Title: Do Chemotherapy Dose-delays impact Patient treatment Outcomes?
Funder: Department of Health and Social Care

Abstract: Background Chemotherapy is administered to patients in treatment cycles, allowing for a rest period between doses. Rest periods allow a patient to recover from adverse effects (AEs) of anticancer therapy such as myelosuppression. Delays to chemotherapy doses occur in around ten percent of patients when AEs are still present at the time of administration; however, some of these could be prevented by the use of supportive care medicines. Policies around supportive care used to prevent AEs differ from hospital to hospital in the United Kingdom and this may have an impact on treatment delays. Delays to treatment can be up to 7 days or occasionally longer; yet, it is unclear the impact of the delay on time to cancer progression for a patient. Aims and Objectives The ultimate aim of this research is to optimise the first chemotherapy treatment course for patients with early stage breast and ovarian cancer. This will be achieved by determining the impact of dose delays to progression free survival or death. If a difference exists then we will investigate the influence of other factors such as region treated on the incidence of dose delays. Methods To achieve the objectives we will use three datasets collected by NHS England. These datasets contain cancer diagnosis information, detailed chemotherapy information and data on death. Data will be linked to enable us to develop Cox regression model, using an outcome as 5-year progression free survival or death. We will report proportional hazard ratios for dose delays as well as other confounders. Timelines for Delivery This research will be achieved in 18 months Impact and Dissemination This study will have impact on the chemotherapy service and for patients. The understanding the research provides could be a goad to better AE management and will be the first real world study to demonstrate the impact of delaying chemotherapy doses. We believe that this will not only change UK practice in prescribing practices but also international policies. Following this work we will engage with both patients and clinicians through the cancer alliances to understand if and how policies around prescribing supportive treatments vary and how equitable access can be achieved. We will communicate the work to the UK Chemotherapy board and publish in a high impact journal.

Lay abstract: Around one tenth of cancer patients will not receive chemotherapy on the day that they were expecting to. The purpose of our work is to understand if this change in schedule worsens the effectiveness of the cancer treatment. Chemotherapy is commonly given into the vein every two to three weeks. The time interval between treatments allows a patients body to recover from side effects such as lowered white blood cells, which can lead to life threatening infections. When white cells are still low or other dangerous side effects are still present, chemotherapy is delayed by a week or two. These delays are inconvenient for patients, but also worry some doctors because the delayed chemotherapy might lead to a cancer returning because it is not treated well enough. Understanding if treatment delays cause a higher chance of a cancer returning (progression) will help us change the way we treat patients in the future. The NHS collects data on the use of chemotherapy nationally. We aim to use this data to study delays and how this affects the time period to the cancer returning. We also can look at the numbers of patients delayed in this country and understand some of the reasons for these. When we have our results we will work with patients, doctors, nurses and pharmacists to decide whether changes need to be made to the way we currently give chemotherapy and how we go about doing this. This study will have impact on the NHS and for patients. We understand from our discussions with patients and carers already that dose delays can be both stressful and an inconvenience. When a patient has a cancer progression they will often be given more cancer treatment that can be more costly to the NHS and more distressing for patients and their families. Having a patient representative as a co-applicant has ensured that our study design will result in direct patient benefit.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CANCER AND NEOPLASMS