Update of overall survival in PALOMA-3 study of palbociclib and fulvestrant for HR+/HER2- advanced breast cancer

The multinational phase 3 PALOMA-3 study randomized patients with HR-positive/HER2-negative advanced breast cancer to palbociclib plus fulvestrant or placebo plus fulvestrant. Updated exploratory analysis of the study showed that with median 73.3 months follow-up the median overall survival was 34.8 months with palbociclib-fulvestrant versus 28.0 months with placebo-fulvestrant (HR 0.81; 95% CI 0.65-0.99) with 6-year OS rate 19.1% versus 12.9%. Favorable OS with palbociclib-fulvestrant compared with placebo-fulvestrant was seen in most subgroups. The authors conclude that the results support palbociclib plus fulvestrant as a standard of care in these patients.