ABSTRACT
To identify the place of conservative treatment in patients [pts] with MIBC using concomitant cisplatin [C] and gemcitabine [G] with bifractionated split course radiotherapy. Eligible pts with stages T2-T4a, No Mo were entered in this study. Treatment began with transurethral resection [TUR] with complete macroscopic debulking followed by induction chemoradiation. The treatment regimen consisted of C 15 mg/m[2] and G 200 mg/m[2] on days 1-3 and 15-17 [one cycle of 6 days induction chemotherapy] .On days 1, 3, 15, and 17, radiation was given immediately following chemotherapy using twice-daily 2 Gy per fraction to the whole pelvis for a total dose of 16 Gy delivered in 8 fractions over 17 days. Patients with a complete response [CR] via cystoscopy after the induction cycle received another chemoradiation cycle as consolidation. Patients who did not achieve CR underwent cystectomy. Both groups received outpatient adjuvant chemotherapy: G 1g/m[2] on days 1, 8, and 15 plus C 70 mg/m[2] on day 1 every 28 days for 4-6 cycles. From July 2001 to January 2003, 36 pts were enrolled. All pts were evaluable for efficacy and toxicity. Twenty pts [55.5%] achieved CR after induction therapy and received consolidation chemoradiation. Of the pts who still had detectable tumor, 9 pts [25.0%] underwent radical cystectomy and 7 [19.4%] refused cystectomy and received the same chemoradiation. 6/16 died of progressive disease. The median follow-up is 22 months. The 2-year overall survival is 80%, and the 2-year probability of surviving with an intact bladder is 69.4%. Grade 3/4 thrombocytopenia was observed in 8 pts [22.2%], non hematologic toxicities in the form of grade 3 radiation cystitis in 3 pts [8.3%] and proctatitis in 4 pts [11.1%].This trial comprising of local TUR plus concurrent C/G, and hypofractionated radiation has been associated with acceptable hematologic toxicity. Both the complete response rate to induction therapy and the 2-year survival rate with an intact bladder are encouraging. Longer follow-up is needed to assess efficacy