Skip to content
Bending the Curve Trial by Trial
?

HR-NBL1.5

HR-NBL1.5 SIOPEN: randomised comparison of MSKCC N5 and rapid COJEC induction for high-risk neuroblastoma

N = 630

Population
Patients aged 1 to 20 years with stage 4 neuroblastoma, or stage 4/4s aged under 1 year with MYCN amplification; 630 randomised.
Design
Randomised comparison of two induction regimens (MSKCC N5 versus rapid COJEC), stratified by national group and metastatic sites, followed by primary-tumour resection, high-dose busulfan-melphalan, radiotherapy and isotretinoin with dinutuximab beta with or without interleukin-2. Primary endpoints metastatic complete response rate and 3-year EFS.
Primary endpoint
mCR rate, EFS
Arms
  • Rapid COJEC (control, n = 313): Rapid COJEC induction (cisplatin, vincristine, carboplatin, etoposide, cyclophosphamide)
  • MSKCC N5 (experimental, n = 317): Memorial Sloan Kettering Cancer Center N5 induction regimen
People
Garaventa A, senior author Ladenstein RL, SIOP Europe Neuroblastoma Group (SIOPEN)
Δ mCR rate+3 pointsΔ 36-month EFS+3 pointsΔ 36-month OS+5 points
Show the numbers
Results reported for HR-NBL1.5
EndpointAnalysisMSKCC N5Rapid COJECEffect
mCR rateEvaluable patients (272 rapid COJEC, 281 MSKCC N5)Metastatic complete response rate after inductionprimaryGaraventa 202135%32%P=0.36886 of 272 vs 99 of 281 evaluable patients.
EFSRandomised patients (630)primaryGaraventa 202147% at 3 y44% at 3 yP=0.527Reported as 44±3% vs 47±3% (± standard error).
OSRandomised patients (630)primaryGaraventa 202165% at 3 y60% at 3 yP=0.379Reported as 60±3% vs 65±3% (± standard error).
Results reported for HR-NBL1.5
EndpointAnalysisMSKCC N5Rapid COJECEffect
mCR rateEvaluable patients (272 rapid COJEC, 281 MSKCC N5)Metastatic complete response rate after inductionprimaryGaraventa 202135%32%P=0.36886 of 272 vs 99 of 281 evaluable patients.
EFSRandomised patients (630)primaryGaraventa 202147% at 3 y44% at 3 yP=0.527Reported as 44±3% vs 47±3% (± standard error).
OSRandomised patients (630)primaryGaraventa 202165% at 3 y60% at 3 yP=0.379Reported as 60±3% vs 65±3% (± standard error).
Primary publication: Garaventa A, Poetschger U, Valteau-Couanet D, Luksch R, Castel V, Elliott M, et al. Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study. J Clin Oncol. 2021;39(23):2552-2563. PubMedDOI

Appears in

Sources

  1. Garaventa A, Poetschger U, Valteau-Couanet D, Luksch R, Castel V, Elliott M, et al. Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study. J Clin Oncol. 2021;39(23):2552-2563.

    PubMedDOI