GRANULOCYTE-COLONY-STIMULATING FACTOR SHORTENS DURATION OF CRITICAL NEUTROPENIA AND PROLONGS DISEASE-FREE SURVIVAL AFTER SEQUENTIAL HIGH-DOSE CYTOSINE-ARABINOSIDE AND MITOXANTRONE (S-HAM) SALVAGE THERAPY FOR REFRACTORY AND RELAPSED ACUTE MYELOID-LEUKEMIA

Patients with primary refractory or relapsed acute myeloid leukemia (A ML) who undergo intensive salvage chemotherapy carry a high risk of tr eatment failure due to infectious complications and early relapses. Th e study presented here assessed the effect of granulocyte colony-stimu lating factor (G-CSF) on the duration of post-treatment neutropenia, t he incidence of infection-related deaths, and the disease-free and ove rall survival. Sixty-eight evaluable patients with relapsed and refrac tory AML received G-CSF 5 mu g/kg per day subcutaneously starting 2 da ys after the completion of salvage treatment with the S-HAM regimen, c onsisting of high-dose cytosine arabinoside twice daily on days 1, 2, 8, and 9 and mitoxantrone on days 3, 4, 10, and 11, Ninety-one patient s who were treated with the identical S-HAM regimen but without G-CSF support during a preceding study served as controls. The application o f G-CSF resulted in a significant shortening of critical neutropenia o f less than 500 mu l (36 vs. 40 days; p = 0.008), which translated int o a trend towards a lower early death rate (21% vs. 30%) and an increa se of complete remissions (56% vs. 47%, p = 0.11). In patients younger than 60 years a significant prolongation of time to treatment failure (159 vs. 93 days, p = 0.038) and of duration of disease-free survival (203 vs. 97 days, p = 0.003) was observed, These results indicate a b eneficial effect of G-CSF on early mortality as well as on long-term o utcome when administered after S-HAM salvage therapy for advanced AML.