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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)
- 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)
- Authors
- Kim, Kyoo Hyun; Jung, Minkyu; Lee, Hyo Jin; Lee, Su Jin; Kim, Miso; Ahn, Mi Sun; Choi, Moon Young; Lee, Na-Ri; Shin, Sang Joon|Korean Canc Study Grp KCSG
- Ewha Authors
- 이수진
- SCOPUS Author ID
- 이수진
- Issue Date
- 2023
- Journal Title
- EUROPEAN JOURNAL OF CANCER
- ISSN
- 0959-8049
1879-0852
- Citation
- EUROPEAN JOURNAL OF CANCER vol. 193
- Keywords
- C-KIT mutation; Regorafenib; Circulating tumour DNA; Malignant melanoma
- Publisher
- ELSEVIER SCI LTD
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- 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/).
- DOI
- 10.1016/j.ejca.2023.113312
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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