PMID- 26557775 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20151111 LR - 20200930 IS - 1428-2526 (Print) IS - 1897-4309 (Electronic) IS - 1428-2526 (Linking) VI - 19 IP - 4 DP - 2015 TI - The outcomes of Polish patients with advanced BRAF-positive melanoma treated with vemurafenib in a safety clinical trial. PG - 280-3 LID - 10.5114/wo.2015.54082 [doi] AB - AIM OF THE STUDY: 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. MATERIAL AND 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. FAU - Rutkowski, Piotr AU - Rutkowski P AD - Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland. FAU - Kozak, Katarzyna AU - Kozak K AD - Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland. FAU - Mackiewicz, Jacek AU - Mackiewicz J AD - 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, Srem, Poland Medpolonia sp. z o.o., Poznan, Poland. FAU - Krzemieniecki, Krzysztof AU - Krzemieniecki K AD - Department of Clinical Oncology, Krakow University Hospital, Krakow, Poland. FAU - Nawrocki, Sergiusz AU - Nawrocki S AD - Division of Radiotherapy and Oncology, Department of Clinical Oncology, Silesian Medical University, Katowice, Poland. FAU - Wasilewska-Tesluk, Ewa AU - Wasilewska-Tesluk E AD - Department of Oncology, University of Warmia and Mazury, Olsztyn, Poland. FAU - Kwinta, Lukasz AU - Kwinta L AD - Department of Chemotherapy, Greater Poland Cancer Centre, Poznan, Poland. FAU - Wysocki, Piotr AU - Wysocki P AD - Department of Clinical Oncology, West Cancer Centre, Szczecin, Poland. FAU - Kosela-Paterczyk, Hanna AU - Kosela-Paterczyk H AD - Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland. FAU - Switaj, Tomasz AU - Switaj T AD - Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland. LA - eng PT - Journal Article DEP - 20150928 PL - Poland TA - Contemp Oncol (Pozn) JT - Contemporary oncology (Poznan, Poland) JID - 101233223 PMC - PMC4631301 OTO - NOTNLM OT - BRAF inhibition OT - melanoma OT - metastatic OT - vemurafenib EDAT- 2015/11/12 06:00 MHDA- 2015/11/12 06:01 PMCR- 2015/01/01 CRDT- 2015/11/12 06:00 PHST- 2015/02/22 00:00 [received] PHST- 2015/04/05 00:00 [revised] PHST- 2015/07/20 00:00 [accepted] PHST- 2015/11/12 06:00 [entrez] PHST- 2015/11/12 06:00 [pubmed] PHST- 2015/11/12 06:01 [medline] PHST- 2015/01/01 00:00 [pmc-release] AID - 25756 [pii] AID - 10.5114/wo.2015.54082 [doi] PST - ppublish SO - Contemp Oncol (Pozn). 2015;19(4):280-3. doi: 10.5114/wo.2015.54082. Epub 2015 Sep 28.