RANDOMIZED TRIAL OF R-METHU GRANULOCYTE-COLONY-STIMULATING FACTOR IN AN INTENSIVE TREATMENT FOR T-CELL LEUKEMIA AND ADVANCED-STAGE LYMPHOBLASTIC LYMPHOMA OF CHILDHOOD - A PEDIATRIC-ONCOLOGY-GROUP PILOT-STUDY

Purpose: Contemporary chemotherapy has significantly improved the even t-free survival (EFS) among patients with T-cell disease. However, mye losuppression has been a significant adverse effect of this approach. In this study, we assessed the impact of r-metHu granulocyte colony-st imulating factor (G-CSF) on the period of neutropenia, number of days of hospitalization, and delays in subsequent administration of chemoth erapy in a cohort of patients with T-cell leukemia (T-ALL) or advanced stage lymphoblastic lymphoma (ASLL). Patients and Methods: This open- label, randomized trial incorporated r-metHuG-CSF into the induction a nd two consecutive continuation-therapy cycles of our intensive progra m for T-cell malignancies. In the induction phase, r-metHuG-CSF was gi ven after two different combinations of chemotherapy, one of which inc luded vincristine, prednisone, cyclophosphamide, and adriamycin and th e other a continuous infusion of high-dose ara-C and L-asparaginase. I n the two continuation-therapy cycles, r-metHuG-CSF was given followin g the combination of vincristine, adriamycin, prednisone, and 6-mercap topurine (MP) and after continuous infusion of high-dose cytarabine (a ra C). Results: Fifty-six patients with T-ALL and 33 with ASLL were en rolled onto study from April 1994 to December 1995. Our data show no s ignificant difference in number of days of absolute neutrophil count ( ANC) less than 500/mu L, hospitalizations, or delays in therapy in the induction phase. However, in the continuation-therapy phase the numbe r of days of ANC less than 500/mu L was significantly shorter (P = .01 7) on the G-CSF-arm without significantly affecting the number of days of hospitalizations or delays in therapy. Conclusion: r-metHuG-CSF di d not significantly affect the period of neutropenia, hospitalization, or delays in therapy in the induction phase, whereas in the two cycle s of continuation therapy, it significantly shortened the period of ne utropenia. (C) 1998 by American Society of Clinical Oncology.