CONSERVATIVE TREATMENT FOR T2-T4 BLADDER-CANCER WITH PRIMARY CHEMOTHERAPY AND RADIOTHERAPY - A PILOT-STUDY

Aims and Background. After radical cystectomy, with or without pelvic radiotherapy, more than 50 % of patients affected by infiltrating bladder cancer died of distant metastases. Polychemotherapy yields 25 % complete remissions (CR) in patients with invasive transitional cell bladder carcinoma; although many concerns exist about the duration of such CR. This study was undertaken with the aim of evaluating the efficacy and safety of an integrated chemo-radiotherapeutic treatment, in order to broaden indications to a conservative surgical therapy. Methods: Thirty-three consecutive patients with bladder urothelial cancer T2-T4, N0, M0, have been treated. Patients received neoadjuvant chemotherapy (rescue-M-VEC) consisted of methotrexate 30 mg/sqm plus folinic acid 15 mg after 24 h on days 1, 15, 22; vinblastine 3 mg/sqm on days 1, 15 and 22; epidoxorubicin 30 mg/sqm on day 17 cisplatin 70 mg/sqm on day 1. This cycle was repeated on day 29. After 2 cycles of rescue-M-VEC patients underwent pelvic cobalt teletherapy 40 Gy combined with low dose cisplatin 25 mg/sqm/week. After restaging, responding patients underwent further radiation therapy (24 Gy) as booster consolidation. Results: After 2 cycles of chemotherapy and pelvic radiotherapy 14/31 evaluable patients (45.2 %) achieved CR and 11/31 (35.4%) partial remission, with an overall response rate of 80.6 % (25/31). With a median follow up of 21 months the actuarial survival rate at 24 months was equal to 79.8 %. Eleven radical cystectomies were performed, 6 of which at restaging in non responding patients and 5 during the follow up due to relapse. Of the 25 patients selected for bladder conservation, 12 (48 %) have not yet shown relapses. Three out of 31 (9,7 %) patients died of distant metastases. No severe toxicity has been observed: moreover no patient developed stomatitis after chemotherapy. Conclusions: Our results seem encouraging but longer follow-up and further phase III studies need to be carried out to demonstrate the feasibility of conservative treatment in muscle infiltrating bladder cancer,