Background: The combination of 5-fluorouracil (5-FU) and folinic acid (FA) has demonstrated activity in most gastrointestinal tumors. The addition of epirubicin (Epi) could increase the efficacy of the combination. This was examined in patients with advanced gastric cancer who had previously received chemotherapy with FAM (5-FU + adriamycin + mitomycin) and relapsed. Patients and Method: The schedule was conducted in 30 patients who had previously received FAM. It consisted of FA 200 mg/m2/day intravenous push administration prior to 5-FU infusion 600 mg/m2/day in 500 ml 5 % normal saline over 1 h for 5 days; Epi 35 mg/m2/day intravenous bolus before FA + 5-FU administration on days 1 and 2. Additionally, allopurinol (AL) 300 mg, 1 tablet × 3/day, started 2 days before treatment for 17 days. The cycle was repeated every 28 days. Results: The sites of the largest measurable lesion included local relapse in 19 patients, liver metastases in 17, and lymph node metastases in 16 patients. Pretreatment characteristics included: age 33-72 (median 63) years, and Karnofsky Performance Status of 80-90%. All patients were evaluable for response and toxicity. Objective tumor responses (partial responses) were seen in 8 of 30 patients (26%) (5 had previously stable diseases and 3 partial responses to FAM). The estimated median survival was 21.8 weeks measured from the onset of therapy, duration of response was 13.6 weeks and time to progression, 19 weeks. Toxocity resulted primarily in nausea and vomiting, diarrhea, alopecia, myelosuppression, and mucositis. Conclusion: We conclude that this second-line combination of Epi + FA + 5-FU with AL protection has moderate activity and increased toxicity in the treatment of advanced gastric cancer.

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