HR-NBL1/SIOPEN
HR-NBL1/SIOPEN: randomised comparison of dinutuximab beta (ch14.18/CHO) with or without subcutaneous interleukin-2 after high-dose therapy
Phase 3N = 406NCT01704716
- Population
- Patients aged 1 to 20 years with high-risk neuroblastoma enrolled at diagnosis in HR-NBL1/SIOPEN; 422 eligible, 406 randomised between October 2009 and August 2013.
- Design
- International, open-label, phase 3 randomisation (1:1; 104 institutions in 12 countries) of dinutuximab beta as an 8-hour infusion for 5 days with or without subcutaneous IL-2, all with isotretinoin for six cycles, in patients who had responded to induction, completed high-dose therapy and received radiotherapy to the primary site. Primary endpoint 3-year EFS, analysed by intention to treat.
- Primary endpoint
- EFS
- Arms
- Dinutuximab beta alone (control, n = 200): Dinutuximab beta 20 mg/m2 per day as an 8-hour infusion for 5 consecutive days per cycle, with isotretinoin
- Dinutuximab beta plus subcutaneous IL-2 (experimental, n = 206): Dinutuximab beta as above plus subcutaneous interleukin-2 6 × 10^6 IU/m2 per day on days 1-5 and 8-12 of each cycle, with isotretinoin
- People
- Ladenstein R, senior author Lode HN, SIOP Europe Neuroblastoma Group (SIOPEN)
Δ 36-month EFS+4 points
Show the numbers
| Endpoint | Analysis | Dinutuximab beta plus subcutaneous IL-2 | Dinutuximab beta alone | Effect |
|---|---|---|---|---|
| EFSITT (406 randomised patients) | primarymedian follow-up 4.7 yearsLadenstein 2018 | 60% at 3 y (53–66%) | 56% at 3 y (49–63%) | P=0.76Median follow-up 4.7 years (IQR 3.9 to 5.3). 83 events with dinutuximab beta and 80 with dinutuximab beta plus IL-2. Both arms received the antibody; the trial did not randomise antibody against no antibody. |
| Endpoint | Analysis | Dinutuximab beta plus subcutaneous IL-2 | Dinutuximab beta alone | Effect |
|---|---|---|---|---|
| EFSITT (406 randomised patients) | primarymedian follow-up 4.7 yearsLadenstein 2018 | 60% at 3 y (53–66%) | 56% at 3 y (49–63%) | P=0.76Median follow-up 4.7 years (IQR 3.9 to 5.3). 83 events with dinutuximab beta and 80 with dinutuximab beta plus IL-2. Both arms received the antibody; the trial did not randomise antibody against no antibody. |