Combined therapy with dabrafenib and trametinib in BRAF-mutated metastatic melanoma in a real-life setting: the INT Milan experience



Combination therapy with dabrafenib and trametinib is safer and more effective than BRAF inhibitor-based monotherapy for metastatic melanoma.


We retrospectively analyzed BRAF-mutated metastatic melanoma patients treated at our institution with daily oral dabrafenib 300 mg and trametinib 2 mg from November 2013 to April 2016. This clinical record included both untreated and previously treated stage IV melanomas. Physical examination and laboratory examinations were performed monthly and disease re-evaluations were performed every 3 months.


A total of 48 patients (24 male, 24 female) with BRAF-mutated metastatic melanoma received dabrafenib and trametinib; median age was 48 years (range 23-75). Median follow-up was 362.5 days (range 72-879). Best overall response rate consisted of 6.2% (3 patients) complete response, 64.6% (31) partial response, and 25% (12) stable disease; median time to best response was 11 weeks (range 5.7-125.5). Progression of disease was seen in 19 patients (39.6%), with median time to progression (TTP) of 26 weeks (range 8-54). A total of 15 patients (31.2%) died due to progression of disease. Median progression-free survival and median overall survival were not reached. To date, 30 patients (62.5%) are still under treatment. A total of 27 (56.2%) patients had at least one adverse event (AE); grade 3-4 AEs were seen in 4 cases (8.3%). The main toxicities were fever (25%), skin rash (14.6%), arthralgias (10.4%), and aspartate aminotransferase/alanine aminotransferase increase (8.3%). Treatment dose was reduced in 7 subjects (14.6%), with only one case of discontinuation due to AE.


Our data, using combined targeted therapy, are in line with the scientific literature in terms of both safety and effectiveness in a real-life setting.

Tumori 2016; 102(5): 501 - 507




Stefano Cavalieri, Lorenza Di Guardo, Carolina Cimminiello, Aldo Bono, Elena Tolomio, Anna Colombetti, Barbara Valeri, Giuseppe Di Tolla, Filippo de Braud, Michele Del Vecchio

Article History


Financial support: No financial support was received for this submission.
Conflict of interest: Filippo de Braud: Tiziana Life Sciences, BMS, Novartis, MSD, Servier, Eli Lilly, Merck Serono, GSK. Michele Del Vecchio: Novartis, Roche, BMS, MSD.

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  •  Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  •  Day Surgery Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  •  Laser Therapy Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  •  Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  •  Radiology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy
  •  Medical Oncology Department, University of Milan, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan - Italy

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