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Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study

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...

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Autores principales: Reynolds, Craig, Masters, Elizabeth T., Black-Shinn, Jenny, Boyd, Marley, Mardekian, Jack, Espirito, Janet L., Chioda, Marc
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6025021/
https://www.ncbi.nlm.nih.gov/pubmed/29844259
http://dx.doi.org/10.3390/jcm7060129
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author Reynolds, Craig
Masters, Elizabeth T.
Black-Shinn, Jenny
Boyd, Marley
Mardekian, Jack
Espirito, Janet L.
Chioda, Marc
author_facet Reynolds, Craig
Masters, Elizabeth T.
Black-Shinn, Jenny
Boyd, Marley
Mardekian, Jack
Espirito, Janet L.
Chioda, Marc
author_sort Reynolds, Craig
collection PubMed
description 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.
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spelling pubmed-60250212018-07-09 Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study Reynolds, Craig Masters, Elizabeth T. Black-Shinn, Jenny Boyd, Marley Mardekian, Jack Espirito, Janet L. Chioda, Marc J Clin Med Article 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. MDPI 2018-05-29 /pmc/articles/PMC6025021/ /pubmed/29844259 http://dx.doi.org/10.3390/jcm7060129 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Reynolds, Craig
Masters, Elizabeth T.
Black-Shinn, Jenny
Boyd, Marley
Mardekian, Jack
Espirito, Janet L.
Chioda, Marc
Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title_full Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title_fullStr Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title_full_unstemmed Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title_short Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study
title_sort real-world use and outcomes of alk-positive crizotinib-treated metastatic nsclc in us community oncology practices: a retrospective observational study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6025021/
https://www.ncbi.nlm.nih.gov/pubmed/29844259
http://dx.doi.org/10.3390/jcm7060129
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