Eltrombopag during induction chemotherapy in older patients with newly diagnosed acute myeloid leukemia is safe and reduces platelet transfusion requirements: The EPAG-2015 French Innovative Leukemia Organization phase 2 randomized trial.
Arnaud Pigneux, Pierre-Yves Dumas, Marc Bernard et al.
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In 30 seconds
The multicentre, phase 2 randomized trial EPAG-2015 evaluated eltrombopag started after induction chemotherapy in patients aged 60 years or older with newly diagnosed acute myeloid leukemia. Among 110 participants, eltrombopag did not improve overall survival (hazard ratio, 1.59; 95% CI, 0.65-3.89; p = .31) and did not increase grade 3/4 adverse events. It was associated with fewer platelet transfusions: the median was eight (IQR, 6-14) with eltrombopag versus 10 (IQR, 7-14) with placebo, a 20% benefit.
Key findings
- Overall survival did not differ significantly between groups (hazard ratio, 1.59; 95% CI, 0.65-3.89; p = .31).
- Median platelet transfusions were eight (IQR, 6-14) with eltrombopag versus 10 (IQR, 7-14) with placebo, a 20% benefit.
- Eltrombopag was not associated with increased grade 3/4 adverse events.
- Complete response or CR with incomplete reconstitution occurred in 45 patients in each group.
Why it matters
Thrombocytopenia during intensive AML induction can require substantial platelet support. This trial suggests that eltrombopag begun after chemotherapy may reduce transfusion requirements without an observed increase in severe adverse events, while providing no evidence of a survival advantage. The findings help distinguish a potential supportive-care benefit from an effect on leukemia outcomes.
What to keep in mind
The phase 2 trial did not demonstrate a survival advantage; the reported confidence interval for the overall-survival hazard ratio is wide.