Phase II study of the paclitaxel, cisplatin, 5-fluorouracil and leucovorin (TPFL) regimen in the treatment of advanced or metastatic gastric cancer.

Advanced or metastatic gastric cancer, which is one of the most common malignancies in Korea, is difficult to cure by surgery alone and generally requires combination chemotherapy. Paclitaxel is active against gastric cancer and when combined with 5-fluorouracil/leucovorin and/or cisplatin is effective in the treatment of gastric cancer. We attempted to determine the effect and safety with the combination of paclitaxel with split cisplatin and 5-fluorouracil/leucovorin in advanced or metastatic gastric cancer. Patients with histologically-proven locally advanced/metastatic or recurrent gastric cancer with an ECOG performance status 0-2 were enrolled. The patients received 135 mg/m(2) of paclitaxel as a 3-h intravenous infusion on day 1 and 5-fluorouracil (1200 mg/m(2)) plus leucovorin (20 mg/m(2)) as an intravenous infusion over 12 h plus cisplatin (30 mg/m(2)) by continuous intravenous infusion on days 1-3, every 21 days. Between September 2003 and April 2005, 30 patients (26 evaluable patients) with a median age of 57 years (range 34-74) were enrolled and underwent 111 completed treatment cycles (a median of 3 cycles per patient). Of the evaluable patients, 12 patients showed a partial response and 8 patients had stable disease. The overall response rate was 46.2%. The median progression-free survival was 5.6 months (95% CI. 3.76-7.4 months), and the median overall survival was 9.6 months (95% CI. 6.67-12.47 months). The hematologic and non-hematologic toxicities were tolerable. The grade III and IV hematologic toxicities were anemia (6.8%) and neutropenia (2.6%). Febrile neutropenia was observed in 1 patients and 1 cycle. Other hematologic toxicities and grade III and IV non-hematologic toxicities, except nausea (66.7%) and vomiting (33.3%) were uncommon and not severe. TPFL combination chemotherapy is effective and tolerable with acceptable toxicities in patients with advanced/metastatic, recurrent gastric cancer.