Abstract
Introduction
Premenopausal women with hormone receptor positive (HR+) and human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (aBC) often present with aggressive tumor types that lead to poor prognosis, high rates of recurrence, and mortality. Although clinical guidelines provide evidence-based recommendations for optimal treatment and monitoring, there is a dearth of information regarding treatment and monitoring patterns in clinical practice. In this study, we describe treatment and monitoring patterns among premenopausal women with HR+/HER2− aBC in real-world practice.
Methods
A large US claims database was used to describe treatment patterns for patients in first, second, and third lines of therapy. Treatment monitoring included complete blood count (CBC), liver function test (LFT), and electrocardiogram (EKG) monitoring, described for the first three lines of therapy, and separately for patients receiving endocrine monotherapy (ET) and chemotherapy.
Results
Among 3203 patients, chemotherapy was the most common treatment used in first-line (63.6%) and second-line therapy (66.9%). ET was used in 34.4, 30.1, and 73.6% of patients in first, second, and third lines of therapy, respectively. The two most common treatment sequences were a single line of ET (27.3%), and two consecutive lines of chemotherapy followed by a line of ET (19.3%). Patients receiving chemotherapy were monitored with CBC on average more than two times per month, and for LFT one to two times per month. Patients receiving ET were monitored with CBC and LFT on average once every 2–3 months. Overall, approximately 20% of patients were monitored with an EKG at some point during each line of therapy.
Conclusion
A considerable proportion of premenopausal women with aBC received first- and second-line chemotherapy, which appears inconsistent with current clinical guidelines. The observed treatment heterogeneity points to a lack real-world consensus on the management of premenopausal women with HR+/HER2− aBC.
Funding
Novartis Pharmaceuticals Corporation.
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Acknowledgements
Funding
Sponsorship for this study and article processing charges were funded by Novartis Pharmaceuticals Corporation. All authors had full access to all of the data in this study and take complete responsibility for the integrity and accuracy of the data analysis.
Medical Writing, Editorial, and Other Assistance
Medical writing assistance was provided by Sara Kaffashian, an employee of Analysis Group, Inc. Analysis Group received consulting fees from Novartis for the conduct of this study.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Author Contributions
All authors participated in the design and analytical approach of the study and contributed to the manuscript development. Results were summarized and interpreted in collaboration with all authors.
Disclosures
Anand A. Dalal is an employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Tania Small is an employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Geneviève Gauthier is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation.Patrick Gagnon-Sanschagrin is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Rebecca Burne is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Annie Guérin is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Polly Niravath received honoraria from Novartis as a consultant.
Compliance with Ethics Guidelines
Data are de-identified and comply with the confidentiality requirements outlined in the Health Insurance Portability and Accountability Act. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Data Availability
The claims database (Truven Health Analytics MarketScan Commercial database) is proprietary, provided by a third-party vendor, and the authors do not have permission to disseminate the data without the vendor’s approval. The study sponsor has purchased access to the database (the authors have been granted access to the data on a contract per project use). Access to this data set is available to any other interested parties for a fee set by Truven Health Analytics MarketScan Commercial database (https://marketscan.truvenhealth.com/marketscanportal/).
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Dalal, A.A., Gauthier, G., Gagnon-Sanschagrin, P. et al. Treatment and Monitoring Patterns Among Premenopausal Women with HR+/HER2− Advanced Breast Cancer. Adv Ther 35, 1356–1367 (2018). https://doi.org/10.1007/s12325-018-0764-3
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DOI: https://doi.org/10.1007/s12325-018-0764-3