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Dabrafenib plus trametinib is effective in the treatment of BRAF V600-mutated metastatic melanoma patients: analysis of patients from the dabrafenib plus trametinib Named Patient Program (DESCRIBE II)
V. Atkinson, S. Sandhu, G. Hospers, GV. Long, M. Aglietta, PF. Ferrucci, S. Tulyte, GCA. Cappellini, V. Soriano, S. Ali, A. Poprach, A. Cesas, D. Rodriguez-Abreu, M. Lau, E. de Jong, P. Legenne, D. Stein, B. King, JV. van Thienen
Language English Country Great Britain
Document type Journal Article, Research Support, Non-U.S. Gov't
- MeSH
- Compassionate Use Trials MeSH
- Adult MeSH
- Imidazoles administration & dosage MeSH
- Middle Aged MeSH
- Humans MeSH
- Melanoma drug therapy genetics MeSH
- Skin Neoplasms drug therapy genetics MeSH
- Oximes administration & dosage MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Proto-Oncogene Proteins B-raf genetics MeSH
- Pyridones administration & dosage MeSH
- Pyrimidinones administration & dosage MeSH
- Retrospective Studies MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
In clinical trials, dabrafenib plus trametinib improved overall survival (OS) compared with single-agent BRAF inhibitors (BRAFi) in patients with BRAF V600-mutant unresectable or metastatic melanoma. We investigated dabrafenib plus trametinib therapy in a compassionate-use setting [Named Patient Program (NPP); DESCRIBE II]. A retrospective chart review of patients with BRAF V600-mutated unresectable stage III/IV melanoma receiving dabrafenib plus trametinib as compassionate use was conducted. Treatment patterns and duration, clinical outcomes, and tolerability were evaluated. Of 271 patients, 92.6% had stage IV melanoma, including 36.5% with brain metastases. Overall, 162 patients (59.8%) were BRAFi naive and 171 (63.1%) received first-line dabrafenib plus trametinib. Among BRAFi-naive patients, the overall response rate (ORR) was 67.3%, median OS (mOS) was 20.0 months, and median progression-free survival (mPFS) was 7.5 months. In BRAFi-naive patients with known brain metastases (n = 62), ORR was 61.3%, mOS was 15.5 months, and mPFS was 6.2 months. Eighty-four patients received BRAFi monotherapy for >30 days and switched to dabrafenib plus trametinib prior to progression. Of these 84 patients, 63 had known disease status at the time of switch, and 22 improved with the combination therapy. No new safety signals were identified, and dabrafenib plus trametinib was well tolerated. Dabrafenib plus trametinib showed substantial clinical activity in NPP patients with BRAF V600-mutated unresectable or metastatic melanoma. Analysis of treatment patterns demonstrated the effectiveness of the combination in patients with brain metastases and across lines of therapy with a well tolerated and manageable safety profile.
Canberra Hospital Garran ACT Australia
Department of Oncology Candiolo Cancer Center University of Torino Torino
Department of Oncology Klaipeda University Hospital Klaipeda Lithuania
Department of Oncology Peter MacCallum Cancer Centre Melbourne VIC Australia
Medical Oncology IVO Servicio de Oncología Valencia Spain
Novartis Pharma AG Basel Switzerland
Tumor Biotherapy Unit European Institute of Oncology IRCCS Milano Italy
United BioSource Corporation An Express Scripts Company London UK
United BioSource Corporation An Express Scripts Company Montreal QC Canada
References provided by Crossref.org
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