Journal of Clinical Oncology, Vol 16, 3576-3583, Copyright © 1998 by American Society of Clinical Oncology
Phase III trial of neoadjuvant chemotherapy in patients with invasive bladder cancer treated with selective bladder preservation by combined radiation therapy and chemotherapy: initial results of Radiation Therapy Oncology Group 89-03
WU Shipley, KA Winter, DS Kaufman, WR Lee, NM Heney, WR Tester, BJ Donnelly, PM Venner, CA Perez, KJ Murray, RS Doggett and LD True
Department of Radiation Oncology, Massachusetts General Hospital, Boston 02114, USA.
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 AND METHODS:
One hundred twenty-three eligible patients with tumor, node, metastasis
system clinical stage T2 to T4aNXMO bladder cancer were randomized to
receive (arm 1, n=61 ) two cycles of MCV before 39.6- Gy pelvic irradiation
with concurrent cisplatin 100 mg/m2 for two courses 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 tumor-site biopsy and urine cytology
results were negative. The CR patients 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 months. RESULTS: Seventy-four percent of the patients
completed the protocol 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 49% in arm 2. Thirty-five percent of the patients had evidence of
distant metastases at 5 years; 33% in arm 1 and 39% in arm 2. The 5- year
survival rate with a functioning bladder was 38%, 36% in arm 1 and 40% in
arm 2. None of these differences are statistically significant. CONCLUSION:
Two cycles of MCV neoadjuvant chemotherapy were not shown to increase the
rate of CR over that achieved with our standard induction therapy or to
increase freedom from metastatic disease. There was no impact on 5-year
overall survival.
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