Cited 83 times in
Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-09-29T02:09:24Z | - |
dc.date.available | 2021-09-29T02:09:24Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184741 | - |
dc.description.abstract | Purpose: Genetic rearrangements of the tyrosine receptor kinase ROS proto-oncogene 1 (ROS1) are oncogenic drivers in non-small-cell lung cancer (NSCLC). We report the results of an updated integrated analysis of three phase I or II clinical trials (ALKA-372-001, STARTRK-1, and STARTRK-2) of the ROS1 tyrosine kinase inhibitor, entrectinib, in ROS1 fusion-positive NSCLC. Methods: The efficacy-evaluable population included adults with locally advanced or metastatic ROS1 fusion-positive NSCLC with or without CNS metastases who received entrectinib ≥ 600 mg orally once per day. Co-primary end points were objective response rate (ORR) assessed by blinded independent central review and duration of response (DoR). Secondary end points included progression-free survival (PFS), overall survival (OS), intracranial ORR, intracranial DoR, intracranial PFS, and safety. Results: In total, 161 patients with a follow-up of ≥ 6 months were evaluable. The median treatment duration was 10.7 months (IQR, 6.4-17.7). The ORR was 67.1% (n = 108, 95% CI, 59.3 to 74.3), and responses were durable (12-month DoR rate, 63%, median DoR 15.7 months). The 12-month PFS rate was 55% (median PFS 15.7 months), and the 12-month OS rate was 81% (median OS not estimable). In 24 patients with measurable baseline CNS metastases by blinded independent central review, the intracranial ORR was 79.2% (n = 19; 95% CI, 57.9 to 92.9), the median intracranial PFS was 12.0 months (95% CI, 6.2 to 19.3), and the median intracranial DoR was 12.9 months (12-month rate, 55%). The safety profile in this updated analysis was similar to that reported in the primary analysis, and no new safety signals were found. Conclusion: Entrectinib continued to demonstrate a high level of clinical benefit for patients with ROS1 fusion-positive NSCLC, including patients with CNS metastases. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Rafal Dziadziuszko | - |
dc.contributor.googleauthor | Matthew G Krebs | - |
dc.contributor.googleauthor | Filippo De Braud | - |
dc.contributor.googleauthor | Salvatore Siena | - |
dc.contributor.googleauthor | Alexander Drilon | - |
dc.contributor.googleauthor | Robert C Doebele | - |
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 | Anna F Farago | - |
dc.contributor.googleauthor | Chia-Chi Lin | - |
dc.contributor.googleauthor | Christos S Karapetis | - |
dc.contributor.googleauthor | Yu-Chung Li | - |
dc.contributor.googleauthor | Bann-Mo Day | - |
dc.contributor.googleauthor | David Chen | - |
dc.contributor.googleauthor | Timothy R Wilson | - |
dc.contributor.googleauthor | Fabrice Barlesi | - |
dc.identifier.doi | 10.1200/JCO.20.03025 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 33646820 | - |
dc.identifier.url | https://ascopubs.org/doi/10.1200/JCO.20.03025 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 39 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1253 | - |
dc.citation.endPage | 1263 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.39(11) : 1253-1263, 2021-04 | - |
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