HR+ MBC: Ribociclib and Patient Quality of Life

Aditya Bardia, MD, MPH: In terms of quality of life with the use of CDK4/6 inhibitor in the metastatic setting, studies have looked at the impact of CDK4/6 inhibitor on quality of life in the pivotal clinical trial. This is very important because when we speak to a patient with metastatic breast cancer, we say our goal is 2-fold. We want to prolong your survival, and we want to improve and maintain their quality of life.

Quality of life is an important metric in this setting. In the MONALEESA-3 and MONALEESA-7 trial, investigators looked at the impact of quality of life with ribociclib plus endocrine therapy vs endocrine therapy without ribociclib or placebo. MONALEESA-3 was a trial that looked at fulvestrant as the endocrine backbone and MONALEESA-7 looked at aromatase inhibitor or tamoxifen plus ovarian suppression because it was in the pre- or perimenopausal setting. Overall, the study showed that patients who were receiving ribociclib had a better quality of life. There was an improvement in maintenance of the quality-of-life score as measured by global health status in patients who were receiving ribociclib compared with the control group.

The team also looked at the impact of quality of life in patients who were living longer vs living shorter. In general, patients who were living longer had improvement in quality of life over the course of treatment. With the use of CDK4/6 inhibitors, patients can live longer. This confirms that with the use of a CDK4/6 inhibitor, quality of life is maintained and can even be improved. Conceptually, this makes sense because we know that when there’s disease progression, that can impact quality of life. So if you have better disease control, you’ll also have better quality of life. This is exactly what we’re seeing in the MONALEESA-3 and MONALEESA-7 trials.

Quality of life is an important metric for patients with metastatic disease. In randomized clinical trials, the studies are often powered to look at efficacy in terms of progression-free survival or overall survival. Sometimes it can be difficult to have enough power to look at quality of life, but that’s where pooled analysis can be helpful, where you’re pooling studies so you have enough power to look at the impact of an intervention on quality of life. The other thing that could be done with pooled analysis or big studies is you can look at patients who did very well for years. What was their quality of life? You can look at the association between survival and quality of life by looking at data from these large studies.

Transcript edited for clarity.