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Blog
From innovation to impact: Harnessing Real-World data to generate Real-World insights that accelerate the impact of precision medicine in Breast Cancer Treatment
Vickram S. Tittrea, Consultant, Real World Solutions, IQVIA UK&I
Julia Levy, Principal, Real World Solutions, IQVIA UK&I
Valeria Lascano, Principal, Real World Solutions, UKI, IQVIA
Oct 26, 2023
  • Locations
  • United Kingdom
  • From innovation to impact: Harnessing Real-World data to generate Real-World insights that accelerate the impact of precision medicine in Breast Cancer Treatment

Breast cancer affects millions of people worldwide. In 2020, 2.3 million women were diagnosed with breast cancer globally (1). In the UK, it is the most common cancer among women, with over 55,000 new cases diagnosed each year (2). Around 0.5-1% of breast cancers occur in men (1). In the UK, survival rates for breast cancer are lower for Black and Asian women compared to white women. Black patients are more likely to be diagnosed with more severe forms of breast cancer than other ethnic groups (3). Common treatment options include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapies. Surgery often involves breast-conserving procedures or mastectomy, depending on the tumour’s size and characteristics.

Precision medicine in the oncology space has ushered in a new era of progress in the treatment of breast cancer. Through advances in genomics and molecular profiling, oncologists can now tailor therapies with unprecedented accuracy, maximising their effectiveness while reducing unnecessary side effects. Liquid biopsy testing, which uses circulating tumour DNA (ctDNA) in the blood is another major advance that enables oncologists to adapt treatment plans promptly, optimising their effectiveness.

One of the ground-breaking developments was the identification of specific genetic mutations that drive breast cancer progression and predictive biomarkers, which can be used for targeted therapy. For example, the presence of Human Epidermal Growth Factor Receptor 2 (HER2) mutations led to advancements in targeted therapies such as Herceptin, significantly improving outcomes for HER2-positive breast cancer patients. More recently, HER2 status has been further characterised by the identification of HER2-Low subsets, accounting for around 50%-60% of all breast cancers. Furthermore, the discovery of BRCA gene mutations has paved the way for therapies like PARP inhibitors, offering new options for individuals with hereditary breast cancer.

Immunotherapies have also emerged as a promising treatment option. A class of drugs known as immune checkpoint inhibitors are showing potential in treating triple-negative breast cancer (TNBC), a particularly aggressive subtype, characterised by the absence of three specific receptors that are commonly found in other types of breast cancer: estrogen receptors (ER), progesterone receptors (PR), and HER2.

In honour of Breast Cancer awareness month, we are highlighting the role of real-world data (RWD) in harnessing the power of precision oncology in the understanding and treatment of breast cancer.

RWD refers to data concerning the health of patients and the provision of healthcare, typically gathered from various sources including electronic health records, medical insurance claims, information obtained from product or disease databases, and data collected from other sources like digital health technologies. RWD can be used to generate robust Real-world Evidence (RWE) which can play a crucial role complementing traditional Randomised Control Trials (RCTs) in informing breast cancer treatment. Examples of how RWE can be leveraged include:

  • Early Detection and Screening: RWE can assist in evaluating the effectiveness of breast cancer screening programs, helping to identify the most efficient and cost-effective methods for early detection. This can lead to earlier diagnosis and improved survival rates.
  • Identifying Subpopulations: RWE can reveal specific patient subpopulations that respond particularly well or poorly to certain treatments. This information can guide personalised treatment strategies, ensuring that patients receive therapies that are more likely to benefit them.
  • Patient Profiling and Stratification: Precision medicine relies on the identification of specific genetic mutations, biomarkers, and other patient-specific characteristics. RWD, such as electronic health records (EHRs) and genetic profiles, can be used to create comprehensive patient profiles. This information enables healthcare providers to stratify patients into subgroups based on their unique genetic and clinical attributes, allowing for more targeted treatment strategies.
  • Treatment Effectiveness: RWE can help assess how breast cancer treatments are working in real-world patients, outside of clinical trials. By analysing data on treatment outcomes, healthcare providers can make more informed decisions about the most effective therapies for individual patients.
  • Comparative Effectiveness Research: RWE allows for comparisons between different treatment options, helping clinicians and policymakers identify which therapies are most effective for specific patient populations.
  • Adherence and Quality of Life: RWE can also shed light on patient adherence to treatment regimens and their quality of life during and after breast cancer treatment. This helps healthcare providers address issues related to treatment compliance and the overall well-being of patients.
  • Regulatory Approvals: RWE is playing an increasingly vital role in regulatory approvals for pharmaceuticals and medical devices. It offers insights into a product’s performance in everyday clinical settings, complementing traditional clinical trial data and helping regulators make more informed decisions about safety and efficacy. As healthcare evolves, the integration of RWE into the approval process is likely to continue growing in importance.
  • Treatment Guidelines and Reimbursement: Healthcare authorities can use RWE to inform treatment guidelines and reimbursement decisions. If RWE consistently shows positive results for a particular treatment, it may become more readily available and covered by healthcare systems, ensuring greater access for patients.
  • Health Economics and Resource Allocation: RWE can inform healthcare budget allocation by assessing the cost-effectiveness of different breast cancer treatments and interventions. This ensures that resources are used efficiently to benefit the maximum number of patients.

