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Cytokine efficiency in the treatment of high-grade malignant non-Hodgkin's lymphomas: Results of a randomized double-blind placebo-controlled study with intensified COP-BLAM ± rhGM-CSF

In high-grade malignant non-Hodgkin's lymphomas (hNHL) recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was evaluated as support to chemotherapy. In a phase III trial, 172 patients (age 18–73 years, stage II-IV) were risk-stratified according to LDH levels and lymph...

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Published in:Annals of oncology 1994, Vol.5 (suppl-2), p.S123-S125
Main Authors: Engelhard, M., Gerhartz, H., Brittinger, G., Engert, A., Fuchs, R., Geiseler, B., Gerhartz, D., Haunauske, A.R., Hartlapp, H.-J., Huhn, D., Ludwig, W.-D., Meusers, P., Müller, P., Pees, H.-W., Peschel, C.h., Radtke, H., Schadeck-Gressel, C., Schlimok, G., Siegert, W., Spann, W., Terhardt, E., Thiel, E., Wilmanns, W., Brandmaier, R., Ehrlich, H.J., Färber, L., Parwaresch, M., Tiemann, M., Lennert, K.
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Language:English
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Summary:In high-grade malignant non-Hodgkin's lymphomas (hNHL) recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was evaluated as support to chemotherapy. In a phase III trial, 172 patients (age 18–73 years, stage II-IV) were risk-stratified according to LDH levels and lymphoma size and randomized to receive rhGM-CSF (400 μg) (87 patients) or placebo (85 patients) subcu-taneously days 8–14 of each cycle of an intensified COP-BLAM regimen. RhGM-CSF significantly reduced the length and nadir of neutropenia, the length of fever episodes, the frequency of all and of severe infections, and of hospitaliza-tion and antibiotic requirements. Complete response rates were 63% for all patients and 64% vs. 61% (n.s.) in the rhGM-CSF vs. the control group. Deviations from protocol in applied dosages of myelotoxic drugs and in cycle intervals maintained differed slightly in favor of the rhGM-CSF arm. However, there were no significant differences in overall survival between the GM-CSF treatment and control groups (21 vs. 23 months). Early relapse rates were markedly lower than in the standard-dose COP-BLAM/IMVP-16 regimen. Thus, GM-CSF abates toxic side effects of chemotherapy and may help to maintain dose intensity in high-risk hNHL.
ISSN:0923-7534
1569-8041
DOI:10.1093/annonc/5.suppl_2.S123