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

摘要

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 150mg/m2 on d1;fractionated cisplatin 15mg/m 2 and continuous infusion 5-FU 600mg/(m2·d) intravenously on d1-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 secondline 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.