HRQoL is increasingly being measured in clinical trials

Health-related quality of life (HRQoL) is increasingly being recognized as an important outcome for individuals, both as part of clinical care, as well as in research, along with conventional outcomes like response or survival. HRQoL includes several domains of functioning, and it is complex and difficult to measure alongside other outcome measures to evaluate the full range of effects of an intervention from the patients’ perspective.

I will present the opinion of Ian Tannock, MD, PhD, in Oncology News Central. Thus, he says that there are two things one can do to improve outcomes in me­di­cine: guide therapy so that patients live longer, or live better, or preferably both⁽¹⁾.

In oncology, overall survival is ob­viously an important and well-recognized outcome measure. On the other hand, patients’ quality of life during that period is also important. Tonnock points out that, if you recommended a treatment that extended life for a short period of about two or three months, but you increased toxicity to the point where those months are not very pleasant, that would be a questionable step forward. It is now generally accepted that in large clinical trials – usually randomized trials of a new treatment versus the current standard of care – there should be an assessment of both overall survival and quality of life. The way QoL has been done is to compare the average quality of life of a group of patients receiving a treatment at some point after it starts with the same quality for the group receiving the standard treatment. The problem is that average quality of life is a very difficult concept. There will be some people who will join the trial and have a wonderful response to the new treatment – whose quality of life will improve significantly –, and there may be others who will have severe toxi­city and whose quality of life will be worse. So, these two things tend to cancel each other out (response and quality of life).

The question that the clinical resear­cher should be asking is: what is the expectation that this treatment will lead to a significant improvement in the patient’s quality of life or, conversely, to a significant deterioration in it, which you would want to stop? There have been a few trials that have done this, and it is a much easier concept to explain to both oncologists and patients.

The author highlights another problem: if you have a first-line treatment, it can add toxicity, and 100% of people who take it will experience toxicity, but only about 5% are likely to benefit, because many of the patients will not relapse and are not helped by the new treatment. These possibilities need to be discussed with patients.

Conclusions

The article discusses the importance of quality of life (QoL) measures in cancer trials, and advocates for a more straightforward approach to reporting outcomes rather than relying on group averages. It emphasizes that clinicians should focus on the probability of treatment meaningfully improving a patient’s QoL, rather than just measuring overall survival⁽¹⁾.

A systematic review found that glo­bal QoL is significantly associated with the mortality risk in cancer patients, highlighting the need for comprehensive QoL assessments⁽²⁾.

Another article also addresses the challenges in evaluating QoL in cancer care, suggesting that integrating QoL measures into clinical practice can lead to better treatment outcomes⁽³⁾.