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Systematic Literature Review of the Impact of Endocrine Monotherapy and in Combination with Targeted Therapy on Quality of Life of Postmenopausal Women with HR+/HER2− Advanced Breast Cancer

Abstract

Introduction

A major treatment goal for advanced breast cancer (ABC) is to maintain or ideally improve patient quality of life (QoL). Given the changing disease landscape, this systematic literature review (SLR) aims to assess the impact of endocrine therapies (ET), including ET monotherapy (ET mono) and ET combined with targeted therapy (ET + TT), on QoL of women with HR+/HER2− ABC.

Methods

A SLR was conducted to identify randomized controlled trials (RCTs) meeting the following criteria: (1) included ET mono or ET + TT, (2) reported QoL outcomes, (3) focused on women with HR+/HER2− ABC, and (4) published after 2007 (when standardized HER2 testing became available). The databases searched included MEDLINE, EMBASE, Cochrane Library, and key conference proceedings from 2013 to 2016. QoL outcomes for ET mono, ET + TT, and comparisons between the two were summarized from the identified trials.

Results

A total of 11 studies (representing 6 RCTs) were identified. The study populations included first-line (5 studies) and ET-failure settings (6 studies). Across settings, global health status (GHS) maintained or deteriorated slightly on these treatments during the trial period. Time to deterioration (TTD) in QoL measured by GHS was analyzed in 6 studies and 4 RCTs. In the first-line setting, reported median TTD in GHS was similar between ET mono and ET + TT (7.2–13.8 months in ET mono; 11.1 months in ET + TT). In the ET-failure setting, ET + TT showed significantly longer TTD vs. ET mono in GHS (median 5.6–8.4 months in ET mono and 8.3–11.7 months in ET + TT) and some additional domains.

Conclusions

ET + TT users experienced similar QoL in the first-line and ET-failure setting relative to patients on ET mono. Moreover, ET + TT users experienced better QoL outcomes in some domains in the ET-failure setting relative to ET mono users.

Funding

Novartis.

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Acknowledgements

Sponsorship for this study and article processing charges were funded by Novartis. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Editorial assistance in the preparation of this manuscript was provided by Dr. Shelley Batts of Analysis Group, Inc. Support for this assistance was funded by Novartis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.

Disclosures

Derek H. Tang is an employee of Novartis and owns stock/stock options. Zhou Zhou is an employee of Analysis Group, Inc., which has received consulting fees from Novartis. Jipan Xie is an employee of Analysis Group, Inc., which has received consulting fees from Novartis. Rajeev Ayyagari is an employee of Analysis Group, Inc., which has received consulting fees from Novartis. Eric Wu is an employee of Analysis Group, Inc., which has received consulting fees from Novartis. Polly A. Niravath received consulting fees from Novartis.

Compliance with Ethics Guidelines

This article is based on previously conducted studies and does not involve any new studies of human or animal subjects performed by any of the authors. As only previously published data were analyzed in this study, no institutional review was required.

Data availability

Data sharing is not applicable to this article as no data sets were generated or analyzed during the current study.

Previous presentation

Portions of this work were presented at the NCCN Annual Meeting held 23–25 March 2017 in Orlando, Florida.

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Correspondence to Zhou Zhou.

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Zhou, Z., Tang, D.H., Xie, J. et al. Systematic Literature Review of the Impact of Endocrine Monotherapy and in Combination with Targeted Therapy on Quality of Life of Postmenopausal Women with HR+/HER2− Advanced Breast Cancer. Adv Ther 34, 2566–2584 (2017). https://doi.org/10.1007/s12325-017-0644-2

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Keywords

  • Advanced breast cancer
  • Endocrine therapy
  • HR+/HER2−
  • Quality of life
  • Systematic literature review
  • Targeted therapy