Susan Faye Dent, MD, professor of medicine, Duke University School of Medicine, member, Duke Cancer Institute, medical oncologist, associate director, Breast Cancer Clinical Research, co-director, Duke Cardio-Oncology Program, Duke Health, discusses the clinical implications of the phase 3 MONALEESA-2 trial (NCT01958021) in hormone receptor (HR)–positive, HER2-negative breast cancer.

Updated results from the MONALEESA-2 trial demonstrated that with at least 6.5 years of follow-up, the first-line regimen of ribociclib (Kisqali) plus letrozole (Femara) demonstrated a statistically significant and clinically meaningful overall survival benefit compared with placebo plus letrozole in postmenopausal patients with HR-positive, HER2-negative advanced breast cancer. Additionally, no new safety signals were observed with the ribociclib-containing regimen and the incidence of adverse effects of special interest, such as QT interval prolongation, hepatobiliary toxicity, neutropenia, and interstitial lung disease/pneumonitis did not increase, Dent explains. Most of the toxicities associated with ribociclib appear to occur within the first year of treatment, so patients are likely to derive efficacy benefit without significant toxicity, Dent adds. 

In the context of other available CDK4/6 inhibitors, these results suggest that ribociclib may be the preferred agent for this patient population because it is associated with the longest survival data, Dent explains. At a minimum, ribociclib plus letrozole should be considered as a treatment option for patients with HR-positive, HER2-negative disease, Dent concludes.

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Susan Faye Dent, MD, discusses the clinical implications of the phase 3 MONALEESA-2 trial in hormone receptor–positive, HER2-negative breast cancer.  


Susan Faye Dent, MD

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Dr. Dent on the Clinical Implications of the MONALEESA-2 Trial in HR+/HER2- Breast Cancer