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ESM0 2016 Breast Cancer CDK4/6 Headlines
ESMO 2016 Palbociclib
The results of the first-in-class CDK4/6 inhibitor palbociclib included a biomarker analysis in the phase III PALOMA-2 trial and a poster discussion on the health-related quality of life (HRQoL) in the same study.
About the PALOMA-2
The phase III PALOMA-2 study randomised 666 women with HR+ and HER2-negative ABC in a 2:1 fashion to either receive palbociclib (125 mg/day for 21 days in 28-day cycles) plus letrozole (2.5 mg/day, continuously) or palbociclib-matching placebo plus letrozole as a first-line treatment.
During the American Society of Clinical Oncology (ASCO) annual conference, held in June 2016, the efficacy results of the PALOMA-2 study were presented. At that time, the results showed a significant 42% relative risk reduction for PFS in women receiving palbociclib plus letrozole when compared to placebo plus letrozole. Median PFS was 24.8 months vs. 14.5 months respectively (HR = 0.58; 95% CI: 0.46-0.72; P < 0.0001).
“Endocrine therapy is an established first-line treatment for ABC. However, endocrine therapy resistance and disease progression eventually occur in most patients. Cyclin-dependent kinase 4/6 inhibition is a valid treatment strategy for hormone receptor positive advanced breast cancer and may help overcome or delay endocrine therapy resistance. “
ESMO 2016 Abemaciclib
ESMO abemaciclib data included two oral presentations.
Dr Hurvitz presented results of the phase II neoadjuvant neoMONARCH study in women with untreated early-stage invasive HR+ and HER2-negative breast cancer (Abstract LBA13).
The study compared in a 1:1:1 fashion abemaciclib (150 mg BID) plus anastrozole (1 mg QD), abemaciclib monotherapy, and anastrozole monotherapy and investigated drop in Ki67 after two weeks of treatment. Upon completion of initial two-week treatment, all patients continued to receive abemaciclib plus anastrozole for an additional 14 weeks, to complete 16 weeks of neoadjuvant treatment. Patients received prophylactic loperamide concomitantly with abemaciclib.