Reducing Maintenance Produced ‘Outstanding’ Survival Outcomes in Pediatric Acute Lymphoblastic Leukemia

Reducing the frequency of maintenance treatment produced “excellent” results in pediatric patients with intermediate-risk B-cell acute lymphoblastic leukemia (B-ALL), researchers reported in the Journal of Clinical Oncology.

Disease-free survival (DFS) and overall survival (OS) were similar whether patients received maintenance every 4 weeks or every 12 weeks in the Phase 3 Children’s Oncology Group AALL0932 study (ClinicalTrials.gov Identifier: NCT01190930).

The AALL0932 study was designed to evaluate risk-adjusted therapy. For part of the study, researchers compared a reduced frequency of vincristine plus dexamethasone maintenance to the standard frequency in pediatric patients with standard-risk B-ALL.

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Of the 9226 patients with newly diagnosed B-ALL enrolled in the study, 2,364 intermediate-risk patients were randomly assigned to 1 of 4 maintenance arms:

In arm A, 600 patients received vincristine plus dexamethasone along with 20 mg/m2 methotrexate once weekly every 4 weeks.

In arm B, 586 patients received vincristine plus dexamethasone with 40 mg/m2 once weekly methotrexate every 4 weeks.

In arm C, 586 patients received vincristine plus dexamethasone with 20 mg/m2 once weekly methotrexate every 12 weeks.

In arm D, 592 patients received vincristine plus dexamethasone with 40 mg/m2 once weekly methotrexate every 12 weeks.

Overall, the 5-year DFS and OS rates from maintenance initiation 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 = 0.69).

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 = 0.06). The 5-year OS rates were 98.7%, 97.9%, 98.9%, and 98.4%, respectively (p = 0.61)

The maintenance was well tolerated, according to the researchers. There were no differences in targeted toxicities between the arms.

However, patients who received maintenance every 12 weeks had a lower incidence of neuropathy compared to patients who received maintenance every 4 weeks – 1.8% and 3.4%, respectively (p = 0.015).

“AALL0932 showed excellent results with maintenance pulses of vincristine/dexamethasone given every 12 weeks,” the researchers wrote. “Reducing vincristine/dexamethasone maintenance pulses by two-thirds reduces the burden of therapy and may translate into improved quality of life.”

Disclosures: This research was supported by the Children’s Oncology Group and the National Cancer Institute. Some of the study authors stated that they have ties to biotech, pharmaceutical and/or device companies. See the original reference for a full list of author disclosures.

Reference

Angiolillo AL, Schore RJ, Kairalla JA, et al. Excellent results 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

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