EFFECTS OF INTERLEUKIN-3 FOLLOWING CHEMOTHERAPY OF NON-HODGKINS-LYMPHOMA - A PROSPECTIVE, CONTROLLED PHASE I II STUDY/

The effect of rhIL-3 was investigated in 32 patients with newly diagno sed non-Hodgkin lymphoma in a phase I/II trial. All patients received 6 cycles of standard CHOP chemotherapy, and each patient was his own c ontrol where rhIL-3 was given as a daily s.c. injection for 14 days (d ay 2-15) in cycle 2 and 4, while cycle 1 and 3 were control cycles. Fi ve dose levels were examined (0.5 - 1 - 5 - 7.5 - 10 mu g/kg). Compare d to the other more lineage-specific hemopoietic growth factors G- and GM-CSF, the effect of rhIL-3 on the hemopoiesis was less dramatic and more delayed, i.e. the most apparent effect was observed in the 2 wee ks of treatment. Thus, the neutrophil counts from days 15 to 22 follow ing CHOP were significantly raised and the duration of neutropenia was shorter (significantly only at 10 mu g/kg), while the nadir values we re unaffected. Platelet recovery from days 12-22 was significantly inc reased and nadir values occurred earlier compared to control cycles, b ut were only increased in some subsets. Other cell populations affecte d moderately in the recovery period were eosinophils and monocytes. Re ticulocytes increased, but no effect on hemoglobin or RBC transfusion requirement was noted. Only moderate adverse reactions occurred such a s fever, chills, flushing of the face and flu-like symptoms. There was no evidence of stimulation of tumor growth. Most significant, the rhI L-3 treatment at all but the lowest dose levels led to an improved tol erance to chemotherapy, as indicated by a decline in number of delayed cycles. A conclusion concerning the role of rhIL-3 as post-chemothera py adjuvant should await studies using rhIL-3 in combination with more lineage-restricted hemopoietic growth factors.