© 2002 European Society for Medical Oncology Neoadjuvant therapy of rectal carcinoma with UFT–leucovorin plus radiotherapy

Background: The object of this phase II study was to assess the impact of preoperative external radia-tion therapy combined with UFT and leucovorin on tumor response, sphincter preservation and tumor control in patients with rectal carcinoma. Patients and methods: Forty-one patients with resectable extraperitoneal rectal adenocarcinoma received radiation therapy and two courses of chemotherapy. Chemotherapy consisted of a 2-h infusion of 6S-steroisomer of leucovorin (6SLV) 250 mg/m2 on day 1, oral 6SLV 7.5 mg every 12 h on days 2–14, and UFT either 350 or 300 mg/m2 on days 1 to 14 every 28 days. Six additional courses of chemotherapy were given after surgery. Results: Seven of 16 patients (43%) who received 350 mg/m2/day of UFT had grade 3–4 diarrhea and two other patients (12%) had grade 3–4 dermatitis. The next 25 patients received 300 mg/m2/day of UFT and only 14 % of them had grade 3–4 diarrhea. Surgery consisted of low-anterior resection in 26 patients (63%) and abdominal-perineal amputation in 15 (37%). There were six histological complete responses (15%). Downstaging occurred in 25 patients (63%). The overall survival at 3 years was 90% and the pelvic disease-free survival 92%. Conclusions: Preoperative therapy with radiotherapy and UFT–6SLV downstaged 63 % of tumors and allowed a sphincter-preserving procedure in some patients. Toxicity was moderate. This scheme is con-venient because of the oral administration of chemotherapy