Pyrotinib Plus Taxanes or Vinorelbine for the Treatment of Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Prospective Evaluation of Efficacy and Safety.

PURPOSE

The clinical benefits of pyrotinib plus taxanes or vinorelbine have not been studied systemically. Consequently, we conducted a prospective evaluation to assess the efficacy and safety of pyrotinib plus taxanes or vinorelbine in patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC).

METHODS

Patients with HER2-positive MBC were included to receive pyrotinib combined with taxanes or vinorelbine in Jiangsu Cancer Hospital. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), and adverse effects (AEs).

RESULTS

Between December 22, 2020 and January 11, 2023, a total of 101 patients were assigned to pyrotinib plus taxanes (n = 83) and pyrotinib plus vinorelbine (n = 18) groups. As of May 24, 2023, the median PFS for all patients was 11.5 months (95% confidence interval [CI], 8.8-15.7). The median PFS was significantly longer in pyrotinib plus taxanes group than in pyrotinib plus vinorelbine group (median PFS, 12.2 months [95% CI, 9.2-18.6] vs. 8.4 months [95% CI, 5.5-13.7]; P = .005). All the treatment-related side effects were tolerated. The most frequent grade 3 or 4 side effects included diarrhea (22.8%), leukopenia (19.5%), and neutropenia (18.2%).

CONCLUSION

Pyrotinib plus taxanes could be an alternative or even the preferred treatment strategy for patients with HER2-positive MBC after trastuzumab and small-molecule tyrosine kinase inhibitors (TKIs). We also suggest that pyrotinib combined with vinorelbine has a therapeutic potential.

REGISTRATION

This trial was registered in Chinese Clinical Trial Registry. URL: https://www.chictr.org.cn/showproj.html?proj=65697 (ChiCTR2000041217).