PMID- 34964940 OWN - NLM STAT- MEDLINE DCOM- 20220412 LR - 20220520 IS - 1776-260X (Electronic) IS - 1776-2596 (Print) IS - 1776-2596 (Linking) VI - 17 IP - 1 DP - 2022 Jan TI - Real-World Outcomes Among Crizotinib-Treated Patients with ROS1-Positive Advanced Non-Small-Cell Lung Cancer: A Community Oncology-Based Observational Study. PG - 25-33 LID - 10.1007/s11523-021-00860-z [doi] AB - BACKGROUND: Crizotinib was the first oral targeted therapy approved by the US Food and Drug Administration (FDA), on 11 March 2016, for c-ros oncogene 1 (ROS1)-positive advanced non-small-cell lung cancer (NSCLC). Data to support long-term clinical benefit in a real-world setting are limited. OBJECTIVE: This study aimed to assess real-world clinical outcomes among patients with ROS1-positive advanced NSCLC treated with crizotinib in the US community oncology setting. PATIENTS AND METHODS: We conducted a retrospective cohort study using iKnowMed electronic health record data to identify adult patients with ROS1-positive advanced NSCLC who initiated crizotinib between 17 January 2013 (time of the addition of crizotinib for ROS1-positive NSCLC to National Comprehensive Cancer Network (NCCN) treatment guidelines) and 1 June 2019 with a potential follow-up period through 1 December 2019. Patient characteristics were assessed descriptively. Kaplan-Meier analyses were used to evaluate time to treatment discontinuation (TTD), time to next treatment (TTNT), and overall survival (OS). A Cox proportional hazards model was conducted to determine factors associated with OS. RESULTS: The study cohort included 38 ROS1-positive patients treated with crizotinib. The median age was 68 years (interquartile range 60.0-73.0) and 65.8% were female. Over 50% were current/former smokers, and 18.4% had an Eastern Cooperative Oncology Group (ECOG) performance status of 2. Overall, 21 (55.3%) patients remained on crizotinib, 10 (26.3%) had evidence of subsequent treatment, and 16 (42.1%) died. The median TTD, TTNT, and OS were 25.2 months [95% confidence interval (CI): 5.2-not reached (NR)], 25.0 months (95% CI 5.2-61.0), and 36.2 months (95% CI 15.9-NR), respectively. In a multivariate Cox regression model, ECOG performance status of 2 was associated with a 4.9-fold higher risk of death (hazard ratio = 4.9; 95% CI 1.1-21.4) compared to ECOG performance status of 0 or 1. CONCLUSIONS: This ROS1-positive NSCLC real-world population was older and had a higher proportion of smokers and of patients with poorer ECOG performance status than those investigated in clinical trials. Nevertheless, our findings support the clinical benefit of crizotinib in this patient population with ROS1-positive advanced NSCLC. CI - (c) 2021. The Author(s). FAU - Waterhouse, David AU - Waterhouse D AD - Oncology Hematology Care, The US Oncology Network, Cincinnati, OH, USA. AD - The US Oncology Network, McKesson Life Sciences, The Woodlands, TX, USA. FAU - Iadeluca, Laura AU - Iadeluca L AD - Pfizer Inc, New York, NY, USA. FAU - Sura, Sneha AU - Sura S AD - Ontada, The Woodlands, TX, USA. FAU - Wilner, Keith AU - Wilner K AD - Pfizer Inc, New York, NY, USA. FAU - Emir, Birol AU - Emir B AD - Pfizer Inc, New York, NY, USA. FAU - Krulewicz, Stan AU - Krulewicz S AD - Pfizer Inc, Collegeville, PA, USA. FAU - Espirito, Janet AU - Espirito J AD - Ontada, The Woodlands, TX, USA. FAU - Bartolome, Lauren AU - Bartolome L AUID- ORCID: 0000-0002-0649-2902 AD - Pfizer Inc, New York, NY, USA. lauren.bartolome@pfizer.com. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20211229 PL - France TA - Target Oncol JT - Targeted oncology JID - 101270595 RN - 0 (Protein Kinase Inhibitors) RN - 0 (Proto-Oncogene Proteins) RN - 53AH36668S (Crizotinib) RN - EC 2.7.10.1 (Protein-Tyrosine Kinases) RN - EC 2.7.10.1 (ROS1 protein, human) SB - IM MH - Adult MH - Aged MH - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics MH - Crizotinib/pharmacology/therapeutic use MH - Female MH - Humans MH - *Lung Neoplasms/drug therapy/genetics MH - Oncogenes MH - Protein Kinase Inhibitors/pharmacology/therapeutic use MH - Protein-Tyrosine Kinases/genetics MH - Proto-Oncogene Proteins/genetics MH - Retrospective Studies PMC - PMC8783880 COIS- David Waterhouse has an advisory role/consulting from Bristol Myers Squibb, AZTherapies, AbbVie, Amgen, McGivney Global Advisors, Janssen Oncology, Seattle Genetics, Jazz Pharmaceuticals, Exelixis, Eisai, EMD Serono, Merck, Pfizer, Mirati Therapeutics, and Regeneron/Sanofi, speakers' bureau from Bristol Myers Squibb, Janssen Oncology, Merck, AstraZeneca, and travel, accommodation and expenses from Bristol Myers Squibb. Laura Iadeluca is an employee of Pfizer, Inc. and owns stock in Pfizer, Inc. Sneha Sura is an employee of Ontada. Keith Wilner is an employee of Pfizer, Inc. and owns stock in Pfizer, Inc. Birol Emir is an employee of Pfizer, Inc. and owns stock in Pfizer, Inc. Janet Espirito is an employee of Ontada and owns stock in McKesson, which received consulting fees in connection with this study from Pfizer, Inc. Lauren Bartolome is an employee of Pfizer, Inc. and owns stock in Pfizer, Inc. Stan Krulewicz is an employee of Pfizer, Inc. and owns stock in Pfizer, Inc. EDAT- 2021/12/30 06:00 MHDA- 2022/04/13 06:00 PMCR- 2021/12/29 CRDT- 2021/12/29 12:36 PHST- 2021/11/26 00:00 [accepted] PHST- 2021/12/30 06:00 [pubmed] PHST- 2022/04/13 06:00 [medline] PHST- 2021/12/29 12:36 [entrez] PHST- 2021/12/29 00:00 [pmc-release] AID - 10.1007/s11523-021-00860-z [pii] AID - 860 [pii] AID - 10.1007/s11523-021-00860-z [doi] PST - ppublish SO - Target Oncol. 2022 Jan;17(1):25-33. doi: 10.1007/s11523-021-00860-z. Epub 2021 Dec 29.