Combination chemotherapy with paclitaxel, cisplatin and fluorouracil for patients with advanced and metastatic gastric or esophagogastric junction adenocarcinoma： a multicenter prospective study

Objective： To evaluate the efficacy and toxicity of the combination regimen of paclitaxel, cisplatin and 5-FU （PCF） as first-line or second-line therapy in patients with advanced gastric and esophagogastric junction （EGJ） adenocarcinoma in China. Methods： The patients were treated with paclitaxel 150 mg/m2 on dl; fractionated cisplatin 15 mg/m2 and continuous infusion 5-FU 600 mg/（mLd） intravenously on d 1-d5 of a 21-d cycle until disease progression or unacceptable toxicities. Results： Seventy-five patients have been enrolled, among which, 41 received PCF regimen as the first-line therapy （group A） and 34 received the regimen as the second-line therapy （group B） with the median age of 59 years old and Karnofsky performance status （KPS） score 〉80. Toxicities were analyzed in all 75 patients. Seventy-one patients were evaluable for efficacy. The median overall survival （mOS） was 12.0 months （95% CI： 7.9-16.2 months） in group A and 7.3 months （95% CI： 4.3-10.3 months） in group B, respectively. The median progression-free survival （mPFS） was 5.7 months （95% CI： 4.1-7.2 months） and 5.0 months （95% CI： 3.1-6.9 months）, respectively. The response rate （CR~PR） was 40% （16/40; 95% CI： 24.9-56.7%） in group A and 22.6% （7/31; 95% CI： 9.6-41.1%） in group B. Major grade 3 or 4 adverse events include neutropenia （41.3 %）, febrile neutropenia （9.3 %）, nausea/anorexia （10.7%）, and vomiting （5.3 %）. There was no treatment-related death. Conclusions： The combination chemotherapy with PCF is active and tolerable as first-line and second- line therapy in Chinese patients with advanced gastric and EGJ adenocarcinoma. The response and survival of PCF are same as those of DCF, but the tolerance is much better.