Cited 12 times in
Open-label, phase IIa study of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma
DC Field | Value | Language |
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dc.contributor.author | 신상준 | - |
dc.contributor.author | 이용상 | - |
dc.contributor.author | 장항석 | - |
dc.date.accessioned | 2021-09-29T02:31:10Z | - |
dc.date.available | 2021-09-29T02:31:10Z | - |
dc.date.issued | 2020-08 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184956 | - |
dc.description.abstract | Purpose: This study (NCT02083354) assessed the efficacy and safety of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. Method: Overall, 77 patients of East Asian origin (including 61 from Mainland China) with unresectable or metastatic BRAF V600-mutant cutaneous melanoma were enrolled. Prior treatment was allowed except with BRAF/MEK inhibitors. Patients received dabrafenib 150 mg twice daily and trametinib 2 mg once daily. The primary end-point was objective response rate (ORR) using Response Evaluation Criteria in Solid Tumours 1.1. Secondary end-points were duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics and safety. Results: At data cutoff (February 23, 2018; median follow-up, 8.3 months), treatment was ongoing in 36 patients (47%). The median age was 52 years; 32% of patients had elevated lactate dehydrogenase, and 84% had received prior systemic therapy. ORR was 61% (95% confidence interval: 49.2-72.0), with four patients (5%) achieving complete response. Median DOR and PFS were 11.3 and 7.9 months, respectively. Median OS was not reached. The most common adverse event (AE) of any grade was pyrexia (56%). Grade ≥III AEs occurred in 29 patients (38%). The most common grade ≥III AEs were pyrexia (8%) and anaemia (6%). AEs led to permanent discontinuation in five patients (6.5%). Mean Cmax for dabrafenib and trametinib was 3560 and 11.5 ng/mL (day 1) and 2680 and 27.1 ng/mL (day 15), respectively. Conclusion: These results support the efficacy and tolerability of dabrafenib in combination with trametinib in East Asian patients with unresectable or metastatic BRAF V600-mutant cutaneous melanoma. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier Science Ltd | - |
dc.relation.isPartOf | EUROPEAN JOURNAL OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / administration & dosage* | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics | - |
dc.subject.MESH | Asia | - |
dc.subject.MESH | Biomarkers, Tumor / genetics* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Imidazoles / administration & dosage* | - |
dc.subject.MESH | Imidazoles / adverse effects | - |
dc.subject.MESH | Imidazoles / pharmacokinetics | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Melanoma / drug therapy* | - |
dc.subject.MESH | Melanoma / genetics | - |
dc.subject.MESH | Melanoma / mortality | - |
dc.subject.MESH | Melanoma / pathology | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mutation* | - |
dc.subject.MESH | Oximes / administration & dosage* | - |
dc.subject.MESH | Oximes / adverse effects | - |
dc.subject.MESH | Oximes / pharmacokinetics | - |
dc.subject.MESH | Progression-Free Survival | - |
dc.subject.MESH | Protein Kinase Inhibitors / administration & dosage* | - |
dc.subject.MESH | Protein Kinase Inhibitors / adverse effects | - |
dc.subject.MESH | Protein Kinase Inhibitors / pharmacokinetics | - |
dc.subject.MESH | Proto-Oncogene Proteins B-raf / genetics* | - |
dc.subject.MESH | Pyridones / administration & dosage* | - |
dc.subject.MESH | Pyridones / adverse effects | - |
dc.subject.MESH | Pyridones / pharmacokinetics | - |
dc.subject.MESH | Pyrimidinones / administration & dosage* | - |
dc.subject.MESH | Pyrimidinones / adverse effects | - |
dc.subject.MESH | Pyrimidinones / pharmacokinetics | - |
dc.subject.MESH | Skin Neoplasms / drug therapy* | - |
dc.subject.MESH | Skin Neoplasms / genetics | - |
dc.subject.MESH | Skin Neoplasms / mortality | - |
dc.subject.MESH | Skin Neoplasms / pathology | - |
dc.subject.MESH | Time Factors | - |
dc.title | Open-label, phase IIa study of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Lu Si | - |
dc.contributor.googleauthor | Xiaoshi Zhang | - |
dc.contributor.googleauthor | Sang Joon Shin | - |
dc.contributor.googleauthor | Yun Fan | - |
dc.contributor.googleauthor | Chia-Chi Lin | - |
dc.contributor.googleauthor | Tae Min Kim | - |
dc.contributor.googleauthor | Arunee Dechaphunkul | - |
dc.contributor.googleauthor | Jedzada Maneechavakajorn | - |
dc.contributor.googleauthor | Chi Sing Wong | - |
dc.contributor.googleauthor | Palanichamy Ilankumaran | - |
dc.contributor.googleauthor | Dung-Yang Lee | - |
dc.contributor.googleauthor | Eduard Gasal | - |
dc.contributor.googleauthor | Haifu Li | - |
dc.contributor.googleauthor | Jun Guo | - |
dc.identifier.doi | 10.1016/j.ejca.2020.04.044 | - |
dc.contributor.localId | A02105 | - |
dc.contributor.localId | A02978 | - |
dc.contributor.localId | A03488 | - |
dc.relation.journalcode | J00809 | - |
dc.identifier.eissn | 1879-0852 | - |
dc.identifier.pmid | 32534242 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0959804920302495 | - |
dc.subject.keyword | BRAF | - |
dc.subject.keyword | Chinese | - |
dc.subject.keyword | Dabrafenib | - |
dc.subject.keyword | Melanoma | - |
dc.subject.keyword | Trametinib | - |
dc.contributor.alternativeName | Shin, Sang Joon | - |
dc.contributor.affiliatedAuthor | 신상준 | - |
dc.contributor.affiliatedAuthor | 이용상 | - |
dc.contributor.affiliatedAuthor | 장항석 | - |
dc.citation.volume | 135 | - |
dc.citation.startPage | 31 | - |
dc.citation.endPage | 38 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF CANCER, Vol.135 : 31-38, 2020-08 | - |
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