COMBINED EPIRUBICIN, EPIRUBICIN, 5-FLUOROURACIL AND FOLINIC ACID WITHALLOPURINOL PROTECTION FOR 2ND-LINE TREATMENT OF ADVANCED GASTRIC-CANCER - A PILOT-STUDY

Background: The combination of 5-fluorouracil (5-FU) and folinic acid (FA) has demonstrated activity in most gastrointestinal tumors. The ad dition of epirubicin (Epi) could increase the efficacy of the combinat ion. This was examined in patients with advanced gastric cancer who ha d previously received chemotherapy with FAM (5-FU + adriamycin + mitom ycin) and relapsed. Patients and Method: The schedule was conducted in 30 patients who had previously received FAM, It consisted of FA 200 m g/m(2)/day intravenous push administration prior to 5-FU infusion 600 mg/m(2)/day in 500 ml 5% normal saline over. 1 h for 5 days; Epi 35 mg /m(2)/day intravenous bolus before FA + 5-FU administration on days 1 and 2. Additionally, allopurinol (AL) 300 mg, 1 tablet x 3/day, starte d 2 days before treatment for 17 days. The cycle was repeated every 28 days. Results: The sites of the largest measurable lesion included lo cal relapse in 19 patients, liver metastases in 17, and lymph node met astases in 16 patients. Pretreatment characteristics included: age 33 - 72 (median 63) years, and Karnofsky Performance Status of 80-90%. Al l patients were evaluable for response and toxicity. Objective tumor r esponses (partial responses) were seen in 8 of 30 patients (26%) (5 ha d previously stable diseases and 3 partial responses to FAM). The esti mated median survival was 21.8 weeks measured from the onset of therap y, duration of response was 13.6 weeks and time to progression, 19 wee ks. Toxocity resulted primarily in nausea and vomiting, diarrhea, alop ecia, myelosuppression, and mucositis. Conclusion: We conclude that th is second-line combination of Epi + FA + 5-FU with AL protection has m oderate activity and increased toxicity in the treatment of advanced g astric cancer.