Reducing the frequency of maintenance treatment produced “outstanding” outcomes in pediatric patients with average-risk B-cell acute lymphoblastic leukemia (B-ALL), researchers reported in the Journal of Clinical Oncology.
Disease-free survival (DFS) and overall survival (OS) rates were similar whether patients received maintenance every 4 weeks or every 12 weeks on the phase 3 Children’s Oncology Group AALL0932 trial (ClinicalTrials.gov Identifier: NCT01190930).
The AALL0932 trial was designed to evaluate risk-adapted therapy. For part of the trial, researchers compare a reduced frequency of vincristine plus dexamethasone maintenance with the standard frequency in pediatric patients who had standard-risk B-ALL.
Of the 9226 patients with newly diagnosed B-ALL enrolled in the trial, 2364 average-risk patients were randomly assigned to 1 of 4 maintenance arms:
In arm A, 600 patients received vincristine plus dexamethasone every 4 weeks along with methotrexate at 20 mg/m2 once a week.
In arm B, 586 patients received vincristine plus dexamethasone every 4 weeks with methotrexate at 40 mg/m2 once a week.
In arm C, 586 patients received vincristine plus dexamethasone every 12 weeks with methotrexate at 20 mg/m2 once a week.
In arm D, 592 patients received vincristine plus dexamethasone every 12 weeks with methotrexate at 40 mg/m2 once a week.
Overall, the 5-year DFS and OS rates from the start of maintenance were 94.6% and 98.5%, respectively.
The 5-year DFS rate was 94.1% for patients receiving maintenance every 4 weeks and 95.1% for patients receiving maintenance every 12 weeks (P =.86). The 5-year OS rates were 98.3% and 98.6%, respectively (P =.69).
The 5-year DFS rate was 95.4% for arm A, 92.8% for arm B, 94.7% for arm C, and 95.6% for arm D (P =.06). The 5-year OS rates were 98.7%, 97.9%, 98.9%, and 98.4%, respectively (P =.61)
Maintenance was well-tolerated, according to the researchers. There were no differences in targeted toxicities between the arms.
However, patients receiving maintenance every 12 weeks had a lower incidence of neuropathy compared with patients receiving maintenance every 4 weeks — 1.8% and 3.4%, respectively (P =.015).
“AALL0932 demonstrated outstanding outcomes with vincristine/dexamethasone maintenance pulses given every 12 weeks,” the researchers wrote. “Reducing maintenance vincristine/dexamethasone pulses by two-thirds lessens the burden of therapy and may translate to improved quality of life.”
Disclosures: This research was supported by the Children’s Oncology Group and National Cancer Institute. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Angiolillo AL, Schore RJ, Kairalla JA, et al. Excellent outcomes with reduced frequency of vincristine and dexamethasone pulses in standard-risk B-lymphoblastic leukemia: results from Children’s Oncology Group AALL0932. J Clin Oncol. 2021;39(13):1437-1447. doi:10.1200/JCO.20.00494