COMBINATION 5-FLUOROURACIL (FU), FOLINIC ACID (FA), AND ALPHA-INTERFERON 2B IN ADVANCED GASTRIC-CANCER - RESULTS OF A PHASE-II TRIAL

Background: Based on encouraging treatment results with FU/FA or FU/IF N in gastrointestinal tract cancer, a phase II study was conducted to evaluate the effects and toxicity of combination FU/FA/IFN in patients (pts) with inoperable/metastatic gastric cancer. Patients and methods : IFN 6 M.U, s.c. 1 x/week, FU 500 mg/m(2) bolus i.v. 1 x/week and FA 500 mg/m(2) 1 x/week as a 2-hour infusion. Of 72 treated pts, 72 (22 f emales, 50 males) are evaluable for response and toxicity. Median age was 55.6 years (28-80), and median Karnofsky performance status was 80 % (70-100). Sites of measurable disease were inoperable primary tumors /local recurrence (18), liver metastasis (22), lymph nodes (31) and pe ritoneum (20). One pt had bone marrow metastasis and another had paran eoplastic hyperfibrinolytic coagulopathy. Results: 10/72 pts had compl ete response, 20/72 pts par tial response, 40/72 pts tumor stabilizati on and 2/72 pts progressive disease. The median duration of response ( CR/PR) was 9 months, the median progression-free interval 6 months, th e median survival time was 9 months, and for responding patients (CR/P R) 12.5 months. Toxicity: 1/72 pts had WHO grade 4 toxicity (diarrhea) , 5/72 pts had WHO grade 3 toxicity (nausea 1, diarrhea 4). Except for 1 treatment-limiting grade 4 toxicity, no modifications of dose or sc hedule due to toxicity were required. Thirty-six of 44 pts experienced a significant reduction in tumor-related pain under treatment. Conclu sion: Biochemical modulation of FU with FA and IFN is effective in adv anced gastric cancer. Moderate toxicity, outpatient treatment setting and high rates of amelioration tumor-related pain contribute to an eff ective palliation.