The Absolute Effect / Evidence / BC2001
Bladder Cancer · Radiation Oncology · Bladder Preservation

BC2001

Clinical question

For bladder-preserving RT, does concurrent chemotherapy improve locoregional control?

Trial context
Population
360 patients with T2–T4a N0 M0 muscle-invasive bladder cancer
Intervention
Concurrent 5-FU + mitomycin C with RT vs RT alone
Key endpoint
2-year locoregional disease-free survival
Time horizon / follow-up
2 years
Absolute Effect

What changes for patients?

Concurrent chemotherapy improved 2-year locoregional disease-free survival from 58% to 71%, an absolute benefit of about 13 percentage points (NNT 8). At 10 years, locoregional control remained significantly better, while OS was not significantly different. NNT is based on 2-year locoregional disease-free survival.

NNT: 8

Treatment burden / harm

Grade 3–4 acute toxicity

NNH: 30

Relative effect

HR: 0.61

95% CI 0.42–0.90; P=.01

Clinical interpretation

The randomized benefit is better locoregional control from concurrent 5-FU/mitomycin with radiotherapy, supporting trimodality bladder preservation in selected patients rather than radiotherapy alone.

Primary publication

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Current-practice context · reviewed 14 October 2026

For patients seeking bladder preservation who are suitable for trimodality therapy, maximal TURBT followed by radiotherapy with concurrent radiosensitizing chemotherapy is an established alternative to radical cystectomy. Selection requires a suitable tumour, bladder function, ability to undergo close cystoscopic surveillance and willingness to accept salvage cystectomy if needed; radiotherapy alone is less effective for locoregional control.

BC2001 primary/long-term report ↗ · Current guideline guidance ↗