title: Clinical outcome of the ACCORD 12/0405 PRODIGE 2 randomized trial in rectal cancer.
abstract: OBJECTIVE
  The ACCORD 12 trial investigated the value of two different preoperative chemoradiotherapy (CT-RT) regimens in T3-4 Nx M0 resectable rectal cancer. Clinical results are reported after follow-up of 3 years.
  
  
  METHODS
  Between November 2005 and July 2008, a total of 598 patients were randomly assigned to preoperative CT-RT with CAP45 (45-Gy RT for 5 weeks with concurrent capecitabine) or CAPOX50 (50-Gy RT for 5 weeks with concurrent capecitabine and oxaliplatin). Total mesorectal excision was planned 6 weeks after CT-RT. The primary end point was sterilization of the operative specimen, which was achieved in 13.9% versus 19.2% of patients, respectively (P = .09). Clinical results were analyzed for all randomly assigned patients according to the intention-to-treat principle.
  
  
  RESULTS
  At 3 years, there was no significant difference between CAP45 and CAPOX50 (cumulative incidence of local recurrence, 6.1% v 4.4%; overall survival, 87.6% v 88.3%; disease-free survival, 67.9% v 72.7%). Grade 3 to 4 toxicity was reported in four patients in the CAP45 group and in two patients in the CAPOX50 group. Bowel continence, erectile dysfunction, and social life disturbance were not different between groups. In multivariate analysis, the sterilization rate (Dworak score) of the operative specimen was the main significant prognostic factor (hazard ratio, 0.32; 95% CI, 0.21 to 0.50).
  
  
  CONCLUSIONS
  At 3 years, no significant difference in clinical outcome was achieved with the intensified CAPOX regimen. When compared with other recent randomized trials, these results indicate that concurrent administration of oxaliplatin and RT is not recommended.
authors.affiliation: Centre Antoine Lacassagne, Nice, France. jean-pierre.gerard@nice.unicancer.fr
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Gérard
authors.forename: David
authors.initials: D
authors.lastname: Azria
authors.forename: Sophie
authors.initials: S
authors.lastname: Gourgou-Bourgade
authors.forename: Isabelle
authors.initials: I
authors.lastname: Martel-Lafay
authors.forename: Christophe
authors.initials: C
authors.lastname: Hennequin
authors.forename: Pierre-Luc
authors.initials: PL
authors.lastname: Etienne
authors.forename: Véronique
authors.initials: V
authors.lastname: Vendrely
authors.forename: Eric
authors.initials: E
authors.lastname: François
authors.forename: Guy
authors.initials: G
authors.lastname: de La Roche
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Xavier
authors.initials: X
authors.lastname: Mirabel
authors.forename: Bernard
authors.initials: B
authors.lastname: Denis
authors.forename: Laurent
authors.initials: L
authors.lastname: Mineur
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Berdah
authors.forename: Marc-André
authors.initials: MA
authors.lastname: Mahé
authors.forename: Yves
authors.initials: Y
authors.lastname: Bécouarn
authors.forename: Olivier
authors.initials: O
authors.lastname: Dupuis
authors.forename: Gérard
authors.initials: G
authors.lastname: Lledo
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Seitz
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Béata
authors.initials: B
authors.lastname: Juzyna
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil