title: Low-dose gamma-interferon therapy is ineffective in renal cell carcinoma patients with large tumour burden.
abstract: The efficacy and immunomodulatory effects of low-dose gamma-interferon (gamma IFN) were investigated in an unselected population of patients with metastasising renal cell carcinoma. 36 patients suffering from metastasising renal cell carcinoma with a performance status exceeding Karnofsky index of 50 were entered into the open phase I/II trial. The majority of the patients recruited displayed a large tumour burden, and 28 patients (78%) had metastases involving two to six organ sites. Treatment was started with a 2-week cycle of either daily or weekly subcutaneous administration of either 100, 200 or 400 micrograms gamma IFN. After a therapy-free interval of 2 weeks treatment was switched to the alternate mode of administration. Subsequently, treatment was continued with the same dose applied once a week for a minimum of 3 months. Serum levels of neopterin and beta-2-microglobulin, as well as flow cytometric analyses of peripheral blood mononuclear cells, were used for the assessment of biological response. Minimal antitumour activity was observed in this high-risk patient group and only 1 patient experienced a partial response (PR) lasting 36 + months. Comparison of the patients' characteristics to those of other low-dose gamma IFN trials revealed a highly significant difference in the tumour burden and clinical response. We conclude that patient selection is a decisive parameter for the outcome of treatment with low-dose gamma IFN, and that patients with poor prognostic features and a large tumour burden are not likely to respond to this almost atoxic treatment.
authors.affiliation: Department of Urology, General Hospital Salzburg, Austria.
authors.forename: W E
authors.initials: WE
authors.lastname: Aulitzky
authors.forename: J
authors.initials: J
authors.lastname: Lerche
authors.forename: A
authors.initials: A
authors.lastname: Thews
authors.forename: I
authors.initials: I
authors.lastname: Lüttichau
authors.forename: N
authors.initials: N
authors.lastname: Jacobi
authors.forename: M
authors.initials: M
authors.lastname: Herold
authors.forename: W
authors.initials: W
authors.lastname: Aulitzky
authors.forename: C
authors.initials: C
authors.lastname: Peschel
authors.forename: M
authors.initials: M
authors.lastname: Stöckle
authors.forename: F
authors.initials: F
authors.lastname: Steinbach
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000473:pathology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D007958:Leukocyte Count; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis
chemical_list: D007371:Interferon-gamma