Retrospective Cohort Study of Intraoperative Administration of Sustained-Release 5-Fluorouracil Implants in Advanced Gastric Cancer Patients

Abstract

Background: 5-fluorouracil (5-FU) is basically used in the field of postoperative chemotherapy of gastric cancer (GC), the goal of this study was to evaluate improvement of long-term survival rate among GC patients after the 5-FU implants treatment.Methods: The study included 145 patients with gastric cancer who received postoperative chemotherapy with 5-FU implants and had complete follow-up information. According to the sex, age and clinical stage of 5-FU implants group, 74 patients were matched as the control group at the same time. In the study, we compared the 5-year overall survival rate with progression-free survival rate in the two groups, and the drug safety for both groups during the treatment was also compared.Results: The median follow-up time was 85 months (range 60–116 months). 31 patients (21.38%) died of tumor recurrence in 5-FU implants group and 21 (28.38%) in control group. In the control group, metastatic lesions were found in the small intestine, left adrenal gland and peritoneum in three patients. The 5-year progression-free survival (PFS) rate was 79.71% in 5-FU group and 67.12% in control (p = 0.0045). The 5-year overall survival (OS) rate was 77.68% in 5-FU implants group and 64.87% in control (p = 0.0159). Both the 5-years OS and PFS rates in 5-FU group were better than control group without significant side effect.Conclusions: 5-FU implants may improve 5-years OS and PFS rates after surgery in gastric cancer patients, while good safety profile suggests it could be reliable.

No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

“…The use of sustained-release 5-FU implants has shown survival benefits in different types of digestive system tumors such as colon cancer and primary hepatic cellular cancer[ 29 , 30 ]. Furthermore, a few studies on the treatment of gastric cancer, which showed similar results, were also reported by Chinese researchers[ 21 , 22 ]. However, P values of survival benefits obtained in previous studies on gastric cancer were lower, but close to 0.05.…”

“…The use of sustained-release 5-FU implants intraoperatively is a relatively newly developed method and has been used widely in almost all types of digestive tract cancer in China[ 20 ]. When this drug was placed intraoperatively into the tumor bed, it was released continuously, and it maintained a locally high drug concentration for approximately 1 mo[ 21 ]. The potential remnant tumor tends to grow quickly in the first year after resection owing to the decreased immunity and absence of adjuvant chemotherapy[ 9 ].…”

“…Recently, a multi-center, randomized, open-label, controlled clinical study showed that for cTNM stage III gastric cancer patients, the use of intraoperative 5-FU implants, combined with postoperative adjuvant chemotherapy, may reduce the risk of peritoneal recurrence and prolong progression-free survival significantly[ 22 ]. Another retrospective study with 5-FU implants in advanced gastric cancer patients showed that the use of 5-FU implants may improve 5-years overall survival (OS) and progression-free survival rates after surgery in gastric cancer patients[ 21 ]. However, these studies had limitations.…”