Abstract
The aim of this study was to describe the characteristics and outcomes of a large cohort of patients treated with sorafenib in clinical practice and to identify predictive factors associated with prognosis. Patient data were obtained from the national Czech registry (RenIS). Data of virtually all Czech patients receiving targeted therapies are entered into this non-interventional post-registration database. Demographics and clinical data, as well as all treatment sequences and clinical outcomes, are reported in this registry. A total of 836 patients treated with sorafenib before March 2013 were included in the analysis. Median age was 63 years and 70 % were men. Most patients had received prior treatment with cytokines, sunitinib or both. Sorafenib was the first-line treatment in 15 % of patients. Median overall survival and progression-free survival were 21.7 months and 7.5 months, respectively. Median overall survival and progression-free survival was 26.3 and 8.3 months, respectively, in patients receiving sorafenib as first-line therapy. Cox proportional models identified several parameters associated with poor outcome including time ≤1 year from diagnosis to first-line systemic treatment, performance status ≥2, low hemoglobin, and LDH >1.5 times the upper limit of normal. Our data demonstrate that the outcomes of real-life patients are comparable to those enrolled in clinical trials. Prognostic factors identified in the present study were consistent with previously reported models.
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Acknowledgments
The authors would like to thank the following department representatives of the Comprehensive Cancer Centers which contributed to the RENIS project: Prof. MUDr. Jiří Petera, Ph.D (Fakultní nemocnice Hradec Králové); Prof. MUDr. Jindřich Fínek, Ph.D (Fakultní nemocnice Plzeň); Prof. MUDr. Luboš Petruželka, CSc (Všeobecná fakultní nemocnice v Praze); Prim. MUDr. Jiří Bartoš, MBA (Krajská nemocnice Liberec, a.s); Doc. MUDr. David Feltl, Ph.D., MBA (Fakultní nemocnice Ostrava); Prim. MUDr. Jana Katolická, Ph.D. (Fakultní nemocnice u sv. Anny v Brně); Prim. MUDr. Lubomír Slavíček (Nemocnice Jihlava); Prim. MUDr. Milan Kohoutek (Krajská nemocnice T. Bati, a.s.); Prim. MUDr. Václav Janovský (Nemocnice České Budějovice, a.s.); Prof. MUDr. Bohuslav Melichar, Ph.D. (Fakultní nemocnice Olomouc); Prof. MUDr. Jiří Vorlíček, CSc. (Fakultní Masarykův onkologický ústav Brno); Prof. MUDr. Jiří Mayer, CSc (Fakultní nemocnice Brno); Prim. doc. MUDr. Renata Soumarová, Ph.D., MBA (Nemocnice s poliklinikou v Novém Jičíně); Prim. MUDr. Milan Lysý (Masarykova nemocnice v Ústí nad Labem, o.z); Prim. MUDr. Martina Chodacká (Nemocnice Chomutov); Prim. doc. MUDr. Jaroslav Vaňásek, CSc. (Pardubická krajská nemocnice, a.s.); MUDr. Martin Šafanda (Nemocnice Na Homolce); and Prim. pplk. MUDr. Petr Cínek, Ph.D. (Ústřední vojenská nemocnice Praha).
The authors also thank Abir Tadmouri, PhD (ClinSearch) for providing editorial assistance in the preparation of the manuscript.
Conflict of interest
Katerina Kubackova received travel grants and lecture honoraria from Bayer and Pfizer.
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Kubackova, K., Bortlicek, Z., Pavlik, T. et al. Prognostic factors in renal cell carcinoma patients treated with sorafenib: results from the Czech registry. Targ Oncol 10, 385–392 (2015). https://doi.org/10.1007/s11523-014-0343-8
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DOI: https://doi.org/10.1007/s11523-014-0343-8