COMBINED MODALITY PROGRAM WITH POSSIBLE ORGAN PRESERVATION FOR INVASIVE BLADDER-CARCINOMA - RESULTS OF RTOG PROTOCOL 85-12

Purpose: This Phase II study was designed to test the tolerance and ef fectiveness of concurrent cisplatin-radiotherapy in the treatment of i nvasive bladder cancer. Objectives were to determine toxicity, complet e response rate, bladder preservation rate, and survival. Methods and Materials: Patients with invasive bladder cancer, clinical Stages T2-4 , NO-2 or NX, MO were treated with pelvic radiotherapy 40 Gy in 4 week s and cisplatin 100 mg/m2 on days 1 and 22. Complete responders were g iven an additional 24 Gy bladder boost plus a third dose of cisplatin; patients with residual tumor after 40 Gy were assigned radical cystec tomy. Results: The complete remission rate following cisplatin and 40 Gy for evaluable cases was 31/47 (66%). Acute toxicity was acceptable with only two patients not completing induction therapy. Patients with poorly differentiated tumors were more likely to achieve complete rem ission. Of fully evaluable patients, 28/42 (67%) achieved complete rem ission with induction therapy, 11 remain continuously in remission, an d eight have relapsed with bladder as the only site of failure. Five o f these eight cases relapsed with noninvasive tumor. Of the 14 patient s who failed to achieve complete remission, only three remain disease- free. Median survival is not reached, with 17/42 (19/48) deaths report ed. Actuarial survival is 64% at 3 years. Conclusion: This combined ci splatin-radiotherapy regimen was moderately well-tolerated and associa ted with tumor clearance in 66% of patients treated. Isolated bladder recurrences with invasive carcinoma are infrequent. Better definition of pretreatment selection criteria is needed if combined modality trea tment is to achieve disease control and organ preservation for patient s with bladder cancer.