Neoadjuvant combined modality program with selective organ preservation for invasive bladder cancer: Results of Radiation Therapy Oncology Group phase II trial 8802

Purpose: This phase II study was designed to evaluate effectiveness and toxicity of a combined chemoradiotherapy program with selective bladder preservation in the management of patients with invasive bladder cancer. Patients and Methods: Ninety-one eligible patients with invasive 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 cisplatin. 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 patients, 85 underwent camplete urologic evaluation and 68 (75%; 95% confidence interval [CI], 59% to 84%) had documented complete responses. Fourteen operable patients with residual tumor underwent immediate cystectomy. Of 70 patients treated with consolidation cisplatin-radiotherapy, 36 subsequently developed bladder recurrences, 23 of which were invasive. patients with invasive recurrence (n = 16), extensive noninvasive recurrence (n = 6), or severe treatment complications (n = 1) underwent salvage cystectomy. Thus, a total of 37 of 91 patients (40%) required 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 31%). The 4-year actuarial survival rate of the entire group was 62% (95% 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 this 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-up study. (C) 1996 by American Society of Clinical Oncology.