ATRA-ATO combo safe, effective in acute promyelocytic leukaemia

Real-world data confirm that the combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) is an effective treatment regimen for patients with acute promyelocytic leukaemia (APL), a recent study suggests.

“Our data illustrate the possibility of delivering the highest standard of care at a universally affordable cost to treat a leukaemia and meets the aspiration, for the first time, of global equitable healthcare delivery in leukaemia,” the researchers said.

A total of 134 APL patients were enrolled into the study, in whom a per-protocol approach was taken to assess regimen safety and efficacy, excluding patients who opted to undergo treatments at other centres and who had severe infections or bleeding at presentation.

Of the 123 patients in the per-protocol analysis, eight (6.5 percent) died during induction, while four (3.3 percent) were discharged against medical advice before completing induction. The remaining 111 (90.2 percent) patients achieved complete remission after a median of 43 days.

During the 854 days of follow-up, only two patients saw haematologic relapse (1.6 percent) while no deaths were reported. The 2-year overall survival and event-free survival estimates were 93.4 percent and 91.6 percent, respectively.

At presentation, 81 patients showed bleeding symptoms, 19 of whom were deemed as major cases. Nine more patients developed major bleeding during induction, along with four patients who developed thrombosis. Nineteen patients were diagnosed with differentiation symptom during induction.

In addition, more than half (55 percent) of patients had at least one documented infection during induction, while eight (6.5 percent) developed grade 3 hepatotoxicity. ATRA-associated headache or benign intracranial hypertension was documented in 10 patients.