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- W2591295891 abstract "e15173 Background: Neoadjuvant platinum-based chemotherapy has demonstrated survival benefits in miUC patients. Mediators of tumor angiogenesis including the vascular endothelial growth factor receptor (VEGFR) play a critical role in UC metastases. A phase II study of neoadjuvant cisplatin (C), gemcitabine (G), and the multi-targeted VEGFR tyrosine kinase inhibitor sunitinib (S) in miUC patients was conducted to determine the clinical efficacy and safety of the CGS regimen. Methods: Muscle-invasive UC patients with ECOG performance status (PS) 0-1 and creatinine clearance > 60 ml/min received C 60 mg/m2 iv d1, G 800 mg/m2 iv d1, 8, and S 37.5 mg po d1-14 on a q21d cycle for a maximum of 4 cycles followed by cystectomy. The primary endpoint was pathologic complete response rate (pCR). Results: 9 pts were enrolled and treated. Patient demographics included: median age – 70, M/F – 8/1, ECOG PS 0/1 – 6/3. Baseline tumor staging included: T2 – 4, T3 – 2, T4a – 3. All patients were clinically N0 M0. All 9 patients experienced at least one Grade 3-4 treatment related toxicity exceeding the pre-defined study toxicity stopping rule. Grade 3-4 hematologic toxicity included: perioperative bleeding 4 pts, neutropenia 2 pts, neutropenic fever 1 pt, thrombocytopenia 1 pt, anemia 1 pt. Grade 3-4 non-hematologic toxicity included: nausea/emesis 3 pts, syncope 2 pts, myocardial infarction 1 pt, fatigue 1 pt. No treatment-related-deaths were observed. Pathologic response data is available for 8 patients. 2 pCR’s (22%) were observed with full post-cystectomy staging summarized below. Conclusions: While pCR’s were observed, the excess toxicity of CGS in the neoadjuvant treatment of miUC precludes further development of the regimen in this population. Patient T-stage N-stage M-stage 1 T4 N3 MX 2 T3b N2 M0 3 T4a N0 M0 4 T0 N0 M0 5 T4a N3 MX 6 T0 N0 MX 7 T4a N1 MX 9 T3a N0 MX" @default.
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- W2591295891 date "2011-05-20" @default.
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- W2591295891 title "A phase II trial of neoadjuvant cisplatin (C), gemcitabine (G), and sunitinib (S) in muscle-invasive urothelial carcinoma (miUC): Results from Hoosier Oncology Group GU07-123 trial." @default.
- W2591295891 doi "https://doi.org/10.1200/jco.2011.29.15_suppl.e15173" @default.
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