Epidoxorubicin and high dose leucovorin plus 5-fluorouracil in advanced gastric cancer: a phase II study

We conducted a multicentric phase Il study on advanced gastric cancer to determine the efficacy and toxicity of treatment with epidoxorubicin (EPO plus high doses of leucovorin (LV) and 5-fluorouracil (5-FU). Thirty-seven patients with measurable dIsease were enrolled Into the trial and treated with EPI 75 mg/m2 on day 1 and LV 200 mg/m2 plus &FU 450 mg/m2 from day 1 to 3, the cycle beIng repeated every H weeks from a medlan of five cycles per patients. The response rate was 49% in 35 evaluable patIents, wIth two complete remissions and 15 partlal responses. Medlan response duratlon was 12.4 months; median survival tor responding patients was 17.3 months, which was significantly longer than 8.7 months tor non-re9ponding patIents. General toxicity was usually mild, myelotoxicity was moderate, and there was no evidence of cardiac toxicity. These results show that EPI-LV4FU is an effective regimen for advanced gastric carcinoma. The efficacy of this combination should now be tested as an adjuvant therapy in resectable gastric cancer