Preoperative Weekly 24-hour Infusion of High-dose 5-Fluorouracil and Leucovorin (HDFL) with Concurrent Radiation for T3, T4 Rectal Cancer on a Outpatient Basis

Background. Because of high local recurrent with traditional approaches for advanced rectal cancer, we investigated preoperative radiation-chemotherapy (5 -fluorouracil and leucovorin) for patients with T3, T4 rectal cancer. Methods. Twenty-eight outpatients (18men, 10women; median age 56.5years, range 28-74) with T3, T4 rectal adenocarcinoma received preoperative chemoradiation therapy (CCRT). The 24-hour infusions of 2600 mg/m^2 5-fluorouracil and 300 mg/m^2 leucovorin were given concurrently with radiation (5O4OcGy, 28 fractions over 5.5 weeks). Prior to curative total mesorectal excision (mean interval from CCRT, 5.7 weeks). Twelve cases received laparoscopic surgery, including one converted to an open procedure. Low anterior resection with J-pouch, transverse coloplasty pouch, or straight end-to-end anastomosis was done for two eight and nine patients, respectively. Results. Acute toxicity consisted of three patient with grade 3 diarrhea and one patient with neutropenic fever who discontinued chemotherapy (latter excluded from analysis). A total of 18 (62.96%) of 27 patients achieved tumor downstaging, and 8 (29.63%) had pathologic complete remission. Sphincter-preserving surgery was achieved in 6 (46.15%) of 13 low rectal cases. Surgical complication rate was 22.22%, including anastomosis dehiscence (n=2) and anastornosis stenosis (n=1). At 28.9 months median follow-up, the four-year overall survival and disease-free survival rates were 81.62% and 69.37% (mean overall survival time, 53.09 months). Five patients developed distal metastasis; two initially had local recurrence. Conclusions. Outpatient CCRT decreases hematologic toxicity while showing promise in improving outcomes such as pathologic remission and tumor downstaging, sphincter preservation, local recurrence/metastasis, and survival.