GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR INTERLEUKIN-3 FUSIONPROTEIN VERSUS GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR AFTERAUTOLOGOUS BONE-MARROW TRANSPLANTATION FOR NON-HODGKINS-LYMPHOMA - RESULTS OF A RANDOMIZED DOUBLE-BLIND TRIAL

Purpose: A phase III trial to compare PIXY321 with granulocyte-macroph age colony-stimulating factor (GM-CSF) following high-dose therapy and autologous bone marrow transplant (ABMT) was conducted to evaluate th e time to hematopoietic recovery. Patients and Methods: One hundred se venty-seven patients with non-Hodgkin's lymphoma (NHL) receiving ABMT were randomized to receive either PIXY321 750 mu g/m(2)/d divided into two subcutaneous (SC) doses or GM-CSF 250 mu g/m(2)/d as a 2-hour int ravenous (IV) infusion starting on day 0 post-ABMT for a maximum of 28 days. Results: The median time to reach an absolute neutrophil count (ANC) greater than or equal to 500/mu L in the PIXY321 group was 17 da ys versus 19 days in the GM-CSF group (P = .07) and the median time to reach platelet transfusion independence in the PIXY321 group was 25 d ays versus 23 days in the GM-CSF group (P = .30). the toxicity profile s of the two agents appeared to be equivalent with the exception of mo re patients in the PIXY321 group with a rash (64%) compared with the G M-CSF group (48%) (P = .028). A logistic regression model identified t he use of a non-total-body irradiation (TBI) regimen and/or receipt of unpurged marrow and a body-surface area greater than 2.0 m(2) as pred ictive of faster neutrophil engraftment, and those three factors, as w ell as the receipt of less than or equal to two prior chemotherapy reg imens as predictive for rapid platelet engraftment. Conclusion: There was a trend toward a slight improvement in neutrophil engraftment post -ABMT with the PIXY321 administered by an SC route compared with GM-CS F administered by an IV route. However, no differences could be identi fied between the two agents with respect to the time to platelet trans fusion independence. Patient, regimen, and graft characteristics were most predictive of the engraftment tempo. (C) 1997 by American Society of Clinical Oncology.