TY - JOUR
T1 - Outcome in children with standard-risk b-cell acute lymphoblastic leukemia
T2 - Results of children's oncology group trial aall0331
AU - Maloney, Kelly W.
AU - Devidas, Meenakshi
AU - Wang, Cindy
AU - Mattano, Leonard A.
AU - Friedmann, Alison M.
AU - Buckley, Patrick
AU - Borowitz, Michael J.
AU - Carroll, Andrew J.
AU - Gastier-Foster, Julie M.
AU - Heerema, Nyla A.
AU - Kadan-Lottick, Nina
AU - Loh, Mignon L.
AU - Matloub, Yousif H.
AU - Marshall, David T.
AU - Stork, Linda C.
AU - Raetz, Elizabeth A.
AU - Wood, Brent
AU - Hunger, Stephen P.
AU - Carroll, William L.
AU - Winick, Naomi J.
N1 - Funding Information:
Supported by Grants No. U10 CA98543, U10 CA98413, U10 CA180886, 1U24-CA196173, U10CA180886, and U10 CA180899 from the National Institutes of Health and by St Baldrick’s Foundation.
Publisher Copyright:
© 2019 by American Society of Clinical Oncology.
PY - 2020/2/20
Y1 - 2020/2/20
N2 - PURPOSE Children's Oncology Group (COG) AALL0331 tested whether intensified postinduction therapy that improves survival in children with high-risk B-cell acute lymphoblastic leukemia (ALL) would also improve outcomes for those with standard-risk (SR) ALL. PATIENTS AND METHODS AALL0331 enrolled 5,377 patients between 2005 and 2010. All patients received a 3-drug induction with dexamethasone, vincristine, and pegaspargase (PEG) and were then classified as SR low, SR average, or SR high. Patients with SR-average disease were randomly assigned to receive either standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC). Those with SR-high disease were nonrandomly assigned to the full COG-augmented BFM regimen, including 2 interim maintenance and delayed intensification phases. RESULTS The 6-year event-free survival (EFS) rate for all patients enrolled in AALL0331 was 88.96% 6 0.46%, and overall survival (OS) was 95.54% 6 0.31%. For patients with SR-average disease, the 6-year continuous complete remission (CCR) and OS rates for SC versus IC were 87.8% 6 1.3% versus 89.1% 6 1.2% (P = .52) and 95.8% 6 0.8% versus 95.2% 6 0.8% (P = 1.0), respectively. Those with SR-average disease with endinduction minimal residual disease (MRD) of 0.01% to , 0.1% had an inferior outcome compared with those with lower MRD and no improvement with IC (6-year CCR: SC, 77.5% 6 4.8%; IC, 77.1% 6 4.8%; P = .71). At 6 years, the CCR and OS rates among 635 nonrandomly treated patients with SR-high disease were 85.55% 6 1.49% and 92.97% 6 1.08%, respectively. CONCLUSION The 6-year OS rate for . 5,000 children with SR ALL enrolled in AALL0331 exceeded 95%. The addition of IC to treatment for patients with SR-average disease did not improve CCR or OS, even in patients with higher MRD, in whom it might have been predicted to provide more value. The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.
AB - PURPOSE Children's Oncology Group (COG) AALL0331 tested whether intensified postinduction therapy that improves survival in children with high-risk B-cell acute lymphoblastic leukemia (ALL) would also improve outcomes for those with standard-risk (SR) ALL. PATIENTS AND METHODS AALL0331 enrolled 5,377 patients between 2005 and 2010. All patients received a 3-drug induction with dexamethasone, vincristine, and pegaspargase (PEG) and were then classified as SR low, SR average, or SR high. Patients with SR-average disease were randomly assigned to receive either standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC). Those with SR-high disease were nonrandomly assigned to the full COG-augmented BFM regimen, including 2 interim maintenance and delayed intensification phases. RESULTS The 6-year event-free survival (EFS) rate for all patients enrolled in AALL0331 was 88.96% 6 0.46%, and overall survival (OS) was 95.54% 6 0.31%. For patients with SR-average disease, the 6-year continuous complete remission (CCR) and OS rates for SC versus IC were 87.8% 6 1.3% versus 89.1% 6 1.2% (P = .52) and 95.8% 6 0.8% versus 95.2% 6 0.8% (P = 1.0), respectively. Those with SR-average disease with endinduction minimal residual disease (MRD) of 0.01% to , 0.1% had an inferior outcome compared with those with lower MRD and no improvement with IC (6-year CCR: SC, 77.5% 6 4.8%; IC, 77.1% 6 4.8%; P = .71). At 6 years, the CCR and OS rates among 635 nonrandomly treated patients with SR-high disease were 85.55% 6 1.49% and 92.97% 6 1.08%, respectively. CONCLUSION The 6-year OS rate for . 5,000 children with SR ALL enrolled in AALL0331 exceeded 95%. The addition of IC to treatment for patients with SR-average disease did not improve CCR or OS, even in patients with higher MRD, in whom it might have been predicted to provide more value. The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.
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U2 - 10.1200/JCO.19.01086
DO - 10.1200/JCO.19.01086
M3 - Article
C2 - 31825704
AN - SCOPUS:85080085453
SN - 0732-183X
VL - 38
SP - 602
EP - 612
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 6
ER -