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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Tan, Weiwei Zheng, Zongli Iafrate, A. John Ou, Sai-hong I. Stephenson, Patricia Solomon, Benjamin J. Tye, Lesley M. Wilner, Keith D. Shreeve, S. Martin Salgia, Ravi Doebele, Robert C. Riely, Gregory J. Camidge, D. Ross Varella-garcia, Marileila Christensen, James G. Shapiro, Geoffrey I. Costa, Daniel B. Shaw, Alice T. Clark, Jeffrey W. Le, Long Phi Bang, Yung-jue |
| Description | Author Affiliation: Shaw AT ( From the Massachusetts General Hospital Cancer Center (A.T.S., L.P.L., Z.Z., J.W.C., A.J.I.), Dana-Farber Cancer Institute (G.I.S.), and Beth Israel Deaconess Medical Center (D.B.C.) - all in Boston) |
| Abstract | BACKGROUND: Chromosomal rearrangements of the gene encoding ROS1 proto-oncogene receptor tyrosine kinase (ROS1) define a distinct molecular subgroup of non-small-cell lung cancers (NSCLCs) that may be susceptible to therapeutic ROS1 kinase inhibition. Crizotinib is a small-molecule tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK), ROS1, and another proto-oncogene receptor tyrosine kinase, MET. METHODS: We enrolled 50 patients with advanced NSCLC who tested positive for ROS1 rearrangement in an expansion cohort of the phase 1 study of crizotinib. Patients were treated with crizotinib at the standard oral dose of 250 mg twice daily and assessed for safety, pharmacokinetics, and response to therapy. ROS1 fusion partners were identified with the use of next-generation sequencing or reverse-transcriptase-polymerase-chain-reaction assays. RESULTS: The objective response rate was 72% (95% confidence interval [CI], 58 to 84), with 3 complete responses and 33 partial responses. The median duration of response was 17.6 months (95% CI, 14.5 to not reached). Median progression-free survival was 19.2 months (95% CI, 14.4 to not reached), with 25 patients (50%) still in follow-up for progression. Among 30 tumors that were tested, we identified 7 ROS1 fusion partners: 5 known and 2 novel partner genes. No correlation was observed between the type of ROS1 rearrangement and the clinical response to crizotinib. The safety profile of crizotinib was similar to that seen in patients with ALK-rearranged NSCLC. CONCLUSIONS: In this study, crizotinib showed marked antitumor activity in patients with advanced ROS1-rearranged NSCLC. ROS1 rearrangement defines a second molecular subgroup of NSCLC for which crizotinib is highly active. (Funded by Pfizer and others; ClinicalTrials.gov number, NCT00585195.). |
| ISSN | 00284793 |
| e-ISSN | 15334406 |
| Journal | New England Journal of Medicine |
| Issue Number | 21 |
| Volume Number | 371 |
| Language | English |
| Publisher | Massachusetts Medical Society (United States) |
| Publisher Date | 2014-11-20 |
| Publisher Place | United States |
| Access Restriction | Open |
| Subject Keyword | Carcinoma, Non-Small-Cell Lung Drug Therapy Lung Neoplasms Protein Kinase Inhibitors Therapeutic Use Protein-Tyrosine Kinases Genetics Proto-Oncogene Proteins Pyrazoles Pyridines Administration, Oral Disease-Free Survival Gene Rearrangement In Situ Hybridization, Fluorescence Kaplan-Meier Estimate Adverse Effects Vision Disorders Chemically Induced Clinical Trial, Phase I Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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