Ribociclib + ET for HR+/HER2- MBC: QoL and OS Data

Joyce O’Shaughnessy, MD: Another set of very important trials are the MONALEESA-3 and MONALEESA-7. Neil, can you tell us what those are and where we are in the data analysis with them?

Neil Iyengar, MD: In terms of those trials, we’ve heard from Gabe about the efficacy data, but what I appreciate from MONALEESA-7 and MONALEESA-3 are the quality-of-life data because this is critical. We want our patients living longer, but we also want them living well. These trials nicely built in quality-of-life assessments. There might have been a general concern in the beginning that escalating endocrine therapy with CDK4/6 inhibitors might increase toxicity and decrease quality of life. That’s the opposite of what was observed and reported. In fact, quality of life was maintained with the addition of ribociclib to endocrine therapy in both MONALEESA-7 and MONALEESA-3. We have data for pre- and post-menopausal women. What’s interesting with the data that were recently reported at ESMO [European Society for Medical Oncology Congress] is that when you pool the data from MONALEESA-7 and MONALEESA-3, you see a maintenance of quality of life. In fact, in patients with extended overall survival, you see an improved quality of life. The bottom line is that ribociclib with endocrine therapy is not only improving overall survival, helping our patients live longer, but also helping our patients live better.

Gabriel Hortobagyi, MD, MACP, FASCO: You make a very important point, Neil. It’s important to remember that many of our patients start treatment without symptoms from their metastatic disease. We can’t possibly improve their quality of life. We can worsen it only if the treatment produces important adverse effects. A subset of patients who started out symptomatic can have an improvement in quality of life. That’s why we needed the pooled analysis to demonstrate that.

Transcript edited for clarity.