New research indicates that the chemo-free combo of ATRA and ATO, typically used for low-risk acute promyelocytic leukemia, was also beneficial for patients with high-risk APL.
also shows superior benefits in the high-risk APL population, suggesting the regimen should become the standard in those patients as well, new research shows.
However, the treatment regimen has not been evaluated in randomized trials in patients with high-risk APL, defined as having a white blood cell count of more than 10,000 cells/μL. The patients were randomized into one of two groups: ATRA/ATO, involving treatment consisting of two doses of idarubicin on days 1 and 3 at the time of induction therapy, in addition to ATO 0.15 mg/kg and ATRA 45 mg/m, daily until complete remission, or the ATRA-chemotherapy arm, involving standard ATRA also with idarubicin induction, followed by three cycles of chemotherapy-based consolidation, as well as 2 years of maintenance treatment.
Overall, participants had a mean age of 46 years, 50% were female, their median Eastern Cooperative Oncology Group score was 1. Their median white blood cell count was 36 × 10Molecular resistance occurred in 1.7% in the ATRA/ATO arm vs 5.5% in the ATRA chemotherapy arm, which was not statistically significant . However, the incidence of molecular relapse was much lower without chemotherapy, at 1.6% with ATRA/ATO vs 14% with ATRA and chemotherapy.
In terms of toxicities, the ATRA/ATO group had significantly lower rates of hematologic toxicity vs ATRA-chemotherapy, including rates of thrombocytopenia grades 1-4 andQTc prolongation grades 3-4 occurred in 4.4 patients receiving ATRA/ATO compared with 0 in the ATRA-chemotherapy group. However, Dr Platzbecker said the cases had no clinical implications.
Acute Leukaemia Acute Promyelocytic Leukemia Acute Progranulocytic Leukemia APL APML Acute Promyelocytic Leukaemia Acute Progranulocytic Leukaemia Chemotherapy Thrombocytopenia Toxicology Toxicity Poisoning Toxins Leukemia Leukaemia Blood Cancer White Blood Cell Count Leukocyte Count WBC Count White Count Acute Myeloblastic Leukemia Acute Myeloid Leukemia
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