title: Subcutaneous interleukin-2 and alpha-interferon in advanced colorectal carcinoma. A phase II study.
abstract: Subcutaneous administration of low doses of recombinant interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) on an out-patient basis has been reported not to significantly compromise the response frequency compared to intravenous IL-2 in patients with renal cell carcinoma and melanoma. As part of an ongoing program to develop a biotherapeutic concept in patients with colorectal carcinoma (CRC) we studied the clinical effects of such a regimen in 15 patients with metastatic CRC. The daily dose of IL-2 varied between 4.8-14.4 x 10(6) U/m2 and of IFN-alpha between 3-6 x 10(6) U/m2. The cycle length was 6 weeks. The course was repeated every 8 weeks until disease progression. Maximum 4 cycles were administered. Maintenance therapy was given to responding patients once a week every month. No patient showed a major response (CR or PR). Six patients had a stable disease ranging from 3 months to 18 months with a median duration time of 5 months. The median survival of all patients was 13 months. The main adverse reactions were fever, chills, anorexia and shortness of breath. No treatment related deaths occurred. 6/14 patients developed abnormal concentration of serum levels of thyroid hormones. It is concluded that the present treatment schedule using IL-2 and IFN-alpha in advanced CRC seemed not to be of clinical benefit.
authors.affiliation: Department of Oncology (Radiumhemmet), Karolinska Hospital, Stockholm, Sweden.
authors.forename: A L
authors.initials: AL
authors.lastname: Hjelm
authors.forename: P
authors.initials: P
authors.lastname: Ragnhammar
authors.forename: J
authors.initials: J
authors.lastname: Fagerberg
authors.forename: I
authors.initials: I
authors.lastname: Magnusson
authors.forename: J E
authors.initials: JE
authors.lastname: Frodin
authors.forename: R
authors.initials: R
authors.lastname: Svanstrom
authors.forename: J
authors.initials: J
authors.lastname: Shetye
authors.forename: H
authors.initials: H
authors.lastname: Mellstedt
authors.forename: J P
authors.initials: JP
authors.lastname: Wersall
mesh_terms: D000328:Adult; D000368:Aged; D001772:Blood Cell Count; D015179:Colorectal Neoplasms / Q000097:blood / Q000628:therapy*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013961:Thyroid Gland / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D007376:Interleukin-2