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Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A
Craig Reynolds1,2, Elizabeth T Masters3, Jenny Black-Shinn4
1Florida Cancer Specialists and Research Institute, Ocala, FL 34471, USA. chrmd@hotmail.com.
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.
Insights
Real-world data show crizotinib effectively treats ALK-positive non-small cell lung cancer (NSCLC). This study confirms crizotinib
Area of Science:
- Oncology
- Pharmacology
- Clinical Research
Background:
- Anaplastic Lymphoma Kinase (ALK)-positive Non-Small Cell Lung Cancer (NSCLC) accounts for 3-5% of cases.
- Crizotinib is the first approved ALK inhibitor, but real-world data on its utilization and patient outcomes are limited.
Purpose of the Study:
- To evaluate the utilization and patient outcomes of crizotinib in a real-world clinical setting.
- To compare real-world effectiveness with data from prior clinical trials.
Main Methods:
- Retrospective, observational study of 199 ALK-positive metastatic NSCLC patients treated with crizotinib (2011-2014).
- Data sourced from electronic health records, supplemented by chart abstraction.
- Overall Survival (OS) and Time to Treatment Failure (TTF) analyzed using Kaplan-Meier method.
Main Results:
- Crizotinib was used as first-line therapy in 61.8% of patients.
- Median OS was 33.8 months; median TTF was 10.4 months.
- Progression was the primary reason for discontinuation (58.7%); toxicity led to discontinuation in 3.2%.
Conclusions:
- Real-world crizotinib usage patterns align with clinical trial findings.
- The study demonstrates the real-world effectiveness of crizotinib in ALK-positive NSCLC.
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