THE SIDE EFFECTS OF SORAFENIB, SUNITINIB, AND TEMSIROLIMUS AND THEIR THERAPY IN PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA
https://doi.org/10.17650/1726-9776-2009-5-4-25-36
Abstract
Objective: to provide a systematic review of the adverse reactions of sorafenib, sunitinib, and temsirolimus and to outline actions for their prevention and correction.
Materials and methods. To provide a description of the main methods to decrease the toxicity of these drugs, the authors made a systemat- ic review of their adverse reactions, by using the publications available in the PubMed database, monographs on the medicines, and instruc- tions for their medical use.
Results. The frequency of their adverse reactions varied from < 1 to 72%. Grades III—IV side effects are noted more rarely; their incidence is < 1 to 13% for sorafenib, < 1 to 16% for sunitinib, and 1 to 20% for temsirolimus. Sinitinib causes most grades III—IV adverse reactions and sofafenib does the least. However, close comparative studies of the safety of these kinase inhibitors are still lacking. Virtually all side effects can be effectively prevented and treated.
Conclusion. The prevention, timely recognition, and treatment of the adverse reactions of these agents are of great importance, which allows avoidance of the unneeded dosage reduction that may result in worse therapeutic efficiency.
About the Authors
N. BhojaniCanada
C. Jeldres
Canada
J.-J. Patard
France
P. Perrotte
Canada
N. Suardi
Italy
G. Hutterer
Austria
F. Patenaude
Canada
S. Oudard
France
P. I. Karakiewicz
Canada
References
1. Escudier B., Eisen T., Stadler W.M. et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125—34.
2. Motzer R.J., Hutson T.E., Tomczak P. et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115—24.
3. Hudes G., Carducci M., Tomczak P. et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271—81.
4. Ljungberg B., Hanbury D.C., Kuczyk M.A. et al. Renal cell carcinoma guideline. Eur Urol 2007;51:1502—10. 5
5. . Patard J.-J., Rioux-Leclercq N., Fergelot P. Understanding the importance of smart drugs in renal cell carcinoma. Eur Urol 2006;49:633—43.
6. Awada A., Hendlisz A., Gil T. et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. Br J Cancer 2005;92:1855—61.
7. Moore M., Hirte H.W., Siu L. et al. Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Ann Oncol 2005;16:1688—94.
8. Strumberg D., Richly H., Hilger R.A. et al. Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 2005;23:965—72.
9. Clark J.W., Eder J.P., Ryan D. et al. Safety and pharmacokinetics of the dual action Raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43- 9006, in patients with advanced, refractory solid tumors. Clin Cancer Res 2005;11:5472—80.
10. National Cancer Institute Common Toxicity Criteria Version 2.0, 2003.
11. Faivre S., Delbaldo C., Vera K. et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitar- get tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 2006;24:25—35.
12. Raymond E., Alexandre J., Faivre S. et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 2004;22:2336—47.
13. National Cancer Institute Common Toxicity Criteria Version 3.0. 2006.
14. Ratain M.J., Eisen T., Stadler W.M. et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcino- ma. J Clin Oncol 2006;24:2505—12.
15. Motzer R.J., Rini B.I., Bukowski R.M. et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA 2006;295:2516—24.
16. Bayer Inc. NEXAVAR product mono- graph. Toronto, ON, Canada: Bayer Inc; 2007.
17. Pfizer Canada Inc. SUTENT product monograph. Kirkland, QC, Canada: Pfi zer Canada Inc; 2006.
18. Wyeth Pharmaceuticals Inc. TORISEL prescribing information. Madison, NJ: Wyeth Pharmaceuticals Inc; 2007.
19. Rini B.I., Tamaskar I., Shaheen P. et al. Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 2007;99:81—3.
20. Atkins M.B., Hidalgo M., Stadler W.M. et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol 2004;22:909—18.
21. Gillessen S., Graf L., Korte W., Cerny T. Macrocytosis and cobalamin defi ciency in patients treated with sunitinib. N Engl J Med 2007;356:2330—1.
