Streptozotocin (NSC‐85998) was administered to 53 patients at a dose of 1 to 2 g/m2 weekly. Response to therapy could be evaluated in 39 patients. Responses exceeding 50% in magnitude of tumor reduction were noted in three patients; responses of 25–50% were noted in an additional four patients. Responses were noted in two of four patients with islet cell carcinoma, one of four patients with malignant carcinoid, one of two patients with carcinoma of the lung, one of two patients with squamous carcinoma of the oral cavity, one patient with synovial sarcoma, and one patient with adenocarcinoma of the gallbladder. Renal toxicity was manifested by azotemia in 21 patients and by proteinuria in 28 patients. Elevation of serum glucose occurred in seven patients, but clinical diabetes did not develop. Nausea and vomiting occurred in 40 patients. Hematologic toxicity was noted in four patients.
5‐Fluorouracil (5‐FU) has usually been administered by rapid intravenous injection of 15 mg/kg daily for 3‐5 days and 7.5 mg/kg every 2 or 3 days to toxicity, repeated monthly (antitumor response about 10‐30%). Drug morbidity and mortality have been excessive. Modifications of this course have shown similar response rates but decreased toxicity and mortality. In the present WCCCG study, 548 patients with disseminated cancer were treated weekly with 5‐FU, without a loading dose, by rapid intravenous injection, beginning at 15 mg/kg/week for one month, and increased to 20 mg/kg/week (if necessary) to levels producing mild toxicity or an antitumor effect. Of the 339 patients now evaluated for response, 6 had complete responses, 54 had decreases in tumor size > 50%, and 34 had decreases in tumor size of 25‐50%. The response rates > 50% (I‐B and I‐C) for adenocarcinoma of the breast, stomach, and colon were 37.8%, 28.6%, and 16%, respectively. Of the 430 patients evaluated for toxicity, 62 manifested no toxicity, and 368 patients had mild‐to‐severe toxicity. There were 8 drug‐related deaths in patients who received 5‐FU in dosages higher than those allowed in the protocol. There were no drug deaths in patients who received 5‐FU as stipulated by the protocol.
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