MP55-13 ADJUVANT INTRAARTERIAL CHEMOTHERAPY FOLLOWING SURGERY IN TREATING PATIENTS WITH LOCALLY ADVANCED BLADDER CANCER: A CHINA,PROSPECTIVE, MULTICENTER, RANDOMIZED PHASE III TRIAL

Abstract

You have accessJournal of UrologyBladder Cancer: Invasive II (MP55)1 Apr 2020MP55-13 ADJUVANT INTRAARTERIAL CHEMOTHERAPY FOLLOWING SURGERY IN TREATING PATIENTS WITH LOCALLY ADVANCED BLADDER CANCER: A CHINA,PROSPECTIVE, MULTICENTER, RANDOMIZED PHASE III TRIAL Lijuan Jiang, Kai Yao, Zike Qin, Fangjian Zhou, and Zhuowei Liu* Lijuan JiangLijuan Jiang More articles by this author , Kai YaoKai Yao More articles by this author , Zike QinZike Qin More articles by this author , Fangjian ZhouFangjian Zhou More articles by this author , and Zhuowei Liu*Zhuowei Liu* More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000924.013AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Introduction: Neoadjuvant chemotherapy showed survival benefit in randomized trials and meta-analyses. Adjuvant chemotherapy after radical cystectomy for patients with pT3/4 and/or LN positive (N+) disease without metastases (M0) is still under debate for the limited evidence. This was an open-label, prospective, multicenter, randomized, controlled phase III two-arm study. Patients with locally advanced urothelial carcinoma of the bladder after cystectomy were randomly assigned (1 : 1) to 1 of 2 treatment arms. Arm 1 (control): No immediate post-surgery treatment. Patients undergo observation followed by intra-arterial cisplatin and gemcitabine at local relapse, or receive intravenously chemotherapy with cisplatin and gemcitabine at multiple metastases. Arm 2 (treatment): Surgery of percutaneous catheter system for arterial chemotherapy was done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique. Treatment would begin between 1-5 weeks after radical cystectomy (within 40 days is recommended). Objective: The purpose of the study was to evaluate the benefit of adjuvant intraarterial chemotherapy (IAC) versus radical cystectomy alone in patients with locally advanced bladder cancer. METHODS: One hundred and sixty-one patients with bladder cancer of pT3-4 or N1-3 without distant metastasis were randomly allocated to control group (75 patients) or to three courses of GC (86 patients). These latter patients were further to receive gemcitabine 800 mg/m2 intra-arterial, cisplatin 25 mg/m2 intra-arterial once a week for 3 weeks followed by 1-week rest period. Maximum of three cycles. RESULTS: At a median follow-up of 33 months, the 5-year overall survival (OS) was 40%, with a statistical difference between the two groups (P=0.037, IAC group 55.4% and control group 41.7%, respectively). The 2 and 1 arms had significantly different disease-free survival(DFS) (P=0.021, 55.4% and 41.7%, respectively). About 79% (68/86) of patients received the planned cycles, and hematologic toxicity was the most common. CONCLUSIONS: Gemcitabine combined with cisplatin intra-arterial adjuvant chemotherapy proved to be an effective adjuvant therapy for patients with locally advanced bladder cancer. The IAC showed improve DFS and OS in this study. (CLINICAL TRIALS.GOVIDENTIFIER: NCT01627197). Source of Funding: 5010 project of sun yat-sen university © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e843-e843 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lijuan Jiang More articles by this author Kai Yao More articles by this author Zike Qin More articles by this author Fangjian Zhou More articles by this author Zhuowei Liu* More articles by this author Expand All Advertisement PDF downloadLoading ...