1445P - Inclusion of older patients with colorectal cancer in clinical trials: the SAGE prospective multicenter cohort study

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Bioethics, Legal, and Economic Issues
Cancer in Pregnancy
Colon Cancer
Rectal Cancer
Presenter Florence Canouï-Poitrine
Citation Annals of Oncology (2017) 28 (suppl_5): v511-v520. 10.1093/annonc/mdx385
Authors F. Canouï-Poitrine1, A. Lievre2, F. Dayde1, D. Lopez-Trabada-Ataz D3, I. Baumgartner4, O. Dubreuil3, F. Brunetti5, T. Aparicio6, R. Coriat7, K. Maley8, O. Colussi9, C. Tournigand10, E. Paillaud11, S. Bastuji-Garin1
  • 1Public Health, Centre hospitalier universitaire Henri-Mondor, 94010 - Créteil/FR
  • 2Service Gastro-entérologie, CHU Rennes, Rennes/FR
  • 3Service D'oncologie Médicale, APHP, Paris/FR
  • 4Medical Oncology, Centre hospitalier universitaire Henri-Mondor, 94010 - Créteil/FR
  • 5Department Of Digestive Surgery, CHU Henri Mondor, Créteil/FR
  • 6Gastroenterology, Saint Louis Hospital, 75010 - Paris/FR
  • 7Gastroenterology And Digestive Oncology, Hôpital Cochin, 75014 - PARIS/FR
  • 8Service De Geriatrie, APHP, Paris/FR
  • 9Service Gastro-entérologie, APHP, Paris/FR
  • 10Medical Oncology, CHU Henri Mondor, 94000 - Creteil/FR
  • 11Geriatrics, Centre hospitalier universitaire Henri-Mondor, 94010 - Créteil/FR

Abstract

Background

Whereas older patients represent the major part of new cancer cases, their underrepresentation in clinical trials leads to weak external validity. The main objective was to assess the proportions of older patients for whom there is an ongoing clinical trial available, eligible to at least one trial, invited to participate and finally included. Secondary objective was to investigate associated factors.

Methods

The SAGE multicenter prospective cohort study settled up in 7 centers in Paris Area between 2013 and 2016. All patients aged 65 years or more with a colorectal cancer were included. The endpoints were 1) the presence of at least one ongoing clinical trial available regarding stage and tumor location 2) the patient’s eligibility 3) invitation and 4) inclusion.

Results

577 patients (mean age: 75.6 years +/-7; 56% of men; 74% of colon tumor; 40.9% with metastasis) were included; 37 trials were ongoing (9 trials in median per center; academic sponsors: 62.2%; phaseI/II: 59.5%; chemotherapy: 75.7%). Overall, 12.3% of patients were included in a trial (65-69 yrs class: 19.1%; 70-75 yrs: 14.9%; 75-79 yrs: 12.8%; 80 yrs or more: 2.6%; p  800.05 (0.01-0.29)PS 0Reference (1.00)0.0210.19 (0.06-0.62)≥ 20.50 (0.09-2.75)Body Mass Index, kg/m2 21-24.9Reference (1.00)0.09< 210.25 (0.07-0.90)≥250.76 (0.24-2.42)*

Hierarchical multivariate logistic regression with the patient at the level 1 and the center at the level 2 and adjustment for all variables listed in the table, the number of trials in the center and the number of chemotherapy trials.

Conclusions

Inclusion of older cancer patients decreased dramatically after 80 years. Non-eligibility was the main reason for non-inclusion but rarely related to chronological age. Moreover, one-third are non-invited to participate and one-fifth refused.

Clinical trial identification

NCT01754636

Legal entity responsible for the study

AP-HP (Assistance Publique - Hôpitaux de Paris)

Funding

French Ministry of Health - PHRC

Disclosure

All authors have declared no conflicts of interest.