PrefHER: putting patient choice and preferences at the forefront of breast cancer management

Approximately one in five patients diagnosed with breast cancer worldwide will have HER2-positive (HER2+) breast cancer, a particularly aggressive form of the disease. HER2+ breast cancer patients require treatment via the targeted anti-HER2 monoclonal antibody agent, trastuzumab following surgery, chemotherapy and radiotherapy.  

This demands hospital attendance for intravenous administration via a cannula, an in situ port, or line, 3 times weekly for 12 months. Intravenous administration is inconvenient and can take several hours exerting a considerable physical and emotional burden, limiting patients’ ability to resume normal life. In 2013 NICE approved a new subcutaneous formulation of trastuzumab with similar efficacy and safety as its intravenous counterpart, but with an administration time of just five minutes. In the wider clinical context patient preference is a key factor when drugs or administration methods have similar efficacy and safety properties. Taking patient preference into account helps to ensure optimal treatment adherence and improves the patient experience and satisfaction with treatment.  

Measuring patient preference for subcutaneous or intravenous HER2 positive breast cancer treatment

Professor Dame Lesley Fallowfield and colleagues at the Sussex Health Outcomes Research and Education in Cancer Centre (SHORE-C) have pioneered a body of research on Psycho-Oncology with a particular focus on patient preference and health professionals’ communication skills with patients, especially those with cancer. The team is also leading the field in assessing patients’ quality of life in cancer trials including the MRC/NIHR funded UK Collaborative Trial of Ovarian Cancer Screening.

Brighton and Sussex Medical School (BSMS) researchers, led by Professor Dame Lesley Fallowfield, designed, conducted and analysed study-specific patient interview schedules used in the international clinical trial, PrefHER, to measure patient preference for subcutaneous or intravenous HER2+ breast cancer treatment. The findings of the PrefHER study were pivotal to the regulatory approval of trastuzumab subcutaneous by the Australian Therapeutic Goods Administration in 2015 and the US Federal Drug Administration in 2019, thus opening the route to market in these countries.

For the trials, patients had the trastuzumab administered first subcutaneously and then switched to intravenous, or vice-versa. Fallowfield and colleagues at SHORE-C led the development, optimisation and implementation of the study-specific patient interviews in each participating country. Two sets of interviews were carried out, one before patient randomization, and one after the treatment cycles. The PrefHER study was global and yet, irrespective of culture, the primary outcome was the same, with patients expressing a strong and compelling preference for subcutaneous delivery. 

Patient preference studies such as PrefHER can serve as a powerful tool to engage patients and their communities. Moreover, it can quantify the patient voice across different stages of clinical drug development, drug regulatory approval and care management to support patient-centric, healthcare decision-making. By revealing an overwhelming preference for its subcutaneous route of administration. This finding contributed to the market approval of trastuzumab subcutaneous by the US Food and Drug Administration (FDA) and its Australian counterpart. In practice, it also provided the research evidence to support the delivery of cancer treatments closer to the patient’s home– a central tenet of the NHS Five Year Forward plan for improvement in outcomes for cancer patients.  

As part of its multi-disciplinary review and evaluation of the application, the FDA commented on the robustness of the SHORE-C led interview methods and approved product labelling that refers to the PrefHER trial data to support the Patient Experience.

 

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