Preoperative chemoradiotherapy with capecitabine and oxaliplatin in locally advanced rectal carcinoma: A phase II trial

Abstract

4044 Background: The aim of this phase II trial was to assess the impact of preoperative external radiation therapy combined with Capecitabine and Oxaliplatin on pathologic tumor response, sphincter preservation and tumor control in patients with locally advanced rectal carcinoma. Methods: Sixty-seven patients with locally advanced rectal carcinoma (T3/T4 or N+) received radiotherapy (50.4 Gy/28 fractions) and chemotherapy with Capecitabine 825 mg/m2/12 hours on days 1–5 + Oxaliplatin 50 mg/m2 on day 1 every week (weeks 1–6). Surgery with TME was performed 6–7 weeks after the end of the treatment. Adjuvant chemotherapy was administered after surgery according investigator‘s crtiteria. Results: Patients have been recruited between February 2005 and June 2006. 47 male/20 female. Median age 67 years (range 38–79). Performance status (ECOG) 0 in 45 patients. Clinical stage (determined by EUS+CT or RMI): cT2 3p/cT3 58p/cT4 6p/cN+ 47p. Tumor location (from anal verge): = 5 cm in 27p. Median CEA level 3,69 ng/ml (0,7–391). Surgery (performed in 65 patients) consisted of low anterior resection in 37p, abdominal perineal resection in 28p. Tumor downstaging was observed in 52p (78%), 50 (76,9%) had negative lymph nodes, including 13p with complete pathological response (19,4%) and ten with only microfoci of tumor remaining (14,9%). 80% of the patients received adjuvant chemotherapy. Main adverse effects (NCI-CTC): diarrhea G3/4 25%, sensitive peripheral neurotoxicity G1 60%, skin G2 9%, skin G3 3%, nausea/vomiting G2 7.5%, fatigue G2 50%, fatigue G3 4%, neutropenia G3/4 4%. Conclusions: Those results show that preoperative chemoradiotherapy with capecitabine and oxaliplatin is a well tolerated regimen for locally advanced operable rectal cancer leading to a high probability of tumor downstaging. No significant financial relationships to disclose.