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Assessment of early therapy discontinuation and health-related quality of life in breast cancer patients treated with aromatase inhibitors: B-ABLE cohort study

Abstract

Purpose

The most frequent adverse effects of aromatase inhibitors (AI) are arthralgia and bone loss induction. These reduce the quality of life of patients and their adherence to the treatment. This study evaluates the early AI cessation caused by AI intolerance, and the evolution of joint pain and health-related quality of life (HRQoL) during AI treatment until 1-year after AI completion.

Methods

Data of 910 women diagnosed with early breast cancer and candidates for AI were recruited in B-ABLE cohort. AI discontinuation was analyzed by survival analysis, including Kaplan–Meier estimation and Cox regression. Patients were distributed in three groups of the study according to previous tamoxifen (TAM) exposure and length of AI treatment: TAM-2yAI, TAM-3yAI, and 5yAI. Evolution of joint pain and HRQoL in osteoporosis was evaluated using Visual Analog Scale (VAS) and ECOS-16 tests, respectively, from baseline to 1-year after AI completion through repeated-measures ANOVA.

Results

Risk of AI discontinuation was increased in patients previously exposed to tamoxifen compared to non-exposed (adjusted HR 5.30 [95% CI 2.23 to 12.57]). VAS and ECOS-16 scores of TAM-2yAI and TAM-3yAI groups increased during AI treatment, mainly during the first 3–12 months. After 1-year from AI completion, values tend to decrease to baseline levels. In 5yAI group, VAS and ECOS-16 levels increased at three months, and VAS remained significantly higher at 1-year post-treatment.

Conclusions

AI therapy increased joint pain and reduced HRQoL, mainly during the first year of treatment. Patients previously treated with tamoxifen experienced greater pain when they switched to AI therapy and had an excess risk of discontinuation during the first 12 months.

Trial registration

ClinicalTrials.gov: NCT03811509. Registered 28 January 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03811509.

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Acknowledgements

We would like to thank Elaine M. Lilly, PhD, for providing language assistance, helpful advice, and critical reading of the manuscript.

Funding

This work was funded by the Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES) [Grant Number CB16/10/00245]; FIS Project from Instituto de Salud Carlos III (ISCIII), Ministerio de Ciencia e Innovación [Grant Number PI16/00818 and PI17/01875], and FEDER funds.

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Correspondence to Natalia Garcia-Giralt.

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All authors declare that they have no conflict of interest.

Ethical approval

The ethics committee of Parc de Salut Mar (2016/6803/I) approved the study protocol, which was carried out in accordance with the 1964 Declaration of Helsinki and its later amendments.

Informed consent

Informed consent was obtained from all individual participants included in the study after they had read the study information sheet and any questions had been answered. The privacy rights of human subjects are carefully protected in our institution.

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Pineda-Moncusí, M., Servitja, S., Tusquets, I. et al. Assessment of early therapy discontinuation and health-related quality of life in breast cancer patients treated with aromatase inhibitors: B-ABLE cohort study. Breast Cancer Res Treat 177, 53–60 (2019). https://doi.org/10.1007/s10549-019-05289-7

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Keywords

  • Aromatase inhibitors
  • Tamoxifen
  • Breast cancer
  • Joint pain
  • Arthralgia
  • Health-related quality of life
  • B-ABLE cohort