FLAG-IDA in the treatment of refractory/relapsed acute leukaemias: single centre study.

OBJECTIVE: To evaluate the efficacy and toxicity profile of the combination of fludarabine, high dose cytarabine, idarubicin, and granulocyte colony stimulating factor in refractory relapsed cases of acute leukaemia, a study is being conducted at Armed Forces Bone Marrow Transplant Centre (AFBMTC) Rawalpindi since January 2003. Data up to June 2004 (early report) is being presented. METHODS: Twelve Patients with refractory/relapsed (Ref/Rel) acute leukaemia (AL) were treated with fludarabine 30 mg/m2 and cytosine arabinoside (AraC) Arac 2 g/m2 for 5 days, idarubicin 10 mg/m2 for 3 days, and granulocyte colony stimulating factor G-CSF 5 micro g/kg from day 0 till neutrophil recovery (ANC > 1.0 x 10(9)/1). Response was evaluated by bone marrow examination on day 20-post chemotherapy. RESULTS: Patients included were refractory acute lymphoblastic leukaemia (ALL) (n=2), relapsed ALL (n = 3), refractory acute myeloid leukaemia (AML) (n = 3), secondary AML (n=2) relapsed AML (n = 1) and acute undifferentiated leukaemia (AUL) (n = 1). Complete remission (CR) was achieved in 8 (66.6%) patients. Three (25%) patients died of post chemotherapy complications and one patient failed to achieve remission. Out of 8 patients who achieved CR, 4 underwent allogeneic bone marrow transfusion (BMT), 1 is being evaluated for the same, 1 received idorubicin, AraC and etopuside (ICE) and high dose AraC, 1 did not receive further chemotherapy and 1 relapsed two months after remission. Seven patients are still in CR after a median follow up of 8 months (range 3-18). Major complications encountered were diarrhoea, mucositis, toxic ileus, transient hepatic toxicity, fungal and bacterial infections. CONCLUSION: In our experience, FLAG-IDA is well tolerated and effective regimen in relapsed/refractory acute leukaemias. The toxicity is acceptable, enabling most patients to receive further treatment, including transplantation procedures.