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Bending the Curve Trial by Trial
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Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy

N = 311

Population
Children aged 1 to 9 years with white-cell count of at least 50,000 per cubic millimeter, or aged 10 years or older, with newly diagnosed ALL and a slow response to initial therapy who entered remission
Design
Randomised trial, January 1991 to June 1995: 311 children with newly diagnosed high-risk ALL who had a slow response to initial therapy (more than 25 percent marrow blasts on day 7) and entered remission were randomly assigned to standard (156) or augmented (155) intensive post-induction chemotherapy. Patients with lymphomatous features were excluded. Event-free and overall survival were measured from the end of induction.
Arms
  • Standard post-induction (control, n = 156): Standard intensive post-induction chemotherapy
  • Augmented post-induction (experimental, n = 155): Augmented intensive post-induction chemotherapy
People
Nachman JB, senior author Gaynon PS
Δ 60-month EFS+20 pointsΔ 60-month OS+11.7 points
Show the numbers
Results reported for Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy
EndpointAnalysisAugmented post-inductionStandard post-inductionEffect
EFSRandomised patients in remission at end of induction (311)primaryNachman 199875% at 5 y55% at 5 yP<0.001Kaplan-Meier estimates measured from the end of induction, with standard deviations as published: 75.0 (3.8) augmented, 55.0 (4.5) standard. The abstract gives the time point in words ('the outcome at five years').
OSRandomised patients in remission at end of induction (311)primaryNachman 199878.4% at 5 y66.7% at 5 yP=0.02Kaplan-Meier estimates measured from the end of induction, with standard deviations as published: 78.4 (3.7) augmented, 66.7 (4.2) standard. The abstract gives the time point in words ('the outcome at five years').
Results reported for Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy
EndpointAnalysisAugmented post-inductionStandard post-inductionEffect
EFSRandomised patients in remission at end of induction (311)primaryNachman 199875% at 5 y55% at 5 yP<0.001Kaplan-Meier estimates measured from the end of induction, with standard deviations as published: 75.0 (3.8) augmented, 55.0 (4.5) standard. The abstract gives the time point in words ('the outcome at five years').
OSRandomised patients in remission at end of induction (311)primaryNachman 199878.4% at 5 y66.7% at 5 yP=0.02Kaplan-Meier estimates measured from the end of induction, with standard deviations as published: 78.4 (3.7) augmented, 66.7 (4.2) standard. The abstract gives the time point in words ('the outcome at five years').
Primary publication: Nachman JB, Sather HN, Sensel MG, Trigg ME, Cherlow JM, Lukens JN, et al. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. N Engl J Med. 1998;338(23):1663-71. PubMedDOI

Appears in

Sources

  1. Nachman JB, Sather HN, Sensel MG, Trigg ME, Cherlow JM, Lukens JN, et al. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. N Engl J Med. 1998;338(23):1663-71.

    PubMedDOI