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Bending the Curve Trial by Trial
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ANBL0532

Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma

Phase 3N = 355NCT00567567

Population
Patients aged 30 years or younger with protocol-defined high-risk neuroblastoma: 652 eligible patients enrolled, 355 randomised.
Design
Randomised comparison (Children's Oncology Group, 142 centres, enrolment November 2007 to February 2012) of tandem versus single autologous stem-cell transplant after induction; designed to test one-sided superiority of tandem transplant for event-free survival.
Primary endpoint
EFS
Arms
  • Single transplant (control, n = 179): Single autologous transplant with carboplatin, etoposide and melphalan
  • Tandem transplant (experimental, n = 176): Tandem transplant: thiotepa and cyclophosphamide followed by dose-reduced carboplatin, etoposide and melphalan
People
Park JR, senior author Diller L, Children's Oncology Group
Δ 36-month EFS+13.2 points
Show the numbers
Results reported for ANBL0532
EndpointAnalysisTandem transplantSingle transplantEffect
EFSRandomised patients (355 of 652 eligible patients enrolled)Event-free survival from randomisation to first relapse, progression, secondary malignancy or death from any causeprimarymedian follow-up 5.6 yearsPark 201961.6% at 3 y (54.3–68.9%)48.4% at 3 y (41.0–55.7%)P=0.006One-sided log-rank P. The abstract gives 5.6 years (range 0.6 to 8.9) as the median duration of follow-up after randomisation for the 181 patients without an event.
Results reported for ANBL0532
EndpointAnalysisTandem transplantSingle transplantEffect
EFSRandomised patients (355 of 652 eligible patients enrolled)Event-free survival from randomisation to first relapse, progression, secondary malignancy or death from any causeprimarymedian follow-up 5.6 yearsPark 201961.6% at 3 y (54.3–68.9%)48.4% at 3 y (41.0–55.7%)P=0.006One-sided log-rank P. The abstract gives 5.6 years (range 0.6 to 8.9) as the median duration of follow-up after randomisation for the 181 patients without an event.
Primary publication: Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, et al. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019;322(8):746-755. PubMedDOI

Appears in

Sources

  1. Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, et al. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019;322(8):746-755.

    PubMedDOI