PHASE-II TRIAL OF HIGH-DOSE RECOMBINANT LEUKOCYTE-ALPHA-2 INTERFERON FOR METASTATIC COLORECTAL-CANCER WITHOUT PREVIOUS SYSTEMIC TREATMENT

  • 1 January 1985
    • journal article
    • research article
    • Vol. 69  (2) , 185-187
Abstract
Ten patients with metastatic colorectal cancer after resection of the primary tumor were treated with high-dose recombinant leukocyte .alpha.-2 interferon. For a period of 12 wk, the patients received up to 20 .times. 106 IU/m2 i.m. twice weekly. Follow-up varied from 6-11 mo. after stopping treatment. All 10 patients were evaluable for tumor response and toxicity. There was 1 partial response. Nine patients showed growth of metastatic marker lesions. Only 3 of these patients qualified as having progressive disease (> 25% increase in tumor mass). The response rate was 10%, with a 95% confidence interval of 0.3%-44.5%. Toxicity proved considerable and consisted of flu-like symptoms, fatigue, anorexia and weight loss. Fatigue was the single most important dose-limiting factor. There were no drug-related deaths. Three patients died 3, 5 and 7 mo. after stopping treatment. Median survival was 18 mo.