Prospective Randomized Trial Using 5-Fluorouracil, Adriamycin and Methotrexate (FAMTX) versus FAM for Treatment of Advanced Gastric Cancer

Abstract

Background: In 1982, a favorable response rate of 63 % in patients with advanced gastric carcinoma treated by sequential high-dose methotrexate and 5-fluorouracil combined with adriamycin (FAMTX) was reported. In order to confirm these data, a prospective randomized comparison with a standard regimen seemed to be necessary.Materials and Methods: 213 patients with advanced measurable or nonmeasurable gastric cancer were randomized for administration of methotrexate (1,500 mg/m2), followed after 1 h by 5-fluorouracil (1,500 mg/m2) on day 1. Leucovorin rescue was started after 24 h (15 mg/m2, orally, every 6 h for 48 h), and adriamycin (30 mg/m2) was given on day 15. The FAM regimen consisted of 5-fluorouracil (600 mg/m2, on days 1, 8, 29 and 36), of adriamycin (30 mg/m2, on days 1 and 29) and of mitomycin C (10 mg/m2, on day 1). The cycles were repeated every 4 and 8 weeks, respectively. Results: The results show a significantly superior response rate, 41 versus 9 % (p < 0.0001), and survival, median 44 weeks versus 29 weeks (p = 0.002) for FAMTX. There was a cumulative thrombocytopenia seen in FAM, but not in FAMTX. Conclusion: The FAMTX protocol should be the reference treatment in future clinical trials which seek to improve the therapeutic outcome in advanced gastric cancer.