Feasibility of organ preservation in muscle-invasive transitional cell carcinoma bladder: A single institutional approach

Background: Trimodality treatment initial transurethral resection of the bladder tumor [TURBT] followed by concurrent chemotherapy and radiation and organ preservation have been gradually replacing the radical cystectomy in muscle-invasive transitional cell carcinoma (TCC) of bladder. Aims: The aims of this study is to determine the clinical effectiveness, safety and protocol completion rate of trimodality treatment in muscle-invasive TCC of the bladder. Settings and Design: Prospective randomized and open-labeled study. Subjects and Methods: Patients with TCC of bladder, American Joint Committee on Cancer tumor node metastasis (TNM) Bladder Cancer Staging (2002) T2-3, N0, M0. Were underwent TURBT followed by three cycles of neoadjuvant chemotherapy with methotrexate, vinblastine, adriamycin, and cisplatin regimen. The patients were then randomized to receive either concurrent cisplatin 75 mg/m ² in week 1 and 4 (arm-A) or no cisplatin (arm-B) along with external beam radiation therapy (EBRT) 45 Gy, in 25 fractions over 5 weeks. 4 weeks after completion of the initial phase of treatment, all patients were re-evaluated with TURBT. Those with complete remission (CR) received additional 15 Gy of EBRT in 8 fractions, while patients with residual disease were recommended for immediate radical cystectomy. All the patients of arm-B received boost dose of 15 Gy of EBRT. Statistical Analysis Used: The major statistical endpoints of this study were the CR rate at 8 weeks post-concurrent chemoradiotherapy (CCRT) and only radiotherapy. Statistical significance was accepted at the P < 0.05 (two-sided) level. Statistical analysis was performed entirely using the Statistical Package for the Social Sciences for Windows, version 17 (SPSS Inc., Chicago, IL, U.S.A.). Results: 8 weeks after completion of treatment 13/16 (81%) patients were in CR in CCRT arm (arm-A) compare to 6/15 (40%) patients receiving radiation only (arm-B). Conclusions: Patients, after TURBT receiving CCRT, had a better chance of organ preservation (81%) than those receiving radiation only.