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Objectives: Sunitinib is the standard care for first-line treatment of metastatic renal cell carcinoma. The aim of this study was to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could maintain the same dose-intensity as the standard 4-weeks on/2-weeks off schedule, and provide the same efficacy in terms of objective response, progression-free survival and overall survival, while reducing drug-related toxicity., Methods: A total of 31 patients with metastatic renal cell carcinoma received sunitinib orally at the dose of 50 mg/day in a 2-weeks on/1-week off regimen until disease progression or intolerable toxicities occurred., Results: All enrolled patients were assessable in terms of toxicity and response. They received treatment for a median of 16 months (range 2.0-36.0+ months). A total of 13 patients (42%) obtained an objective response; disease stabilization was achieved in 10 patients (32%), whereas eight patients (26%) experienced disease progression. The most important toxicities were anemia, gastrointestinal effects, fatigue and hypertension, but they were all controlled., Conclusions: Sunitinib 50 mg given orally in a 2-weeks on/1-week off regimen can provide a high response rate and avoid drug-related toxicities, achieving the same dose intensity as the standard schedule, and probably longer disease control., (© 2012 The Japanese Urological Association.)

Sunitinib, an orally multitargeted tyrosine kinase inhibitor and standard first-line treatment for metastatic renal cell carcinoma, is usually administered on a 6-week schedule. Toxicities reported with this drug are usually of moderate grade, which results in good treatment tolerability and patients' compliance. However, in some cases high-grade or prolonged toxicities require temporary treatment interruption or dose adjustment, possibly resulting in reduced treatment efficacy. We describe three cases of metastatic renal cell carcinoma patients (a 53-year-old male, a 70-year-old woman, and a 65-year-old woman) who received a shortened 3-week sunitinib administration schedule, 2 weeks daily administration followed by 1 week of rest (2/1) due to toxicities developed on the classic 6-week schedule, which would have required a temporary treatment interruption or a dose reduction. Treatment was generally well tolerated with manageable toxicities. A 3-week administration schedule of sunitinib may represent a valid alternative for managing toxicity while maintaining the planned dose intensity over a 6-weeks period of time. Sunitinib may thus be administered using a flexible dosing schedule to meet individual patient needs, achieving better tolerability and maintaining significant response to treatment.