Targeted Oncology

, Volume 10, Issue 3, pp 385–392 | Cite as

Prognostic factors in renal cell carcinoma patients treated with sorafenib: results from the Czech registry

  • Katerina KubackovaEmail author
  • Z. Bortlicek
  • T. Pavlik
  • B. Melichar
  • Z. Linke
  • P. Pokorna
  • R. Vyzula
  • J. Prausova
  • T. Buchler
  • on behalf of the Czech Renal Cancer Cooperative Group
Original Research


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.


Renal cell carcinoma Metastasis Targeted therapy Outcomes First-line therapy 



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.


  1. 1.
    Rini BI, Campbell SC, Escudier B (2009) Renal cell carcinoma. Lancet 373(9669):1119–1132. doi: 10.1016/S0140-6736(09)60229-4 CrossRefPubMedGoogle Scholar
  2. 2.
    Hudes GR, Carducci MA, Choueiri TK, Esper P, Jonasch E, Kumar R, Margolin KA, Michaelson MD, Motzer RJ, Pili R, Roethke S, Srinivas S (2011) NCCN Task Force report: optimizing treatment of advanced renal cell carcinoma with molecular targeted therapy. J Natl Compr Cancer Netw 9(Suppl 1):S1–S29Google Scholar
  3. 3.
    Escudier B, Eisen T, Porta C, Patard JJ, Khoo V, Algaba F, Mulders P, Kataja V (2012) Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 23(Suppl 7):vii65–vii71. doi: 10.1093/annonc/mds227 CrossRefPubMedGoogle Scholar
  4. 4.
    Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, Negrier S, Laferriere N, Scheuring UJ, Cella D, Shah S, Bukowski RM (2009) Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 27(8):1280–1289. doi: 10.1200/JCO.2008.19.3342 CrossRefPubMedGoogle Scholar
  5. 5.
    Krown SE (1987) Interferon treatment of renal cell carcinoma. Current status and future prospects. Cancer 59(3 Suppl):647–651CrossRefPubMedGoogle Scholar
  6. 6.
    Coppin C, Kollmannsberger C, Le L, Porzsolt F, Wilt TJ (2011) Targeted therapy for advanced renal cell cancer (RCC): a Cochrane systematic review of published randomised trials. BJU Int 108(10):1556–1563. doi: 10.1111/j.1464-410X.2011.10629.x CrossRefPubMedGoogle Scholar
  7. 7.
    Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356(2):125–134. doi: 10.1056/NEJMoa060655 CrossRefPubMedGoogle Scholar
  8. 8.
    Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM (2009) Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol 27(20):3312–3318. doi: 10.1200/JCO.2008.19.5511 CrossRefPubMedGoogle Scholar
  9. 9.
    Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O’Dwyer PJ (2006) Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 24(16):2505–2512. doi: 10.1200/JCO.2005.03.6723 CrossRefPubMedGoogle Scholar
  10. 10.
    FDA (2005) FDA approves new treatment for advanced kidney cancer. Silver Spring, MD 20993Google Scholar
  11. 11.
    Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R (2006) Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res 12(24):7271–7278. doi: 10.1158/1078-0432.CCR-06-1249 CrossRefPubMedGoogle Scholar
  12. 12.
    EMA (2006) Sorafenib Marketing AuthorisationGoogle Scholar
  13. 13.
    Motzer RJ, Agarwal N, Beard C, Bhayani S, Bolger GB, Carducci MA, Chang SS, Choueiri TK, Hancock SL, Hudes GR, Jonasch E, Josephson D, Kuzel TM, Levine EG, Lin DW, Margolin KA, Michaelson MD, Olencki T, Pili R, Ratliff TW, Redman BG, Robertson CN, Ryan CJ, Sheinfeld J, Spiess PE, Wang J, Wilder RB (2011) Kidney cancer. J Natl Compr Cancer Netw 9(9):960–977Google Scholar
  14. 14.
    Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ (2011) Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 378(9807):1931–1939. doi: 10.1016/S0140-6736(11)61613-9 CrossRefPubMedGoogle Scholar
  15. 15.
    Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B (2014) Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol 15(3):286–296. doi: 10.1016/S1470-2045(14)70030-0 CrossRefPubMedGoogle Scholar
  16. 16.
    Buchler T, Klapka R, Melichar B, Brabec P, Dusek L, Vyzula R, Abrahamova J (2012) Sunitinib followed by sorafenib or vice versa for metastatic renal cell carcinoma—data from the Czech registry. Ann Oncol 23(2):395–401. doi: 10.1093/annonc/mdr065 CrossRefPubMedGoogle Scholar
