A Phase I study of recombinant human interleukin-21 (rIL-21) in combination with sunitinib in patients with metastatic renal cell carcinoma (RCC)

Figures & data

Figure 1. Study design of the phase I part of the study. Sunitinib was initiated 1 week prior to rIL-21 exposure and consisted of 50 mg OD at a ‘4 weeks on and 2 weeks off’ schedule.

Table I. Patient characteristics.

		N	%
Number of patients		9	100
Age (years)
median	55.0
range	48.0–71.0
Sex	Male	6	66.7
	Female	3	33.3
Prior therapy	Nephrectomy	9	100
	Radiotherapy	2	22.2
Histology	Clear cell Carcinoma	6	66.7
	Chromophobe Carcinoma	2	22.2
	Papillary carcinoma	1	11.1
ECOG	0	7	77.8
	1	2	22.2
Median time since diagnosis of metastatic disease (years)	0.4 (0.1–2.4)	–	–
MSKCC risk criteria	Favorable	4	44.4
	Intermediate	5	55.6

Table II. Drug-related adverse event profile occurring in more than 30% of patients or grade 3-4 severity.

		rIL-21 3 μg/kg				rIL-21 10 μg/kg				rIL-21all
System organ class	adverse event	Gr 1 n	Gr 2 n	Gr 3 n	Gr 4 n	Gr 1 n	Gr 2 n	Gr 3 n	Gr 4 n	dose-levels all grades n
Gastrointestinal disorders	Stomatitis	2	2	0	0	0	1	0	0	5 (56)
	Diarrhea	2	0	0	0	1	0	0	0	3 (33)
General disorders	Injection site reaction	2	1	0	0	3	0	0	0	6 (67)
	Fatigue	0	2	0	0	2	0	0	0	4 (44)
	Chills	1	1	0	0	1	0	0	0	3 (33)
	Pyrexia	1	1	0	0	1	0	0	0	3 (33)
	Dysgeusia	2	0	0	0	2	0	0	0	4 (44)
Skin and subcutaneous tissue disorders	Rash	1	1	0	0	1	0	0	0	3 (33)
	Yellow skin	2	0	0	0	1	0	0	0	3 (33)
Vascular disorders	Hypertension	0	1	2	0	0	1	0	0	4 (44)
Blood	Neutropenia	0	0	0	0	0	0	1	1	2 (22)
	Thrombocytopenia	1	0	0	0	0	0	1	0	2 (22)
Hepatic	Gammaglutamyltransferase elevation	0	0	1	0	0	0	0	0	1 (11)
Endocrine	Lipase increase	0	0	0	0	0	0	1	0	1 (11)

Figure 2. Soluble (s)CD25 after the treatment with rIL-21 for 3 and 10 μg/kg dose-levels. Increase of sCD25 was seen at both dose-levels suggesting activation of immune response.