A phase II study of sequential chemotherapy with docetaxel after the weekly PELF regimen in advanced gastric cancer. A report from the Italian group for the study of digestive tract cancer

In advanced gastric cancer, we investigated feasibility and activity of seq uential chemotherapy with docetaxel after an intensive weekly regimen consi sting of cisplatin, epidoxorubicin, fluorouracil, leucovorin (PELF) plus fi lgrastim. Chemotherapy-naive patients with relapsed or metastatic gastric c ancer received 8 weekly administrations of chemotherapy with cisplatin 40 m g/m(2), fluorouracil 500 mg/m(2),epidoxorubicin 35 mg/m(2), 6S-steroisomer of leucovorin 250 mg/m(2) and glutathione 1.5 g/m(2), On the other days fil grastim 5 mug kg(-1) was administered by subcutanous injection. Subsequentl y, patients with partial response or stable disease received 3 cycles of do cetaxel 100 mg/m(2) every 3 weeks. 40 patients have been enrolled and they are evaluable for response and toxicity. After the PELF regimen, 3 patients achieved complete response, 13 patients showed partial response, 21 patien ts had stable disease and 3 patients progressed (40% response rate; 95% CI 25% to 55%). After docetaxel, 9 out 34 patients improved the outcome (26.5% ); 7 patients with stable disease achieved partial response and 2 patients with partial response achieved complete response. The overall response rate in the 40 patients was 57.5% (95% CI, 42.5% to 72.5%). The PELF regimen di d not cause any grade IV toxicity, the most frequent grade III acute side-e ffects were thrombocytopenia and vomiting which occurred in the 10% of 320 PELF cycles. Docetaxel caused grade III-IV neutropenia and thrombocytopenia in the 10% and the 19% of cycles respectively. Fatigue was a frequent side -effect during both PELF and docetaxel chemotherapy. The sequential applica tion of docetaxel after PELF chemotherapy gained major objective responses with manageable toxicity. This strategy is worth of further investigation i n the setting of palliative or neoadjuvant chemotherapy. (C) 2001 Cancer Re search Campaign.