  17. 17.
    Poprach A, Bortlicek Z, Buchler T, Melichar B, Lakomy R, Vyzula R, Brabec P, Svoboda M, Dusek L, Gregor J (2012) Patients with advanced and metastatic renal cell carcinoma treated with targeted therapy in the Czech Republic: twenty cancer centres, six agents, one database. Med Oncol 29(5):3314–3320. doi: 10.1007/s12032-012-0286-9 CrossRefPubMedGoogle Scholar
  18. 18.
    Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ (2013) Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol 14(13):1287–1294. doi: 10.1016/S1470-2045(13)70465-0 CrossRefPubMedGoogle Scholar
  19. 19.
    Park SJ, Lee JL, Park I, Park K, Ahn Y, Ahn JH, Lee DH, Ahn S, Song C, Hong JH, Kim CS, Ahn H (2012) Comparative efficacy of sunitinib versus sorafenib as first-line treatment for patients with metastatic renal cell carcinoma. Chemotherapy 58(6):468–474. doi: 10.1159/000346484 CrossRefPubMedGoogle Scholar
  20. 20.
    Michel SM, Vervenne W, de Santis M, von Weikersthal LF, Goebell PJ, Lerchenmueller J, Zimmermann U (2014) SWITCH: a randomized sequential open-label study to evaluate efficacy and safety of sorafenib (SO)/sunitinib (SU) versus SU/SO in the treatment of metastatic renal cell cancer (mRCC). J Clin Oncol 32(suppl 4; abstr 393)Google Scholar
  21. 21.
    Hutson TE, Escudier B, Esteban E, Bjarnason GA, Lim HY, Pittman KB, Senico P, Niethammer A, Lu DR, Hariharan S, Motzer RJ (2014) Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 32(8):760–767. doi: 10.1200/JCO.2013.50.3961 CrossRefPubMedGoogle Scholar
  22. 22.
    Stenner F, Chastonay R, Liewen H, Haile SR, Cathomas R, Rothermundt C, Siciliano RD, Stoll S, Knuth A, Buchler T, Porta C, Renner C, Samaras P (2012) A pooled analysis of sequential therapies with sorafenib and sunitinib in metastatic renal cell carcinoma. Oncology 82(6):333–340. doi: 10.1159/000338001 CrossRefPubMedGoogle Scholar
  23. 23.
    Epidemiology of malignant tumors in the Czech Republic (1977–2008)
  24. 24.
    Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M (2002) Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol 20(1):289–296CrossRefPubMedGoogle Scholar
  25. 25.
    Patil S, Figlin RA, Hutson TE, Michaelson MD, Negrier S, Kim ST, Huang X, Motzer RJ (2011) Prognostic factors for progression-free and overall survival with sunitinib targeted therapy and with cytokine as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol 22(2):295–300. doi: 10.1093/annonc/mdq342 CrossRefPubMedGoogle Scholar
  26. 26.
    Bracarda S, Porta C, Boni C, Santoro A, Mucciarini C, Pazzola A, Cortesi E, Gasparro D, Labianca R, Di Costanzo F, Falcone A, Cinquini M, Caserta C, Paglino C, De Angelis V (2013) Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY). Eur Urol 63(2):254–261. doi: 10.1016/j.eururo.2012.08.027 CrossRefPubMedGoogle Scholar
  27. 27.
    Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H (2011) Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int 108(11):1813–1819. doi: 10.1111/j.1464-410X.2011.10281.x CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Katerina Kubackova
    • 1
    • 6
    Email author
  • Z. Bortlicek
    • 2
  • T. Pavlik
    • 2
  • B. Melichar
    • 3
  • Z. Linke
    • 1
  • P. Pokorna
    • 1
  • R. Vyzula
    • 4
  • J. Prausova
    • 1
  • T. Buchler
    • 5
  • on behalf of the Czech Renal Cancer Cooperative Group
  1. 1.Department of Oncology, University Hospital in MotolCharles UniversityPragueCzech Republic
  2. 2.Institute of Biostatistics and AnalysesMasaryk UniversityBrnoCzech Republic
  3. 3.Department of OncologyPalacky University Medical School and Teaching HospitalOlomoucCzech Republic
  4. 4.Department of Comprehensive Cancer CareMasaryk Memorial Cancer InstituteBrnoCzech Republic
  5. 5.Department of OncologyThomayer Hospital and Charles University First Faculty of MedicinePragueCzech Republic
  6. 6.Department of Oncology, University Hospital MotolCharles UniversityPragueCzech Republic

Personalised recommendations