title: Prediction of mesorectal nodal metastases after chemoradiation for rectal cancer: results of a randomised trial: implication for subsequent local excision.
abstract: OBJECTIVE
  For patients with rectal cancer treated with full thickness local excision the risk of mesorectal nodal metastases has to be very low. The aim was to assess this risk after preoperative radiotherapy in relation to pathological T-category.
  
  
  METHODS
  Three hundred sixteen patients with resectable cT3-4 low rectal carcinoma were randomised to receive either pre-operative 5 x 5 Gy irradiation with subsequent surgery performed within 7 days or chemoradiation (50.4, 1.8 Gy per fraction plus bolus 5-fluorouracil and leucovorin) followed by surgery after 4-6 weeks. The pathological reports of patients who fulfilled entry criteria and had preoperative irradiation followed by transabdominal surgery were analysed.
  
  
  RESULTS
  Significant downstaging of primary tumour (P<0.001) and of nodal disease (P=0.007) was observed after chemoradiation in comparison with short-course irradiation. In chemoradiation group, for patients with complete pathological response and for ypT1 category, the rate of nodal metastases was low - 5% (95% confidence interval [CI] 0-14%) and 8% (95% CI 0-24%), respectively. The rate of ypN-positive disease in chemoradiation group was similar to that recorded in short-course irradiation group for ypT2 category 26% (95% CI 14-38%) vs. 28% (95% CI 16-40%), P=0.83 and for ypT3-4 category 55% (95% CI 41-69%) vs. 64% (95% CI 54-74%), respectively, P=0.37. For ypT2 category after chemoradiation, the rate of nodal disease remained high even in subgroup with low residual cancer cells density (20%, 95% CI 4-36%).
  
  
  CONCLUSIONS
  For patients with tumours downstaged by chemoradiation to ypT0 and ypT1 full thickness local excision may be considered as an acceptable approach, because the risk of mesorectal lymph nodes metastases is low. The selection criteria for preoperative radio(chemo)therapy and local excision are discussed.
authors.affiliation: Department of Radiotherapy, Maria SkŁodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland. bujko@coi.waw.pl
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bujko
authors.forename: Marek P
authors.initials: MP
authors.lastname: Nowacki
authors.forename: Anna
authors.initials: A
authors.lastname: Nasierowska-Guttmejer
authors.forename: Lucyna
authors.initials: L
authors.lastname: Kepka
authors.forename: Barbara
authors.initials: B
authors.lastname: Winkler-Spytkowska
authors.forename: Rafal
authors.initials: R
authors.lastname: Suwiński
authors.forename: Janusz
authors.initials: J
authors.lastname: Oledzki
authors.forename: Grazyna
authors.initials: G
authors.lastname: Stryczyńska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Wieczorek
authors.forename: Krystyna
authors.initials: K
authors.lastname: Serkies
authors.forename: Danuta
authors.initials: D
authors.lastname: Rogowska
authors.forename: Piotr
authors.initials: P
authors.lastname: Tokar
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008207:Lymphatic Metastasis; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011379:Prognosis; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil