A PHASE-II TRIAL OF PACLITAXEL AND WEEKLY 24 H INFUSION OF 5-FLUOROURACIL FOLINIC ACID IN PATIENTS WITH ADVANCED GASTRIC-CANCER

A phase II trial was performed to evaluate the efficacy and toxicity o f the combination of paclitaxel and 5-fluorouracil (5-FU)/folinic acid in patients with advanced gastric carcinoma, Twenty-two patients (six female and 16 male) with advanced or metastatic disease were enrolled , None of them had received prior chemotherapy. Paclitaxel was adminis trated as a 3 h infusion of 175 mg/m(2) at days 1 and 22, 5-FU 2000 mg /m(2) i.v. over 24 h and folinic acid 500 mg/m(2) i.v. 2 h prior to 5- FU weekly from days 1 to 36. Seven patients (32%) had partial remissio ns including the lungs, skin, lymph nodes and locally advanced primary tumor. The median overall survival was 11 months (range 1-17+) and th e median progression-tree interval was 8 months (range 1-13+). Neutrop enia (WHO grade III/IV) occurred in 14% of patients. Other main toxici ties were alopecia In 45%, fever/infection in 9%, and nausea/vomiting and diarrhea in 5%. In conclusion, the combination of paclitaxel and c ontinuously infused 5-FU/folinic acid appears to be an active regimen far advanced gastric carcinoma with a remission rate comparable to ELF or FAMtx. The moderate toxicity allows treatment on an outpatient bas is.