A PHASE I II TRIAL OF TRANSURETHRAL SURGERY COMBINED WITH CONCURRENT CISPLATIN, 5-FLUOROURACIL AND TWICE-DAILY RADIATION FOLLOWED BY SELECTIVE BLADDER PRESERVATION IN OPERABLE PATIENTS WITH MUSCLE INVADING BLADDER-CANCER/

Purpose: We describe a protocol designed to evaluate the use of twice daily radiation used together with cisplatin and 5 fluorouracil (5-FU) in the treatment of operable transitional cell carcinoma of the bladd er with potential bladder preservation. Materials and Methods: A total of 18 consecutive patients with T2-T4a bladder tumors underwent as co mplete a transurethral resection as possible, which was visibly comple te in 14 cases. They then received twice daily radiation and infusion cisplatin and 5-FU during an induction phase. No therapy was given for 3 weeks, following which patients were reevaluated cystoscopically. C ases of clinical complete response by biopsy and cytology were consoli dated with further chemotherapy/radiation using the same chemotherapeu tic agents and radiation schedule. Patients who had incomplete respons es were advised to undergo an immediate radical cystectomy. Of the 18 patients 15 subsequently received 3 cycles of adjuvant chemotherapy, c onsisting of methotrexate, cisplatin and vinblastine. Median followup for the entire group is 32 months. Results: Of the 18 patients 14 had no detectable tumor after induction therapy. Of the 4 patients with pe rsistent tumor 2 underwent radical cystectomy and 2 refused cystectomy , 1 of whom was treated with partial cystectomy and the other with con solidation chemotherapy/radiation. The actuarial overall survival at 3 years was 83%. The chance of a patient being alive at 3 years with a native bladder was 78%. No patient required cystectomy for hematuria o r bladder shrinkage. Three patients in whom superficial tumors develop ed were treated successfully with bacillus Calmette-Guerin. Small bowe l obstruction in 1 case was corrected surgically. Conclusions: This pi lot study demonstrates a high rate of response to this combined chemot herapy/radiation regimen in conjunction with a visibly complete transu rethral resection. Reevaluation after a short induction phase allows f or the early selection of patients with persistent disease for radical cystectomy.