The use of, and outcomes associated with, systemic treatments in patients with cancer in routine care in England. Analyses of outcomes using the SACT dataset. Short title: Systemic treatments in malignancy

The Data will be used for the purpose of a research project: The use of, and outcomes associated with, systemic treatments in patients with cancer in routine care in England. Analyses of outcomes using the SACT dataset. Short title: Systemic treatments in malignancy.

The Data will be used to answer the following questions:

Primary objective: study survival outcomes in large well-defined cohorts of patients receiving cancer drugs with a clearly defined place in therapy for poor prognosis cancer

Secondary Objectives:

- To define patient, system and organisational characteristics that may influence survival and other outcomes

- To study patient experience and quality of life in these cohorts

- To study and develop drug and indication specific measures of significant toxicity.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NDRS Linked HES APC, NDRS Linked Cancer Waiting Times, NDRS Cancer Registrations, SACT, RTDS, NDRS Linked DIDs, NDRS Linked HES AE, NDRS Linked HES Outpatient, NDRS Somatic Molecular Dataset and CPES datasets to the University of Oxford (UoO). The Data will:

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

Encrypted monthly backup tapes are stored separately in the UoO’s storage facility.

The Data will be accessed onsite at the premises of UoO only.

Academic outputs and if appropriate reports, policy documents and media releases (grey literature) related to study survival and toxicity outcomes in patients who have received cancer drugs. We will study survival outcomes and compare them to those reported in prospective published and/or presented studies.

To provide a perspective on outcomes from the use of cancer drugs within the context of routine care. These include survival outcomes and serious toxicities. This will better inform patients and clinicians and inform health economic analyses.

This has previously largely been done using outcomes from prospective trials but these have limited external generalisability and may not reflect outcomes in routine care.

The SACT data have enabled the University of Oxford to examine the delivery, safety and outcomes of systemic anti-cancer treatment at population level in routine NHS practice. This provides information that cannot readily be obtained from clinical trials alone, particularly for patient groups who are often under-represented in trials, including older people and patients with substantial comorbidity.

The work has generated evidence on patterns of treatment, treatment-associated outcomes, and variation between patient groups and other characteristics across a number of cancers. In particular, analyses using these data have helped to:

• describe how systemic anti-cancer treatments are used in routine NHS practice and how treatment patterns and outcomes differ

• quantify outcomes in older and other under-represented patient groups, providing evidence that complements clinical trial findings and can inform discussions about treatment selection and risk

• identify areas in which outcomes or treatment utilization differ between groups highlighting questions relevant to clinical practice, service delivery and future research

• provide population-level evidence on treatment toxicity, hospitalisation, survival and longer-term adverse outcomes, helping clinicians and healthcare services to better understand the benefits and risks associated with systemic treatment in real-world NHS populations

• establish an evidence base for subsequent studies designed to improve treatment selection and the prediction of adverse outcomes from systemic anti-cancer treatment.

The principal benefit is the generation of robust, population-level evidence from routine NHS care that can support clinical decision-making, inform the design and prioritisation of subsequent research, and improve understanding of the effectiveness and safety of cancer treatments in patient groups encountered in everyday NHS practice.