AAML1031: bortezomib with standard chemotherapy for children with acute myeloid leukaemia does not improve outcomes
Adding the proteasome inhibitor bortezomib to standard chemotherapy for children with newly diagnosed acute myeloid leukaemia did not help them live longer or relapse less, and it caused more nerve damage and intensive care admissions.
Overview
Report of the randomised bortezomib question in the Children's Oncology Group phase 3 AAML1031 trial: 1,097 patients under 30 with de novo acute myeloid leukaemia were randomised to standard chemotherapy with (n 555) or without (n 542) bortezomib 1.3 mg/m2 on days 1, 4 and 8 of each course.
Remission induction rates were the same (89 against 91 percent), three-year event-free survival was 44.8 against 47.0 percent and overall survival 63.6 against 67.2 percent. Bortezomib was associated with more peripheral neuropathy and intensive care unit admissions during the first course.
- Complete remission 89 percent with bortezomib versus 91 percent without (p 0.531).
- Three-year event-free survival 44.8 versus 47.0 percent (p 0.236) and overall survival 63.6 versus 67.2 percent (p 0.356).
- More peripheral neuropathy (p 0.006) and intensive care admissions (p 0.025) with bortezomib.
Bortezomib should not be added to standard chemotherapy for childhood acute myeloid leukaemia; the trial's FLT3-ITD sorafenib cohorts were reported separately.
- Open-label randomisation; the trial's high allelic ratio FLT3-ITD patients were treated in non-randomised sorafenib cohorts and excluded from this comparison.
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