EPIDOXORUBICIN AND DOUBLE BIOCHEMICAL 5-FLUOROURACIL MODULATION WITH FOLINIC ACID AND HUMAN LYMPHOBLASTOID INTERFERON IN ADVANCED GASTRIC-CARCINOMA - A MULTICENTRIC PHASE-II STUDY OF THE SOUTHERN ITALY ONCOLOGY GROUP (GOIM)

In our previous randomized trial of advanced gastric cancer patients, the addition of epirubicin (EPI) to 5-fluorouracil (FU) with folinic a cid (FA) resulted in an improved response rate and survival in the res ponder patients. Preclinical studies also showed an enhancement of FU and anthracyclines with interferon. To evaluate the possibility of hum an lymphoblastoid interferon (IFN) to enhance the therapeutic activity of the FA-FU + EPI combination regimen, 39 advanced gastric cancer pa tients received: FU at 375 mg/m(2) i.v. immediately after FA (I-isomer form) at 100 mg/m(2) i.v. for 5 consecutive days; EPI at 60 mg/m(2) i .v. on day 1, and IFN 3 MU s.c. for 7 consecutive days, starting 2 day s before the FA-FU administration. Thirty-seven patients were evaluabl e for response and toxicity. Twelve partial responses were observed wi th an overall response rate of 32% (95% CI, 17-48%). The median respon se duration was 6 months, and the median survival time was 8 months. T oxicity was mild and no grade 4 side effects or treatment-related deat hs were observed. However, the addition of IFN to the FA-FU + EPI regi men did not improve response, duration of response or survival.