Aims: The aim of this prospective study is to elucidate feasibility of protocol of neoadjuvant concomitant radiochemotherapy with capecitabine and long course radiotherapy with subsequent laparoscopic rectal resection. We assessed treatment toxicity, downstaging rate, pathological response to the neoadjuvant treatment, surgery complications, rate of conversions and sphincter-preserving surgical procedures, and intraoperative and early postoperative complications too.
Methods: We acquired data of 78 patients from 1 January 2005 to 31 December 2007 with a locally advanced rectal cancer in our study. All patients were indicated for the neoadjuvant concomitant chemoradiotherapy due to locally advanced tumor (T3 or T4) or lymph nodes involvement suspicion (N+). Both radiotherapy (to pelvic region) and chemotherapy (capecitabine) were administered. Rectal tumors were localized within 12 cm from the anocutaneous verge. The average follow-up time was 23.9 months.
Results: All patients completed their treatment according to the planned regimen and dose. The surgery was performed laparoscopicaly within 4-8 weeks following the concomitant chemoradiotherapy - in 17% cases was converted into conventional surgery. Downstaging was achieved in 69% of patients, pathological complete response in 10%, histologically negative lymph nodes were documented in 58% of patients. Grade 3 toxicity of the concomitant chemoradiotherapy was present in 3%; grade 2 in 29% of patients, particularly skin and gastrointestinal form. Intraoperative and early postoperative complications of the surgery were 18%. Re-operation was needed in 5% cases.
Conclusions: We demonstrated safety and low toxicity of the concomitant chemoradiotherapy with capecitabine.
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