Phase II trial of paclitaxel/cisplatinum concomitant with adjuvant radiotherapy for treatment of bladder cancer.

Abstract

e15084 Background: Radical cystectomy is still considered a standard management for muscle-invasive bladder cancer. Yet, bladder sparing approach by concomittant chemoradiotherapy is gaining acceptance. Methods: 63 patients having T2-4a N0M0 transitional cell carcinoma of the bladder were enrolled in this study. All patients had complete TURBT as possible followed by chemo-radiotherapy (44 Gy radiation plus weekly paclitaxel/cisplatinum for 4 weeks). Complete responders, by biopsy, received chemoradiation (20 Gy plus weekly paclitaxel/cisplatinum for 2 weeks). Eight weeks later, those who maintained complete response received adjuvant chemotherapy (four-monthly cycles of paclitaxel/cisplatinum). Results: Three patients could not tolerate the induction chemoradiation and were excluded from the study. Sixty patients (38 T2 and 22 T3-4a) completed the induction course. Complete response was observed in 45 patients (75%) of them, 41 patients (68.3%) kept their complete response after the consolidation course and received the adjuvant chemotherapy. After a median follow up of 29 months (6-41 months), superficial recurrence of the disease was observed in 7 patients (11.7%) and 36 patients were alive and free of muscle invasive disease (60%). All these 36 patients kept their intact bladder although 17 (47.2%) had dysuria, 12 (33.3%) had frequency and 5 had bothering nocturnal enuresis (13.9%). Three patients could not tolerate the chemo radiation and were excluded from the study. Sixty patients (43 males and 17 females) (38 T2 and 22 T3-4a) completed the induction course. Complete response was observed in 45 patients (75%) of them, 41 patients (68.3%) kept their complete response and received the adjuvant chemotherapy. After a median follow up of 29 months (6-41 months), recurrence of the disease was observed in 7 patients (11.7%) and 36 patients were alive and free of disease (60%). All these 36 patients kept their intact bladder although 17 (47.2%) had dysuria, 12 (33.3%) had frequency and 5 had nocturnal enuresis (13.9%). Conclusions: Paclitaxel/cisplatinum chemotherapy concomitant with &adjuvant to radiotherapy can offer a satisfactory oncologic outcome while keeping an intact bladder. No significant financial relationships to disclose.