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A phase II trial of interferon‐α and 5‐fluorouracil in patients with advanced renal cell carcinoma: A Southwest Oncology Group study
Author(s) -
Elias Laurence,
Blumenstein Brent A.,
Kish Julie,
Flanigan Robert C.,
Wade James L.,
Lowe Bruce A.,
Goodwin John Wendall,
Crawford E. David
Publication year - 1996
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19960901)78:5<1085::aid-cncr19>3.0.co;2-z
Subject(s) - medicine , renal cell carcinoma , fluorouracil , oncology , interferon , carcinoma , chemotherapy , immunology
BACKGROUND Renal cell carcinoma is a common neoplasm that is often refractory to treatment. It is occasionally responsive to immunomodulating agents including interferon‐α, which enhances the effects of 5‐fluorouracil upon cells. Combinations of these two drugs have been most frequently tested in patients with gastrointestinal cancers, with some promising results. Because interferon‐α has activity for renal cell carcinoma, a trial of this combination in patients with this malignancy was undertaken. METHODS The Southwest Oncology Group performed a Phase II clinical trial of the combination of 5‐fluorouracil and interferon‐α for recurrent or metastatic renal cell carcinoma. Eligibility criteria included no prior treatment with medications for cancer, a performance status of 2 or better, and bidimensionally measurable disease. The regimen studied consisted of 5‐fluorouracil, 750 mg/M 2 /day, by continuous intravenous infusion on Days 1–5, and interferon‐α‐2b (Intron A), 5 × 10 6 U/M 2 /day, subcutaneously on Days 1, 3, and 5, repeated every 21 days. RESULTS Forty eligible patients were treated; twenty of the 40 underwent a nephrectomy. The regimen was tolerable: 3 patients had Grade 4, and 17 had Grade 3 toxicity. There were 5 partial responses (13% with 95% confidence limits of 4–27%). Median progression free survival for all 40 patients was 4 months and median overall survival was 15 months from the time of registration. CONCLUSIONS The combination of 5‐fluorouracil and interferon‐α given by this schedule, although tolerable and occasionally yielding responses, is not an improvement over existing therapies. Cancer 1996;78:1085‐8.