Representativeness of trial participants : linking the EORTC boost-no boost trial to the Netherlands cancer registry
Abstract: Background and Objectives: 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. Methods: 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 popul... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2022 |
Schlagwörter: | Human medicine |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-28782055 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://hdl.handle.net/10067/1891080151162165141 |
Abstract: Background and Objectives: 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. Methods: 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. Results: 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. Conclusion: 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. (C) 2022 The Author(s). Published by Elsevier Inc.