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.
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.
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 80
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.
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
Legal entity responsible for the study
AP-HP (Assistance Publique - Hôpitaux de Paris)
French Ministry of Health - PHRC
All authors have declared no conflicts of interest.