Sorafenib for advanced renal cell carcinoma in real-life practice: a literature review

Steven Simoens
DOI: 10.4236/health.2011.32016                

Abstract

Sorafenib is a new treatment indicated for patients with advanced renal cell carcinoma who have failed prior cytokine-based therapy or are considered unsuitable for such therapy. Although treatment with sorafenib under ‘ideal trial conditions’ has been extensively studied, registration and reimbursement authorities are also interested in the behavior of sorafenib in real-life practice. This study aims to conduct a literature review of the dosage and treatment duration; safety, tolerability and effectiveness; costs and cost-effectiveness of sorafenib in routine clinical care. Studies were identified by searching PubMed, Embase, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, and EconLit up to November 2010. The literature search included articles published in peer-reviewed journals, congress abstracts, and internal studies of Bayer Schering Pharma. Eight studies were included. An open-label study observed stable disease for at least eight weeks in 80% of patients. The most common drug-related adverse events were hand-foot skin reaction, rash, hypertension, and fatigue. Although treatment with sorafenib led to fewer dose reductions, it was also associated with a shorter treatment duration, less time to pro-gression and a shorter survival time as compared to sunitinib. Monthly health care costs were lower with sorafenib as compared to sunitinib. A post-marketing surveillance study showed that patients rated the tolerability and effectiveness of sorafenib as very good, good or sufficient. In conclusion, the current evidence is too limited to derive conclusions and existing studies suffer from methodological shortcomings.

Keywords

Sorafenib; Advanced Renal Cell Carcinoma; Real-Life Practice; Literature Review

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Belgian Cancer Registry. (2010) Cancer registry data. http://www.registreducancer.be.
[2]	Gupta, K., Miller, J.D., Li, J.Z., Russell, M.W., Charbonneau, C. (2008) Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review. Cancer Treat Review, 34, 193-205.
[3]	Ather, M.H., Masood, N., Siddiqui, T. (2010) Current management of advanced and metastatic renal cell carcinoma. Urology Journal, 7, 1-9. doi:10.1016/j.ctrv.2007.12.001
[4]	European Medicines Agency. (2006) EU Summary of Product Characteristics. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000690/human_med_000929. jsp&murl=menus/medicines/medicines.jsp.
[5]	Adjei, A.A., Hidalgo, M. (2005) Intracellular signal transduction pathway proteins as targets for cancer therapy. Journal of Clinical Oncology, 23, 5386-5403. doi:10.1200/JCO.2005.23.648
[6]	Kim, W.Y., Kaelin, W.G. (2004) Role of VHL gene mutation in human cancer. Journal of Clinical Oncology, 22, 4991-5004. doi:10.1200/JCO.2004.05.061
[7]	Wilhelm, S.M., Carter, C., Tang, L. et al. (2004) BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Research, 64, 7099-7109. doi:10.1158/0008-5472.CAN-04-1443
[8]	Ratain, M.J., Eisen, T., Stadler, W.M. et al. (2006) Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. Journal of Clinical Oncology, 24, 2505-2512. doi:10.1200/JCO.2005.03.6723
[9]	Escudier, B., Eisen, T., Stadler, W.M. et al. (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. The New England Journal of Medicine, 356, 125-134. doi:10.1056/NEJMoa060655
[10]	Flaherty, K.T. (2007) Sorafenib in renal cell carcinoma. Clinical Cancer Research, 13, 747-752. doi:10.1158/1078-0432.CCR-06-2063
[11]	Flaherty, K.T. (2007) Sorafenib: delivering a targeted drug to the right targets. Expert Review of Anticancer Therapy, 7, 617-626. doi:10.1586/14737140.7.5.617
[12]	McKeage, K., Wagstaff, A.J. (2007) Sorafenib: in advanced renal cancer. Drugs, 67, 475-483. doi:10.2165/00003495-200767030-00009
[13]	Norum, J., Nieder, C., Kondo, M. (2010) Sunitinib, sorafenib, temsirolimus or bevacizumab in the treatment of metastatic renal cell carcinoma: a review of health economic evaluations. Journal of Chemotherapy, 22, 75-82.
[14]	Drummond, M., Sculpher, M.J., Torrance, G.W., O'Brien, B.J., Stoddart, G.L. (2005) Methods for the economic evaluation of health care programmes. Oxford University Press, Oxford.
[15]	Hammerman, A., Klang, S., Liebermann, N. (2009) Real life treatment duration of sorafenib or sunitinib in first line metastatic renal cell carcinoma patients - a comparative analysis. 12th ISPOR Annual European Congress, Paris.
[16]	Keefe, M., Moyneur, E., Barghout, V. (2009) A retrospective claims database comparison of sorafenib and sunitinib dosing patterns in patients with renal cell carcinoma. 14th ISPOR Annual International Meeting, Orlando.
[17]	Bukowski, R.M., Stadler, W.M., McDermott, D.F. et al. (2010) Safety and efficacy of sorafenib in elderly patients treated in the North American advanced renal cell carcinoma sorafenib expanded access program. Oncology, 78, 340-347. doi:10.1159/000320223
[18]	Stadler, W.M., Figlin, R.A., McDermott, D.F. et al. (2010) Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer, 116, 1272-1280. doi:10.1002/cncr.24864
[19]	Simoens, S., Parmet, B., van Dijck, W. (2010) Prospective open-label non-interventional non-controlled multicenter observational Phase IV trial to evaluate the effectiveness and safety of Nexavar? treatment under daily-life treatment conditions. Data on file.
[20]	Duh, M.S., Dial, E., Choueiri, T.K. et al. (2009) Cost implications of IV versus oral anti-angiogenesis therapies in patients with advanced renal cell carcinoma: retrospective claims database analysis. Current Medical Research and Opinion, 25, 2081-2090. doi:10.1185/03007990903084800
[21]	Quinn, D., Barghout, V., Moyneur, E. (2009) Retrospective claims database analysis of the direct medical costs associated with sorafenib and sunitinib in the treatment of patients with renal cell carcinoma who are under 65 years old. 14th ISPOR Annual International Meeting, Orlando.
[22]	Demlova, R., Ondrackova, B., Kominek, J. (2009) The economic evaluation of sunitinib and sorafenib in MRCC patients in the Czech Republic. 12th ISPOR Annual European Congress, Paris.
[23]	Denis, A., Mergaert, L., Fostier, C., Cleemput, I., Simoens, S. (2010) Issues surrounding orphan disease and orphan drug policies in europe. Applied Health Economics and Health Policy, 8, 343-350. doi:10.2165/11536990-000000000-00000