Phase II study of weekly paclitaxel plus 5-fluorouracil in patients with unresectable advanced or recurrent gastric cancer

Abstract

4075 Background: We conducted a phase I study on the paclitaxel (PTX) and 5-fluorouracil (5-FU) combination therapy in 18 patients with unresectable advanced or recurrent gastric cancer. The recommended dose was set at 600 mg/m2 for 5-FU and 80 mg/m2 for PTX as a result of that study. The present phase II multicenter cooperative study was conducted in 22 medical institutions using these doses from March 2003 to March 2004. Methods: Patients with unresectable advanced or recurrent gastric cancer with ECOG PS2 or better performance status were enrolled. The primary endpoint of this study was response rate. However, patients without measurable lesions were also enrolled, and the safety, overall survival, and QOL were evaluated. 5-FU was administered at 600 mg/m2 by 24-hr continuous infusion from days 1 through 5 and PTX at 80 mg/m2 by infusion on days 8, 15 and 22. This treatment was repeated every 4 weeks as long as possible. The response was evaluated according to the RECIST. Results: A total of 88 patients including the targeted 65 with measurable lesions were enrolled. The median age was 63 (range, 33–75). Sixty-six were males and 22 females. The performance status was 0/1/2/3 in 50/30/7/1 patients, respectively. Thirty- three patients had previous chemotherapy. The response rate was 35% with 2 CRs (3.3%) and 19 PRs (31.7%) in 60 evaluable patients. The median survival time was 375 days and the one-year survival rate 47.5% in all patients including those without measurable lesions. The incidence of hematological toxicities was 9.8% for G3/4 leukopenia, 17.1% for neutropenia, and 13.4%, for decreases in hemoglobin. Among non-hematological toxicities the incidence of G2 alopecia was 35.4%, but the incidence of GI toxicities was extremely low. Patients and received a median of 4 cycles (range, 1–15); 46.6% 4 or more cycles, and 20.5% 6 or more cycles. The compliance with this regimen was fairly good. Conclusions: The combination of weekly PTX and 5-FU is effective and well tolerated in advanced or recurrent gastric cancer and it is expected to contribute to better QOL and prognosis. No significant financial relationships to disclose.