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Real-world efficacy and safety data for dabrafenib and trametinib combination therapy in Japanese patients with BRAF V600 mutation-positive advanced melanoma.
- Source :
-
The Journal of dermatology [J Dermatol] 2020 Mar; Vol. 47 (3), pp. 257-264. Date of Electronic Publication: 2019 Dec 26. - Publication Year :
- 2020
-
Abstract
- We conducted a retrospective investigation of the efficacy and safety of dabrafenib and trametinib combination therapy in Japanese patients with BRAF V600 mutation-positive advanced melanoma in real-world clinical practise. The study analyzed 50 patients who received dabrafenib and trametinib combination therapy for BRAF V600 mutation-positive advanced melanoma in our hospital (26 men and 24 women, aged 21-86 years, inclusive; median age, 53 years). The response rate was 72.3%, with complete response (CR) achieved in eight cases (17.0%), partial response in 26 (55.3%), stable disease in nine (19.1%) and progressive disease in four (8.5%). Median progression-free survival (PFS) was 12 months, and median overall survival (OS) was 23 months. Disease progression occurred in 29 of the 50 patients during the study period, and 25 patients died. Baseline lactate dehydrogenase and the number of organs with metastasis were important predictive factors for PFS and OS, and CR to combination therapy was a predictive factor for long-term remission. Adverse events occurred in 88% of cases; 16% were grade 3 or worse. The adverse events observed in 50% of more of patients were rash (56%) and pyrexia (52%). The efficacy of dabrafenib and trametinib combination therapy in Japanese patients was similar to that reported in global studies, and the same adverse events were generally reported; however, rash tended to occur more frequently in the patients in our study.<br /> (© 2019 Japanese Dermatological Association.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols adverse effects
Disease Progression
Drug Eruptions etiology
Exanthema chemically induced
Female
Fever chemically induced
Humans
Imidazoles administration & dosage
Japan
L-Lactate Dehydrogenase blood
Male
Melanoma genetics
Melanoma secondary
Middle Aged
Mutation
Oximes administration & dosage
Progression-Free Survival
Pyridones administration & dosage
Pyrimidinones administration & dosage
Response Evaluation Criteria in Solid Tumors
Retrospective Studies
Skin Neoplasms genetics
Skin Neoplasms pathology
Survival Rate
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Melanoma drug therapy
Proto-Oncogene Proteins B-raf genetics
Skin Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1346-8138
- Volume :
- 47
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- The Journal of dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 31876308
- Full Text :
- https://doi.org/10.1111/1346-8138.15204