Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer: A phase II study of the Gruppo Oncologico dell’ Italia Meridionale (GOIM)

Abstract Introduction Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ⩾ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m 2 on day 1, Taxotere at 50 mg/m 2 on day 1, Folinic Acid at 100 mg/m 2 on days 1–2, Fluorouracil bolus at 400 mg/m 2 on days 1–2 and Fluorouracil 22 h continuous infusion on days 1–2 every three weeks. Results Amongst the 38 evaluable patients we observed 5 CR (13%), 9 PR (24%), 9 SD (24%) and 15 PD (39%) for an ORR of 37% (95% CI: 22–52) and a tumor growth control rate of 61%. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III–IV haematologic toxicities were leucopenia 7%, neutropenia 5% and anemia 5% while non-haematologics were diarrhoea 2%, alopecia 2% and cardiac 2%. Conclusion The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.