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- Title
Safety of vemurafenib in patients with BRAF mutated metastatic melanoma: the Spanish experience.
- Authors
Arance, A.; Berrocal, A.; Lopez-Martin, J.; Cruz-Merino, L.; Soriano, V.; Martín Algarra, S.; Alonso, L.; Cerezuela, P.; Orden, B.; Espinosa, E.
- Abstract
Objectives: Vemurafenib tolerability was assessed in a large, open-label, multicentre study in patients with BRAF mutated advanced melanoma. We investigated safety, tolerability and efficacy of vemurafenib in Spanish patients participating in that study. Methods: Patients with previously treated or treatment-naive, unresectable stage IIIC or stage IV, BRAF mutation-positive melanoma received vemurafenib 960 mg twice daily until disease progression, unacceptable toxicity, withdrawal of consent or death. The primary endpoint was safety; secondary endpoints included overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: 301 Spanish patients were included, 70 % with M1c disease, 22 % with brain metastases and 51 % with prior systemic therapy for metastatic disease. Most frequent adverse events included fatigue (48 %), arthralgia (45 %), rash (41 %), photosensitivity (34 %) and skin neoplasms (21 %). Grade 3/4 adverse events occurred in 156 patients (52 %), including cutaneous squamous cell carcinoma (including keratoacanthoma; 16 %), fatigue (6 %) and arthralgia (5 %). The ORR was 28 % (95 % CI 23-34 %). Responses occurred in patients with brain metastases (18 %), elevated baseline lactate dehydrogenase (19 %) and poor performance status (15 %), and elderly patients (22 %). Median PFS was 5.8 (95 % CI 5.0-6.4) months; median OS was 10.5 (95 % CI 9.5-13.5) months. Conclusion: Our results for Spanish patients in the vemurafenib safety study indicate similar efficacy and a comparable safety profile in Spanish patients with no new safety signals compared with the overall population. Clinical benefit was demonstrated in poor-prognosis patients and in those with favourable baseline characteristics, suggesting that poor-prognosis patients may also benefit from vemurafenib treatment.
- Publication
Clinical & Translational Oncology, 2016, Vol 18, Issue 11, p1147
- ISSN
1699-048X
- Publication type
Article
- DOI
10.1007/s12094-016-1498-9