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Sunitinib and sorafenib represent new treatment options for renal cell cancer
Targeted drugs have shown modest survival improvements but still pack tremendous promise.
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Orally administered tyrosine kinase inhibitors are among the fastest growing areas of antineoplastic therapy. Two new agents, sunitinib (Sutent, Pfizer) and sorafenib (Nexavar; Bayer Pharmaceuticals, Onyx Pharmaceuticals), were recently approved by the FDA for use in patients with renal cell cancer (and gastrointestinal stromal tumors in the case of sunitinib).
Other tyrosine kinase inhibitors include gefitinib (Iressa, AstraZeneca), imantinib (Gleevec, Novartis) and erlotinib (Tarceva; Genentech, OSI Oncology). All of these agents are orally administered for prolonged periods and lack significant typical chemotherapy side effects, but all cause some degree of dermatologic side effects.
Sunitinib
Sunitinib has been studied in patients with renal cell carcinoma and gastrointestinal stromal tumors. Motzer and colleagues studied sunitinib 50 mg daily (four weeks on, two weeks off) in 63 renal cell carcinoma patients in a phase-2 trial.
They reported partial responses in 40% of patients, and stable disease in 27% of these patients. The median time to progression was 8.7 months.
In 2005, this research group presented the results from 83 renal cell carcinoma patients enrolled in a phase-2 trial. In this trial, they reported complete response in 1.2% of patients, partial responses in 19% of patients and an additional 8.4% of patients were awaiting confirmation of partial response status.
Sorafenib
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Ratain and colleagues studied sorafenib in 65 renal cell cancer patients with stable disease after 12 weeks of therapy. Patients received 400 mg (oral, twice daily) in a phase-2, randomized, discontinuation trial. Patients were randomized to either continued therapy with sorafenib or to switch to placebo. In the sorafenib-treated group, the progression-free survival was 23 weeks, compared with six weeks in the placebo group.
Escudier and colleagues examined sorafenib in a phase-3 trial with 769 patients with renal cell carcinoma. Patients were randomized to treatment with sorafenib 400 mg (oral, twice daily) or to placebo. The progression-free survival was 24 weeks in the patients treated with sorafenib vs. 12 weeks in the patients given placebo.
Results
Sunitinib and sorafenib are important new therapies in the treatment of renal cell carcinoma. Although both agents have dermatologic side effects, these agents are well tolerated, without typical chemotherapy adverse effects.
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For more information:
- Motzer RJ, Michaelson MD, Redman BG, et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006; 24:16-24.
- Escudier B, Szczylik C, Eisen T, et al. Randomized phase III trial of the RAF kinase and VEGFR inhibitor sorafenib (BAY 43-9006) in patients with advanced renal carcinoma. Abstract 4510. Presented at: 41st Annual Meeting of the American Society of Clinical Oncology; May 13-17, 2005; Orlando, Fla.
- Motzer RJ, Rini BI, Michaelson MD, et al. Phase 2 trials of SU11248 show antitumor activity in second-line therapy for patients with metastatic renal cell carcinoma. Abstract 4508. Presented at: 41st Annual Meeting of the American Society of Clinical Oncology; May 13-17, 2005; Orlando, Fla.
- Ratain MJ, Eisen T, Stadler WM, et al. Final findings from a phase II, placebo-controlled, randomized discontinuation trial of sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma. Abstract 4544. Presented at: 41st Annual Meeting of the American Society of Clinical Oncology; May 13-17, 2005; Orlando, Fla.
About the author:
- Lisa K. Lohr, PharmD, is a clinical pharmacy specialist in oncology at Fairview University Medical Center in Minneapolis and is the section editor for pharmacology on Hem/Onc Today’s editorial board.