Abstract
Introduction
Recent approval of novel agents has changed the treatment landscape for post menopausal women with hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2−) metastatic breast cancer (mBC). The objective of this study was to describe contemporary treatment patterns among postmenopausal women with HR+/HER2− mBC in the real-world setting.
Methods
Data were collected from 64 community oncologists in the US between February and June 2017 using an online medical records extraction tool. Physicians reviewed medical records and provided information on patient demographics and disease characteristics, and treatment regimens. Treatment patterns were described overall and separately by line of therapy and type of treatment received. Discontinuation rates were estimated using Kaplan–Meier analyses to account for censoring.
Results
Data were collected on 401 patients. Mean age at the time of mBC diagnosis was 67 years. In the first-line setting, 52.4% of patients received a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based regimen, most commonly with an aromatase inhibitor (AI) (39.2%) or fulvestrant (10.0%); 30.2% received endocrine therapy, most commonly an AI (21.4%) or fulvestrant (5.2%) in monotherapy, while 12.7% received a chemotherapy-based regimen. In the second-line setting, 42.9% of patients received a CDK4/6 inhibitor-based regimen, 18.4% received endocrine therapy, and 22.4% received a chemotherapy-based regimen. The 18-month discontinuation rate was 34.5% for patients receiving a CDK4/6 inhibitor-based regimen and 45.8% for patients receiving endocrine monotherapy.
Conclusion
CDK4/6 inhibitor-based regimens were the most commonly prescribed treatment in both first- and second-line settings. A wide variety of treatment sequences were observed which suggests an absence of a standard of care for postmenopausal women with HR+/HER2− mBC in real-world practice.
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Acknowledgements
We thank the participants of the study.
Funding
Funding for this research, including the journal’s article processing charges, was provided by Novartis Pharmaceuticals Corporation.
Author contributions
The study sponsor was involved in all stages of the study research and manuscript preparation. 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. Manuscript was prepared by the authors with the assistance from a professional medical writer ultimately paid by the sponsor. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis
Medical Writing 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.
Disclosures
Anand A. Dalal is a current employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Tania Small is a former employee of Novartis Pharmaceuticals Corporation and may own stock/stock options. Deborah Goldschmidt is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Hela Romdhani is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Sneha Kelkar is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Annie Guerin is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Genevieve Gauthier is an employee of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation. Eric Q. Wu 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
This study is based on retrospective data and does not include any interaction with human participants or animals performed by any of the authors.
Data Availability
The datasets analyzed during the current study are available from the corresponding author upon reasonable request. Please note that institutional review board confirmation will be needed before the data can be shared with additional parties.
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Goldschmidt, D., Dalal, A.A., Romdhani, H. et al. Current Treatment Patterns Among Postmenopausal Women with HR+/HER2− Metastatic Breast Cancer in US Community Oncology Practices: An Observational Study. Adv Ther 35, 482–493 (2018). https://doi.org/10.1007/s12325-018-0676-2
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DOI: https://doi.org/10.1007/s12325-018-0676-2