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What is the role of sunitinib malate (Sutent) in the treatment of sarcomas?

—Nikki Carden

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Sunitinib is a tyrosine kinase inhibitor that inhibits multiple growth factor receptors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and stem cell factor (KIT) receptors. Although sunitinib has been studied in multiple types of soft-tissue sarcomas, the only sarcoma for which it has FDA approval is gastrointestinal stromal tumor (GIST). In patients with GIST who had disease progression on imatinib (Gleevec), or did not tolerate imatinib, treatment with sunitinib improved time-to-progression (27.3 weeks vs 6.4 weeks) and progression-free survival (24.1 weeks vs 6 weeks) compared with placebo. Most of the patients in the placebo arm received sunitinib after disease progression, limiting the ability to find a significant difference in overall survival (72.7 weeks vs 64.9 weeks). The recommended dose for GIST is sunitinib 50 mg orally once daily for 4 weeks, followed by 2 weeks off. 

The National Comprehensive Cancer Network (NCCN) Soft Tissue Sarcoma guidelines recommend sunitinib for the treatment of GIST as described above. These guidelines also note that some data support single-agent sunitinib in the treatment of angiosarcoma, alveolar soft part sarcoma, and chordoma, although there is not as much evidence in these settings. If available, a clinical trial is preferred. 

Sunitinib is generally well-tolerated; the most frequent adverse effects reported in clinical trials included fatigue, asthenia, diarrhea, nausea and vomiting, mucositis, dyspepsia, pain, arthralgias, constipation, fever, hypertension, peripheral edema, bleeding, hand-foot syndrome, rash, skin discoloration or dryness, hair color changes, taste changes, decreased appetite, headache, cough, and dyspnea. Patients may take sunitinib with or without food, but should be advised to avoid grapefruit and Seville orange products while taking sunitinib. Sunitinib may be affected by CYP 3A4 inducers and inhibitors, so the complete medication list should be reviewed to detect and manage these drug interactions. 


How to dispose of medications safely

Instructions for safe disposal of expired, unused, or unwanted medications are available on the FDA Web site (www.FDA.gov). Select the Drugs tab and click on Consumers in the Resources for You box. Safe Disposal of Medicines is listed under Using Medicines Safely. ONA

Lisa Thompson is assistant professor, Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Colorado.