Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma
Robert J. Motzer, M.D., Thomas E. Hutson, D.O., Pharm.D., Piotr Tomczak, M.D., M. Dror Michaelson, M.D., Ph.D., Ronald M. Bukowski, M.D., Olivier Rixe, M.D., Ph.D., Stéphane Oudard, M.D., Ph.D., Sylvie Negrier, M.D., Ph.D., Cezary Szczylik, M.D., Ph.D., Sindy T. Kim, B.S., Isan Chen, M.D., Paul W. Bycott, Dr.P.H., Charles M. Baum, M.D., Ph.D., and Robert A. Figlin, M.D.
Background Since sunitinib malate has shown activity in twouncontrolled studies in patients with metastatic renal-cellcarcinoma, a comparison of the drug with interferon alfa ina phase 3 trial is warranted.
Methods We enrolled 750 patients with previously untreated,metastatic renal-cell carcinoma in a multicenter, randomized,phase 3 trial to receive either repeated 6-week cycles of sunitinib(at a dose of 50 mg given orally once daily for 4 weeks, followedby 2 weeks without treatment) or interferon alfa (at a doseof 9 MU given subcutaneously three times weekly). The primaryend point was progression-free survival. Secondary end pointsincluded the objective response rate, overall survival, patient-reportedoutcomes, and safety.
Results The median progression-free survival was significantlylonger in the sunitinib group (11 months) than in the interferonalfa group (5 months), corresponding to a hazard ratio of 0.42(95% confidence interval, 0.32 to 0.54; P<0.001). Sunitinibwas also associated with a higher objective response rate thanwas interferon alfa (31% vs. 6%, P<0.001). The proportionof patients with grade 3 or 4 treatment-related fatigue wassignificantly higher in the group treated with interferon alfa,whereas diarrhea was more frequent in the sunitinib group (P<0.05).Patients in the sunitinib group reported a significantly betterquality of life than did patients in the interferon alfa group(P<0.001).
Conclusions Progression-free survival was longer and responserates were higher in patients with metastatic renal-cell cancerwho received sunitinib than in those receiving interferon alfa(ClinicalTrials.gov numbers, NCT00098657
[ClinicalTrials.gov]
and NCT00083889
[ClinicalTrials.gov]
).
Source Information
From the Memorial Sloan-Kettering Cancer Center, New York (R.J.M.); Baylor Sammons Cancer Center–Texas Oncology, Dallas (T.E.H.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Massachusetts General Hospital Cancer Center, Boston (M.D.M.); Cleveland Clinic Foundation, Cleveland (R.M.B.); Hôpital Pitié–Salpêtrière (O.R.) and Hôpital Européen Georges Pompidou (S.O.) — both in Paris; Centre Léon Bérard, Lyon, France (S.N.); Military Institute of Medicine, Warsaw, Poland (C.S.); Pfizer Global Research and Development, La Jolla, CA (S.T.K., I.C., P.W.B., C.M.B.); and City of Hope Comprehensive Cancer Center, Los Angeles (R.A.F.).
Address reprint requests to Dr. Motzer at the Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021, or at motzerr{at}mskcc.org.
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(2008). Documentation of Thyroid Function in Clinical Studies With Sunitinib: Why Does It Matter?. JCO
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Finke, J. H., Rini, B., Ireland, J., Rayman, P., Richmond, A., Golshayan, A., Wood, L., Elson, P., Garcia, J., Dreicer, R., Bukowski, R.
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Hahn, O. M., Yang, C., Medved, M., Karczmar, G., Kistner, E., Karrison, T., Manchen, E., Mitchell, M., Ratain, M. J., Stadler, W. M.
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Schneider, B. P., Wang, M., Radovich, M., Sledge, G. W., Badve, S., Thor, A., Flockhart, D. A., Hancock, B., Davidson, N., Gralow, J., Dickler, M., Perez, E. A., Cobleigh, M., Shenkier, T., Edgerton, S., Miller, K. D.
(2008). Association of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor-2 Genetic Polymorphisms With Outcome in a Trial of Paclitaxel Compared With Paclitaxel Plus Bevacizumab in Advanced Breast Cancer: ECOG 2100. JCO
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Stein, W. D., Yang, J., Bates, S. E., Fojo, T.
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Hutson, T. E., Figlin, R. A., Kuhn, J. G., Motzer, R. J.
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