Background: The use of organ sparing strategies to treat penile cancer (PC) is currently supported by evidence that has indicated the safety, efficacy and benefit of this surgery. However, radical penectomy still represents up to 15-20% of primary tumor treatments in PC patients. The aim of the study was to evaluate efficacy in terms of overall survival (OS) and disease-free survival (DFS) of radical penectomy in PC patients.Methods: Data from a retrospective multicenter study (PEnile Cancer ADherence study, PECAD Study) on PC patients treated at 13 European and American urological centers (Hospital "
INTRODUCTION AND OBJECTIVE: Introduction: Neoadjuvant chemotherapy showed survival benefit in randomized trials and metaanalyses. Adjuvant chemotherapy after radical cystectomy for patients with pT3/4 and/or LN positive (Nþ) 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/m 2 intra-arterial, cisplatin 25 mg/m 2 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 intraarterial 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).
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