Clinical Outcomes of 130 Patients with Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Treated with Palbociclib plus Endocrine Therapy and Subsequent Therapy: A Real-World Single-Center Retrospective Study in China

BACKGROUND: This retrospective single-center study conducted in China aimed to investigate the clinical outcomes of patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC) treated with palbociclib plus endocrine therapy (ET) and subsequent therapy. MATERIAL/METHODS: Eligible patients were women with HR+ and HER2− MBC who initiated palbociclib plus ET between September 2016 and August 2019 at Fudan University Shanghai Cancer Center. Clinical characteristics and efficacy data were retrospectively recorded from the electronic medical record system. RESULTS: In total, 130 patients were included in the study, of whom 87.0% of patients started palbociclib on 125 mg/day, 8.5% of patients had dose reduction, and 2.3% of patients discontinued the treatment because of toxicity. Overall, the disease control rate was 77.4% and clinical benefit rate was 63.4%. After a median follow-up period of 10.6 months, the median progression-free survival was 9.2 months. There was limited efficacy in patients who received palbociclib as no less than a fourth line of ET, except for patients who added palbociclib to the ET, which they had acquired resistance to. After disease progression on palbociclib, further treatment with chemotherapy and ET had similar efficacy (P=0.571). CONCLUSIONS: The findings from this real-world single-center study in China showed that treatment with palbociclib plus ET exhibited favorable efficacy and good tolerance in patients with HR+ and HER2− MBC, even in patients who were initially resistant to endocrine therapy, and there was no difference in outcomes between subsequent treatment with chemotherapy and ET.