Subcutaneous low-dose recombinant interleukin 2 and alpha-interferon in patients with metastatic renal cell carcinoma

A double-institution phase II study was performed in patients with metastatic renal cell carcinoma treated subcutaneously (s.c.) with interleukin 2 (IL-2) and alpha-interferon (INF-alpha). Thirty-eight patients were treated over a course of 7 weeks. Initially (day 1 + 2) patients received s.c. IL-2...

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Bibliographic Details
Published in:British journal of cancer 1994-06, Vol.69 (6), p.1111-1114
Main Authors: RAVAUD, A, NEGRIER, S, CANY, L, MERROUCHE, Y, LE GUILLOU, M, BLAY, J. Y, CLAVEL, M, GASTON, R, OSKAM, R, PHILIP, T
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Biological and medical sciences
Carcinoma, Renal Cell - pathology
Carcinoma, Renal Cell - therapy
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Immunotherapy
Injections, Subcutaneous
Interferon Type I - therapeutic use
Interferon Type I - toxicity
Interleukin-2 - therapeutic use
Interleukin-2 - toxicity
Kidney Neoplasms - pathology
Kidney Neoplasms - therapy
Male
Medical sciences
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Pharmacology. Drug treatments
Recombinant Proteins - therapeutic use
Recombinant Proteins - toxicity
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Summary:A double-institution phase II study was performed in patients with metastatic renal cell carcinoma treated subcutaneously (s.c.) with interleukin 2 (IL-2) and alpha-interferon (INF-alpha). Thirty-eight patients were treated over a course of 7 weeks. Initially (day 1 + 2) patients received s.c. IL-2 at 18 x 10(6) IU m-2. During the following 6 weeks, patients received s.c. IL-2 at 3.6 x 10(6) IU m-2 for 5 days per week and s.c. INF-alpha at 5 x 10(6) for 3 days per week. Thirty-eight patients were evaluated for response. An objective response was seen in seven patients (18.4 +/- 12.3%), with one complete response and six partial responses. Median duration of response was 6.7 months. Toxicity could be evaluated in 38 patients and was limited. Mild to moderate toxicity included fever (97%), fatigue or malaise (76%), nausea or vomiting (50%), anorexia (32%), hypotension (26%), neurological disturbances (26%) and hypercreatininaemia (39%). In addition, four grade IV haematological toxicities were noted. No cardiac side-effects were seen. IL-2 and INF-alpha given by this schedule can be safely administered in an outpatient setting. The objective response rate was similar to our previous treatments with high-dose IL-2 given as a continuous infusion.
ISSN:0007-0920
1532-1827
DOI:10.1038/bjc.1994.218