HEMATOPOIETIC GROWTH-FACTORS - RESULTS OF A CONTROLLED CLINICAL-TRIALCOMPARING INDIVIDUAL GROWTH-FACTOR THERAPY

Preclinical studies of hematopoietic growth factors have demonstrated multilineage hematopoiesis enhancement when administered sequentially. However, these initial results have not been confirmed in later studi es. This study was designed to evaluate the safety, tolerability and u sefulness of hematopoietic growth factors after intensive chemotherapy for patients with malignant lymphoma and Hodgkin's disease used alone or sequentially. Patients received intensive (but sublethal dose) che motherapy and were randomized to enter one of the four study groups to receive 1) Granulocyte colony-stimulating factor (GM-CSF); 5 ug/kg/da y, subcutaneously for 10 days started on day 5 after chemotherapy admi nistration, 2) Granulocyte-macrophage colony-stimulating factor (GM-CS F) in the same dose, route and time; 3) GM-CSF for the first 5 days fo llowed by G-CSF for the last 5 days of each cycle of hematopoietic gro wth factors, 4) G=CSF followed by GM-CSF in the same schedule of group 3. The doses, route of administration and schedules were similar in t he four arms. Laboratory evaluation was performed daily during hospita lizations and weekly after discharge. The results showed that granuloc yte recovery was shorter in the group of patients who received GM-CSF alone (11.6 days) compared to G-CSF (15.4 days), G-CSF followed by GM- CSF (15.3 days) and GM-CSF followed by G-CSF (13.8 days) with statisti cal differences (<.01). Febrile episodes and delays on treatment were also fewer in the patients who received GMCSF alone. Side effects and complications were similar in the four groups. No fatalities were obse rved. All patients received the planned doses of cytotoxic drugs. We c annot confirm whether sequential use of hematopoietic growth factors i s better that compared to individual use. Our results suggest that GM- CSF appear to be preferable with respect to G-CSF or sequential use of available hematopoietic growth factos.