A phase II study of recombinant beta-interferon at maximum tolerated dose in patients with advanced non-small cell lung cancer: a cancer and leukemia group B study.
Forty-one patients with advanced non-small cell lung cancer (NSCLC) were entered into a phase II study of high dose recombinant interferon (rIFN)-beta. Patients received intravenous (i.v.) rIFN-beta on a Monday, Wednesday, Friday schedule with a weekly dose escalation until > or = grade 3 toxicity or 720 x 10(6) IU/dose was achieved. Thirty-eight patients were eligible. Seventeen patients received the highest planned dose of rIFN-beta and 11 experienced dose-limiting toxicity at lower doses. Ten patients developed progressive disease before grade 3 toxicity was reached. There were no objective responses observed. Significant and dose-limiting toxicities included nausea and vomiting, fever, rigors, severe dyspnea, hypotension, and hypertension. IFN-beta has no measurable antitumor activity against NSCLC even at maximum tolerated doses (MTDs).
Comprehensive Cancer Center, University of Alabama at Birmingham 35294-3300.
R H
RH
Wheeler
J E
JE
Herndon
G H
GH
Clamon
M R
MR
Green
D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D016899:Interferon-beta