Quantify’s Mathias Lilja and Johan Mesterton are co-authors on a new study on cytarabine dosing for treating secondary and high-risk AML using a synthetic control arm study design.
Since 1980’s, the standard treatment of acute myeloid leukemia (AML) is cytarabine infusion with anthracycline (7 + 3 regimen). Our latest research at Quantify aimed to assess if higher cytarabine dosing in induction may provide a benefit in older patients with secondary and high-risk AML compared with the standard 7 + 3 regimen.
To address this question, we collaborated with national clinical experts to leverage a synthetic control arm approach, combining unique data from the Swedish AML registry, including granular information on patient characteristics, treatments, and outcomes, with clinical trial data from the US and Canada. This study fills an important gap in the evidence base and offers new insights into treatment strategies for this vulnerable patient population.
What’s New?
Quantify’s recent study compared two key treatment protocols:
- Standard 7+3 Regimen: 100 mg/m² cytarabine via continuous infusion for 7 days, plus 60 mg/m² daunorubicin for the first 3 days.
- Swedish Standard-of-Care:1g/m² cytarabine twice daily for 7 days, along with 60 mg/m² daunorubicin administered in eight-hour infusions for the first 3 days.
Key Strength
A key challenge in any study of drug effectiveness—particularly when using external comparators—is ensuring that the study groups have similar characteristics. This study ensured comparability by aligning the Swedish AML registry patients with the trial’s eligibility criteria and through propensity scoring, including age, sex, and indicators of disease activity as matching variables.
Key Findings
Our results suggest that intensified cytarabine dosing during induction is feasible also in high-risk older AML patients without increased early mortality and with beneficial long-term survival.
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