The Efficacy of Chemoradiotherapy for Organ Preservation in Patients with Localized Bladder Cancer - Expert Commentary

Definitive treatment of muscle-invasive bladder cancer (MIBC) involves cystectomy or radiotherapy. The Bladder Cancer 2001 (BC2001) is a large bladder preservation trial comparing the efficacy of chemoradiotherapy with 5-fluorouracil (5FU) and mitomycin C (MMC) to radiotherapy alone.

Hall et al. reported the long-term results of BC2001. The trial included 458 patients recruited between 2001 and 2008 from 45 centers in the United Kingdom. Patients were randomized, with 178 in the radiotherapy group, 182 in the chemoradiotherapy group, 108 in the standard radiotherapy group, and 111 in the reduced high-dose-volume radiotherapy group. The median follow-up was 9.9 years. Chemoradiotherapy led to significantly better locoregional disease control than radiotherapy, with 5-year recurrence-free rates of 63% in the former and 49% in the latter. After adjusting for prognostic factors, the hazard ratio was 0.59 (95% CI 0.42–0.84, p = 0.004). Disease-free survival and metastasis-free survival were not significantly different between the two groups.

Chemoradiotherapy was also associated with a reduction in cystectomy, at a rate of 14% across five years versus 22% in the radiotherapy group. Most cystectomies (81%) were needed due to disease recurrence. Within two years of treatment initiation, 9.8% of patients in the chemoradiotherapy group exhibited invasive local recurrence compared to 19% of patients in the radiotherapy group. The 5-year overall survival rates were 49% in the chemoradiotherapy group and 37% in the radiotherapy group. The 10-year overall survival rates were 30% in the former and 26% in the latter.

This updated analysis from long-term follow-up of MIBC patients in the BC2001 trial confirms the benefit of chemoradiotherapy compared to radiotherapy alone. This is also associated with reduced salvage cystectomy rates, providing evidence for the possibility of bladder preservation. Notably, the combination of chemotherapy and radiotherapy did not result in increased toxicity.

Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine


  1. Hall E, Hussain SA, Porta N, et al. Chemoradiotherapy in Muscle-invasive Bladder Cancer: 10-yr Follow-up of the Phase 3 Randomised Controlled BC2001 Trial. Eur Urol. 2022;82(3):273-279. doi:10.1016/j.eururo.2022.04.017

Read the Abstract
email news signup