Cited 83 times in
Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid Tumors
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2022-08-23T00:43:21Z | - |
dc.date.available | 2022-08-23T00:43:21Z | - |
dc.date.issued | 2022-04 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/189585 | - |
dc.description.abstract | Purpose: Entrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with NTRK fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up. Patients and methods: Patients with locally advanced/metastatic NTRK fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR); secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose. Results: At clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months; 61.2% of patients had a complete (n = 19) or partial response (n = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0-38.2]; median PFS was 13.8 months (95% CI, 10.1-19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8-89.1) and median intracranial DoR was 22.1 (95% CI, 7.4-not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients. Conclusions: With additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with NTRK fusion-positive solid tumors. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Association for Cancer Research | - |
dc.relation.isPartOf | CLINICAL CANCER RESEARCH | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Benzamides | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Child | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Indazoles | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Protein-Tyrosine Kinases | - |
dc.subject.MESH | Proto-Oncogene Proteins | - |
dc.title | Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid Tumors | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | George D Demetri | - |
dc.contributor.googleauthor | Filippo De Braud | - |
dc.contributor.googleauthor | Alexander Drilon | - |
dc.contributor.googleauthor | Salvatore Siena | - |
dc.contributor.googleauthor | Manish R Patel | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Stephen V Liu | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Chao-Hua Chiu | - |
dc.contributor.googleauthor | Jessica J Lin | - |
dc.contributor.googleauthor | Koichi Goto | - |
dc.contributor.googleauthor | Jeeyun Lee | - |
dc.contributor.googleauthor | Lyudmila Bazhenova | - |
dc.contributor.googleauthor | Thomas John | - |
dc.contributor.googleauthor | Marwan Fakih | - |
dc.contributor.googleauthor | Sant P Chawla | - |
dc.contributor.googleauthor | Rafal Dziadziuszko | - |
dc.contributor.googleauthor | Takashi Seto | - |
dc.contributor.googleauthor | Sebastian Heinzmann | - |
dc.contributor.googleauthor | Bethany Pitcher | - |
dc.contributor.googleauthor | David Chen | - |
dc.contributor.googleauthor | Timothy R Wilson | - |
dc.contributor.googleauthor | Christian Rolfo | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-21-3597 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J00564 | - |
dc.identifier.pmid | 35144967 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 28 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1302 | - |
dc.citation.endPage | 1312 | - |
dc.identifier.bibliographicCitation | CLINICAL CANCER RESEARCH, Vol.28(7) : 1302-1312, 2022-04 | - |
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