Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 이수진 | * |
dc.date.accessioned | 2023-10-19T16:31:09Z | - |
dc.date.available | 2023-10-19T16:31:09Z | - |
dc.date.issued | 2023 | * |
dc.identifier.issn | 0959-8049 | * |
dc.identifier.issn | 1879-0852 | * |
dc.identifier.other | OAK-34186 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/266232 | - |
dc.description.abstract | Background: c-KIT mutations are found in approximately 15% of patients with malignant melanoma in the Asian population. Regorafenib, an oral multikinase inhibitor, acts against both wild-type and mutant KIT.Objective: This multi-institutional, phase II, single-arm study aimed to evaluate the efficacy of regorafenib against metastatic malignant melanoma harbouring c -KIT mutations.Methods: Patients with metastatic melanoma positive for c -KIT mutations, upon progression after at least one line of systemic treatment, were enroled. Patients received oral regorafenib 160 mg once daily for 3 weeks (4-week cycle). The primary endpoint was disease control rate (DCR), and secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).Results: In total, 23 patients were enrolled. c -KIT mutations were frequently reported in exon 11 (14/23, 60.9%), followed by exons 13, 17, and 9 in 5 (21.7%), 5 (21.7%), and 2 (8.7%) patients, respectively. DCR at 8 weeks was 73.9%, with 2 patients (8.7%) achieving complete response, 5 (21.7%) achieving partial response, and 10 (43.5%) showing stable disease. ORR was 30.4% (7/23). The median follow-up period was 15.7 months (95% confidence interval [CI], 9.6-21.3), and median OS and PFS were 21.5 months (95% CI, 15.1-27.9) and 7.1 months (95% CI, 5.0-9.2), respectively. Circulating tumour DNA analysis in selected patients showed high c -KIT correlation (85.7%) with tissue-based tumour mutational profiles. The most common adverse events (AEs) were skin reactions, including palmar-plantar erythrodysesthesia (52.2%), and grade 3 AEs were reported in 39.1% (9/23) of the patients.Conclusion: Regorafenib in second-or later-line settings demonstrated significant activity in patients with metastatic melanoma harbouring c -KIT mutations.(c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by_nc/4.0/). | * |
dc.language | English | * |
dc.publisher | ELSEVIER SCI LTD | * |
dc.subject | C-KIT mutation | * |
dc.subject | Regorafenib | * |
dc.subject | Circulating tumour DNA | * |
dc.subject | Malignant melanoma | * |
dc.title | A phase II study on the efficacy of regorafenib in treating patients with c<i>-KIT</i>-mutated metastatic malignant melanoma that progressed after previous treatment (KCSG-UN-14-13) | * |
dc.type | Article | * |
dc.relation.volume | 193 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | EUROPEAN JOURNAL OF CANCER | * |
dc.identifier.doi | 10.1016/j.ejca.2023.113312 | * |
dc.identifier.wosid | WOS:001137973100001 | * |
dc.identifier.scopusid | 2-s2.0-85171864270 | * |
dc.author.google | Kim, Kyoo Hyun | * |
dc.author.google | Jung, Minkyu | * |
dc.author.google | Lee, Hyo Jin | * |
dc.author.google | Lee, Su Jin | * |
dc.author.google | Kim, Miso | * |
dc.author.google | Ahn, Mi Sun | * |
dc.author.google | Choi, Moon Young | * |
dc.author.google | Lee, Na-Ri | * |
dc.author.google | Shin, Sang Joon|Korean Canc Study Grp KCSG | * |
dc.contributor.scopusid | 이수진(55931708700) | * |
dc.date.modifydate | 20240131144606 | * |