TY - JOUR
T1 - A Randomized Study of Low and High Doses off Leukocyte α-lnterferon in Metastatic Renal Cell Carcinoma
T2 - The American Cancer Society Collaborative Trial
AU - Kirkwood, John M.
AU - Vera, Raul
AU - Fischer, David S.
AU - Emstoff, Marc S.
AU - Lutes, Richard
AU - Lytton, Bernard
AU - Harris, Jules E.
AU - Sandler, Steven
AU - Khandekar, Janardan
AU - Gordon, Leo
AU - Bonomi, Philip
AU - Cobleigh, M.
AU - Taylor IV, Samuel J.
PY - 1985/2/1
Y1 - 1985/2/1
N2 - A prospective randomized trial of low versus high doses of human leukocyte a-interferon (1 x 108 units/day for 28 days versus 10 x 106 units/day for 28 days) was carried out in 30 patients with metastatic renal cell carcinoma, to test the tolerance and relative antitumor effects of these interferon doses. Both doses were tolerated well, and responses to the human leukocyte a-interferon were observed overall in seven individuals, including complete, partial, and minimal tumor regressions. Six of the seven responses occurred in patients who received the high dosage, and three of these responses were major responses. While not statistically significant, this result suggested a dose-response relationship. One minimal response was observed in a patient treated at low dosage. Nine individuals who were stable after 1 month of therapy at low dosage were randomized to a further month of therapy at low or high dosage, during which one of four at high dosage had a partial response, and none of five at low dosage manifested response. Regression of pulmonary disease in one individual was delayed, occurring 3 months after therapy at the high dose and enduring for a period of 28 months. Major objective responses in other patients were of 4 and 15 months duration. Human leukocyte a-interferon is an active agent in renal cell carcinoma at the dosage of 10 million units daily. No relationship of toxicity to response was evident in this trial. Optimum dosage and duration of treatment have yet to be established.
AB - A prospective randomized trial of low versus high doses of human leukocyte a-interferon (1 x 108 units/day for 28 days versus 10 x 106 units/day for 28 days) was carried out in 30 patients with metastatic renal cell carcinoma, to test the tolerance and relative antitumor effects of these interferon doses. Both doses were tolerated well, and responses to the human leukocyte a-interferon were observed overall in seven individuals, including complete, partial, and minimal tumor regressions. Six of the seven responses occurred in patients who received the high dosage, and three of these responses were major responses. While not statistically significant, this result suggested a dose-response relationship. One minimal response was observed in a patient treated at low dosage. Nine individuals who were stable after 1 month of therapy at low dosage were randomized to a further month of therapy at low or high dosage, during which one of four at high dosage had a partial response, and none of five at low dosage manifested response. Regression of pulmonary disease in one individual was delayed, occurring 3 months after therapy at the high dose and enduring for a period of 28 months. Major objective responses in other patients were of 4 and 15 months duration. Human leukocyte a-interferon is an active agent in renal cell carcinoma at the dosage of 10 million units daily. No relationship of toxicity to response was evident in this trial. Optimum dosage and duration of treatment have yet to be established.
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M3 - Article
C2 - 3881175
AN - SCOPUS:0021915420
SN - 0008-5472
VL - 45
SP - 863
EP - 871
JO - Cancer Research
JF - Cancer Research
IS - 2
ER -
