ABSTRACT
Background: Achieving a high rate of complete pathological response with pre-operative chemoradiotherapy in rectal cancer is an unmet need. We evaluated the efficacy and toxicity of the combination of cetuximab, capecitabine and radiation therapy in the pre-operative setting of localized rectal cancer
Patients and methods: Patients with clinically staged T3, T4 or nodepositive rectal cancer were treated with concurrent capecitabine and radiotherapy with weekly cetuximab starting one week before the start of radiation. This was followed by total mesorectal excision within 6-8 weeks. All patients achieving R0 resection received adjuvant capecitabine for 6 cycles
Results: Fifteen patients were treated and all underwent surgery. Sphincter preservation was achieved in 11 patients [73.3%] and pathological complete response in two. With a median follow up of 48 months [range 8.4-57.5], 12 patients were relapse-free and 14 were alive with 4- year relapse free survival of 80%. Overall survival was 93%. Significant grade 3 and 4 toxicity was mainly cetuximab-induced skin reactions [33%], radiation-induced skin toxicity [13%] and diarrhea [20%]
Conclusions: Adding cetuximab to pre-operative concurrent capecitabine and radiotherapy provides modest efficacy with manageable toxicity