RETROSPECTIVE COMPARISON OF REAL-LIFE SURVIVAL DATA FROM SINGLE CENTRE TRIALS - THE CLINICAL OUTCOME OF VEMURAFENIB THERAPY IN METASTATIC MELANOMA PATIENTS

Author(s)

Porneczy E1, Czirbesz K1, Toth E1, Liszkay G1, Boncz I2
1National Institute of Oncology, Budapest, Hungary, 2University of Pecs, Pecs, Hungary

OBJECTIVES: The selection of the MM patient group, eligible for BRAFi therapy is based on the molecular pathologic diagnostics of the BRAF V600 gain-of-function mutation. The sensitivity and specificity of Cobas 4800 BRAF V600 in vitro diagnostic test is excessively high to detect the V600 mutation. In the BRIM-3 study, vemurafenib showed improved PFS and OS in patients carrying BRAF mutation. Our aim is to analyze the vemurafenib international and local real-life survival data of the patients treated in the National Institute of Oncology, in case of individual reimbursement application. METHODS: We retrospectively assessed the single centre Hungarian real-life survival data from 2012 to May 2015. We compared the outcome of the Hungarian and the French real-life and BRIM-3 data. RESULTS: In the selection of the patient group suitable for BRAFi therapy, we carried out 277 BRAF mutation analysis with Cobas test during the given period. 148 cases were wide type, the mutation rate was 46,57% with 129 mutant cases. In Hungary, BRAFi therapy is reimbursed, only on the basis of individual reimbursement application. 36 MM patients were enrolled, with median age of 53,5 years. The median PFS reached 5,4 months, the OS reached 12,3 months. In the previously published French single centre trial, in temporary authorisation program, the median PFS was 3,6 months, the median OS was 7,5 months. The BRIM-3 study demonstrated mPFS 6,9 months and OS 13,6 months. CONCLUSIONS: The detection of BRAF mutation is essential in the therapeutic strategy of metastatic melanoma patients. The Cobas 4800 BRAF test allows a more exact selection of the patient group to be treated by BRAFi. Our single centre OS data are close to BRIM3 clinical trial data. In case of previous vemurafenib therapy started in appropriate treatment line, further improvement can be expected in survival results.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN67

Topic

Clinical Outcomes

Topic Subcategory

Relating Intermediate to Long-term Outcomes

Disease

Oncology

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