A recent literature review published in The Lancet Oncology shows increased use of health-related quality of life (HRQOL – self-assessment of health and symptoms by the patient) as an endpoint in advanced breast cancer studies and clear improvement in the quality of HRQOL reporting in ABC RCTs.
The systematic review, which looks at over 49 advanced breast cancer clinical trials published from 2001 to 2014, compares results with a similar one published in 2001, and evaluates whether there have been improvements in assessing and reporting health-related quality of life criteria.
“This review was a major international effort, involving experts from the EORTC Breast Cancer Group as well as the EORTC Quality of Life Group,” said first author Irina Ghislain. “Careful, critical review of these trials showed that recommendations made a decade ago have been largely accepted by the research community, and confirmed the increasing importance of HRQOL in clinical trials. The only aspect that was less well reported over time is the a priori HRQOL hypothesis, but this was much more commonly found in clinical trials addressing targeted therapy and immunotherapy. Since this is a relatively new field, it is difficult to form a HRQOL hypothesis, so we can interpret this as a run-in phase in a rapidly changing environment.”
Breast cancer accounts for 25% of all cancer cases and 15% of all cancer deaths among women. Approximately 30–40% of early-stage breast cancer patients will develop metastatic disease. HRQOL criteria are particularly important for patients in advanced breast cancer, who are facing a high disease burden with a limited treatment success rate. “The time of patient-centered care is upon us, and patients’ views increasingly influence treatment decisions,” said Andrew Bottomley, senior author, Head of the EORTC Quality of Life Department. “It’s therefore encouraging to see that an increasing proportion of trials are including these HRQOL criteria. However, lack of standardization in methodology and reporting limits the use of these results in clinical practice.”
With the advent of novel therapies and their differential effects, the review shows that traditional QOL criteria may no longer adequately represent patient experience. This may require the development of an up-to-date questionnaire and a new approach to collecting HRQOL data in clinical trials in general, whereby more flexible questionnaires are constructed reflecting technological advances in the field.