Factors associated with enrolment in clinical trials among women with early-stage breast cancer

D Presti, J Havas, D Soldato, P Lapidari, E Martin, B Pistilli, C Jouannaud, G Emile, O Rigal, M Fournier, P Soulie, M-A Mouret-Reynier, C Tarpin, M Campone, S Guillermet, A-L Martin, S Everhard, A Di Meglio, D Presti, J Havas, D Soldato, P Lapidari, E Martin, B Pistilli, C Jouannaud, G Emile, O Rigal, M Fournier, P Soulie, M-A Mouret-Reynier, C Tarpin, M Campone, S Guillermet, A-L Martin, S Everhard, A Di Meglio

Abstract

Background: Clinical trials allow development of innovative treatments and ameliorate the quality of clinical care in oncology. Data show that only a minority of patients are enrolled in clinical trials. We assessed enrolment in clinical trials and its correlates among women with early breast cancer.

Methods: We included 9516 patients with stage I-III breast cancer from the multicenter, prospective CANTO study (NCT01993498), followed-up until year 4 (Y4) post-diagnosis. We assessed factors associated with enrolment using multivariable logistic regression. In exploratory, propensity score matched analyses, we used multiple linear regression to evaluate the relationship of enrolment in clinical trials with the European Organisation for Research and Treatment of Cancer Quality Of Life (QoL) questionnaire (EORTC QLQ-C30) Summary Score and described clinical outcomes (distant disease event, invasive disease event, and death by any cause) according to enrolment.

Results: Overall, 1716 patients (18%) were enrolled in a clinical trial until Y4 post-diagnosis of breast cancer. Socioeconomic factors were not associated with enrolment. Centres of intermediate volume were most likely to enrol patients in clinical trials [versus low volume, odds ratio 1.45 (95% confidence interval (CI) 1.08-1.95), P = 0.0124]. Among 2118 propensity score matched patients, enrolment was associated with better QoL at Y4 (adjusted mean difference versus not enrolled 1.37, 95% CI 0.03-2.71, P = 0.0458), and clinical outcomes (enrolled versus not enrolled, distant disease event 7.3% versus 10.1%, P = 0.0206; invasive disease event 8.2% versus 10.5%, P = 0.0732; death by any cause 2.8% versus 3.7%, P = 0.2707).

Conclusions: In this large study, one in five patients enrolled on a clinical trial until Y4 after diagnosis of early breast cancer. Geographical and centre-related factors were significantly associated with enrolment in clinical trials. Inclusion in clinical trials seemed associated with improved QoL and clinical outcomes. Access to innovation for early-stage breast cancer patients should be encouraged and facilitated by overcoming organizational and geographical barriers to recruitment.

Keywords: breast neoplasms; clinical trial; quality of life; survivorship.

Conflict of interest statement

Disclosure BP reports personal fees from AstraZeneca, Myriad, Pfizer, Pierre Fabre, Daiichi Sankyo, and non-financial support from Daiichi Sankyo, Merus, Puma, Pfizer, AstraZeneca. All other authors have declared no conflicts of interest.

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1
Figure 1
CONSORT diagram of patient population.
Figure 2
Figure 2
Line graphs with mean Summary Score values [European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30] over time by enrolment in clinical trials. C30 Summary Score is calculated using the mean scores for 13 of the 15 QLQ-C30 domains (the Global Health and the Financial Impact scales are not included). Higher C30 Summary Scores indicate a better quality of life. dx, diagnosis; Y1, 1 year after diagnosis; Y2, 2 years after diagnosis; Y4, 4 years after diagnosis.

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Source: PubMed

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