Trisenox arsenic trioxide: Phase III data
An open-label, European Phase III trial in 156 patients with newly diagnosed low- to intermediate-risk APL showed that Trisenox plus all-trans retinoic acid (ATRA) met the primary endpoint of non-inferiority to anthracycline-based chemotherapy plus ATRA in the rate of 2-year EFS (97% vs. 86%, p<0.001 for non-inferiority and p=0.02 for superiority). At a median follow-up of 34.4 months, Trisenox plus ATRA led to a complete remission rate of 100% (n=77) vs. 95% for chemotherapy plus ATRA (n=79). Additionally, Trisenox plus ATRA significantly improved OS vs. chemotherapy plus ATRA (p=0.02). Compared to the control arm, Trisenox plus ATRA was associated with less hematologic toxicity and fewer infections, but more hepatic toxicity. The trial was sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Data were published in the New England Journal of Medicine. ...