Patient Characteristics, Treatment Patterns and Long-term Outcomes from a Real-World Population of Early Breast Cancer Patients at High Risk of Recurrence in Scotland

In an effort to better describe patients affected with node-positive HR+, HER2− early breast cancer, the Edinburgh Cancer Informatics conducted a retrospective study looking at the demographic and clinical characteristics of these patients in South-East Scotland, in a real-world setting. Long term outcomes and treatment profiles were also reported, along with healthcare utilisation. 


Such audits are essential, alongside clinical trials, to support the submission of health technology assessment to government bodies such as Scottish Medicines Consortium (SMC), and to improve Health Service Providers confidence in the results generated by cost-effectiveness modelling conducted by pharmaceutical companies such as Eli Lilly, who is funding this project. This ultimately directly benefits patient care, and access to cancer drugs.  


A total of 4600 Lothian patients diagnosed with the above between 2005 and 2020 inclusive were used for this study. The demographic, clinical and treatment data came from several sources, such as the cancer registry, SCAN audit, or SESCD. More information about methods can be found in the links below. 


Patients were then grouped based on their risk profile (high risk vs non high risk), as defined by the MonarchE Clinical trial criteria, a phase 3 study which highlighted the benefit of using adjuvant Abemaciclib with endocrine therapy.


Figure 1: Subsets and population selection process

Outcomes were reported for the following subgroups:

  • Comorbidity level
  • Postmenopausal status
  •  Number of positive lymph nodes
  • Tumour size
  • PR-
  • Grade
  • Age group
  • Inflammatory
  • Pre-post COVID pandemic (01/01/2020 cut-off date)

The main results found are described below:

  • Approximately half of pts with hRisk disease (52.1%) had ≥4 pALNs and more than a quarter (27.6%) had tumour size ≥5cm 
  • Nearly a quarter of pts with hRisk disease received neoadjuvant chemotherapy (24.9%) versus 37.0% in the monarchE Cohort 1, respectively (However, as data were not available for 31.4% of all pts with hRisk disease, direct comparison may not be safe)
  • Real-world data from the major cancer centre in South East Scotland show that node-positive HR+, HER2− EBC with high risk factors similar to the Cohort 1 of the monarchE trial is associated with poor long-term outcomes, with a clear unmet need for improved treatments
  • Increasing burden of nodal disease was associated with worse 10-year IDFS and OS – 36% of pts with 1-3 pALNs plus additional risk features (tumour grade 3 and/or tumour size ≥5cm) experienced a recurrence event at 10 years; this increased to 42% for 4-9 pALNs and 52% for 10+ pALNs
  •  10-year IDFS and OS were adversely affected by postmenopausal status, age ≥70 years and greater tumour size, as well
  •  All hRisk pts had poor long term outcomes (10-year IDFS and OS) irrespective of tumour grade

Additional information can be found in our poster presented at the St Gallen conference (2023), along with the respective abstract, and an extensive report:

Lilly 1 – Poster

Lilly 1 – FSR

A subsequent study in partnership with DATA-CAN will describe similar outcomes in English patients, and will be reported on this website once finalised (expected 2024).

This work was sponsored by Eli Lilly. The patient data was analysed by NHS analysts and never left the NHS IT environment. Only an aggregated report (attached) was shared with the Eli Lilly team after undergoing disclosure control as per NHS policy to protect patients’ identification. This project was supported by DataLoch.       

Patient Characteristics, Treatment Patterns and Long-term Outcomes from a Real-World Population of Early Breast Cancer Patients at High Risk of Recurrence in Scotland

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