BACKGROUNDOrgan preservation has been investigated in patients with muscleâinvasive bladder carcinoma over the past decades as an alternative to radical cystectomy. The majority of studies reported that trimodal schedules, including transurethral resection of bladder tumor (TURB), radiotherapy (RT), and chemotherapy, are a feasible and safe organâsparing approach without deferring the survival probability. However, to the authors' knowledge the best combination of RT and chemotherapy has yet to be well defined. The current study evaluated the longâterm results of a schedule of concurrent cisplatin and 5âfluorouracil (5âFU) administered as protracted intravenous infusions (PVI) during hyperfractionated radiotherapy (HFRT) with organâsparing intent in patients with infiltrating transitional cell carcinoma of the bladder (TCCB).METHODSSeventyâseven patients with a classification of T2âT4aN0M0 TCCB were enrolled in the current study. After a complete TURB and bladder mapping, 42 of 77 patients underwent 2 cycles of induction chemotherapy. All 77 patients underwent HFRT and a schedule of cisplatin (4â6 mg/m2 per day) and 5âFU (180â220 mg/m2 per day) as concomitant PVI (radiochemotherapy [RCT]). Six to 8 weeks after RCT, patient response was evaluated by computed tomography scan, urine cytology, and TURB. Patients who achieved a complete response (CR) were followed at regular intervals. For patients with residual or recurrent invasive tumor, salvage cystectomy was recommended.RESULTSSeventyâtwo patients were evaluable for response: 65 achieved a CR (90.3%) and 7 (9.7%) achieved a partial response. No significant difference was observed for the different prognostic factors with the exception of stage of disease (T2 [95.7%] vs. T3âT4a [80.0%]; P = 0.04). The observed toxicity, mainly hematologic, was higher among the patients who received induction chemotherapy compared with the patients who did not receive induction chemotherapy, even though the difference was not statistically significant. After a median followâup of 82.2 months (range, 30â138 months), 44 of 65 (57.1%) patients who achieved a CR were alive. Of these 44 patients, 33 had tumorâfree bladders. The 5âyear overall, bladderâintact, tumorâspecific, diseaseâfree, and cystectomyâfree survival rates for all 77 patients were 58.5%, 46.6%, 75.0%, 53.5%, and 76.1%, respectively. No associations were observed in overall and tumorâspecific survival with different prognostic factors.CONCLUSIONSCombined treatment appeared to provide high response rates and can be offered as an alternative option to radical cystectomy in selected patients who refuse or are unsuitable for surgery. Cancer 2004. © 2004 American Cancer Society.