Results of semimonthly 5-florouracil/leucovorin combined with paclitaxel and oxaliplatin in treatment of advanced gastric cancer (AGC)
15045 Background: At present there is still no standard chemotherapy regimen for AGC, the progress of AGC exhibits a pessimistic result with a median survival of less than 9 months. The purpose of this trial was designed to enhance the treatment efficacy for AGC by using semimonthly FU/LV combined with paclitaxel and oxaliplatin. Methods: Patients chosen with histologically proven diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, locally advanced (i.e., unresectable) or metastatic and measurable disease. The chemotherapy regimen was comprised of a 3-hour infusion of 135 mg/m2 of paclitaxel followed by oxaliplatin 85 mg/m2 and LV 400 mg/m2, administered simultaneously as a 2-hour infusion, then continued a 46-hour infusion of FU 2.4 g/m2 using an ambulatory pump. Treatment was continued until disease progressed, unacceptable toxicity, or patient choice. The primary endpoint was response rate. Results: Twenty-seven patients were enrolled onto this study in our center between September 19, 2005 and December 25, 2006. The median patient age was 51 years (range, 28 to 66 years), 21 were males and 6 were females. All patients received the chemotherapy between at least two cycles and maximum eight cycles with a median of three. Four CRs of 27 enrolled patients, fifteen PRs and eight SDs were observed. Nineteen patients were chemonaive within enrolled patients: Four CRs, eleven PRs. At a median follow-up of 8.7 months, the median survival was 6.8 months. Frequent grade 3 to 4 toxicities were: neutropenia (37.0%), stomatitis (7.4%), nausea (7.4%), vomiting (7.4%), hepatic dysfunction (3.7%), paresthesia (18.5%). No treatment-related death occurred. Conclusion: Semimonthly FU/LV combined with paclitaxel and oxaliplatin appears to be of well efficacy and is well tolerated in patients with AGC. Currently, this regimen is being tested in the phase III trial involving patients with AGC on the basis of well result. No significant financial relationships to disclose.