Clinical Research Of Intraperitoneal Chemotherapy With Fluorouracil Sustained Release For Implant In Colorectal Cancer

Objective:Major objective: To evaluate the efficacy of preventingⅡ,Ⅲcolorectal cancer local recurrence and distance metastasis after implanted with FSRI in abdominal cavity.Secondary objective: To observe the safety of using FSRI from drug-related adverse events with the situations.Methods:Colorectal cancer patients in gastrointestinal surgery department of the first affiliated hospital of Guangzhou Medical college from January, 2007 to April, 2009,have been selected and screened 108 cases who areⅡ,Ⅲcolorectal cancer according to inclusion and exclusion criteria, and then divided into two groups—study group and control group .Study group with 35 cases: After the standard radical resection of colorectal cancer, according to the site of the primary lesion, the total of 900mg FSRI was implanted into the region of operation and around the mesentery artery. Control group with 73 cases: After the standard radical resection of colorectal cancer, 5-FU500mg/m2+ 500ml physiological saline were irrigated abdominal cavity and pelvic cavity and then reserved. After operations, they have been given the systemic chemotherapy in 4 weeks according to the NCCN guideline with FOLFOX4 as first-line program. According to comparing serious or specific adverse events occurred in the perioperative period between study group with control group, the safety of using FSRI for regional chemotherapy has been evaluated. Through the long-term follow-up, the advantage has been estimated between study group with control group in disease-free survival time, metastasis rate in abdominal pelvic cavity, liver, lung, and the 2-years-survival rate.Results:Safety: (1) systemic safety: all patients of study group had no serious systemic adverse reactions during the period after operation to the first systemic chemotherapy.2) Local safety: In the chemical peritonitis, wound (drainage tube) infection and dehiscence, anastomotic leakage, abdominal bleeding or infection and adhesive intestinal obstruction,there was no significant difference (P> 0.05). (3) side effects: reactions of the study group in the digestive tract, bone marrow suppression response, liver and kidney function and other aspects were mild, and had no significant differences appraised with the control group (P> 0.05) . Efficacy: It's the most common that recurrence or metastasis happened in two years after operations. The first two sites of recurrence and metastasis were the local or abdominal pelvic cavity and liver,and not the metastasis of lung and bone in study group. 2-year disease-free survival (DFS)of study group and control group were 85.71% and 60.27%, the difference was statistically significant (P <0.05); 2-years overall survival (OS) of study group and the control group were 94.3% and 83.6%, there was no significant difference (P> 0.05).Conclusions:Implanting FSRI in the abdominal cavity in the operations ofⅡ,Ⅲcolorectal cancer patients is safe. It has no obvious adverse reactions and side effects, and would not affect the patients'recovery and systemic vein chemotherapy in normal program. Simultaneously, it had not be found the metastasis of lung and bone, and has the ?obvious superiority in the 2-years survival rate ,but disease-free survival rate was no significant difference.