Combination treatment of paclitaxel, cisplatin and infusional 5-fluorouracil (PCF) as first-line chemotherapy for metastatic or recurrent gastric cancer: Prospective multicenter clinical trial

15035 Background: Paclitaxel has been shown to be effective in patients with advanced gastric cancer. We assess the combination of paclitaxel (Anzatax®, Mayne Pharma), infusional 5-fluorouracil and Cisplatin as first-line chemotherapy for metastatic or recurrent gastric cancer. Methods: Patients with previously untreated metastatic gastric adenocarcinomas are eligible. Fifty patients received paclitaxel (Anzatax®, Mayne Pharma) 150mg/m2 by 2-hour infusion day 1, cisplatin 15 mg/m 2 daily days 1 through 5, and 5- fluorouracil by continuous infusion at a dose of 600 mg//m 2 daily days 1 through 5. Cycles were repeated every 3weeks until progression. Objective tumor responses, duration of response, time to progression, and toxicity profile are the end points evaluated in this study. Results: Total 50 patients were enrolled (41 men, 9 women). The median age was 59 years (range 32 - 75). All patients had ECOG performance status (PS) 0–2 and adequate organ functions. 50 patients completed one-six cycles (mean 3 cycles). Forty-four patients were evaluable and all patients were assessable toxicity. In these 44 assessable patients, 1 CRs and 14 PRs were obtained, resulting in an overall response rate of 34%. 19 patients (43.2%) had stable disease, and 3 patients (8.9%) progressed. The tumor control rate was 77.3%. The median time to progression(TTP) was 5 months. The major (Grade 3–4) toxicities were neutropenia (22%) and anorexia (4%). There were no treatment-related deaths were recorded in all patients. The median and overall survival times are now being followed up and the results will be announced during the ASCO 2007 annual meeting. Conclusion: The combination of paclitaxel (Anzatax®, Mayne Pharma), cisplatin,and 5-FU has substantial antitumor activity in advanced gastric cancer. The toxicity of this regimen is within acceptable range, but no remarkable response rate was noted. Paclitaxel is an important new agent in the treatment of gastric cancer, and further evaluation of this agent in combination chemotherapy is warranted. No significant financial relationships to disclose.