title: Results in the elderly with locally advanced rectal cancer from the ACCOR12/PRODIGE 2 phase III trial: tolerance and efficacy.
abstract: BACKGROUND
  Rectal cancer predominantly affects the elderly. Unfortunately, this age category is under-represented in clinical trials because clinicians are loath to include patients with a high risk of comorbidity.
  
  
  METHODS
  An exploratory analysis of the ACCORD12/PRODIGE 2 phase III trial was carried out to retrospectively compare the benefit of neoadjuvant chemotherapy between the elderly (≥70 years; n=142) and younger patients (<70 years; n=442), this analysis was not preplanned in the study protocol. Patients with histologically confirmed resectable stage T3 or T4 rectal adenocarcinoma were eligible with an age limit of 80 years.
  
  
  RESULTS
  Overall, the two age categories did not statistically differ in terms of patient's clinical and tumor baseline characteristics. Preoperative chemoradiotherapy leads to more severe grade 3/4 toxicities (25.6% vs. 15.8%, p=0.01) and more permanent stomas (33.3% vs. 22.8%, p=0.014) in elderly patients who were less often operated on than younger patients (95.8% vs. 99.0%, p=0.008). The relative number of interventions per surgery type (p=0.18), treatment efficacy in terms of R0 resection rate (88.6% vs. 90.6%; p=0.54) and complete pathological response (14.7% vs. 16.9%; p=0.55) were nearly identical between the two categories.
  
  
  CONCLUSIONS
  Altogether these results warrant the development of specific optimal therapeutic strategies for the elderly.
authors.affiliation: Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France. Electronic address: eric.francois@nice.unicancer.fr.
authors.forename: Eric
authors.initials: E
authors.lastname: François
authors.affiliation: Department of Radiotherapy, Centre Val d'Aurelle, Montpellier, France.
authors.forename: David
authors.initials: D
authors.lastname: Azria
authors.affiliation: Biostatistics Unit, Centre Val d'Aurelle, Montpellier Cedex 05, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gourgou-Bourgade
authors.affiliation: Biostatistics Unit, Centre Val d'Aurelle, Montpellier Cedex 05, France.
authors.forename: Marta
authors.initials: M
authors.lastname: Jarlier
authors.affiliation: Department of Radiotherapy, Centre Léon Bérard, Lyon, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Martel-Laffay
authors.affiliation: Department of Radiotherapy, Hôpital Saint Louis, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hennequin
authors.affiliation: Department of Medical Oncology, Clinique Armoricaine de Radiologie, Saint-Brieuc, France.
authors.forename: Pierre-Luc
authors.initials: PL
authors.lastname: Etienne
authors.affiliation: Department of Oncology, Hôpital Saint André, Bordeaux, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Vendrely
authors.affiliation: Department of Digestive Oncology, Hôpital la Timone, Marseille Cedex 5, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Seitz
authors.affiliation: Department of Medical Oncology, Centre Alexis Vautrin, Vandœuvre-les-Nancy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
authors.affiliation: R&D UNICANCER, Paris Cedex 13, France.
authors.forename: Beata
authors.initials: B
authors.lastname: Juzyna
authors.affiliation: Department of Radiotherapy, Centre Antoine Lacassagne, Nice, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Gerard
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
keywords: Capecitabine; Elderly; Exploratory analysis; Neoadjuvant chemoradiotherapy; Oxaliplatin; Rectal cancer