Background & objective: The hematological complete remission (CR) rate of the FLAG regimen [fludarabine and cytarabine (Ara-C) and granulocyte-colony stimulating factor] for relapsed and refractory acute non- lymphocytic leukemia (ANLL) was 50-64%. The aim of this study was to investigate the modified FLAG regimen (Ara-C reduced to 200 mg per day intravenous injection for 5 to 7 days, and the patients were not administrated G-CSF before fludarabine and Ara-C) to examine whether it can achieve the same effectiveness and minor side effects.
Methods: Of 33 patients with acute leukemia, there were 16 cases with ANLL, 12 cases with refractory acute lymphocytic leukemia (ALL) and 5 cases with relapsed ALL, respectively. All patients received fludarabine (Flu) 30 mg/m(2)/d intravenous injection for 5 days. And every patient received simultaneously Flu in combination with Ara-C intravenously for 5-7 days, 18 cases with Ara-C at a dose of 200 mg per day, 5 cases with Ara-c 500 mg/d and 10 cases with Ara-c 1000 mg/d, respectively. One course consisted of 7 days. ALL patients and the patients received Ara-C at a dose of 200 mg per day were not treated with G-CSF before chemotherapy. ALL patients received vincristine at a dose of 2 mg/w for 2 times and prednisone 60-80 mg/d for 14 days. Of these 33 patients, the cases with white blood cell(WBC) counts less than 1.0 x 10(9)/L were treated with G-CSF at a dose of 300 microg/d subcutaneously until WBC counts were more than 3.0 x 10(9)/L. All patient were examined for bone marrow after every course.
Results: The CR rate of 16 patients with refractory ANLL was 56.3%, whereas the CR rate of 12 cases with refractory ALL was 17% (P< 0.01). The CR rate of the patients with refractory ANLL who received Ara-C 200 mg/d was higher than those with refractory ANLL receiving Ara-C at the medial doses (70% versus 33%, P >0.05). The average durations of WBC< 0.6 x 10(9)/L and platelet< 15.6 x 10(9)/L were 5 days and 4.3 days, respectively. Infection rate of the patients receiving Ara-C 200 mg/d was significantly lower than those receiving Ara-C at the medial doses (58% versus 87.5%,P< 0.05).
Conclusion: The CR rate of modified FLAG regimen is higher than classic FLAG, whereas the infection rate of the former is lower than the latter.