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Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients

N = 938

Population
Previously untreated patients with Binet stage B (651) or stage C (287) chronic lymphocytic leukemia.
Design
Randomised comparison of six monthly courses of ChOP (cyclophosphamide, vincristine, prednisone plus doxorubicin), CAP (cyclophosphamide, doxorubicin plus prednisone) or fludarabine (FAMP), stratified by Binet stage, in 73 centres, 1 June 1990 to 15 April 1998. Endpoints named in the abstract: overall survival, treatment response and tolerance. No NCT number in the PubMed record.
Arms
  • ChOP (control): ChOP, 6 monthly courses
  • CAP (control): CAP, 6 monthly courses
  • Fludarabine (experimental): Fludarabine (FAMP), 6 monthly courses
People
Leporrier M, French Cooperative Group on Chronic Lymphocytic Leukemia
Δ ORR−0.4 pointsΔ CR rate+10.5 pointsΔ median OS+2 months
Show the numbers
Results reported for Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients
EndpointAnalysisFludarabineChOP / CAPEffect
ORRRandomised patients (analysis population not stated in the abstract)primaryLeporrier 200171.1%71.5%P<0.0001Reported as overall remission rate. CAP was lower than each of the other two; ChOP and fludarabine are described as close.
CR rateRandomised patients (analysis population not stated in the abstract)primaryLeporrier 200140.1%29.6%P=0.003Reported as clinical remission rate.
OSRandomised patients (analysis population not stated in the abstract)primaryLeporrier 2001median 69 monthsmedian 67 monthsDescribed in the abstract as not significantly different; no p-value given.
Results reported for Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients
EndpointAnalysisFludarabineChOP / CAPEffect
ORRRandomised patients (analysis population not stated in the abstract)primaryLeporrier 200171.1%71.5%P<0.0001Reported as overall remission rate. CAP was lower than each of the other two; ChOP and fludarabine are described as close.
CR rateRandomised patients (analysis population not stated in the abstract)primaryLeporrier 200140.1%29.6%P=0.003Reported as clinical remission rate.
OSRandomised patients (analysis population not stated in the abstract)primaryLeporrier 2001median 69 monthsmedian 67 monthsDescribed in the abstract as not significantly different; no p-value given.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%050100150Months (modelled)
  • ChOP (control)
  • CAP (control)
  • Fludarabine (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsChOPCAPFludarabine
0100.0%100.0%100.0%
4463.4%64.7%64.3%
8840.2%41.8%41.3%
13125.8%27.3%26.8%
17516.4%17.7%17.2%
Primary publication: Leporrier M, Chevret S, Cazin B, Boudjerra N, Feugier P, Desablens B, et al. Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients. Blood. 2001;98(8):2319-25. PubMedDOI

Appears in

Sources

  1. Leporrier M, Chevret S, Cazin B, Boudjerra N, Feugier P, Desablens B, et al. Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients. Blood. 2001;98(8):2319-25.

    PubMedDOI