Objective To evaluate the effectiveness and safety of implanted sustained-release fluorouracil in gastric cancer surgery.
Methods Literature search was conducted in the following databases: PubMed, EMbase, The Cochrane Library (Issue 6, 2012), CNKI, VIP and WanFang Data from inception to June, 2012. Randomized controlled trials (RCTs) or quasi-randomized controlled trials on implanted sustained-release fluorouracil for gastric cancer were included. Two reviewers independently identified the literature according to the inclusion and exclusion criteria, and then extracted the data and assessed the quality of the included studies. Then, meta-analysis was conducted using RevMan 5.1 software.
Results A total of 7 studies involving 742 patients were included. The results of meta-analysis showed no significant difference in the rate of postoperative complications between the two groups (OR=0.93, 95%CI 0.54 to 1.59, P=0.79), while a significant reduction was found in the recurrence rate in the sustained-release fluorouracil group during 1 to 3 year follow-up (1 year after surgery: OR=0.32, 95%CI 0.22 to 0.46, P=0.02; 2 years after surgery: OR=0.19, 95%CI 0.08 to 0.42, P lt;0.001; 3 years after surgery: OR=0.40, 95%CI 0.24 to 0.67, P=0.004). As for the survival rate, no significant difference was found between the two groups 1 year after surgery (OR=1.98, 95%CI 0.92 to 4.25, P=0.08), while it was significantly higher in the sustained-release fluorouracil group than in the control group 2 to 3 years after surgery (2 years after surgery: OR=2.63, 95%CI 1.17 to 5.91, P=0.02; 3 years after surgery: OR=2.42, 95%CI 1.53 to 3.83, P=0.002). Adverse reaction rates in the sustained-release fluorouracil group were lower than those in the control group, but without significantly differences between the two groups (OR=1.22, 95%CI 0.49 to 3.07, P=0.67).
Conclusion Compared with the control group, implanted sustained-release fluorouracil for gastric cancer can significantly reduce the recurrence rate 1 to 2 years after surgery and improve the overall survival rate 2 to 3 years after surgery without increasing the incidences of the postoperative complications and adverse reaction. However, due to the limitation of quantity and quality of the included studies, this conclusion should be further confirmed by more high quality, larger sample and multi-center RCTs.
Citation： ZENG Linmiao,GUO Xiaojing,YU Xiaolian,GUO Lianghua,ZHOU Xinwei,LIU Peng. Effectiveness and Safety of Sustained-Release Fluorouracil for Gastric Cancer: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2013, 13(8): 1001-1007. doi: 10.7507/1672-2531.20130173 Copy