title: The outcomes of Polish patients with advanced BRAF-positive melanoma treated with vemurafenib in a safety clinical trial.
abstract: OBJECTIVE
  The BRAF inhibitor vemurafenib has improved progression-free survival and overall survival in patients with BRAFV600-mutation-positive metastatic melanoma. Here we present the results of an open-label safety study with vemurafenib in patients with metastatic melanoma enrolled in Polish oncological centres.
  
  
  METHODS
  Patients with untreated or previously treated Stage IIIC/IV BRAFV600 mutation-positive melanoma were treated with oral vemurafenib in an initial dose of 960 mg twice daily. Assessments for safety and efficacy were made every 28 days. For the survival analysis the Kaplan-Meier estimator was used with the log-rank tests for bivariate comparisons.
  
  
  RESULTS
  In total, 75 Polish patients were enrolled in the safety study across four centres. At data cut-off, 28 patients died (37%), mainly (26) due to disease progression; 33 (44%) patients continued vemurafenib after disease progression. The objective response rate was 46%, including two patients with a complete response and 29 with a partial response. Median progression-free survival was 7.4 months. The one-year overall survival rate was 61.9% (median overall survival was not reached). Seventy-three (97.3%) patients reported adverse events (AEs), and grade 3-5 toxicity was reported in 49.4% (37) patients. The most common AEs were: skin lesions (including rash and photosensitivity), arthralgia, and fatigue.
  
  
  CONCLUSIONS
  The overall safety profile and response rate of vemurafenib were comparable to those reported in previous studies of this drug. Our study confirmed the value of well-established prognostic features for overall survival, such as initial LDH (lactate dehydrogenase) level and AJCC staging.
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Rutkowski
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Kozak
authors.affiliation: Chair of Medical Biotechnology, University of Medical Sciences, Poznan, Poland Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Centre, Poznan, Poland Medical Oncology Department, Malgorzata Medical Centre, Śrem, Poland Medpolonia sp. z o.o., Poznan, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Mackiewicz
authors.affiliation: Department of Clinical Oncology, Krakow University Hospital, Krakow, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Krzemieniecki
authors.affiliation: Division of Radiotherapy and Oncology, Department of Clinical Oncology, Silesian Medical University, Katowice, Poland.
authors.forename: Sergiusz
authors.initials: S
authors.lastname: Nawrocki
authors.affiliation: Department of Oncology, University of Warmia and Mazury, Olsztyn, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Wasilewska-Teśluk
authors.affiliation: Department of Chemotherapy, Greater Poland Cancer Centre, Poznan, Poland.
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Kwinta
authors.affiliation: Department of Clinical Oncology, West Cancer Centre, Szczecin, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Wysocki
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Hanna
authors.initials: H
authors.lastname: Koseła-Paterczyk
authors.affiliation: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Świtaj
keywords: BRAF inhibition; melanoma; metastatic; vemurafenib