In an analysis reported in the Journal of Clinical Oncology, Ariffin et al found noninferior event-free survival with an anthracycline-free vs anthracycline-containing regimen among children with favorable-risk B-cell precursor acute lymphocytic leukemia (ALL) enrolled in two Malaysia-Singapore ALL studies.
Study Details
The analysis included 369 children (aged 1–9 years) with no extramedullary disease and no high-risk genetics who cleared measurable residual disease (≤ 0.01%) at the end of remission induction. They included 167 patients from the Malaysia-Singapore ALL 2003 study (MS2003) who received standard-risk treatment, including 120 mg/m2 of anthracyclines during delayed intensification, and 202 patients from the Malaysia-Singapore ALL 2010 study (MS2010) who received an anthracycline-free standard-risk protocol. The primary outcome measure was a noninferiority margin of 1.15 on the upper 95% confidence interval (CI) of the hazard ratio for 6-year event-free survival between the MS2003 and MS2010 groups.
Key Findings
Event-free survival at 6 years was 95.2% ± 1.7% in the MS2003 group vs 96.5% ± 1.5% in the MS2010 group (P = .46). In an analysis adjusting for race, sex, age, presenting white blood cells, day 8 prednisolone response, and favorable genetic subgroups, the hazard ratio for the MS2010 vs MS2003 group was 0.98 (95% CI = 0.84–1.14, P = .79), satisfying the noninferiority criterion.
Overall survival at 6 years was 97.6% ±1.2% in the MS2003 group vs 99% ± 0.7% in the MS2010 group (P = .81). The cumulative incidence of relapse at 6 years was 3.6% vs 2.6% (P = .42).
Compared with the MS2003 group, the MS2010 group had significantly lower rates of bacteremia (30% vs 45.6%, P = .04) and intensive care unit admission (1.5% vs 9.5%, P = .004).
The investigators concluded: “In comparison with MS2003 [standard-risk] protocol], the anthracycline-free MS2010 [standard-risk] protocol is not inferior and was less toxic as treatment for favorable-risk childhood B-cell precursor ALL.”
Hany Ariffin, PhD, MBBS, of the Department of Pediatrics, University of Malaya, Kuala Lumpur, Malaysia, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from Kementerian Sains, Teknologi dan Inovasi, Malaysia, Cancer Science Institute of Singapore, National University of Singapore, and others. For full disclosures of the study authors, visit ascopubs.org.
