Work

Palbociclib treatment in patients with HR+/HER2− advanced or metastatic breast cancer and visceral metastasis: A systematic literature review

Year: 2025

Type: review

Abstract: BACKGROUND: Visceral metastasis is prevalent among patients with advanced/metastatic breast cancer (ABC) and is a prognostic indicator of poor survival. We conducted a systematic literature review of the evidence for palbociclib plus endocrine therapy (ET) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) ABC and visceral metastasis. METHODS: PubMed, EMBASE, Cochrane Library, and relevant conference proceedings were searched through September 2023. Phase 2/3 randomized clinical trials (RCTs) and real-world evidence (RWE) studies evaluating efficacy/effectiveness, safety, and health-related quality-of-life (QoL) of palbociclib plus ET were included. RESULTS: Qualitative synthesis was conducted on 70 articles; 24 reported results from 8 RCTs; 46 were RWE studies. Data from >10,000 patients with visceral metastasis treated with palbociclib were included. All RCTs and RWE studies (5 each) that assessed palbociclib plus ET versus ET alone in patients with HR+/HER2- ABC and visceral metastasis showed significant reduction in risk of disease progression and/or death with palbociclib plus ET (34 %-50 % reduction in RCTs; 31 %-47 % in RWE studies). In RCTs, overall survival was not significantly different between the treatment groups; however, 4 of 5 RWE studies showed a significant benefit (36 %-42 % reduced risk of death) with palbociclib plus ET. Although data for other outcomes were limited, palbociclib plus ET was generally safe and well tolerated while QoL was maintained. CONCLUSION: Both RCTs and RWE studies consistently showed that palbociclib plus ET is efficacious/effective in patients with HR+/HER2- ABC and visceral metastasis; further research is warranted focused on safety, tolerability, and QoL in this patient group.

Source: The Breast

DOI: 10.1016/j.breast.2025.104569