title: Prognostic value of pathologic complete response after neoadjuvant therapy in locally advanced rectal cancer: long-term analysis of 566 ypCR patients.
abstract: OBJECTIVE
  In the literature, a favorable prognosis was observed for complete pathologic response after preoperative therapy (ypCR) in patients with locally advanced rectal cancer. The aim of this study is to verify whether ypCR predicts a favorable outcome in a large series of patients.
  
  
  METHODS
  The Gastro-Intestinal Working Group of the Italian Association of Radiation Oncology collected clinical data for 566 patients with ypCR (ypT0N0) after neoadjuvant therapy. Eligibility criteria included locally advanced rectal cancer with no evidence of metastases at the time of diagnosis, evidence of ypCR after preoperative radiotherapy +/- chemotherapy (CT).
  
  
  RESULTS
  Median radiation dose was 50 Gy. A total of 527 patients (93%) received one of 12 different neoadjuvant CT schedules. Sphincter preservation, anteroposterior resection, and endoscopic surgery were performed in 73%, 22%, and 5% of patients, respectively. Adjuvant CT was administered to 22% of patients. Median follow-up was 46.4 months. Locoregional recurrence occurred in 7 patients (1.6%). Distant metastases occurred in 49 patients (8.9%). Overall, 5-year rates of disease-free survival, overall survival, and cancer-specific survival were 85%, 90%, and 94%, respectively. In multivariate analysis, only age and clinical stage statistically correlated with survival outcome. Adjuvant CT was still of borderline significance (worse for adjuvant CT). No relation was found between survival and neoadjuvant CT schedules.
  
  
  CONCLUSIONS
  A ypCR after neoadjuvant therapy identified a favorable group of patients, even in this large series of 566 patients collected in 61 centers. Locoregional recurrence occurred only in 1.6% patients.
authors.affiliation: Department of Radiotherapy, State Hospital, Rovigo, Italy. capirci.carlo@azisanrovigo.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Capirci
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Luca
authors.initials: L
authors.lastname: Cionini
authors.forename: Antonino
authors.initials: A
authors.lastname: De Paoli
authors.forename: Claus
authors.initials: C
authors.lastname: Rodel
authors.forename: Robert
authors.initials: R
authors.lastname: Glynne-Jones
authors.forename: Claudio
authors.initials: C
authors.lastname: Coco
authors.forename: Mario
authors.initials: M
authors.lastname: Romano
authors.forename: Giovanna
authors.initials: G
authors.lastname: Mantello
authors.forename: Silvia
authors.initials: S
authors.lastname: Palazzi
authors.forename: Falchetti Osti
authors.initials: FO
authors.lastname: Mattia
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Friso
authors.forename: Domenico
authors.initials: D
authors.lastname: Genovesi
authors.forename: Cristiana
authors.initials: C
authors.lastname: Vidali
authors.forename: Maria Antonietta
authors.initials: MA
authors.lastname: Gambacorta
authors.forename: Alberto
authors.initials: A
authors.lastname: Buffoli
authors.forename: Marco
authors.initials: M
authors.lastname: Lupattelli
authors.forename: Maria Silvia
authors.initials: MS
authors.lastname: Favretto
authors.forename: Giuseppe
authors.initials: G
authors.lastname: La Torre
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D013223:Statistics as Topic; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents