The administration of the androgenic, anabolic steroid norethandrolone during post-induction treatment improved survival outcomes among older patients with newly diagnosed acute myeloid leukemia (AML), according to findings from a multicenter, randomized, open-label, phase III study published in the Journal of Clinical Oncology.
“Older patients with AML have a poor prognosis and innovative maintenance therapy could improve their outcomes,” wrote Arnaud Pigneux, MD, from the Université Bordeaux in France, and authors.
Three-hundred and thirty patients received induction therapy consisting of 8 mg/m2 of idarubicin on days one through five, 100 mg/m2 of cytarabine on days one through seven, and 200 mg/m2 of lomustine on day one. Patients were then randomized to receive 10 mg or 20 mg of norethandrolone daily (based on body weight) for a two-year maintenance therapy regimen (n=162; median age = 70 years) or no maintenance therapy (n=163; median age = 70 years).
Complete or partial remission occurred in 247 patients (76%), including 230 patients (70.7%) who achieved a complete response (CR). Of those in CR, 31.2 percent in the maintenance therapy cohort achieved five-year, disease-free survival (primary endpoint), compared with 16.2 percent of patients in the no-maintenance group (p=0.002).
Patients who received maintenance therapy also were more likely to achieve five-year, event-free survival (21.5% vs. 12.9%; p value not provided) and five-year overall survival (26.3% vs. 17.2%; p=0.008), compared with the no-maintenance group.
However, the researchers found that patients with baseline leukocytes >30×109/L did not benefit from norethandrolone.
Source: Pigneux A, Béné MC, Guardiola P, et al. Addition of androgens improves survival in elderly patients with acute myeloid leukemia: A GOELAMS Study. J Clin Oncol. 2016 October 24. [Epub ahead of print]