Recombinant human interleukin 6 in metastatic renal cell cancer: a phase II trial.
A phase II trial investigating the anti-tumour effects of recombinant human interleukin 6 (rhIL-6) in patients with metastatic renal cell cancer was carried out. RhIL-6 (150 microgram) was administered as a daily subcutaneous injection for 42 consecutive days on an outpatient basis. Forty-nine patients were studied, 12 with and 37 without previous immunotherapy. Forty patients were evaluable for response. A partial remission was noted in two patients, stable disease in 17 and progressive disease in 21. Toxicity was moderate and reversible and consisted mainly of fever, flu-like symptoms, nausea, weight loss and hepatotoxicity. Anaemia, leucocytosis and thrombocytosis and induction of acute phase protein synthesis were noted in most patients. In 15% of the patients anti-IL-6 antibodies developed, and were neutralising in only one patient. Baseline plasma IL-6 concentrations did not correlate with tumour behaviour before or after rhIL-6 treatment. In conclusion, rhIL-6 can be safely administered on an outpatient basis for prolonged period of time and has moderate, reversible toxicity. Its administration induces IL-6-antibody production in only a minority of patients. Antitmour effects of rhIL-6 in metastatic renal cancer are limited.
Stouthard
J M
JM
Department of Medical Oncology, Academic Medical Center, University of Amsterdam, The Netherlands.
Goey
H
H
de Vries
E G
EG
de Mulder
P H
PH
Groenewegen
A
A
Pronk
L
L
Stoter
G
G
Sauerwein
H P
HP
Bakker
P J
PJ
Veenhof
C H
CH
D000210:Acute-Phase Reaction / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D002292:Carcinoma, Renal Cell / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D015850:Interleukin-6 / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
D006454:Hemoglobins; D015850:Interleukin-6; D011994:Recombinant Proteins