The effect of oxaliplatin plus capecitabine in combination with radiation for locally advanced lower or middle sited rectal carcinoma

Objective To explore the effectiveness,toxicity and treatment failure patterns for patients with locally advanced rectal adenocarcinoma after pre-operative radiation and concurrent oxaliplatin plus capecitabine.Methods Patients with histopathologically proven rectal adenocarcinoma and clinical stage Ⅱ/Ⅲ were enrolled in a prospective phase Ⅱ clinical trial at 2006-2012 years.One hundred and eighty-six patients received pre-operative chemoradiation,which consisted of 44.0-50.4 Gy in 22-28 fractions with concurrent chemotherapy of oral capecitabine 1650 mg/(m2 · d) in bid from d1-35 and oxaliplatin 50 mg/m2 per week for 5 times.Radical surgery was performed 4-8 weeks after chemoradiotherapy.Survival rates and multivariate prognostic factors were estimated by Kaplan-Meier method,comparisons were completed by the Log-rank test.Results One hundred and thirty-seven patients with clinical stage Ⅱ (n =34) and Ⅲ disease (n =103) underwent radical resection.The lower (the anal distance ≤5 cm) and middle (the anal distance 5-10 cm) located lesions were 102 (74.5％) and 35 (25.5％),respectively.Diarrhea was the most frequent acute Grade 3 toxicity (n =29,21.2％).Sixty-nine patients (50.4％) were downstaged,and 21 patients (15.3％) achieved complete regression of primary lesion,20 patients were pathological comlete response (yp T0N0).With a median follow-up of 22.2 months,the 2-year overall survival,locoregional recurrence free survival and disease free survival for all patients were 92.4％,93.1％ and 71.0％,respectively.In multivariate analysis,pathological stage of yp 0-Ⅱ was identified as independent factor related to OS and DFS.Conclusions When delivering oxalipatin plus capecitabine in combination with radiation for locally advanced lower or middle rectal carcinoma,the 2-year locol control was excellent,pathological stage of yp 0-Ⅱ was correlated to the favorable survival. Key words: Rectal neoplasms/radiochemotherapy;  Radiochemotherapy, concurrent;  Rectal neoplasms/surgery;  Prognosis