Combined 5-fluorouracil and irradiation for transitional cell carcinoma of the urinary bladder.

Thirty-four patients have completed treatment on a bladder-preservation protocol using primary irradiation combined with infusion 5-fluorouracil (5-FU). 4,000 cGy pelvic irradiation was delivered in 5 weeks, with 1,000 mg/m2/day of 5-FU administered as a 96 hr infusion on days 1-4 of week 1 and 4. After a 3-week rest period, patients eligible for cystectomy underwent cystoscopy and biopsy. Those with residual tumor underwent cystectomy, and those without tumor received an additional cycle of chemotherapy and irradiation. Patients ineligible for cystectomy for reasons medical, surgical, or refusal received a third cycle without the 4-week delay or re-evaluation. With a median follow-up of 18 months (range 2-45 months), and with 25/34 patients having T3 (16) or T4 (9) tumors, 17 patients are NED, 4 have died of intercurrent deaths, 7 have died with bladder cancer, and 6 are alive with tumor (2 confined to the bladder). The actuarial cancer-specific survival for the entire group of patients is 64% (+/- 12%) at 45 months, with a freedom from relapse of invasive cancer of 54% (+/- 10%). Twenty-four of the 34 patients retained intact bladders, with 20/24 reporting entirely normal voiding. Of 18 potential surgical candidates, 13/16 (81%) who underwent pathologic re-staging after 2 cycles of chemoradiotherapy had no histologic evidence of residual cancer. Of these 13 patients, 8 remain NED and 2/13 have locally recurrent non-invasive tumors only. Treatment was well-tolerated, with 28/34 patients having received 100% of the planned 5-FU and 34/34 having received greater than 80%. This regimen appears more successful than radiotherapy alone in achieving complete tumor responses, and is an attractive alternative for patients who are unable to receive more aggressive chemotherapy/radiation combinations.