Analysis of survival of patients treated with vemurafenib, ipilimumab and dabrafenib for advanced skin melanoma in daily clinical practice (Real-World Data): retrospective analysis of patients treated under drug/reimbursement programmes in Poland in 2013-2016.

Vemurafenib, ipilimumab and dabrafenib were registered for the treatment of advanced skin melanoma pursuant to the results of randomized phase III clinical trials. Real-world data on survival time for patients treated with those drugs in daily clinical practice are so far limited. Patients with advanced skin melanoma treated under reimbursement programmes (drug programmes), for which they were qualified pursuant to uniform inclusion criteria in force in all oncology centres in Poland. Data were obtained from the electronic databases of the national payer (NFZ) responsible for the implementation and monitoring of reimbursement (drug) programmes. The analysis included all patients included for treatment with vemurafenib (since March of 2013), ipilimumab (since March of 2014) and dabrafenib (since July of 2015) until December 2016. The end date of the observation was set to 31 December 2016. The total survival analysis was performed using the Kaplan-Meier estimator. Until 31 December 2016, 759 patients were treated with vemurafenib, 370 with ipilimumab and 181 with dabrafenib. The overall survival (OS) median was 9.8 months for patients treated with vemurafenib (95% confidence interval: 8.8-10.6) and 6.9 months for patients treated with ipilimumab (95% confidence interval: 5.7-9.2). For patients treated with dabrafenib, the OS median was not reached because of an overly short observation period. The probability of surviving 12 months in the group of patients treated with vemurafenib was 40.5%, ipilimumab was 35.1% and dabrafenib was 60.7%. The probability of surviving 24 and 36 months in the group of patients treated with vemurafenib or ipilimumab amounted to, respectively, 20.1, 15.4 and 21, 18.8%. OS of patients with advanced melanoma treated in daily clinical practice may be comparable to the ones achieved in registration trials. The use of appropriate treatment inclusion criteria may affect the obtained OS.

A comparative assessment of HER2 status in operable breast cancer by real-time RT-PCR and by immunohistochemistry.

BACKGROUND: The most commonly used methods for detecting HER2 gene amplification in breast cancer are immunohistochemistry and fluorescence in-situ hybridization. The aim of this retrospective study was to assess HER2 expression by real-time RT-PCR. MATERIAL/METHODS: Expression of HER2 was analyzed by real-time RT-PCR and immunohistochemistry in specimens of invasive ductal breast cancer tissue obtained from 131 women during radical mastectomy. RESULTS: There was a highly significant difference in mean relative gene expression between HER2-positive and HER2-negative patients as assessed by immunostaining (22.10+/-41.89 vs. 3.17+/-8.76; p<0.001). With a median follow-up of 56 months, the cancer-specific survival of HER2-positive patients assessed by RT-PCR was worse in all cases and in the node-positive group. In multivariate analysis, HER2 status was an independent prognostic factor in all patients. CONCLUSIONS: Real-time RT-PCR is a valuable method for determining HER2 status, but the selection of the cut-off point of the relative gene expression differentiating between HER2-negative and -positive tumors is essential.