiation was 60.0 years (range 27.1-88.2); 54.8% were never smokers, 33.7% were former smokers and 77.4% had an ECOG performance status of 0 or 1. Treatment of 250 mg twice daily was most commonly prescribed (88.4%) with dose unchanged from prior dose in 79.4% of patients. Patients remained on crizotinib for a median duration of 8.5 months (range 0.23-48.3). The primary discontinuation reason was progression (n=91, 58.7%) however only 3.2% of patients were identified as discontinuing crizotinib as a result of treatment-related toxicity. With a median follow-up time of 16.3 months (range 2.2-46.6), median OS from crizotinib initiation was 33.8 months (95% CI=24.3-38.8) in the overall population with 1 and 2-year survival rates of 79.0% and 61.3%. OS was similar across LOT (p= 0.9093) and by brain metastases (p=0.2775). Median TTF was 9.5 months in the overall population and was similar by LOT (p=0.6808) and brain metastases (p= 0.1603). Outcome endpoints were similar between groups, although potentially limited by small sample size. Results from this study were consistent with findings from clinical trials.