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Combination of paclitaxel, cisplatin, and fluorouracil in patients with advanced and metastatic gastric cancer as first- or second-line therapy: A multicenter prospective study.

e14561 Background: We conducted this multicenter prospective study to evaluate the efficacy, toxicity, and feasibility of PCF (paclitaxel, cisplatin [DDP] and fluoruouracil [5-FU]) regimen as first-line and the second-line therapy in patients with advanced gastric cancer (AGC, locally advanced unresectable and metastatic gastric adenocarcinoma) in China.


METHODS
The patients with histologically confirmed AGC were treated with Paclitaxel 150 mg/m2 introvenously on day 1; DDP 15 mg/m2 introvenously on days 1-5 and 5-FU 600mg/m2/day continuously intravenous infusion on days 1-5 every 3 weeks until disease progression or unacceptable toxicities.


RESULTS
Between June 2005 and Sep 2007, a total of 75 patients were treated with the combination: 41 patients as first-line therapy (group A) and 34 patients second-line (group B) with the median age of 59 years old and performance status of KPS ≥ 90. Toxicities were analized in all enrolled 75 patients. Sixty seven patients were evaluable for efficacy. The median overall survival (mOS) were 14.2 months (95% CI, 8.2-20.2 months) in the group A and 9.2 months (95% CI, 5-13.4 months) in the group B. The median progression-free survival (mPFS) in two groups were 5.3 months (95% CI, 4-6.6 months) and 4.7 months (95% CI, 4-5.3 months) respectively. The total response rate of all patients was 32.4% (23/71). The response rates of the two groups were 40% (16/40) and 22.6% (7/31) respectively. Major grade 3 or 4 adverse events include neutropaenic 41.3%, febrile neutropenia 9.3%, nausea/anorexia 10.7%, and vomiting 5.3% . There was no treatment-related deaths.


CONCLUSIONS
The combination of paclitxel, lower doses of cisplatin and 5-FU (PCF) is active and tolerable as a first-line therapy and second-line for patients with AGC.