As no standard
chemotherapy regimen has been established for advanced
gastric cancer, this study sought to evaluate the efficacy and safety of
combination chemotherapy that included
paclitaxel and
leucovorin (LV)-modulated infusional
5-fluorouracil (5-FU) in metastatic
gastric cancer. Patients received a three-hour infusion of 175 mg/m2 of
paclitaxel on day 1. A bolus of 20 mg/m2 of LV was then administered, followed by a 24-h infusion of 1,000 mg/m2 of
5-FU on days 1 through 3. The treatment cycle was re-peated every 3 weeks until
disease progression. Response evaluation was performed according to the RECIST criteria, with toxicity determined by NCI-CTC (version 2.0). A total of 66 patients, including 21 (31.8%) with a history of prior
chemotherapy, were enrolled. Fifteen (71.4%) of the 21 patients with prior
chemotherapy received prolonged infusional
5-FU. In the 56 evaluable patients (37 in the
chemotherapy-naïve group and 19 in the prior
chemotherapy group),
tumor responses according to prior exposure to
chemotherapy were as follows: 17 (45.9%) partial response (PR), 6 (16.2%) stable disease (SD) and 14 (37.8%) progressive disease (PD) in the
chemotherapy-naïve group; 1 (7.1%) complete response, 3 (15.8%) PRs, 8 (42.1%) SDs and 7 (36.8%) PDs in the prior
chemotherapy group. The overall median response duration was 20 weeks (range, 8-61 weeks), with a median progression-free survival of 20 weeks [95% confidence interval (CI), 13.4-26.6 weeks] and 12 weeks (95% CI, 5.7-18.3 weeks) in the
chemotherapy-naïve and prior
chemotherapy groups, respectively. The median overall survival was 48 weeks (95% CI, 38-58 weeks) in the
chemotherapy-naïve group and 28 weeks (95%
CI, 22-34 weeks) in the prior
chemotherapy group. The most frequent grade III/IV toxicity was neutro-penia. Non-hematological toxicity of grade III/IV was rare.
Paclitaxel in combination with 5-FU/LV is clinically beneficial for patients with advanced
gastric cancer and is a feasible salvage regimen for 5-FU-refractory
gastric cancer patients.