BC2001
Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer
Phase 3N = 458NCT00024349
- Population
- Patients with T2-T4a N0M0 muscle-invasive bladder cancer treated with radiotherapy as an alternative to cystectomy
- Design
- Multicentre phase 3 trial with a 2 x 2 factorial design, 458 patients with T2-T4a N0M0 muscle-invasive bladder cancer enrolled 2001 to 2008. 360 were randomised to radiotherapy alone (178) or to radiotherapy with synchronous fluorouracil (500 mg per square meter per day during fractions 1 to 5 and 16 to 20) and mitomycin C (12 mg per square meter on day 1) (182); 218 were randomised to standard whole-bladder or reduced high-dose-volume radiotherapy (the 2022 abstract reports no differences between them; the 2012 abstract does not report this comparison). Radiotherapy 55 Gy in 20 fractions over 4 weeks or 64 Gy in 32 fractions over 6.5 weeks. Primary end point: survival free of locoregional disease (2012 report); locoregional control (2022 report). ClinicalTrials.gov lists 350 participants (estimated).
- Primary endpoint
- Locoregional disease-free survival, Locoregional control
- Arms
- Radiotherapy alone (control, n = 178): Radiotherapy alone: 55 Gy in 20 fractions over 4 weeks or 64 Gy in 32 fractions over 6.5 weeks
- Radiotherapy with fluorouracil and mitomycin C (experimental, n = 182): Radiotherapy with synchronous fluorouracil and mitomycin C
- People
- James ND, senior author Huddart RA, BC2001 Investigators
Locoregional disease-free survivalHR 0.68 (95% CI 0.48–0.96)Δ 24-month Locoregional disease-free survival+13 pointsOSHR 0.82 (95% CI 0.63–1.09)Δ 60-month OS+13 pointsLocoregional controlHR 0.61 (95% CI 0.43–0.86)Locoregional controlHR 0.55 (95% CI 0.36–0.84)
Show the numbers
| Endpoint | Analysis | Radiotherapy with fluorouracil and mitomycin C | Radiotherapy alone | Effect |
|---|---|---|---|---|
| Locoregional disease-free survivalRandomised patients (analysis population not stated in the abstract) | primarymedian follow-up 69.9 monthsJames 2012 | 67% at 2 y (59–74%) | 54% at 2 y (46–62%) | HR 0.68 (95% CI 0.48–0.96)P=0.03 |
| OSRandomised patients (analysis population not stated in the abstract) | primarymedian follow-up 69.9 monthsJames 2012 | 48% at 5 y (40–55%) | 35% at 5 y (28–43%) | HR 0.82 (95% CI 0.63–1.09)P=0.16Overall survival was a secondary end point. |
| Locoregional control | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.61 (95% CI 0.43–0.86)P=0.004 |
| Locoregional controlInvasive locoregional control (the 2022 abstract's term). | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.55 (95% CI 0.36–0.84)P=0.006 |
| DFS | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.78 (95% CI 0.60–1.02)P=0.069 |
| OS | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.88 (95% CI 0.69–1.13)P=0.3 |
| Cystectomy rate | long term-updatemedian follow-up 9.9 yearsHall 2022 | 14% at 5 y (9–21%) | 22% at 5 y (16–31%) | HR 0.54 (95% CI 0.31–0.95)P=0.034Five-year cystectomy rate as printed in the abstract. |
| Endpoint | Analysis | Radiotherapy with fluorouracil and mitomycin C | Radiotherapy alone | Effect |
|---|---|---|---|---|
| Locoregional disease-free survivalRandomised patients (analysis population not stated in the abstract) | primarymedian follow-up 69.9 monthsJames 2012 | 67% at 2 y (59–74%) | 54% at 2 y (46–62%) | HR 0.68 (95% CI 0.48–0.96)P=0.03 |
| OSRandomised patients (analysis population not stated in the abstract) | primarymedian follow-up 69.9 monthsJames 2012 | 48% at 5 y (40–55%) | 35% at 5 y (28–43%) | HR 0.82 (95% CI 0.63–1.09)P=0.16Overall survival was a secondary end point. |
| Locoregional control | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.61 (95% CI 0.43–0.86)P=0.004 |
| Locoregional controlInvasive locoregional control (the 2022 abstract's term). | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.55 (95% CI 0.36–0.84)P=0.006 |
| DFS | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.78 (95% CI 0.60–1.02)P=0.069 |
| OS | long term-updatemedian follow-up 9.9 yearsHall 2022 | — | — | HR 0.88 (95% CI 0.69–1.13)P=0.3 |
| Cystectomy rate | long term-updatemedian follow-up 9.9 yearsHall 2022 | 14% at 5 y (9–21%) | 22% at 5 y (16–31%) | HR 0.54 (95% CI 0.31–0.95)P=0.034Five-year cystectomy rate as printed in the abstract. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Locoregional disease-free survival | 0.68 | 0.48–0.96 |
| OS | 0.82 | 0.63–1.09 |
| Locoregional control | 0.61 | 0.43–0.86 |
| Locoregional control | 0.55 | 0.36–0.84 |
| DFS | 0.78 | 0.6–1.02 |
| OS | 0.88 | 0.69–1.13 |
| Cystectomy rate | 0.54 | 0.31–0.95 |
Appears in
Sources
James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012;366(16):1477-88.
Hall E, Hussain SA, Porta N, Lewis R, Crundwell M, Jenkins P, 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.