OnCo
trialsTrialMixed

SIOPEN HR-NBL1

Europe's long-running high-risk neuroblastoma trial set busulfan-melphalan as the transplant regimen and showed that adding IL-2 to anti-GD2 therapy added toxicity but not benefit.

R1: BuMel superior to CEM (3-year EFS 50% vs 38%; Lancet Oncol 2017). R2: dinutuximab beta + IL-2 vs dinutuximab beta alone: 3-year EFS 56% vs 60%, no benefit, more toxicity (Lancet Oncol 2018). R3/R4 explored induction regimens (rapid COJEC vs modified N7; 2025 report). Over 3,700 children enrolled since 2002.

Setting
High-risk neuroblastoma (Europe): multiple randomisations, including busulfan-melphalan vs CEM conditioning and dinutuximab beta ± IL-2
Phase
Phase 3
Sponsor
SIOPEN / Children's Cancer and Leukaemia Group
Registry
Headline result
BuMel > CEM (EFS 50% vs 38%); IL-2 adds no benefit to anti-GD2.
Reported
2017
Enrolled
3700

Outcomes

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In plain words
What these results mean for people, not percentages
3,700 people took part
Event-free survival at 3 years (R1 conditioning)surrogate endpoint
  • 50 vs 38 out of 100 free of a major event at 3 years with Busulfan-melphalan compared with CEM; 12 more per 100.
  • Roughly one extra person helped for every 8 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (0.0005) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
Event-free survival at 3 years (R2 immunotherapy)surrogate endpoint
  • 56 vs 60 out of 100 free of a major event at 3 years with Dinutuximab beta + IL-2 compared with Dinutuximab beta; 4 fewer per 100.
  • On this measure the first group did worse, not better.
Be careful
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: High-risk neuroblastoma (Europe): multiple randomisations, including busulfan-melphalan vs CEM conditioning and dinutuximab beta ± IL-2. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

3,700 participants enrolled.

Event-free survival at 3 years (R1 conditioning)
· p = 0.0005
Busulfan-melphalan50 of 100
n = 296
CEM38 of 100
n = 302
Source
Event-free survival at 3 years (R2 immunotherapy)
Dinutuximab beta + IL-256 of 100
n = 200
Dinutuximab beta60 of 100
n = 206
Source
EndpointArmnValueHR (95% CI)pSource
Event-free survival at 3 years (R1 conditioning)Busulfan-melphalan29650%0.0005link
CEM30238%
Event-free survival at 3 years (R2 immunotherapy)Dinutuximab beta + IL-220056%link
Dinutuximab beta20660%

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