Cited 123 times in
Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer
DC Field | Value | Language |
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dc.contributor.author | 라선영 | - |
dc.date.accessioned | 2024-02-15T06:58:26Z | - |
dc.date.available | 2024-02-15T06:58:26Z | - |
dc.date.issued | 2023-01 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198096 | - |
dc.description.abstract | BACKGROUND: KRAS p.G12C mutation occurs in approximately 1 to 2% of pancreatic cancers. The safety and efficacy of sotorasib, a KRAS G12C inhibitor, in previously treated patients with KRAS p.G12C-mutated pancreatic cancer are unknown. METHODS: We conducted a single-group, phase 1-2 trial to assess the safety and efficacy of sotorasib treatment in patients with KRAS p.G12C-mutated pancreatic cancer who had received at least one previous systemic therapy. The primary objective of phase 1 was to assess safety and to identify the recommended dose for phase 2. In phase 2, patients received sotorasib at a dose of 960 mg orally once daily. The primary end point for phase 2 was a centrally confirmed objective response (defined as a complete or partial response). Efficacy end points were assessed in the pooled population from both phases and included objective response, duration of response, time to objective response, disease control (defined as an objective response or stable disease), progression-free survival, and overall survival. Safety was also assessed. RESULTS: The pooled population from phases 1 and 2 consisted of 38 patients, all of whom had metastatic disease at enrollment and had previously received chemotherapy. At baseline, patients had received a median of 2 lines (range, 1 to 8) of therapy previously. All 38 patients received sotorasib in the trial. A total of 8 patients had a centrally confirmed objective response (21%; 95% confidence interval [CI], 10 to 37). The median progression-free survival was 4.0 months (95% CI, 2.8 to 5.6), and the median overall survival was 6.9 months (95% CI, 5.0 to 9.1). Treatment-related adverse events of any grade were reported in 16 patients (42%); 6 patients (16%) had grade 3 adverse events. No treatment-related adverse events were fatal or led to treatment discontinuation. CONCLUSIONS: Sotorasib showed anticancer activity and had an acceptable safety profile in patients with KRAS p.G12C-mutated advanced pancreatic cancer who had received previous treatment. (Funded by Amgen and others; CodeBreaK 100 ClinicalTrials.gov number, NCT03600883.). Copyright © 2022 Massachusetts Medical Society. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Administration, Oral | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immune Checkpoint Inhibitors* / administration & dosage | - |
dc.subject.MESH | Immune Checkpoint Inhibitors* / therapeutic use | - |
dc.subject.MESH | Lung Neoplasms / drug therapy | - |
dc.subject.MESH | Mutation | - |
dc.subject.MESH | Pancreatic Neoplasms* / drug therapy | - |
dc.subject.MESH | Pancreatic Neoplasms* / genetics | - |
dc.subject.MESH | Pancreatic Neoplasms* / secondary | - |
dc.subject.MESH | Proto-Oncogene Proteins p21(ras) / genetics | - |
dc.subject.MESH | Pyridines | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | John H Strickler | - |
dc.contributor.googleauthor | Hironaga Satake | - |
dc.contributor.googleauthor | Thomas J George | - |
dc.contributor.googleauthor | Rona Yaeger | - |
dc.contributor.googleauthor | Antoine Hollebecque | - |
dc.contributor.googleauthor | Ignacio Garrido-Laguna | - |
dc.contributor.googleauthor | Martin Schuler | - |
dc.contributor.googleauthor | Timothy F Burns | - |
dc.contributor.googleauthor | Andrew L Coveler | - |
dc.contributor.googleauthor | Gerald S Falchook | - |
dc.contributor.googleauthor | Mark Vincent | - |
dc.contributor.googleauthor | Yu Sunakawa | - |
dc.contributor.googleauthor | Laetitia Dahan | - |
dc.contributor.googleauthor | David Bajor | - |
dc.contributor.googleauthor | Sun-Young Rha | - |
dc.contributor.googleauthor | Charlotte Lemech | - |
dc.contributor.googleauthor | Dejan Juric | - |
dc.contributor.googleauthor | Marko Rehn | - |
dc.contributor.googleauthor | Gataree Ngarmchamnanrith | - |
dc.contributor.googleauthor | Pegah Jafarinasabian | - |
dc.contributor.googleauthor | Qui Tran | - |
dc.contributor.googleauthor | David S Hong | - |
dc.identifier.doi | 10.1056/NEJMoa2208470 | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 36546651 | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.affiliatedAuthor | 라선영 | - |
dc.citation.volume | 388 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 33 | - |
dc.citation.endPage | 43 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.388(1) : 33-43, 2023-01 | - |
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