22. Sunitinib and temsirolimus: two new targeted drugs for advanced kidney cancer. ASCO Annual Meeting 2006, Atlanta. www.cancer.gov/clinicaltrials/results/suni- tiniband-temsirolimus0606 (13 September 2007).
23. Desai J., Yassa L., Marqusee E. et al. Hypothyroidism aft er sunitinib treatment for patients with gastrointestinal stromal tumors. Ann Intern Med 2006;145:660—4.
24. Bokemeyer C., Aapro M.S., Courdi A. et al. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer 2007;43:258—70.
25. Wilson K.G., Chochinov H.M., Skirko M.G. et al. Depression and anxiety disorders in palliative cancer care. J Pain Symptom Manage 2007;33:118—29.
26. Veronese M.L., Mosenkis A., Flaherty K.T. et al. Mechanisms of hyper- tension associated with BAY 43—9006. J Clin Oncol 2006;24:1363—9.
27. Pouessel D., Culine S. High frequency of intracerebral hemorrhage in metastatic renal carcinoma patients with brain metastases treated with tyrosine kinase inhibitors targeting the vascular endothelial growth factor receptor. Eur Urol 2008;53:376—81.
28. Loprinzi C.L., Ellison N.M., Schaid D.J. et al. Controlled trial of mege- strol acetate for the treatment of cancer anorexia and cachexia. J Natl Cancer Inst 1990;82:1127—32.
29. Morin M.J. From oncogene to drug: development of small molecule tyrosine kinase inhibitors as anti-tumor and anti- angiogenic agents. Oncogene 2000;19:6574—83.
30. Robert C., Soria J.C., Spatz A. et al. Cutaneous side-eff ects of kinase inhibitors and blocking antibodies. Lancet Oncol 2005;6:491—500.
31. Taha C., Liu Z., Jin J. et al. Opposite translational control of GLUT1 and GLUT4 glucose transporter mRNAs in response to insulin. Role of mammalian target of rapamycin, protein kinase b, and phosphatidylinositol 3-kinase in GLUT1 mRNA translation. J Biol Chem 1999;274:33085—91.
32. Huffman T.A., Mothe-Satney I., Lawrence Jr. J.C. Insulinstimulated phos- phorylation of lipin mediated by the mammalian target of rapamycin. Proc Natl Acad Sci U S A 2002;99:1047—52.
33. Amato R.J., Harris P., Dalton M. et al. A phase II trial of intrapatient doseesc lated sorafenib in patients with metastatic renal cell cancer [abstract]. American Society of Clinical Oncology meeting abstracts, 2007. p. 5026.
34. Houk B.E., Bello C.L., Michaelson M.D. et al. Exposureresponse of sunitinib in metastatic renal cell carcinoma (mRCC): a population pharmacokinet- ic/pharmacodynamic (PKPD) approach [abstract]. American Society of Clinical Oncology meeting abstracts, 2007. p. 5027.
35. Paick J.S., Yang J.H., Kim S.W., Ku J.H. Are age, anthropometry and com- ponents of metabolic syndrome-risk factors interrelated with lower urinary tract symptoms in patients with erectile dysfunction? A prospective study. Asian J Androl 2007;9:213—20.
36. Oxman A.D., Guyatt G.H. Validation of an index of the quality of review articles. J Clin Epidemiol 1991;44:1271—8.
Review
For citations:
Bhojani N., Jeldres C., Patard J., Perrotte P., Suardi N., Hutterer G., Patenaude F., Oudard S., Karakiewicz P.I. THE SIDE EFFECTS OF SORAFENIB, SUNITINIB, AND TEMSIROLIMUS AND THEIR THERAPY IN PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA. Cancer Urology. 2009;5(4):25-36. (In Russ.) https://doi.org/10.17650/1726-9776-2009-5-4-25-36