Journal of Clinical Oncology, Vol 10, 1879-1888, Copyright © 1992 by American Society of Clinical Oncology
Residual disease at the end of induction therapy as a predictor of relapse during therapy in childhood B-lineage acute lymphoblastic leukemia
R Wasserman, N Galili, Y Ito, JH Silber, BA Reichard, S Shane, RB Womer, B Lange and G Rovera
Division of Oncology, Children's Hospital of Philadelphia, PA.
PURPOSE: More than 95% of children with B-lineage acute lymphoblastic
leukemia (ALL) achieve a clinical remission after the induction phase of
chemotherapy (first 28 days) as evaluated by morphologic criteria. However,
relapse occurs in approximately 30% of these children. The objective of
this study was to determine whether the outcome of patients in clinical
remission at the end of induction therapy could be predicted using a highly
sensitive method to detect residual disease. PATIENTS AND METHODS: All
children diagnosed with B-lineage ALL at the Children's Hospital of
Philadelphia during a 2-year period were eligible. The extent of residual
leukemia was quantitated in remission marrow samples obtained at the end of
induction therapy in 44 children using a phage clonogenic assay in
association with complementarity- determining-region 3 (CDR3)-polymerase
chain reaction (PCR). RESULTS: Residual disease was a significant predictor
of outcome independent of WBC count, age, or sex. The estimated
relapse-free survival (RFS) during therapy was 50.4% (+/- 12.6%) for
patients with high residual disease (> or = 0.6% leukemia cells among
total marrow B cells) versus 91.9% (+/- 5.5%) for those with lower levels
(P < .002). There were no significant differences in off-treatment RFS
between patients with high or low residual disease who completed therapy in
continuous remission (P = .82). The overall estimated RFS was 32.3% (+/-
11.6%) for patients with high residual disease versus 62.6% (+/- 10.7%) for
patients with lower levels of residual leukemia cells, with a median
follow-up of 5.3 years for patients in continuous remission (P < .008).
CONCLUSION: PCR detection of high residual disease at the end of induction
therapy identifies patients at increased risk for relapse during therapy.
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