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

Abstract

3607 Background: The aim of this phase II trial was to assess the impact of preoperative external radiation therapy combined with 5-Fluorouracil (5-FU) and oxaliplatin (LOHP) on pathologic tumor response, sphincter preservation and tumor control in patients with locally advanced rectal carcinoma. Methods: Fifty-three patients with locally advanced rectal carcinoma (T3/T4 or N+) received radiotherapy (50.4 Gy/28 fractions) and chemotherapy with continuous infusion of 5-FU 200 mg/m2/day on days 1–5 + LOHP 60 mg/m2 on day 1 every week (weeks 1–6). Surgery was performed between 5–7 weeks after the end of the treatment. Adjuvant chemotherapy with 5-FU + Folinic Acid (NCCTG) x 4 cycles was administered after surgery. Results: Patients have been recruited since May 2002 to November 2003. 35 male/18 female. Median age 66 years (range 32–78). Clinical stage (determined by EUS+CT or RMI): cT3 43p, cT4 10p, cN+ 32p. Tumor location (from anal verge): ≤ 5 cm in 26p, >5 cm in 27p. Surgery (performed in 43 patients) consisted of low anterior resection in 27p, abdominal perineal resection in 15 and 1 palliative colostomy. Tumor downstaging was observed in 33p (75.6%), 34 (79%) had negative lymph nodes, including 10p with complete pathological response (22.7%). 36% of patients with tumors in distal rectum had sphincter-saving surgery. Main adverse effects (NCI-CTC): diarrhea G3 7.5%, sensitive peripheral neurotoxicity G1 60%, skin G2 10%, skin G3 2%, nausea/vomiting G2 7.5%, asthenia G2 20%, cardiac (miocardial infarct) G4 2%. No G3–4 hematolgic toxicity was observed. Conclusions: Preoperative chemoradiotherapy with 5FU+LOHP is a feasible and well tolerated treatment. Our results are comparable to the best series of preoperative treatment. No significant financial relationships to disclose.