Maintenance therapy with androgens significantly improves survival in older patients with acute myeloid leukemia (AML) without increasing toxicity, according to research published in the Journal of Clinical Oncology (February 2017; 35[4]:387-393).
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Older patients (aged ≥ 60 years) with AML have a particularly poor prognosis due to lower tolerance to intensive chemotherapies and the presence of comorbidities. For this group of patients, improving the efficacy of post-induction chemotherapy while simultaneously lowering treatment-related mortality remains a challenge. Androgens – such as norethandrolone – to treat aplastic anemia have shown to block proliferation in AML cells and potentially improve survival outcomes in patients with such disease.
Researchers from France conducted a multicenter, phase III, randomized open-label trial that assessed the efficacy and safety of adding androgens to maintenance therapy in patients with AML ages 60 years or older. A total of 330 patients with AML were included in the study and were given induction therapy of idarubicine (8 mg/m2, days 1-5), cytarabine (100 mg/m2, days 1-7), and lomustine (200 mg/m2, day 1). Patients were randomly assigned to receive norethandrolone (10 or 20 mg/day, n = 165) or no norethandrolone (n = 165) over the course of a 2-year maintenance regimen. The primary endpoint was disease-free survival and secondary endpoints were event-free survival, overall survival, and safety.
Results of the study showed that norethandrolone significantly improved survival over a 5-year period. Disease-free survival was 31.2% for patients receiving norethandrolone and 16.2% for those not receiving norethandrolone. Event-free survival was 21.5% and 12.9%, and overall survival was 26.3% and 17.2%, respectively. Norethandrolone improved outcomes irrelevant to all prognosis factors.
Additionally, there were no reported differences in toxicity between the two treatment arms.
Additional research is needed to validate maintenance therapy with androgens as a cost-effective approach to AML treatment in older populations. Nonetheless, researchers contend that maintenance therapy with norethandrolone is an effective and safe option for improving survival outcomes for such patients. – Zachary Bessette
