[Effectiveness and safety of the FLAG-IDA regimen in acute refractory or recurrent leukaemia]

To evaluate the effectiveness and safety of the FLAG-IDA regimen in patients with acute refractory and/or recurrent leukaemia.

Descriptive, retrospective, observational study of the clinical histories of patients with the FLAG-IDA regimen during the period of 2005-2010. Effectiveness was measured using objective response, progression-free interval, and global survival. Safety was measured using the NCI classification system of common toxicity criteria for adverse events.

We registered 12 patients (52.17±8.26 years in women, and 54.83±7.22 years in men), 11 cases were acute myeloid leukaemia (5 refractory, 3 in recurrence, 1 secondary to chronic refractory myeloid leukaemia (CML) and 2 secondary to myelodysplastic syndrome (MDS), one of which was refractory and the other had not been previously treated) and one case was acute refractory lymphoblastic leukaemia (ALL). Six patients (50%) reached a complete response (CR). One patient reached a partial response (PR), which was followed by another protocol that produced a CR, two died due to disease progression, and three due to secondary complications from treatment. The progression-free interval for patients that reached a CR was 24.38 weeks (6 months). Median global survival was 8.4 weeks. Mean time needed for the recovery of neutropenia was 23 and 37 days in the first and second cycle, respectively. The mean time required for recuperation of thrombocytopenia was 24 and 35 days in each cycle.

The FLAG-IDA induction regimen for the treatment of high-risk leukaemia patients is an established protocol, with good tolerance and acceptable toxicity levels that offers an opportunity for facilitating the transplantation of haematopoietic progenitors.