Mitoxantrone/high dose ara-C and recombinant human GM-CSF in the treatment of refractory non-Hodgkin's lymphoma: a pilot study

A previous study showed that the combined drug regimen of the anticancer agents mitoxantrone and ara-C was active against non-Hodgkin's lymphoma (NHL) a cancer of the lymphatic system, which was unresponsive to conventional chemotherapy (refractory). However, increasing doses of this regimen, referred to as NOAC, caused myelosuppression, inhibition of bone marrow function. Human granulocyte-macrophage colony-stimulating factor (hGM-CSF) is a protein that activates the production of macrophages, immune cells produced in bone marrow that are capable of ingesting foreign particles. This protein can be produced in large quantities by recombinant technology and the final product is called recombinant human GM-CSF (rhGM-CSF). The effects of rhGM-CSF after NOAC treatment were assessed in 23 patients with refractory NHL and compared with the response of 14 patients who received only NOAC. A severe decrease in neutrophils (a type of white blood cell) and in platelets (cells involved in blood clotting) lasted longer in patients receiving NOAC alone than in patients receiving both rhGM-CSF and NOAC. Patients treated with rhGM-CSF developed fewer infections and stomatitis, inflammation of the mouth, than patients not receiving the factor. Treatment with rhGM-CSF was associated with accumulation of fluids in the lung and abdominal cavities in five patients; the formation of blood clots in two patients; bone pain in two patients; and respiratory distress syndrome (severe breathing impairment) in one patient. A complete remission was achieved in 9 of 23 patients treated with rhGM-CSF and in 2 of 14 patients not treated with the factor. Patients treated with rhGM-CSF survived longer than patients receiving chemotherapy alone. The findings show that rhGM-CSF shortens the period of blood cell suppression, reduces the incidence of stomatitis, and causes few adverse effects. (Consumer Summary produced by Reliance Medical Information, Inc.)