Representativeness of trial participants: linking the EORTC boost-no boost trial to the Netherlands cancer registry

To evaluate the representativeness of Dutch patients participating in the European Organization for Research and Treatment of Cancer EORTC boost-no-boost trial to the target breast cancer patient population. All female breast cancer patients diagnosed between 1989 and 1996, aged ≤70 years, treated w...

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Bibliographic Details
Published in:Journal of clinical epidemiology 2022-08, Vol.148, p.54-64
Main Authors: Neven, Anouk, van Maaren, Marissa C., Schreuder, Kay, Kranse, Ries, Struikmans, Henk, Poortmans, Philip M., Bartelink, Harry, Collette, Laurence, Liu, Lifang, Siesling, Sabine
Format: Article
Language:English
Subjects:
Boost radiation therapy
Breast cancer
Cancer therapies
Data linkage
Epidemiology
Heterogeneity
Lumpectomy
Morphology
Patients
Radiation therapy
Registry
Representativeness
Socioeconomics
Statistical analysis
Surgery
Survival
Trial
Tumors
Variables
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Summary:To evaluate the representativeness of Dutch patients participating in the European Organization for Research and Treatment of Cancer EORTC boost-no-boost trial to the target breast cancer patient population. All female breast cancer patients diagnosed between 1989 and 1996, aged ≤70 years, treated with breast-conserving surgery and radiation therapy, were selected from the Netherlands Cancer Registry (NCR) and linked to the EORTC trial database. Baseline characteristics were compared between trial and non-trial participants, for the Dutch population and according to seven participating institutions. Kaplan-Meier curves and multivariable Cox regression were used to explore potential heterogeneity in overall survival between low, medium and high-volume institutes. Overall, 20,880 patients were identified from the NCR: 2,445 of 2,602 (94%) trial participants could be linked, and 18,435 were treated outside the trial. Trial participants had similar age, morphology, topography, laterality and socioeconomic status as non-trial participants, but more often stage I (62.7% vs. 56.4%) tumours and less often adjuvant treatment (22.9% vs. 26.5%). Crude 20-year survival ranged from 52.5% to 57.4%, without significant differences in multivariable analyses. This case study showed that participants in the boost-no-boost trial well represented the Dutch target population. Data linkage comes with challenges, but can close the gap between research and clinical practice.
ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2022.04.014