ESMO 2018: Novel Combination Therapy for Advanced Breast Cancer
Posted: Wednesday, November 7, 2018
The final analysis of the PALOMA-3 study showed for the first time that treatment with palbociclib and fulvestrant in women with advanced breast cancer may result in improved overall survival. In fact, the improvement in overall survival was even greater in patients who had sensitivity to prior endocrine therapy. Massimo Cristofanilli, MD, of Northwestern University Feinberg School of Medicine, and colleagues, presented their findings at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich (Abstract LBA2_PR).
In this prospective, randomized, phase III trial, 521 women with hormone receptor–positive, HER2-negative recurrent breast cancer were enrolled. Overall survival was a preplanned analysis, and patients were randomized to receive the first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib and fulvestrant or placebo and fulvestrant after their cancer had relapsed or progressed.
The median overall survival improved by 6.9 months in the palbociclib group compared with the placebo (34.9 months vs. 28.0 months). For patients with sensitivity to prior endocrine therapy, the median overall survival improved by 10.0 months. Finally, in patients without visceral disease, the median overall survival improved by 11.5 months. Longer follow-up did not reveal additional safety signals.
“The significant impact of CDK4/6 inhibitors on disease-free and overall survival in metastatic disease leads us to be excited about the potential of this class of agents in early-stage breast cancer, where our goal is to improve the cure rate,” stated Dr. Cristofanilli in an ESMO press release. “On that front, two large randomized adjuvant trials of palbociclib in early-stage breast cancer—PENELOPE-B and PALLAS—are ongoing.”
