Sorafenib-based therapy in HER2-negative advanced breast cancer: Results from a retrospective pooled analysis of

Qi-Xing Tan1, Qing-Hong Qin1, Bin Lian1

  • 1Breast Surgery Department, Tumor Hospital, Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.

Insights

Sorafenib therapy improves progression-free survival (PFS) and time to progression (TTP) in human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC). However, it does not improve overall survival (OS) and increases adverse events.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Standard systemic therapy for HER2-negative advanced breast cancer (ABC) remains an unmet need.
  • Sorafenib, an oral multikinase inhibitor, exhibits antiangiogenic and antiproliferative properties relevant to cancer treatment.

Purpose of the Study:

  • To evaluate the efficacy and safety of sorafenib in patients with HER2-negative ABC through a meta-analysis.
  • To determine the impact of sorafenib-based therapy on progression-free survival (PFS), time to progression (TTP), overall survival (OS), and overall response rate (ORR).

Main Methods:

  • A meta-analysis of four randomized controlled trials involving 844 patients with HER2-negative ABC.
  • Literature search conducted across major databases (PubMed, EMBASE, Cochrane) using relevant keywords.
  • Extracted data on survival outcomes, response rates, and major adverse events (AEs).

Main Results:

  • Sorafenib-based therapy significantly improved PFS (HR, 0.78; 95% CI, 0.54-1.02) and TTP (HR, 0.74; 95% CI, 0.50-0.97) compared to control therapies.
  • No significant improvement was observed in OS (HR, 0.95; 95% CI, 0.75-1.15) or ORR (RR, 1.19; 95% CI, 1.01-1.39).
  • Increased incidence of grade 3/4 AEs, including hand-foot skin syndrome, anemia, fatigue, rash, and stomatitis, was noted with sorafenib.

Conclusions:

  • Sorafenib-based therapy enhances PFS and TTP in HER2-negative ABC patients.
  • The treatment did not demonstrate significant benefits in OS or ORR.
  • Combination therapy with sorafenib is associated with increased toxicities, often necessitating dose reductions.

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