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Effects of recombinant human interleukin-6 in cancer patients: a phase I-II
study
MM van Gameren, PH Willemse, NH Mulder, PC Limburg, HJ Groen, E Vellenga and EG de Vries
Department of Internal Medicine, University Hospital, Groningen, The
Netherlands.
To define the toxicity profile of recombinant human interleukin-6 (rhIL- 6)
and to study its effect on hematopoiesis, biochemical parameters and other
cytokines, rhIL-6 was administered in a phase I-II study to 20 patients
with breast carcinoma or nonsmall cell lung cancer. RhIL-6 doses were 0.5,
1.0, 2.5, 5.0, 10, and 20 micrograms/kg/d, with at least three patients per
dose level. RhIL-6 was administered 24 hours by continuous intravenous
infusion followed by subcutaneous (SC) administration for 6 days, partly on
an outpatient basis. RhIL-6- related side effects were fever, headache,
myalgia, and local erythema. Starting at 2.5 micrograms/kg/d, these side
effects were compounded by nausea, reversible increase in liver enzymes,
and anemia. Flu-like symptoms were controllable up to and including 10
micrograms rhIL- 6/kg/d with acetaminophen. RhIL-6 increased platelet
counts with a decrease in mean platelet volume and increased leukocytes
caused by neutrophil, monocyte, and lymphocyte increase, with an increase
in T cells and natural killer cells at 1.0 and 2.5 micrograms rhIL-6/kg/d.
The reversible anemia was characterized by a decrease in serum iron, and an
increase in ferritin and erythropoietin without reticulocytosis. RhIL-6
reduced total cholesterol levels and a dose-related increase of C-reactive
protein and serum amyloid A plasma levels was observed. Serum IL-6 levels
were increased, especially at 10 and 20 micrograms/kg/d, whereas no change
in IL-1 beta and tumor necrosis factor alpha levels was observed. RhIL-6
can be administered with controllable side effects in this setting, up to
and including a SC dose of 10 micrograms/kg/d on an outpatient basis, and
has a promising stimulating effect on leukopoiesis and thrombopoiesis.
Volume 84,
Issue 5,
pp. 1434-1441,
09/01/1994
Copyright © 1994 by The American Society of Hematology
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