Double-Blind, Randomized, Phase 2 Trial of Maintenance Sunitinib Versus Placebo After Response to Chemotherapy in Patients With Advanced Urothelial Carcinoma

摘要: BACKGROUND Angiogenesis contributes to the progression of urothelial carcinoma (UC). In current study, authors investigated role maintenance sunitinib in patients with advanced UC. METHODS Patients locally recurrent/metastatic UC and adequate organ function who achieved stable disease or a partial complete response after 4 6 chemotherapy cycles were randomized at dose 50 mg/day (28 days on 14 off) placebo. The primary endpoint was 6-month rate. Secondary endpoints safety, survival, change serum vascular endothelial growth factor (VEGF)/soluble VEGF receptor-2 (sVEGFR2), activity developed while receiving A total 38 eligible per treatment arm required select better therapy 90% probability (α = .05). RESULTS A 54 either (26 patients) placebo patients). median number received 2 arm. most common grade 3 adverse events (graded according version 3.0 National Cancer Institute Common Terminology Criteria for Adverse Events) among thrombocytopenia, diarrhea, mucositis, fatigue, hypertension. There no noted among > 5% rate 72% versus 64%. progression-free survival (PFS) 2.9 months (range, 0.5 months-32.5 months) 2.7 0.8 −65 arms, respectively. Patients found have changes their VEGF/sVEGFR2 levels over time. treated had significant level, but sVEGFR2 level significantly decreased 1 (P < .0001) time (P = .0002). baseline that greater than be correlated longer PFS. Sixteen progression, best responses being (6.3%), cases (37.5%), 5 progressive (31.3%); not evaluable response. PFS 3.7 0.1 months-22 months). CONCLUSIONS The multicenter study limited by premature closure small sample size. Maintenance did appear improve Open-label only modest activity. sunitinib. 2014;120:692–701. © 2013 American Society.