CONCOMITANT GRANULOCYTE-COLONY-STIMULATING FACTOR AND INDUCTION CHEMORADIOTHERAPY IN ADULT ACUTE LYMPHOBLASTIC-LEUKEMIA - A RANDOMIZED PHASE-III TRIAL

This prospective multicenter study examined whether simultaneous admin istration of granulocyte colony-stimulating factor (C-CSF; Filgrastim) and induction chemotherapy for adult acute lymphoblastic leukemia (AL L) could prevent treatment-related neutropenia, infections, and result ing treatment delays. Seventy-six patients were randomly assigned to r eceive either G-CSF (n = 37) or no growth factor (n = 39) in conjuncti on with a uniform chemotherapy consisting of cyclophosphamide, cytarab ine, mercaptopurine, intrathecal methotrexate, and cranial irradiation . The median duration of neutropenia (absolute neutrophil count <1 x 1 0(9)/L) during chemotherapy was 8 days in patients receiving G-CSF, co mpared with 12.5 days in the control group (P < .002). A similar reduc tion from 11.5 to 7 days was observed in patients with T-ALL receiving additional mediastinal irradiation (P = .13). Infections occurred in 43% and 56% of patients in the G-CSF and control arm, respectively (P = .25); the incidence of nonviral infections was reduced by 50%, from 32 episodes in the control arm to 16 episodes in the G-CSF arm. Prolon ged interruptions of chemotherapy administration were less frequent, w ith delays of 2 weeks or more occurring in only 24% of patients receiv ing G-CSF as opposed to 46% in the control arm (P = .01). Accordingly, chemotherapy was completed significantly earlier with the use of G-CS F (39 v 44 days, P = .008). With a median followup of 20 months, the p robability of disease-free survival was 0.45 in the G-CSF group and 0. 43 in the control group (P = .34), In conclusion, adult ALL patients a ppear to benefit by the simultaneous administration of G-CSF with indu ction chemotherapy because of a significant reduction in the duration of neutropenia, a trend to fewer infections, and a more rapid completi on of chemotherapy. (C) 1995 by The American Society of Hematology.