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CCLG-ENSG-5

Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year

Phase 3N = 262NCT00365755

Population
Patients aged 1 year or over with stage 4 neuroblastoma who had not received previous chemotherapy.
Design
Randomised comparison, enrolled 30 October 1990 to 18 March 1999 at 29 European centres: rapid induction (COJEC, 10-day interval) versus standard induction (OPEC alternating with OJEC, 21-day interval) with the same total doses (except vincristine), then surgery and melphalan myeloablation with stem-cell rescue in responders. Primary endpoints 3-, 5- and 10-year EFS, intention to treat.
Primary endpoint
EFS
Arms
  • Standard induction (OPEC/OJEC) (control, n = 132): Vincristine, cisplatin, etoposide, cyclophosphamide (OPEC) alternating with vincristine, carboplatin, etoposide, cyclophosphamide (OJEC), every 21 days
  • Rapid induction (COJEC) (experimental, n = 130): Cisplatin, vincristine, carboplatin, etoposide, cyclophosphamide (COJEC) every 10 days irrespective of haematological recovery
People
Pearson AD, senior author Machin D, Children's Cancer and Leukaemia Group (CCLG) and European Neuroblastoma Study Group (ENSG)
EFSHR 0.86 (95% CI 0.66–1.14)Δ 36-month EFS+6.8 pointsΔ 60-month EFS+12 pointsΔ 120-month EFS+8.9 points
Show the numbers
Results reported for CCLG-ENSG-5
EndpointAnalysisRapid induction (COJEC)Standard induction (OPEC/OJEC)Effect
EFSITT (262 randomised patients)primaryPearson 200831% at 3 y24.2% at 3 yHR 0.86 (95% CI 0.66–1.14)P=0.30The abstract gives the hazard ratio alongside the 3-year EFS; the comparison direction is as reported.
EFSITT (262 randomised patients)primaryPearson 200830.2% at 5 y18.2% at 5 yP=0.022Difference 12.0 percentage points (95% CI 1.8 to 22.3), as reported.
EFSITT (262 randomised patients)primaryPearson 200827.1% at 10 y18.2% at 10 yP=0.085Difference 8.9 percentage points (95% CI -1.2 to 19.0), as reported.
Results reported for CCLG-ENSG-5
EndpointAnalysisRapid induction (COJEC)Standard induction (OPEC/OJEC)Effect
EFSITT (262 randomised patients)primaryPearson 200831% at 3 y24.2% at 3 yHR 0.86 (95% CI 0.66–1.14)P=0.30The abstract gives the hazard ratio alongside the 3-year EFS; the comparison direction is as reported.
EFSITT (262 randomised patients)primaryPearson 200830.2% at 5 y18.2% at 5 yP=0.022Difference 12.0 percentage points (95% CI 1.8 to 22.3), as reported.
EFSITT (262 randomised patients)primaryPearson 200827.1% at 10 y18.2% at 10 yP=0.085Difference 8.9 percentage points (95% CI -1.2 to 19.0), as reported.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.860.66–1.14
Primary publication: Pearson AD, Pinkerton CR, Lewis IJ, Imeson J, Ellershaw C, Machin D. High-dose rapid and standard induction chemotherapy for patients aged over 1 year with stage 4 neuroblastoma: a randomised trial. Lancet Oncol. 2008;9(3):247-56. PubMedDOI

Appears in

Sources

  1. Pearson AD, Pinkerton CR, Lewis IJ, Imeson J, Ellershaw C, Machin D. High-dose rapid and standard induction chemotherapy for patients aged over 1 year with stage 4 neuroblastoma: a randomised trial. Lancet Oncol. 2008;9(3):247-56.

    PubMedDOI