Axitinib for the treatment of metastatic renal cell carcinoma: Recommendations for therapy management to optimize outcomes

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 37, Issue 4, 2014, Pages 397-403

  Larkin, James ^a   Fishman, Mayer ^b   Wood, Laura ^c   Negrier, Sylvie ^a   Olivier, Kara ^d   Pyle, Linda ^a   Gorbunova, Vera ^e   Jonasch, Eric ^f   Andrews, Lori ^g   Staehler, Michael ^h  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^f UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^g BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^h UNIVERSITY OF MUNICH   (Germany)

Author keywords

Axitinib; Renal cell carcinoma; Side effect management; Toxicity; Treatment optimization; Tyrosine kinase inhibitor

Indexed keywords

CARCINOMA, RENAL CELL; DIARRHEA; DYSPHONIA; FATIGUE; HUMANS; HYPERTENSION; IMIDAZOLES; INDAZOLES; KIDNEY NEOPLASMS; NAUSEA; PROTEIN KINASE INHIBITORS; PROTEINURIA; VOMITING;

EID: 84905109365     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e31827b45f9     Document Type: Review

References (39)

1. Coppin C, Le L, Porzsolt F, et al. Targeted therapy for advanced renal cell carcinoma. Cochrane Database Syst Rev. 2008; CD006017.
2. Ljungberg B, Cowan N, Hanbury DC, et al. EAU guidelines on renal cell carcinoma: the 2010 update. Eur Urol. 2010; 58: 398-406.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer v.2.2012. Available at: http://www.nccn.org/ professionals/physician-gls/f-guidelines. asp. Accessed April 10, 2012.
4. Escudier B, Gore M. Axitinib for the management of metastatic renal cell carcinoma. Drugs R D. 2011; 11: 113-126.
5. Ravaud A. Treatment-associated adverse event management in the advanced renal cell carcinoma patient treated with targeted therapies. Oncologist. 2011; 16(suppl. 2): 32-44.
6. Rini BI, Wilding G, Hudes G, et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009; 27: 4462-4468.
7. Rixe O, Bukowski RM, Michaelson MD, et al. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007; 8: 975-984.
8. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011; 378: 1931-1939.
9. Rini BI, Escudier B, Tomczak P, et al. Axitinib versus sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC): Results of phase III AXIS trial. J Clin Oncol. 2011; 29(suppl): Abstract 4503.
10. Michaelson MD, Rini BI, Escudier BJ, et al. Phase III AXIS trial of axitinib versus sorafenib in metastatic renal cell carcinoma: updated results among cytokine-treated patients. J Clin Oncol. 2012; 30(suppl): Abstract 4546.
11. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. 2006. Available at: http://ctep. cancer.gov/protocolDevelopment/ electronic-applications/docs/ctcaev3.pdf. Accessed November 20, 2012.
12. Richardson G, Dobish R. Chemotherapy induced diarrhea. J Oncol Pharm Pract. 2007; 13: 181-198.
13. Loriot Y, Perlemuter G, Malka D, et al. Drug insight: gastrointestinal and hepatic adverse effects of molecular-targeted agents in cancer therapy. Nat Clin Pract Oncol. 2008; 5: 268-278.
14. Kamba T, McDonald DM. Mechanisms of adverse effects of anti- VEGF therapy for cancer. Br J Cancer. 2007; 96: 1788-1795.
15. Wood LS. Management of vascular endothelial growth factor and multikinase inhibitor side effects. Clin J Oncol Nurs. 2009; (13 suppl): 13-18.
16. Kollmannsberger C, Soulieres D, Wong R, et al. Sunitinib therapy for metastatic renal cell carcinoma: recommendations for management of side effects. Can Urol Assoc J. 2007; 1: S41-S54.
17. Wood LS. Managing the side effects of sorafenib and sunitinib. Commun Oncol. 2006; 3: 558-562.
18. Osterlund P, Ruotsalainen T, Korpela R, et al. Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: a randomised study. Br J Cancer. 2007; 97: 1028-1034.
19. Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008; 358: 2482-2494.
20. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis v.1.2012. Available at: http://www.nccn.org/ professionals/physician-gls/PDF/antiemesis.pdf. Accessed April 10, 2012.
21. Kovac AL. Benefits and risks of newer treatments for chemotherapy- induced and postoperative nausea and vomiting. Drug Saf. 2003; 26: 227-259.
22. Fishman MN, Carducci M, Bair AH, et al. Axitinib pharmacokinetics and blood pressure changes in front-line metastatic renal cell carcinoma (RCC) patients. Ann Oncol. 2010; 21(suppl. 8): 284.
23. Maitland ML, Bakris GL, Black HR, et al. Initial assessment, surveillance, and management of blood pressure in patients receiving vascular endothelial growth factor signaling pathway inhibitors. J Natl Cancer Inst. 2010; 102: 596-604.
24. Rini BI, Schiller JH, Fruehauf JP, et al. Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors. Clin Cancer Res. 2011; 17: 3841-3849.
25. Powers BJ, Olsen MK, Smith VA, et al. Measuring blood pressure for decision making and quality reporting: where and how many measures? Ann Intern Med. 2011; 154: 781-788.
26. Rini BI, Grünwald V, Fishman MN, et al. Axitinib for first-line metastatic renal cell carcinoma (mRCC): Overall efficacy and pharmacokinetic (PK) analyses from a randomized phase II study. J Clin Oncol. 2012; 30(suppl): Abstract 4503.
27. Larkin J, Pyle LM, Gore ME. Fatigue in renal cell carcinoma: the hidden burden of current targeted therapies. Oncologist. 2010; 15: 1135-1146.
28. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Cancer-Related Fatigue v.1.2011. Available at: http://www.nccn.org/ professionals/physician-gls/PDF/fatigue.pdf. Accessed April 10, 2012.
29. Mukohara T, Nakajima H, Mukai H, et al. Effect of axitinib (AG- 013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients. Cancer Sci. 2010; 101: 963-968.
30. Kollmannsberger C, Bjarnason G, Burnett P, et al. Sunitinib in metastatic renal cell carcinoma: recommendations for management of noncardiovascular toxicities. Oncologist. 2011; 16: 543-553.
31. Breitbart W, Alici Y. Psychostimulants for cancer-related fatigue. J Natl Compr Canc Netw. 2010; 8: 933-942.
32. Brown JC, Huedo-Medina TB, Pescatello LS, et al. Efficacy of exercise interventions in modulating cancer-related fatigue among adult cancer survivors: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2011; 20: 123-133.
33. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009; 141: S1-S31.
34. De Luca A, Normanno N. Tivozanib, a pan-VEGFR tyrosine kinase inhibitor for the potential treatment of solid tumors. IDrugs. 2010; 13: 636-645.
35. Hartl DM, Ferte C, Loriot Y, et al. Dysphonia induced by vascular endothelium growth factor/vascular endothelium growth factor receptors. Invest New Drugs. 2010; 28: 884-886.
36. Baffert F, Thurston G, Rochon-Duck M, et al. Age-related changes in vascular endothelial growth factor dependency and angiopoietin- 1-induced plasticity of adult blood vessels. Circ Res. 2004; 94: 984-992.
37. Baffert F, Le T, Sennino B, et al. Cellular changes in normal blood capillaries undergoing regression after inhibition of VEGF signaling. Am J Physiol Heart Circ Physiol. 2006; 290: H547-H559.
38. Inai T, Mancuso M, Hashizume H, et al. Inhibition of vascular endothelial growth factor (VEGF) signaling in cancer causes loss of endothelial fenestrations, regression of tumor vessels, and appearance of basement membrane ghosts. Am J Pathol. 2004; 165: 35-52.
39. Izzedine H, Massard C, Spano JP, et al. VEGF signalling inhibition-induced proteinuria: Mechanisms, significance and management. Eur J Cancer. 2010; 46: 439-448.