Real-World Evidence in Oncology in England: Epidemiology, Patient Characteristics and Survival

Study type
Protocol
Date of Approval
Study reference ID
18_008
Lay Summary

Cancer is when abnormal cells divide in an uncontrolled way. Some cancers may eventually spread into other tissues. There are more than 200 different types of cancer. Staging and grading of cancer give an idea of how quickly a cancer may grow and which treatments may work best. Treatments can include surgery, radiotherapy and drug treatments (such as chemotherapy, hormone therapy or targeted cancer drugs).

The purpose of this study is to understand the characteristics and outcomes of patients diagnosed with several different types of cancer in England. This research will help to characterise these patients in terms of their demographics and medical history, and to describe how long they survive for depending on their characteristics and stage of disease. This research will help to provide an up-to-date picture of the characteristics and outcomes of patients with these cancers in England.

Technical Summary

According to Cancer Research UK, there were around 357,000 new cases of cancer in the United Kingdom (UK) in 2014, however there is limited recent real-world data on cancer patients in the UK. The rationale of this study therefore is to fill this evidence gap and describe the characteristics and overall survival of patients with a number of cancers in England. Specifically, the aims are to understand patient characteristics (demographic and clinical) and survival rates. In order to do this, the study will link data from the Clinical Practice Research Datalink, Hospital Episodes Statistics, National Cancer Registration and Analysis Service and Office of National Statistics (ONS) in order to provide the most accurate data on patient diagnoses and clinical characteristics.

Patient demographics, baseline clinical characteristics and tumour status will be analysed descriptively. Overall survival (OS) will be summarized as a continuous variable, Kaplan-Meier curves presented and median time estimated. Death rates will be described separately for those with and without advanced/metastatic cancer.

Health Outcomes to be Measured

Outcomes:
- Overall survival (OS): defined as time since index date or initiation of chemotherapy until date of death due to any cause identified from ONS data.
- Incidence rates of cancers: Number of new cases of a specific cancer in the population in 2012, 2013, 2014, and 2015 expressed as number of cancers per 100,000 population at risk.
- Incident cancer events will be identified from the CPRD-Cancer registry databases as the first record for a cancer indication of interest in either of these databases. Diagnoses must be present in both databases.

Collaborators

Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Sreeram Ramagopalan - Corresponding Applicant - London School Of Economics & Political Science
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )

Linkages

HES Admitted Patient Care;NCRAS Cancer Registration Data;NCRAS Systemic Anti-Cancer Treatment (SACT) data;ONS Death Registration Data;Patient Level Index of Multiple Deprivation