Interferon-α, 5-FU and prednisone in metastatic renal cell carcinoma: A phase II study

Abstract

The assessed combination of IFN-alpha, 5-FU and prednisone is moderately active in MRCC, with response rates similar to those seen in patients on IFN-alpha monotherapy. The latter treatment approach seems preferable, as 5-FU-related toxicity (mucositis, cardiac toxicity) is averted.

Feasibility of prolonged use of interferon‐α in metastatic kidney carcinoma

“…22 In many studies the daily dose of INF-␣ has been low, less than 9 MU. 15,19,21 In this study, no objective responses were observed at doses less than 9 MU. Thus, it is possible that a threshold dose level is necessary for clinical benefit of IFN-␣.…”

“…1,5,7,17 Interferon-␣ has been as effective as a single agent or in combinations with interleukin-2, 8,14 vinblastine, 18 -20 and 5-fluorouracil. 21,22 The response rates have varied from 10% to 40%, most often from 15% to 20%. Hormone treatment is not effective in metastatic renal cell carcinoma, although some improvement in the quality of life of the patients can be achieved with medroxyprogesterone acetate.…”

“…19,27 In most previous studies, the duration of the treatment with IFN-␣ has been 6 -12 weeks, 5,15,17 and most responses have been observed within 2 or 4 months of treatment start. 2,4,21 Because host immune mechanisms are apparently important in regulating tumor growth and in patients responding to IFN-␣, 2 we used a prolonged schedule of IFN-␣ administration. The treatment with IFN-␣ was continued for 12 or 24 months or as long as progression or severe side effects were not encountered.…”

C-reactive Protein in Patients with Metastatic Clear Cell Renal Carcinoma: An Important Biomarker for Tumor-associated Inflammation

“…The case calculation for each study based upon available response data following treatment with single agents or combinations of drugs administered. We assumed a response rate ≥ 25% to proceed with the further development of the respective schedule [ Creagan et al 1991 ; Zaniboni et al 1989 ; Haarstad et al 1994 ]. Prerequisite to resume schedule II was a CRP decline > 30% in patients experiencing stable disease or objective response on schedule I independently of whether stage two of a two stage flexible design may be achieved with schedule I [ Chen and Ng, 1998 ].…”

Obscure Gastrointestinal Bleeding from an Ampullary Tumour in a Patient with a Remote History of Renal Cell Carcinoma: A Diagnostic Conundrum

“…Despite the report of success with adjuvant hormonal therapy in this one case, conventional chemotherapy and hormonal agents have little effect on renal cell carcinoma (14). Similarly, the effect of biological immune modifying agents (eg, interferon), which have been reported to be of some value in the treatment of metastatic renal cell carcinoma (10,15,16), is unknown in the setting of gastrointestinal metastases.…”