BEACON
A Randomised Phase IIb Trial of Bevacizumab Added to Temozolomide ± Irinotecan for Children With Refractory/Relapsed Neuroblastoma (ITCC-SIOPEN BEACON-Neuroblastoma)
Phase 2N = 160NCT02308527
- Population
- Patients aged 1 to 21 years with relapsed or refractory high-risk neuroblastoma; 160 eligible patients randomised between July 2013 and February 2019 at 43 sites in 10 European countries.
- Design
- Open-label, randomised phase 2 trial, 3 × 2 factorial: temozolomide, irinotecan-temozolomide or topotecan-temozolomide, each with or without bevacizumab. Primary endpoint best overall response (complete or partial) rate during the first six courses; PFS and OS secondary. Efficacy analysed by intention to treat.
- Primary endpoint
- ORR
- Arms
- Chemotherapy without bevacizumab (control, n = 80): Temozolomide (36), irinotecan-temozolomide (30) or topotecan-temozolomide (14)
- Chemotherapy with bevacizumab (experimental, n = 80): Bevacizumab-temozolomide (34), bevacizumab-irinotecan-temozolomide (30) or bevacizumab-topotecan-temozolomide (16)
- People
- Moreno L, ITCC and SIOPEN
Δ ORR+8 pointsPFSHR 0.89 (95% CI 0.63–1.27)OSHR 1.01 (95% CI 0.70–1.45)
Show the numbers
| Endpoint | Analysis | Chemotherapy with bevacizumab | Chemotherapy without bevacizumab | Effect |
|---|---|---|---|---|
| ORRBevacizumab randomisation (160 randomised patients)Best overall response (complete or partial) during the first six courses | primaryMoreno 2024 | 26% (17–37%) | 18% (10–28%) | P=0.17Risk ratio 1.52 (95% CI 0.83 to 2.77), P = .17. The abstract states that the addition of bevacizumab met the protocol-defined success criteria for response rate. |
| PFSBevacizumab randomisation (160 randomised patients) | primaryMoreno 2024 | — | — | HR 0.89 (95% CI 0.63–1.27)Adjusted hazard ratio for the bevacizumab randomisation; listed as a secondary endpoint in the abstract (the full text states that PFS became a co-primary outcome when the randomisation was expanded to 160 patients). Direction of the ratio is not stated in the abstract. |
| OSBevacizumab randomisation (160 randomised patients) | primaryMoreno 2024 | — | — | HR 1.01 (95% CI 0.70–1.45)Adjusted hazard ratio for the bevacizumab randomisation; listed as a secondary endpoint in the abstract (the full text states that PFS became a co-primary outcome when the randomisation was expanded to 160 patients). Direction of the ratio is not stated in the abstract. |
| Endpoint | Analysis | Chemotherapy with bevacizumab | Chemotherapy without bevacizumab | Effect |
|---|---|---|---|---|
| ORRBevacizumab randomisation (160 randomised patients)Best overall response (complete or partial) during the first six courses | primaryMoreno 2024 | 26% (17–37%) | 18% (10–28%) | P=0.17Risk ratio 1.52 (95% CI 0.83 to 2.77), P = .17. The abstract states that the addition of bevacizumab met the protocol-defined success criteria for response rate. |
| PFSBevacizumab randomisation (160 randomised patients) | primaryMoreno 2024 | — | — | HR 0.89 (95% CI 0.63–1.27)Adjusted hazard ratio for the bevacizumab randomisation; listed as a secondary endpoint in the abstract (the full text states that PFS became a co-primary outcome when the randomisation was expanded to 160 patients). Direction of the ratio is not stated in the abstract. |
| OSBevacizumab randomisation (160 randomised patients) | primaryMoreno 2024 | — | — | HR 1.01 (95% CI 0.70–1.45)Adjusted hazard ratio for the bevacizumab randomisation; listed as a secondary endpoint in the abstract (the full text states that PFS became a co-primary outcome when the randomisation was expanded to 160 patients). Direction of the ratio is not stated in the abstract. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.89 | 0.63–1.27 |
| OS | 1.01 | 0.7–1.45 |