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Leukocyte-Derived Interferon (Alpha) in Human Breast Carcinoma: The American Cancer Society Phase II Trial

ERNEST C. BORDEN, M.D.; JAMES F. HOLLAND, M.D.; THOMAS L. DAO, M.D.; JORDAN U. GUTTERMAN, M.D.; LEO WIENER, M.D.; YUANG-CHI CHANG, M.D.; and JASHBHAIK PATEL, M.D.
[+] Article and Author Information

Grant support: grant CA 20432, National Cancer Institute; and the Medical Research Service of the Veterans Administration.

▸ Requests for reprints should be addressed to Ernest C. Borden, M.D.; K4/414, Wisconsin Clinical Cancer Center, 600 Highland Avenue; Madison, WI 53792.


Madison, Wisconsin; New York and Buffalo, New York; and Houston, Texas


©1982 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1982;97(1):1-6. doi:10.7326/0003-4819-97-1-1
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A multi-institutional trials program was initiated to define the effects of interferons in disseminated human breast carcinoma. Interferon alpha, prepared from buffy coats, was administered intramuscularly at 3 ×106 U daily for an initial period of 28 days. Of 23 patients who entered the program, five had an objective partial response of 92 days mean duration at diverse sites of involvement. Patients who responded were significantly older (p = 0.05) than nonresponders. Dose escalation in eight patients did not result in any clear evidence of additional responses. Major toxicities were fatigue, anorexia with weight loss, and reversible leukopenia (less than 3.5 ×109 leukocytes/L in 16 patients). Natural killer cell and antibody-dependent cell-mediated cytotoxicity were significantly (p < 0.05) enhanced 48 hours after interferon administration began but subsequently declined despite continued therapy. Serum β2microglobulin concentration increased on day 15 (p < 0.05) and remained significantly elevated on day 22 (p < 0.005). Peak interferon titers (mean, 62 U) occurred 6 hours after interferon was started, varied widely between patients, and were higher and more persistent with dose escalation. Once an optimal dose is defined, prospectively randomized trials will define what role interferons may have in systemic therapy of breast carcinoma.

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