Abstract:Objective To explore the clinical safety and efficacy of sustained-release fluorouracil implant in modified radical mastectomy.Methods A total of 187 patients(95 patients with infitrating ductal carcinoma,24 patients with medullary carcinoma and 8 patients with preinvasive carcinoma;134 patients with TNM stage Ⅰ-Ⅱ and 53 patients with TNM stage Ⅲ) were randomly divided into implant group(n=95) and control group(n=92).The fluorouracil(600 mg) was administered to implant group in the tumor,axillary and subclavian vascular region and between pectoralis major muscle and pectoralis minor muscle.Control group was not given fluorouracil implant.All patients received postoperative conventional chemotherapy.Wound infection,effusion,dehiscence,limb edema,tissue ulceration,local pain,skin flap necrosis,local tumor recurrence and 3-year survival rate were observed after operation.Red and white blood cell count and alanine aminotransferase and creatinine levels were measured before and after operation.Results All patients have no incision infection,effusion,dehiscence,limb edema and tissue ulceration.The incidences of local pain,seroma and flap necrosis were 8.42%,15.79% and 10.53% in implant group and 6.52%,11.96% and 11.96% in control group,with no significant differences between the two groups(P>0.05).Moreover,postoperative systemic adverse reactions were not statistically different between the two group(all P>0.05).Compared with control group,fluorouracil implant significantly decreased local recurrence rate(6.3% vs 16.3%,P=0.031),and obviously increased 3-year survival rate(93.7% vs 82.6%,P=0.019).Conclusion Sustained-release fluorouracil implant is safe and effective in modified radical mastectomy,and can reduce local recurrence and improve long-term survival in patients with breast cancer.