PHASE-II STUDY OF RECOMBINANT INTERFERON-BETA AT MAXIMUM TOLERATED DOSE IN PATIENTS WITH ADVANCED NONSMALL CELL LUNG-CANCER - A CANCER AND LEUKEMIA GROUP-B STUDY

Forty-one patients with advanced nonsmall cell lung cancer (NSCLC) wer e entered into a phase II study of high dose recombinant interferon (r IFN)-beta. Patients received intravenous (i.v.) rIFN-beta on a Monday, Wednesday, Friday schedule with a weekly dose escalation until greate r than or equal to grade 3 toxicity or 720 x 10(6) IU/dose was achieve d. Thirty-eight patients were eligible. Seventeen patients received th e highest planned dose of rIFN-beta and 11 experienced dose-limiting t oxicity at lower doses. Ten patients developed progressive disease bef ore grade 3 toxicity was reached. There were no objective responses ob served. Significant and dose-limiting toxicities included nausea and v omiting, fever, rigors, severe dyspnea, hypotension, and hypertension. IFN-beta has no measurable antitumor activity against NSCLC even at m aximum tolerated doses (MTDs).