Abstract
Introduction: Around 3–5% of non-small cell lung cancers (NSCLC) are ALK-positive. Crizotinib was the first approved ALK inhibitor from clinical trials. However, there are less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice. Methods: This was a retrospective, observational study of adult crizotinib-treated ALK-positive metastatic NSCLC patients who received treatment between 1 September 2011 and 31 October 2014, with follow up through 31 December 2015. Data were obtained via programmatic queries of the US Oncology Network/McKesson Specialty Health electronic health record database, supplemented with chart abstraction. Overall survival (OS) and time to treatment failure (TTF) were estimated from crizotinib initiation using the Kaplan–Meier (KM) method. Results: Of the n = 199 ALK-positive crizotinib-treated patients meeting eligibility criteria, crizotinib was prescribed as first line (1 L) in n = 123 (61.8%). The majority (88.9%) had confirmed adenocarcinoma histology and 32.2% had brain metastases at initial diagnosis. Median age at crizotinib initiation was 60.2 years (range 27.1–88.2); 54.8% were never smokers, 33.7% were former smokers. Treatment of 250 mg, twice daily, was most commonly prescribed (89.5%) with the dose unchanged from an initial dose in 79.4% of patients. The primary discontinuation reason was progression (n = 91, 58.7%). Patients (3.2%) were identified as discontinuing crizotinib as a result of treatment-related toxicity. With median follow-up time of 13.0 months (min–max = 0.03–46.6), median OS from crizotinib initiation was 33.8 months (95% CI = 24.3–38.8). Median TTF was 10.4 months. Conclusions: Crizotinib usage evaluated within the real-world setting is consistent with prior phase III clinical trial data, and illustrates the real-world effectiveness of crizotinib.
Highlights
Around 3–5% of non-small cell lung cancers (NSCLC) are anaplastic lymphoma kinase (ALK)-positive
Institutional review board approval was received for this retrospective study of patients diagnosed with metastatic NSCLC and treated with crizotinib in The U.S Oncology Network (USON) of community-based oncology practices, utilizing the iKnowMedTM electronic health record (EHR). iKM is an integrated web-based database and oncology-specific EHR system maintained by McKesson Specialty Health (MSH), that captures outpatient practice encounter histories from approximately 1500 community-based oncology providers across practices in 19 states
A total of 70,300 patients with NSCLC were identified during the study period; 274 metastatic patients initiated treatment with crizotinib during the study period, and 212 met all eligibility criteria
Summary
Around 3–5% of non-small cell lung cancers (NSCLC) are ALK-positive. Crizotinib was the first approved ALK inhibitor from clinical trials. There are less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice. The first FDA-approved ALK inhibitor for ALK-positive metastatic NSCLC treatment in 2011, crizotinib, has shown significant improvement in progression-free survival (PFS) and tumor responses in patients with metastatic NSCLC who carry the ALK gene rearrangement [9]. While crizotinib has demonstrated significant improvement in PFS in phase III studies [12,13], there are less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice. Our study sought to examine treatment patterns and outcomes of crizotinib utilization in NSCLC patients from U.S community oncology practices, and to explore the impact of line of therapy and presence of brain metastases on outcomes
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