title: Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy.
abstract: OBJECTIVE
  The aim was to verify whether preoperative conventionally fractionated chemoradiation offers an advantage in sphincter preservation in comparison with preoperative short-term irradiation.
  
  
  METHODS
  Patients with resectable T3-4 rectal carcinoma without sphincters' infiltration and with a lesion accessible to digital rectal examination were randomised into: preoperative 5x5Gy short-term irradiation with subsequent total mesorectal excision (TME) performed within 7 days or chemoradiation to a total dose of 50.4Gy (1.8Gy per fraction) concomitantly with two courses of bolus 5-fluorouracil and leucovorin followed by TME after 4-6 weeks. Surgeons were obliged to base the type of operation on the tumour status at the time of surgery.
  
  
  RESULTS
  Between 1999 and 2002, 316 patients from 19 institutions were enrolled. The sphincter preservation rate was 61% in the 5x5Gy arm and 58% in the radiochemotherapy arm, P = 0.57. The tumour was on average 1.9 cm smaller (P < 0.001) among patients treated with chemoradiation compared with short-term schedule. For patients who underwent sphincter-preserving procedure, the surgeons generally followed the rule of tailoring the resection according to tumour downsizing; the median distal bowel margin was identical (2 cm) for both randomised groups. However, in the chemoradiation group, five patients underwent abdominoperineal resection despite clinical complete response.
  
  
  CONCLUSIONS
  Despite significant downsizing, chemoradiation did not result in increased sphincter preservation rate in comparison with short-term preoperative radiotherapy. The surgeons' decisions were subjective and based on pre-treatment tumour volume at least in clinical complete responders.
authors.affiliation: Department of Radiotherapy, Maria Skłodowska-Curie Memorial Cancer Centre and Institute of Oncology, W.K. Roentgena 5, 02 781, Warsaw, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Bujko
authors.forename: M P
authors.initials: MP
authors.lastname: Nowacki
authors.forename: A
authors.initials: A
authors.lastname: Nasierowska-Guttmejer
authors.forename: W
authors.initials: W
authors.lastname: Michalski
authors.forename: M
authors.initials: M
authors.lastname: Bebenek
authors.forename: M
authors.initials: M
authors.lastname: Pudełko
authors.forename: M
authors.initials: M
authors.lastname: Kryj
authors.forename: J
authors.initials: J
authors.lastname: Oledzki
authors.forename: J
authors.initials: J
authors.lastname: Szmeja
authors.forename: J
authors.initials: J
authors.lastname: Słuszniak
authors.forename: K
authors.initials: K
authors.lastname: Serkies
authors.forename: J
authors.initials: J
authors.lastname: Kładny
authors.forename: M
authors.initials: M
authors.lastname: Pamucka
authors.forename: P
authors.initials: P
authors.lastname: Kukołowicz
mesh_terms: D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000502:physiology / Q000528:radiation effects / Q000601:surgery*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009361:Neoplasm Invasiveness; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil