A phase II study of leucovorin, 5-FU and docetaxel combination chemotherapy in patients with inoperable or postoperative relapsed gastric cancer.

PURPOSE

To estimate the effect and toxicity of bimonthly low-dose leucovorin (LV) and fluorouracil (5-FU) bolus plus continuous infusion(LV5FU2) with docetaxel combination chemotherapy in patients with inoperable or postoperative relapsed gastric cancer.

MATERIALS AND METHODS

Total 27 patients are enrolled in this study. LV 20 mg/m(2) (bolus), 5FU 400 mg/m(2) (bolus), 5-FU 600 mg/m(2) (24-hour continuous infusion) on day 1, 2, 15, and 16, docetaxel 60 mg/m(2) (1-hour infusion) on day 15 every 4 weeks.

RESULTS

Total of 141 cycles were administered and response rate were 36.8% with 2 complete response (10.5%) and 5 partial response (26.3%) in 19 evaluable patients. The median response duration is 8.1 months (95% CI, 4.0 approximately 12.1). The median progression-free survival time is 6.7 months (95% CI, 5.0 approximately 8.5) and the median overall survival time is 11.9 months (95% CI, 4.8 approximately 19.1). The grade 3-4 toxicity of neutropenia (24.8%) and anemia (11.3%), neutropenic fever (2.8%) is observed. The grade 1 toxicity of injection site reaction is observed all patients and the grade 1-2 toxicity of alopecia is observed 60%.

CONCLUSIONS

LV5FU2 with docetaxel combination chemotherapy is effective and tolerable in patients with inoperable or postoperative relapsed gastric cancer.