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Aromatase inhibitors in the treatment of early ER-positive breast cancer in post-menopausal women

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SBU Assessment

Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.

Conclusions

  • Mono- or sequential therapy with AI increases disease-free survival (DFS) compared to TAM. Prolonged AI therapy after five years of TAM increases DFS compared to placebo.
  • Monotherapy with AI increases overall survival (OS), sequential or prolonged AI therapy however, does not obviously increase OS.
  • AI therapy increases the risk for fractures compared to TAM, but decreases the risk for uterine cancer and deep vein thrombosis.
  • No significant differences between AI and TAM are seen regarding side-effects on the heart and brain vasculatures, or death without recurrence.
  • Scientific evidence is insufficient to be able to say if there are any clinically relevant differences between AI and TAM regarding their effect on cognitive function (thought and memory function).
  • No significant differences between AI and TAM have been seen regarding health-related quality-of-life. The presence of oestrogen receptors (ER) in a tumour is predictive of a positive result from hormone treatment whether it be with AI or with TAM. However the difference in effect between AI and TAM can not be predicted by ER. The presence of progesterone receptors (PgR), proliferation indicators, or overexpression of HER2 have no predictive value regarding success of treatment with AI versus TAM.
  • Before the patent period expired, treatment with AI probably cost no more than 430,000 SEK per QALY regardless of whether it was given as mono-, sequential or prolonged therapy. The price of AI, and thus the cost per QALY, has since fallen considerably almost certainly making AI cost-effective.

How to cite this report: SBU. Aromatase inhibitors in the treatment of early ER-positive breast cancer in post-menopausal women. Stockholm: Swedish Council on Health Technology Assessment (SBU); 2014. SBU report no 2014-02 (in Swedish).

Published: Report no: 2014-02 https://www.sbu.se/201402e

Project group

Experts

  • Johan Ahlgren, associate Professor, Örebro University Hospital
  • Lisa Rydén, associate Professor, Skåne University Hospital

SBU

  • Marianne Heibert Arnlind (Project Director)
  • Emelie Heintz (Health Economist)
  • Malin Höistad (Assistant Project Director)
  • Therese Kedebring (Project Administrator)
  • Anders Norlund (Health Economist)
  • Hanna Olofsson (Information Specialist)
  • Sally Saad (Information Specialist)
  • Sigurd Vitols (Medical Advisor)

More on the subject

Scientific Article

Ryden L, Heibert Arnlind M, Vitols S, Hoistad M, Ahlgren J. Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials. Breast 2016;26:106-14.
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