Abstract
Background: Pyrotinib is a novel irreversible pan-ErbB receptor tyrosine kinase inhibitor. Evidence of the efficacy of pyrotinib-based treatments for HER2-positive metastatic breast cancer (MBC) in patients exposed to lapatinib is limited.Methods: Ninety-four patients who received pyrotinib as a third- or higher-line treatment for HER2-positive MBC were included in this retrospective study. The primary and secondary endpoints were overall survival (OS) and progression‐free survival (PFS). Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) analysis were implemented to balance important patient characteristics between groups.Results: Thirty (31.9%) patients were pretreated with lapatinib and subsequently received pyrotinib as an anti-HER2 treatment, and 64 (68.1%) patients did not receive this treatment. The OS and PFS indicated a beneficial trend in lapatinib-naive group compared to lapatinib-treated group in either the original cohort (PFS: 9.02 vs 6.36 months, p = 0.05; OS: 20.73 vs 14.35 months, p = 0.08) or the PSM (PFS: 9.02 vs 6.08 months, p = 0.07; OS: 19.07 vs 18.00 months, p = 0.61) or IPTW (PFS: 9.90 vs 6.17 months, p = 0.05; OS: 19.53 vs 15.10 months, p = 0.08) cohorts. Subgroup analyses demonstrated lapatinib treatment-related differences in PFS in the premenopausal subgroup and the no prior trastuzumab treatment subgroup, but no significant differences were observed in OS.Conclusion: Pyrotinib-based therapy demonstrated promising effects in HER2-positive MBC patients in a real-world study, especially in lapatinib-naive patients, and also some activity in lapatinib-treated patients.
Highlights
Among patients with metastatic breast cancer (MBC), more than 20% have HER2-positive disease (Cobleigh et al, 2020; Howlader et al, 2014)
The overall survival (OS) and progression-free survival (PFS) indicated a beneficial trend in lapatinib-naive group compared to lapatinib-treated group in either the original cohort (PFS: 9.02 vs 6.36 months, p 0.05; OS: 20.73 vs 14.35 months, p 0.08) or the Propensity score matching (PSM) (PFS: 9.02 vs 6.08 months, p 0.07; OS: 19.07 vs 18.00 months, p 0.61) or inverse probability of treatment weighting (IPTW) (PFS: 9.90 vs 6.17 months, p 0.05; OS: 19.53 vs 15.10 months, p 0.08) cohorts
Subgroup analyses demonstrated lapatinib treatment-related differences in PFS in the premenopausal subgroup and the no prior trastuzumab treatment subgroup, but no significant differences were observed in OS
Summary
Among patients with metastatic breast cancer (MBC), more than 20% have HER2-positive disease (Cobleigh et al, 2020; Howlader et al, 2014). Four TKIs are used to treat HER2-positive MBC, namely, lapatinib, tucatinib, neratinib, and pyrotinib (Xuhong et al, 2019; Lee, 2020). Pyrotinib demonstrated promising effects in brain metastatic HER2positive breast cancer regardless of whether patients were previously treated with trastuzumab (Ma et al, 2019; (Anwar et al, 2021). The TBCRC022 study indicated that neratinib plus capecitabine was effective in HER2-positive patients with brain metastasis of breast cancer among the lapatinib-treated group (Freedman et al, 2019). Evidence of the efficacy of pyrotinib-based treatments for HER2-positive metastatic breast cancer (MBC) in patients exposed to lapatinib is limited
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