PHASE-III TRIAL OF NEOADJUVANT CHEMOTHERAPY IN PATIENTS WITH INVASIVEBLADDER-CANCER TREATED WITH SELECTIVE BLADDER PRESERVATION BY COMBINED RADIATION-THERAPY AND CHEMOTHERAPY - INITIAL RESULTS OF RADIATION-THERAPY ONCOLOGY GROUP-89-03

Purpose: To assess the efficacy of neoadjuvant methotrexate, cisplatin , and vinblastine (MCV) chemotherapy in patients with muscle-invading bladder cancer treated with selective bladder preservation. Patients a nd Methods: One hundred twenty-three eligible patients with tumor, nod e, metasasis system clinical stage T2 to T4aNXMO bladder cancer were r andomized to receive (arm 1, n = 61) two cycles of MCV before 39.6-Gy pelvic irradiation with concurrent cisplatin 100 mg/m(2) for two cours es 3 weeks apart. Patients assigned to arm 2 (n = 62) did not receive MCV before concurrent cisplatin and radiation therapy. Tumor response was scored as a clinical complete response (CR) when the cystoscopic t umor-site biopsy and urine cytology results were negative. The CR pati ents were treated with an additional 25.2 Gy to a total of 64.8 Gy and one additional dose of cisplatin. Those with less than a CR underwent cystectomy. The median follow-up of all patients who survived is 60 m onths. Results: Seventy-four percent of the patients completed the pro tocol with, at most, minor deviations; 67% on arm 1 and 81% on arm 2. The actuarial 5-year overall survival rate was 49%; 48% in arm 1 and 4 9% in arm 2, Thirty-five percent of the patients had evidence of dista nt metastases at 5 years; 33% in arm 1 and 39% in arm 2. The 5-year su rvival rate with a functioning bladder was 38%, 36% in arm 1 and 40% i n arm 2. None of these differences are statistically significant. Conc lusion: Two cycles of MCV neoadjuvant chemotherapy were not shown to i ncrease the rate of CR over that achieved with our standard induction therapy or to increase freedom from metastatic disease. There was no i mpact on 5-year overall survival. (C) 1998 by American Society of Clin ical Oncology.