Neoadjuvant chemoradiotherapy with 5-fluorouracil by bolus

Background: Neoadjuvant chemoradiotherapy (CT-RT) with continuous infusion (c.i.) 5-fluorouracil (5-FU) before resection of high-risk rectal cancer improves overall survival (OS) and pelvic control. Since the presence of cardiomiopathy may contraindicate c.i. of 5-FU, an alternative regimen of 5-FU CT-RT was prospectively studied in these patients. Patients and Methods: From October 2000 to December 2006, patients with clinical stage T3 or T4, or node-positive disease were assigned according to their cardiological status to receive weekly 5-FU bolus administration during radiotherapy (RT). The preoperative treatment consisted of 5,040 cGy, delivered infractions of 180 cGy per day, five days per week, and 5-FU, given in 15 minutes at a dose of 450 mg/m² of body surface area weekly during all radiotherapy. Surgery was performed six weeks after the completion of CT-RT. The primary endpoint was disease-free survival (DFS). Results: Fifty-one patients received preoperative CH-RT. The 2-year OS rate was 92.3% and the 3-year DFS was 87.5%. The five-year cumulative incidence of local relapse was 3.9%. Grade 3 acute toxic effects occurred in 19.6% of the patients; worsening of patient's cardiopathy was never reported. Conclusion: Patients with cardiopathy developed similar local control and DFS, toxicity and OS with 5-FU administered weekly by bolus as those reported by literature data.