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

Abstract

Purpose

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

Methods

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.

Results

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.

Conclusions

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

Article Type: ORIGINAL RESEARCH ARTICLE

DOI:10.5301/tj.5000539

Authors

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

Disclosures

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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Authors

Affiliations

  •  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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