Preoperative concomitant radiochemotherapy with a 5-fluorouracil plus folinic acid bolus in the combined treatment of locally advanced extraperitoneal rectal cancer:: A long-term analysis on 27 patients

Aims and background: Many studies of preoperative chemoradiation in resectable rectal cancer have focused on down-staging and sphincter-saving procedures. The aim of this study was to evaluate long-term outcome in resectable rectal cancer treated with preoperative chemoradiation and surgery by only one surgical team irrespective of the tumor downstaging. Material and methods: From 1992 to 2001, in a cooperative study between the Institute of Semeiotica Chirurgica and the Division of Radiotherapy of the Catholic University of the Sacred Heart, 27 patients with locally advanced rectal cancer were treated with preoperative chemoradiation, followed by surgery after 4-6 weeks, and, just for 6 of them, by adjuvant chemotherapy. Seventeen patients were staged T3 N1 (63%), 4 patients T3N0 (15%), 4 patients T3N2 (15%) and 2 T4N2 (7.5%). Twenty-three patients (85.1%) had signs of nodal involvement at combined imaging. Radiation therapy was delivered to the posterior pelvis at a dose of 45 Gy to the tumor (clinical target volume) and the whole pelvis (planning target volume). Fractionation was conventional: 1.8 Gy/day, 5 fractions a week. Radiotherapy was started on Monday for all Patients and was delivered with a linear accelerator. Concomitant chemotherapy consisted of 5-fluorouracil (350 mg/m(2)/day, as an intravenous bolus on days 1-5 and 29-33 of radiotherapy) and folinic acid (L-isomer) (10 mg/m(2) as an intravenous bolus on days 1-5 and 29-33). This chemotherapy was generally administered about 1 hr before radiotherapy. Data were analyzed on July 2002; median follow-up was 59 months (range, 20-116 months). No patient was lost during the follow-up. Results: All patients completed the treatment. Grade >3 acute toxicity occurred in 11% of the patients and late toxicity was 15%. A pathologic complete response was recorded in 22% of patients; sphincter-preserving surgery was feasible in 44%. Seven patients died: 2 of them perioperatively, 1 patient died with local recurrence, and 1 died with distant metastases; 3 patients died during the follow-up for other causes. Five-year local control was 95% and overall survival was 84%. Conclusions: Our study, although limited in number, demonstrated good results in local control and disease-free survival with a limited toxicity.