ASSESSMENT OF THE VALUE OF TREATMENT WITH GRANULOCYTE-COLONY-STIMULATING FACTOR IN CHILDREN WITH ACUTE LYMPHOBLASTIC-LEUKEMIA - A RANDOMIZED CLINICAL-TRIAL

The present trial was designed to test the effects of G-CSF on the dur ation of the second phase of induction chemotherapy in children with n ewly diagnosed acute lymphoblastic leukemia (ALL). A total of 32 patie nts were assigned randomly to a group that received (14 patients; grou p A) or a group that did not receive (18 patients; group B) G-CSF (10 g/kg/day subcutaneously and daily) throughout of the second phase of i nduction therapy. One of 14 (7.1%)patients in group A and 2 of 18 (11. 1%) patients in group B completed the course of chemotherapy within th e planned time. The median length of this phase was 37 days (range, 29 to 65; mean, 40; SD, 8.6) for patients in group A and 36 days (range, from 29 to 55; mean, 38; SD, 7.4) for those in group B, and the diffe rence was not statistically significant. The number of days during whi ch patients had granulocyte counts of less than 2 x 10(9)/l, the numbe r of febrile episodes of unknown origin, the number of bacterial and f ungal infections and the number of days of hospitalization did not dif fer in a statistically significant manner between the two groups. Our data suggest that G-CSF supportive therapy may be unnecessary in child ren with neutropenia of short duration, for whom the risk of infection is low.