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From Sept. 1991. to Jan. 1995. 80 pts. with advanced gastric cancer entered phase III clinical trial. The aim of the study was to determine activity of high doses of 5-fluorouracil and epirobicin (FE) vs. the same combination + cisplatin (FEP) in that group of pts. Out of 80 pts. 73 were evaluable. The treatment involved in FE arm 120 mg/m2 of epirobicin i.v. on day 1 and 1000 mg/m2 in 6-hour infusion of 5-fluorouracil on days 1, 2, 3, 4, 5: in FEP arm the same combination + cisplatin 30 mg/m2 on days 2.4 was administered. The cycles were repeated after 4 weeks. In FE arm 37 pts. were evaluable with 10 partial and 1 complete remission (29.7%), in FEP arm out of 36 pts. 14 partial and 1 complete remission (41.7%) were observed. Median survival in FE group was 6.3 mos, and in FEP group 8.1 mos. Differences were not statistically significant. Toxicity was tolerable and reversible. Our trial being still under way, the final results will provide a more accurate answer with regard to the value of the two administered protocols. |
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