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. 1998 Jul;46(1):5-10.
doi: 10.1046/j.1365-2125.1998.00036.x.

Pharmacokinetics of recombinant human interleukin-2 in advanced renal cell carcinoma patients following subcutaneous application

G I Kirchner  1 , A Franzke, J Buer, W Beil, M Probst-Kepper, F Wittke, K Overmann, S Lassmann, R Hoffmann, H Kirchner, A Ganser, J Atzpodien
Affiliations

Pharmacokinetics of recombinant human interleukin-2 in advanced renal cell carcinoma patients following subcutaneous application

G I Kirchner et al. Br J Clin Pharmacol. 1998 Jul.

Abstract

Aims: The aim of the study was to investigate the pharmacokinetics of recombinant human interleukin-2 (rhIL-2) in patients with metastatic renal cell carcinoma following different subcutaneous (s.c.) administration regimens.

Methods: RhIL-2 was administered subcutaneously to 10 patients according to two different dosing regimens: group A received 20 x 10(6) IU m(-2) once daily and group B 10 x 10(6) IU m(-2) twice daily (every 12 h). Additionally, in all patients the influence of soluble interleukin-2 receptor (sIL-2R) on the pharmacokinetics of rhIL-2 was investigated.

Results: The mean area under the serum concentration-time curve to 24 h (AUC(0,24 h)) was 627 IU ml(-1) h in treatment group A and 1130 IU ml(-1) h (P=0.029) in treatment group B. In both study groups Cmax and AUC(0,12 h) were not significantly different. Seventy-two hours after the beginning of s.c. rhIL-2 therapy the sIL-2R increased significantly (P=0.016), and sIL-2R levels over 1200 pmol l(-1) seemed to reduce the AUC.

Conclusions: In patients with metastatic renal cell cancer administration of 20 x 10(6) IU m(-2) of rhIL-2 s.c. in two daily doses (10 x 10(6) IU m(-2) every 12 h) provides better bioavailability and is preferable to the single dose administration.

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Figures

Figure 1
Figure 1
Pharmacokinetics of rhIL-2 in patients with metastatic renal cell cancer treated subcutaneously. Serum levels of rhIL-2 were measured with ELISA and are expressed as mean±s.d. (a) Mean levels in seven patients receiving 20×106 IU m−2 s.c. as single injection. (b) Mean levels in three patients receiving 10×106 IU m−2 s.c. twice every 12 h.
Figure 2
Figure 2
Serum concentrations (mean±s.d.) of soluble IL-2 receptor measured by ELISA during rhIL-2 therapy (n=6 until 48 h, n=4 until 72 h).
Figure 3
Figure 3
Serum levels of rhIL-2 (•) and soluble IL-2 (□) receptor after subcutaneous application (10×106 IU m−2 s.c. every 12 h for 3 days, ▾) in one typical patient.
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