title: Pathologic Response, When Increased by Longer Interval, Is a Marker but Not the Cause of Good Prognosis in Rectal Cancer: 17-year Follow-up of the Lyon R90-01 Randomized Trial.
abstract: OBJECTIVE
  The Lyon R90-01 randomized trial investigated whether the interval between preoperative radiation therapy and surgery influenced rectal cancer outcome. Long-term results are reported here after a median follow-up of 17 years.
  
  
  METHODS
  Between February 1991 and December 1995, 210 patients from 29 French centers were randomly assigned (ratio of 1:1) to groups that waited either 2 weeks (short interval [SI]) or 6 to 8 weeks (long interval [LI]) between neoadjuvant radiation therapy and surgery. The primary endpoint was sphincter-preserving surgery.
  
  
  RESULTS
  LI group showed a better pathologic response (complete response or few residual cells) after radiation therapy than the SI group (26% vs 10.3%, P=.015). A better pathologic response was associated in multivariate analysis with significant improvement of overall survival (pT: P=.0293 and pN: P=.0048) but it was irrespective of the interval duration. The median follow-up was 17.2 years. The 5-, 10-, 15-, and 17-year overall survival rates were, respectively, 66.8%, 48.7%, 40.0%, and 34.0% for the SI group and, respectively, 67.1%, 53.5%, 41.9%, and 34.0% for the LI group. There were no significant differences between groups in terms of survival (P=.7656) or local recurrence rates (SI: 14.4% vs LI: 12.1%, respectively; P=.6202). Of 24 local disease recurrences, 20 (83%) occurred during the first 2 postoperative years, and all but one (96%) occurred during the first 5 postoperative years. The rate of second new malignancies was 9.4% (19 patients).
  
  
  CONCLUSIONS
  The radiation-induced sterilization rate of the preoperative cancer specimen was a marker of good prognosis. The interval duration (the treatment being the same) although it is modifying the sterilization rate has no impact on survival. Radiation therapy did not postpone local recurrence, because the rate of local relapse after 5 years was low. Radiation-induced cancers after radiation therapy were unusual and should not influence treatment decisions in adults.
authors.affiliation: Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France. Electronic address: eddy.cotte@chu-lyon.fr.
authors.forename: Eddy
authors.initials: E
authors.lastname: Cotte
authors.affiliation: Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Passot
authors.affiliation: Hospices Civils de Lyon, Pôle IMER, Lyon, France.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Decullier
authors.affiliation: Hospices Civils de Lyon, Pôle IMER, Lyon, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Maurice
authors.affiliation: Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Glehen
authors.affiliation: Department of Digestive Surgery, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Lyon 1 University, EMR 3738, Lyon-Sud/Charles Mérieux Medical University, Oullins, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: François
authors.affiliation: Department of Radiotherapy, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Lorchel
authors.affiliation: Department of Radiotherapy, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chapet
authors.affiliation: Department of Radiotherapy, Centre Antoine-Lacassagne, University Nice-Sophia, Nice, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Gerard
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D059351:Organ Sparing Treatments / Q000379:methods; D011379:Prognosis; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy* / Q000601:surgery*; D015996:Survival Rate; D013997:Time Factors