Treatment patterns and factors associated with the use of everolimus among post-menopausal women with HR+/HER2- metastatic breast cancer: a retrospective US claims study

ABSTRACT

Objective: To assess the real-world use of everolimus in the treatment of hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic-breast-cancer (mBC).

Methods: Postmenopausal women with HR+/HER2- mBC who initiated a new therapy for mBC between 20 July 2012 and 31 March 2014 after a non-steroidal-aromatase-inhibitor were identified from two commercial claims databases. Multivariate logistic regressions were used to identify factors associated with everolimus use versus endocrine-monotherapy or chemotherapy. Dosing patterns and adherence to everolimus were summarized.

Results: A total of 940 everolimus, 6,134 endocrine-monotherapy, and 3,410 chemotherapy regimens were included across patients’ first four lines of therapy. Patients with bone and visceral metastases were more likely to use everolimus versus endocrine-monotherapy. Patients with more comorbidities, visceral or central-nervous-system metastases, and prior chemotherapy use for mBC were less likely to use everolimus versus chemotherapy. Approximately 80% of patients initiated everolimus at label-recommended-dose of 10 mg daily; 60–70% of patients had a medical possession ratio >0.8 to everolimus, and consistently high adherence was observed across lines of therapy.

Conclusions: For HR+/HER2- mBC, patients treated with everolimus had more severe disease than patients treated with endocrine-monotherapy but less severe disease than patients treated with chemotherapy. Most patients used everolimus according to label-recommended dose and adherence was high across lines of therapy.

KEYWORDS:

• Chemotherapy
• endocrine monotherapy
• Everolimus
• metastatic breast cancer
• post-menopausal
• treatment patterns

Declaration of interest

Funding for this research was provided by Novartis Pharmaceuticals Corporation. Y Hao is an employee of Novartis Pharmaceuticals Corporation and owns stock/stock options. D Tang, is an employee of Novartis Pharmaceuticals Corporation and owns stock/ stock options. N Li, V Koo, A. Kageleiry, M Peeples, A Fang, A. Guérin, and E.Q.Wu are employees of Analysis Group Inc., which has received consultancy fees from Novartis Pharmaceuticals Corporation for this project. Novartis Pharmaceuticals Corporation manufactures everolimus. Analysis Group, Inc. is a consulting firm that provides services to a variety of companies in the health care industry. The study sponsor was involved in all stages of the study research and manuscript preparation, but all authors participated in the design of the study and contributed to the manuscript development. Data were collected by Analysis Group and analyzed and interpreted in collaboration with all other authors. Manuscript drafts were prepared by the authors with editorial assistance from a professional medical writer ultimately paid by the sponsor, Novartis Pharmaceuticals Corporation. All the authors vouch for the accuracy and completeness of the data reported and the adherence of the study to the protocol, and all the authors made the decision to submit the manuscript for publication. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing assistance was provided by Cinzia Metallo, PhD, an employee of Analysis Group, Inc. and funded by Novartis Pharmaceuticals Corporation.