Maintenance therapy with norethandrolone improves survival of elderly patients with acute myeloid leukemia (AML) without increasing toxicity, according to a study published in the Journal of Clinical Oncology.1
In a multicenter, phase 3, randomized open-label trial, French researchers examined 330 elderly patients with AML de novo or secondary to chemotherapy or radiotherapy who were randomly assigned to receive norethandrolone 10 or 20 mg per day according to body weight, or no norethandrolone for a 2-year maintenance therapy regimen.
Primary endpoint was disease-free survival by intention to treat, and secondary endpoints were event-free survival, overall survival and safety.
The researchers found that complete remission or partial remission was achieved in 247 patients (76%). Treatment with norethandrolone significantly improved survival for patients who were still in remission at 1 year after induction.
Five-year disease-free survival was 31.2% for patients receiving norethandrolone and 16.2% among those receiving only maintenance therapy, while event-free survival was 21.5% and 12.9% and overall survival was 26.3% and 17.2%, respectively.
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Treatment with norethandrolone improved outcomes regardless of all prognostic factors, and only patients who had baseline leukocytes greater than 30 x 109/L saw no benefit.
- Pigneux A, Bene MC, Guardiola P, et al. Addition of androgens Improves survival in elderly patients with acute myeloid leukemia: A GOELAMS study. J Clin Oncol. 2016 Oct 17. doi: 10.1200/JCO.2016.67.6213 [Epub ahead of print]