Hormone replacement therapy in women with cancer and risk of cancer-specific mortality and cardiovascular disease: A protocol for a cohort study from Scotland and Wales.

Úna C McMenamin, Blánaid Hicks, Carmel Hughes, Peter Murchie, Julia Hippisley-Cox, Tom Ranger, Carol Coupland, Chris R Cardwell* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Background: Hormone replacement therapy (HRT) is widely used and has proven benefits for women with menopausal symptoms. An increasing number of women with cancer experience menopausal symptoms but the safety of HRT use in women with cancer is unclear. There are particular concerns that HRT could accelerate cancer progression inwomen with cancer, and also that HRT could increase the risk of cardiovascular disease in such women. Therefore, our primary aim is to determine whether HRT use alters the risk of cancer-specific mortality in women with a range of common cancers. Our secondary objectives are to investigate whether HRT alters the risk of second cancers, cardiovascular disease, venous thromboembolism and all-cause mortality.
Methods: The study will utilise independent population-based data from Wales using the SAIL databank and Scotland based upon the national Prescribing Information System. The study will include women newly diagnosed with common cancers from 2000 to 2016, identified from cancer registries. Women with breast cancers will be excluded. HRT will be ascertained using electronic prescribing in Wales or dispensing records in Scotland. The primary outcome will be time to cancer-specific mortality from national mortality records. Time-dependent cox regression models will be used to calculate hazard ratios (HR) and 95% confidence intervals (95% CIs) for cancer specific death in HRT users compared with non43 users after cancer diagnosis after adjusting for relevant confounders, stratified by cancer site. Analysis will be repeated investigating the impact of HRT use immediately before cancer diagnosis. Secondary analyses will be conducted on the risk of second cancers, cardiovascular disease, venous thromboembolism and all-cause mortality. Analyses will be conducted within each cohort and pooled across cohorts.
Discussion: Our study will provide evidence to inform guidance given to women diagnosed with cancer on the safety of HRT use and/or guide modifications to clinical practice.
Original languageEnglish
Article number313
Number of pages6
JournalBMC Cancer
Volume21
DOIs
Publication statusPublished - 24 Mar 2021

Bibliographical note

Funding
This work was supported by Cancer Research UK (reference C37316/A29656). The funder had no role in study design, data collection, data analysis, data interpretation or writing the manuscript.

Keywords

  • cancer
  • hormone replacement therapy
  • mortailty
  • cardiovascular disease

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