Abstract 134P
Background
Enrolment in CT affords access to innovation to pts with cancer. Few data extensively characterize factors associated with enrolment and its relationship with patient-reported (PROs) and clinical outcomes in pts with BC.
Methods
We included 9456 pts with stage I-III BC from the multicenter, prospective CANTO cohort (NCT01993498), followed-up until year-4 (Y4) post-diagnosis (dx). Enrolment in a CT was allowed at any time post-dx. Multivariable logistic regression assessed factors associated with enrolment. Multiple linear regression and Cox proportional hazard models evaluated the relationship of enrolment with quality of life (QOL; EORTC QLQ-C30 summary score) and clinical outcomes (distant disease free [dDFS], invasive [iDFS] and overall survival [OS]; adjusting by age, stage, subtype, comorbidities), respectively.
Results
Overall, 1700 pts (18%) were enrolled in a CT, 37% and 32% in a phase III therapeutic and supportive care CT, respectively. Clinical and socio-economic factors were not associated with enrolment. There was some inter-regional variability in enrolment rates (median, 15% [Q1-Q3, 12-24%] across 13 French regions). Small size centers were less likely to enroll pts in CT (Table). Among pts enrolled in a CT vs not, QOL at Y4 post-dx was similar (mean score [SD], 80.6 [13.6] vs 80.7 [13.9]; padjusted=0.68), and hazard ratios were 0.82 for dDFS (95% CI 0.68, 0.99; p=0.04), 0.85 for iDFS (0.71, 1.02; p=0.08), and 0.79 for OS (0.59, 1.06; p=0.12). Table: 134P
Factors associated with enrolment in a CT
| % enrolled (row) | Odds Ratio* | 95% CI | p | |
| Body Mass Index, kg/m2 <25≥25 | 1719 | 11.1 | 0.9,1.2 | 0.56 |
| Charlson comorbidity Index 0≥1 | 1719 | 11.1 | 0.9,1.3 | 0.32 |
| Education Primary schoolHigh schoolCollege | 201917 | 11.11.1 | 0.9,1.40.8,1.4 | 0.330.68 |
| Income (€/month) 2000-4000<2000>4000 | 191917 | 10.90.9 | 0.7,1.10.8,1.1 | 0.260.38 |
| BC Stage IIIIII | 142220 | 11.61.3 | 1.3,1.90.9,1.7 | <.010.08 |
| Provenance Ile-de-FranceCenter/North FranceSouth France | 151920 | 11.21.5 | 1.0,1.51.2,1.9 | 0.01<.01 |
| Center size SmallMediumLarge | 151916 | 11.41.2 | 1.1,1.90.8,1.6 | 0.020.40 |
*by year of dx, age, medical history, psychological factors, BC treatment, proximity to center of care
Conclusions
In this large study of early BC, 1/5 pts enrolled in a CT over 4 years post-dx. Pts were adequately represented irrespective of clinical and socio-demographic features, whereas enrolment seemed mostly impacted by geographical and center-related factors. In this cohort, enrolment was not associated with worse PROs, and there were indications of associations with improved clinical outcomes. Access to innovation for cancer pts should be encouraged and facilitated, including by overcoming organizational barriers to recruitment.
Clinical trial identification
NCT01993498 November 25, 2013.
Editorial acknowledgement
Legal entity responsible for the study
UNICANCER.
Funding
National Research Agency (grant ANR-10-COHO-0004 to Fabrice André for the Cancer Toxicity study).
Disclosure
B. Pistilli: Financial Interests, Personal, Other, Consulting/advising: Puma Biotechnology; Financial Interests, Personal, Other, Consulting/advising: Novartis; Financial Interests, Personal, Other, Consulting/advising: Myriad Genetics; Financial Interests, Personal, Other, Consulting/advising: Pierre Fabre; Financial Interests, Personal, Other, Meeting and/or travel support: Novartis; Financial Interests, Personal, Other, Meeting and/or travel support: AstraZeneca; Financial Interests, Personal, Other, Meeting and/or travel support: MSD Oncology; Financial Interests, Personal, Other, Meeting and/or travel support: Pfizer; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Personal, Research Grant: Puma Biotechnology; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Merus; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: AstraZeneca. C. Jouannaud: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Pfizer. F. André: Financial Interests, Personal, Other, Grants or contracts: Novartis; Financial Interests, Personal, Other, Grants or contracts: Pfizer; Financial Interests, Personal, Other, Grants or contracts: AstraZeneca; Financial Interests, Personal, Other, Grants or contracts: Eli Lilly; Financial Interests, Personal, Other, Grants or contracts: Daiichi Sankyo; Financial Interests, Personal, Other, Grants or contracts: Roche. I. Vaz-Luis: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Kephren; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Amgen. A. Di Meglio: Financial Interests, Personal, Invited Speaker: Thermo Fisher Scientific. All other authors have declared no conflicts of interest.