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• W2242428384 abstract "5072 Background: Suntinib has demonstrated activity in the second-line setting for pts with advanced UC when administered on a 4 week on/2 week off schedule. This study was designed to evaluate an alternative 37.5 mg/day continuous dosing schedule for sunitinib in the same setting. Methods: The primary objectives of this single institution phase II study of sunitinib in pts with UC who have failed prior chemotherapy were: 1) to determine the response rate (by RECIST); and 2) to evaluate toxicity. Secondary endpoints include: 1) correlation of response and toxicity with HIF and mTOR pathway marker expression; and 2) phamacokinetics. Pts may not have received >4 prior cytotoxic agents. Pts received sunitinib 37.5 mg/day continuous dosing.. Response was assessed after each of the initial 4 cycles and every other cycle thereafter. A minimax 2-stage design was used (maximal 32 pts). Results: 31 pts (21 M, 10 F) with a median age of 68 yrs and median KPS of 90 were enrolled between 10/15/07 and 12/18/08. Primary sites included bladder (28), and renal pelvis (3). Prior therapy included 1 pt with 1 drug, 19 pts with 2, 7 with 3 and 4 with 4. 25 pts had visceral metastases and 6 pts had lymph node only metastases. 25 pts were evaluable for response after completing at least 1 cycle. One pt achieved PR, 12 pts had SD, 12 had PD, 2 are too early to assess for response, and 4 patients did not complete cycle 1 (2 related to toxicity, and 2 related to non-treatment-related deaths). Radiographic regression was seen in liver, lung, soft tissue and lymph nodes. With a median follow up of 4 months, median progression free survival was 2 months (95% CI, 1 - 4 months) and median overall survival was 7 months (95% CI, 4 months - not achieved). Clinically significant toxicity (Grade 3/4) included: abdominal pain (1), anorexia (1), diarrhea (1), fatigue (4), hand and foot syndrome (2), hemorrhage (2), hypertension (2), mucositis (2), thrombosis (2), and emesis (1). Conclusions: Sunitinib has modest activity when administered on a 37.5 mg continuous dosing schedule to patients with relapsed or refractory UC with a similar toxicity profile to the 50 mg in the 4 /2 schedule. Upcoming trials will evaluate sunitinib in combination with standard chemotherapy in pts with UC. [Table: see text]" @default.
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• W2242428384 date "2009-05-20" @default.
• W2242428384 modified "2023-09-25" @default.
• W2242428384 title "A phase II study of sunitinib on a continuous dosing schedule in patients (pts) with relapsed or refractory urothelial carcinoma (UC)" @default.
• W2242428384 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.5072" @default.
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