The UK is well placed to support RWE studies in precision medicine in oncology with a number of rich data sources including NHS England’s Cancer Analysis System (CAS), Genomics England (GEL) and the UK BioBank. These sources include genomics and biomarker data, linked to extensive longitudinal clinical information.

  • Through NHS England’s National Cancer Registration and Analysis Service (NCRAS), CAS provides linked secondary care data across the full patient pathway, with 141 million patient records representing approximately 99% of cancer patients in England. These data consist of the following datasets: Diagnostic data (COSD), Radiotherapy treatment data (RTDS), Hospital episodes data (HES), Survival data (ONS), Systemic treatment data (SACT) and Molecular diagnostic testing (CAS-MDx). CAS-MDx is the most recent addition to the CAS and captures somatic molecular data through biomarker testing such as: next generation sequencing (NGS), methylation and immunohistochemistry. Somatic testing is used for cancer diagnosis, prognosis, and precision medicine (targeted therapy). Through our collaboration with NHS England, IQVIA has an established and validated process for performing real world studies in a simulated environment that can then be fully executed in the CAS-MDx database with no risk to patient confidentiality. IQVIA has more than five years' experience with CAS. We have developed an extensive set of tools that allow us to program the analyses in an efficient, robust and reliable way, while maintaining a tailored approach allowing us to deliver timely bespoke studies to our clients.
  • Genomics England was initially launched in 2013 to deliver the ambitious UK Government initiative of sequencing 100,000 whole genomes of patients and integrating genomic medicine into standard NHS practice. Genomics England have established a robust and secure research environment, enabling in-depth exploration of the 100,000 whole genome data collected. Work is now ongoing to increase the number of people whose genome has been sequenced through the Genomics Medicine Centres. Genomics England collaborates effectively with IQVIA to design and execute RWE studies. This dataset offers insights such as the identification of previously unknown genetic connections and assessing the influence of non-coding regions of DNA on phenotypes. It also enables investigation of how various genetic mutations impact patient outcomes prior to the integration of a biomarker into routine clinical practice.
  • The UK BioBank serves as an extensive biomedical database and research tool, housing genetic and health-related information. This resource encompasses data from 500,000 participants in the UK, all aged between 40 and 69 years. These individuals were actively enrolled between 2006 and 2010. Currently, the database includes 200,000 records of Whole Genome Sequencing (WGS), with an additional 300,000 expected to be available by the end of 2023. This comprehensive WGS data is connected with data on lifestyle, biochemical factors, and health outcomes, providing valuable insights that will contribute to and accelerate drug discovery and development efforts.

The multiple possibilities of RWE to accelerate the potential of precision medicine are as exciting as they are complex. Here at IQVIA, our team of RWE experts can provide end to end support from the development of bespoke study designs and treatment algorithms to appropriate data access and analysis that ensures that ethical and patient privacy considerations are fully addressed. Many of our clients are already leveraging the power of RWE to inform innovations in breast cancer and other forms of cancer to realise the full potential of precision medicine.

To understand how IQVIA’s team of experts can help you to leverage RWD and Precision Oncology, contact us here: ASKIQVIA@iqvia.com

1: https://www.who.int/news-room/fact-sheets/detail/breast-cancer

2: Breast cancer | Types of cancer | World Cancer Research Fund UK (wcrf-uk.org)

3: https://www.webmd.com/breast-cancer/breast-cancer-black-women

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