title: Neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic resection in locally advanced tumors of middle and low rectum - toxicity and complications of the treatment.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Radiotherapy and Oncology, J. G. Mendel Cancer Center Novy Jicin, Purkynova 2138/16, Novy Jicin, 741 01, Czech Republic. renata.soumarova@radioterapie.cz
authors.forename: R
authors.initials: R
authors.lastname: Soumarova
authors.forename: M
authors.initials: M
authors.lastname: Skrovina
authors.forename: J
authors.initials: J
authors.lastname: Bartos
authors.forename: J
authors.initials: J
authors.lastname: Gruna
authors.forename: A
authors.initials: A
authors.lastname: Wendrinski
authors.forename: S
authors.initials: S
authors.lastname: Czudek
authors.forename: R
authors.initials: R
authors.lastname: Kycina
authors.forename: J
authors.initials: J
authors.lastname: Parvez
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000069287:Capecitabine; D003082:Colectomy / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005500:Follow-Up Studies; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011183:Postoperative Complications; D011355:Prodrugs; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D011355:Prodrugs; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil