The Efficacy of Pyrotinib as a Third- or Higher-Line Treatment in HER2-Positive Metastatic Breast Cancer Patients Exposed to Lapatinib Compared to Lapatinib-Naive Patients: A Real-World Study

D J Ouyang; Q T Chen; M Anwar; N Xie; Q C Ouyang; P Z Fan; L Y Qian; G N Chen; E X Zhou; L Guo; X W Gu; B N Ding; X H Yang; L P Liu; C Deng; Z Xiao; J Li; Y Q Wang; S Zeng; Shouman Wang; Wenjun Yi

doi:10.3389/fphar.2021.682568

The Efficacy of Pyrotinib as a Third- or Higher-Line Treatment in HER2-Positive Metastatic Breast Cancer Patients Exposed to Lapatinib Compared to Lapatinib-Naive Patients: A Real-World Study

Front Pharmacol. 2021 Aug 26:12:682568. doi: 10.3389/fphar.2021.682568. eCollection 2021.

Authors

D J Ouyang^{1

2}, Q T Chen¹, M Anwar¹, N Xie³, Q C Ouyang³, P Z Fan⁴, L Y Qian⁵, G N Chen¹, E X Zhou¹, L Guo⁶, X W Gu⁴, B N Ding⁵, X H Yang⁷, L P Liu⁷, C Deng⁸, Z Xiao⁶, J Li⁷, Y Q Wang⁹, S Zeng¹⁰, Shouman Wang⁶, Wenjun Yi¹

Affiliations

¹ Department of General Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.
² Department of General Surgery, Xiangya Hospital, Central South University, Changsha, China.
³ Department of Internal Medicine of Breast, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
⁴ Department of Breast and Thyroid Surgery, Hunan Provincial People's Hospital, Changsha, China.
⁵ Department of Breast and Thyroid Surgery, Third Xiangya Hospital, Central South University, Changsha, China.
⁶ Department of Breast Surgery, Xiangya Hospital, Central South University, Changsha, China.
⁷ Department of Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
⁸ Department of Oncology, The Second Xiangya Hospital, Central South University, Changsha, China.
⁹ Department of Traditional Chinese Medicine, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
¹⁰ Department of Internal Medicine-Oncology, Xiangya Hospital, Central South University, Changsha, China.

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.

Keywords: HER2 breast cancer; lapatinib-naive; lapatinib-treated; metastases; pyrotinib.