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Salvage therapy for acute myeloid leukemia with fludarabine, cytarabine, and idarubicin with or without gemtuzumab ozogamicin and with concurrent or sequential G-CSF
American Journal of Hematology, 10/13/09

Martin MG et al. – The current salvage therapies for relapsed/refractory acute myeloid leukemia (AML) are unsatisfactory.

• 71 patients treated 23 with FLAG-I and 48 with FLAG-IM
• 2 salvage regimens: fludarabine, cytarabine, and idarubicin with (FLAG-IM) or without gemtuzumab ozogamicin (GO) (9 mg/m2 on Day 8) (FLAG-I) in relapsed/refractory AML
• Three-quarters of patients also received concurrent G-CSF
• Treatment groups well balanced with median ages of 48 years (range 18-70) and 47 years (range 20-68), unfavorable cytogenetics in 57% and 35%, prior allogeneic stem cell transplant in 43% and 42%, and CR1 duration < 1 year in 60% and 67%, respectively, for FLAG-I and FLAG-IM

• CR rate in FLAG-I group 39% with additional 13% achieving a CRp [overall response rate (ORR) 52%]; the CR rate in FLAG-IM group 29% with additional 27% achieving a CRp (ORR 56%)
• Median duration of response (DOR; 16.8 vs. 8.3 months), event-free survival (EFS; 7.4 vs. 4.1 months), and overall survival (OS; 8.8 vs. 5.0 months) trended to favor FLAG-I over FLAG-IM
• Patients who received G-CSF concurrent with chemotherapy had superior overall response rate (ORR (ORR; 62% vs. 29%, P = 0.026), median EFS (6.2 vs. 3.4 months, P = 0.010), and OS (8.8 vs. 3.9 months, P = 0.004) when compared with those who sequentially received G-CSF and chemotherapy, regardless of chemotherapy regimen
• Addition of GO, at this dose and schedule, to FLAG-I failed to improve outcomes in patients with relapsed/refractory AML
• Patients who received G-CSF concurrently with chemotherapy had improved outcomes

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