Crizotinib in ROS1-Rearranged Non–Small-Cell Lung Cancer
Open accessAbstract
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.).
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First-line crizotinib versus chemotherapy showed higher ORR and longer median PFS, but CNS metastases developed in nearly 50% of patients with ROS1+ NSCLC.
“While a higher objective response rate (ORR) and longer median progression-free survival (PFS) were observed with first-line crizotinib versus chemotherapy (CT), CNS metastases developed in nearly 50% of patients with ROS1+ NSCLC.10-13”
From Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [10]
A study published after the close of the date parameters for the systematic review included 50 patients from a second-line crizotinib trial who had ROS1 rearrangements.
“A study78 was published after the close of the date parameters for the systematic review that included 50 patients from a second-line crizotinib trial who had ROS1 rearrangements.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [78]
In that ROS1 study, the objective response rate was 72% (95% CI, 58 to 84), with three complete responses and 33 partial responses.
“The objective response rate was 72% (95% CI, 58 to 84), and there were three complete responses and 33 partial responses.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [78]
In that ROS1 study, median duration of response was 17.6 months (95% CI, 14.5 to not reached).
“Median duration of response was 17.6 months (95% CI, 14.5 to not reached).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [78]
In that ROS1 study, median PFS was 19.2 months (95% CI, 14.4 to not reached).
“Median PFS was 19.2 months (95% CI, 14.4 to not reached).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [78]
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Ou, S.-H. I., Fujiwara, Y., Shaw, A. T., Yamamoto, N., Nakagawa, K., Fan, F., Hao, Y., Gao, Y., Jänne, P. A., & Seto, T. (2021) · JTO Clinical and Research Reports · doi:10.1016/j.jtocrr.2020.100108 · Cited by 40 · see citing works
Self-citationLi, W., Xiong, A., Yang, N., Fan, H., Yu, Q., Zhao, Y., Wang, Y., Meng, X., Wu, J., Wang, Z., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.24.00731 · Cited by 40 · see citing works
Advances and future directions in <i>ROS1</i> fusion-positive lung cancer
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Metabolic Remodelling: An Accomplice for New Therapeutic Strategies to Fight Lung Cancer
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- Authors
- Shaw, A. T., Ou, S.-H. I., Bang, Y.-J., Camidge, D. R., Solomon, B. J., Salgia, R., Riely, G. J., Varella-Garcia, M., Shapiro, G. I., Costa, D. B., Doebele, R. C., Le, L. P., Zheng, Z., Tan, W., Stephenson, P., Shreeve, S. M., Tye, L. M., Christensen, J. G., Wilner, K. D., Clark, J. W., & Iafrate, A. J.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- University of California, Irvine (US)
- Seoul National University Hospital (KR)
- Peter MacCallum Cancer Centre (AU)
- University of Chicago (US)
- Memorial Sloan Kettering Cancer Center (US)
- Dana-Farber Cancer Institute (US)
- Massachusetts General Hospital (US)
- Karolinska Institutet (SE)
- Rho (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-11-20
- Volume
- 371
- Issue
- 21
- Pages
- 1963-1971
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4264527
- OpenAlex
- W1990626198
- Cited by
- 1,964
- References
- 38
- Citations by year
- 2026: 47 · 2025: 105 · 2024: 130 · 2023: 122 · 2022: 151 · 2021: 198 · 2020: 212 · 2019: 197 · 2018: 238 · 2017: 200 · 2016: 198 · 2015: 154 · 2014: 9 · 2013: 1
- FWCI
- 150.59
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- National Cancer Institute (R21CA161590, P50CA058187, P30CA008748, K12CA086913, P30CA046934)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- crizotinib, ROS1 rearrangement, non-small cell lung cancer, tyrosine kinase inhibitors, anaplastic lymphoma kinase, MET, anticancer activity, novel fusion partners
- MeSH terms
- Crizotinib, Proto-Oncogene Mas, Administration, Oral, Adult, Aged, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Pyrazoles, Pyridines, Vision Disorders, Gene Rearrangement, Treatment Outcome, In Situ Hybridization, Fluorescence, Disease-Free Survival, Protein Kinase Inhibitors, Kaplan-Meier Estimate
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