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• W2603324978 abstract "4581^ Background: Response to neoadjuvant chemotherapy (NC) prior to radical cystectomy (RC) predicts improved overall survival (OS) in MIBC. Associations with enhanced survival include complete pathologic response (pT0; Grossman, NEJM 2003) and eradication of the muscle-invasive component (<pT2; Splinter, J Urol 1992). Sunitinib (S) is active in pretreated pts with advanced disease. We tested if S added to GC was safe, improved the rate of pT0, and improved the rate of <pT2. Methods: Cisplatin-eligible pts with cT2-4aN0 bladder cancer received G 1000 mg/m 2 and C 35 mg/m 2 on day (D) 1 and D8 with S 25 mg orally daily D1-14 of a 21D cycle for 4 cycles. RC plus pelvic lymph node dissection was required to assess response of pT0 or <pT2. A Simon’s Minimax 2-stage design was used to test a null (H0) pT0 rate ≤ 20% against alternative (H1) pT0 rate ≥ 40% with Type I and II error rates of 0.05 and 0.10 respectively. Enrollment to the 2 nd stage of 45 patients was planned if ≥ 6 of the initial 24 evaluable pts achieved pT0. Primary endpoint was pT0N0 and secondary endpoints were: response defined as <pT2N0; safety; time to progression (TTP), and OS. Results: 18 pts (15M, 3F), median age 63 (54-76) were enrolled from 6/09 and 10/11 after which financial support was withdrawn. 3 pts were inevaluable for response endpoints due to: 1.) withdrawal of consent, 2.) declining any surgery, 3.) partial cystectomy instead of RC. All 18 were evaluable for safety, TTP and OS. 1 of 15 pts had pT0N0 (6.6%; 95% CI 0.34 – 29.8%) and 5 had <pT2N0 (33%; 95% CI 15-58%). 4 of 5 pts with status <pT2N0 were pTisN0. Median TTP was 10 months (95% CI 3.5-NR). 3 pts were deceased at time of analysis; median OS not reached. Neutropenia due to the 3 drug combination required routine GCSF support on day 8 of each cycle. Grade 3/4 toxicities were anemia (11 pts), neutropenia (6), thromboembolic events (2), febrile neutropenia (2) and infection (2). Conclusions: Despite incomplete accrual, the pT0 rate was low suggesting that S does not add to GC. Residual non-invasive disease (<pT2) was common, including a large proportion of pts with pTisN0. Given these findings, response criteria for future NC studies should consider either <pT2 or < pTis as the primary endpoint." @default.
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• W2603324978 date "2012-05-20" @default.
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• W2603324978 title "Phase II trial of neoadjuvant gemcitabine (G) and cisplatin (C) with sunitinib in patients (pts) with muscle-invasive bladder cancer (MIBC)." @default.
• W2603324978 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.4581" @default.
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