NEOADJUVANT COMBINED-MODALITY PROGRAM WITH SELECTIVE ORGAN PRESERVATION FOR INVASIVE BLADDER-CANCER - RESULTS OF RADIATION-THERAPY ONCOLOGYGROUP PHASE-II TRIAL 8802

Purpose: This phase II study was designed to evaluate effectiveness an d toxicity of a combined chemoradiotherapy program with selective blad der preservation in the management of patients with invasive bladder c ancer. Patients and Methods: Ninety-one eligible patients with invasiv e bladder cancer stages T2MO to T4AMO suitable for radical cystectomy received two courses of metholtrexate, cisplatin, and vinblastine (MCV regimen) followed by radiotherapy with 39.6 Gy and concurrent cisplat in. After complete urologic evaluation, operable patients who achieved complete response were selected for bladder preservation and treated with consolidation cisplatin-rodiotherapy. Results: Of 91 eligible pat ients, 85 underwent camplete urologic evaluation and 68 (75%; 95% conf idence interval [CI], 59% to 84%) had documented complete responses. F ourteen operable patients with residual tumor underwent immediate cyst ectomy. Of 70 patients treated with consolidation cisplatin-radiothera py, 36 subsequently developed bladder recurrences, 23 of which were in vasive. patients with invasive recurrence (n = 16), extensive noninvas ive recurrence (n = 6), or severe treatment complications (n = 1) unde rwent salvage cystectomy. Thus, a total of 37 of 91 patients (40%) req uired cystectomy. The 4 year cumulative risk of invasive local failure (which includes induction failures) was 43% (95% Cl, 33% to 53%). The 4-year actuarial risk of distant metastasis was 22% (95% Cl, 13% to 3 1%). The 4-year actuarial survival rate of the entire group was 62% (9 5% Cl, 52% to 72%). The 4-year actuarial rate of survival with bladder intact was 44% (95% Cl, 34% to 54%). Conclusion: Initial results of t his combined chemoradiotherapy program show that bladder preservation can be achieved in the majority of patients, and that overall survival is similar to that reported with aggressive surgical approaches, Long -term survival and quality-of-life assessments require longer follow-u p study. (C) 1996 by American Society of Clinical Oncology.