Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma

Abstract

e15108 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma. The primary endpoint of this phase II trial was pathologic tumor response. Secondary endpoint was sphincter preservation and toxicity Methods: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3–4, adequate renal, hematological and liver function. Planned sample for this trial was 40 patients. Treatment schedule: Pelvic radiotherapy (25 Gy/ 5 fractions: 5 Gy on day 1 to day 5) and chemotherapy: Oxaliplatin 85 mg/m2 on 2 hours, day 1 and 15, folinic acid 20 mg/m2 and 5 fluoro-uracil bolus 500 mg/m2 on day 1, 8 and 15 (cycle repeated every 4 weeks). Surgery with TME was performed after the end of the second cycle of chemotherapy. Adjuvant chemotherapy with 5FULV2 was administered after surgery Results: 15 patients have been recruited between January and October 2006: 10 males/5 females. Median age: 45 years (range 26–62). Clinical stage (determined by CT or RMI): T3: 66.6% and T4: 33.3%. Tumor location (from anal verge): < 6 cm in 10pts, >6 cm in 5pts. Surgery (performed in 14 patients) consisted of low anterior resection in 5pts and abdominal-perineal resection in 10p. Tumor down-staging was observed in 10pts (66.6%), including 5pts with complete pathological response (33.3%). Main adverse effects (NCI-CTC): diarrhea G3–4: 14.2%, sensitive peripheral neurotoxicity G1: 26.6%, nausea/vomiting G3–4: 11%, Anemia G3–4: 7.1%, neutropenia G3–4: 14.2% Conclusions: Preliminary results show that preoperative concomitant chemoradiotherapy with oxaliplatin and 5FU-folinic acid is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging. This interim analysis has to be confirmed by the final analysis. No significant financial relationships to disclose.