Cancer Res Treat.  2020 Oct;52(4):1059-1066. 10.4143/crt.2019.633.

Real-World Data of Pyrotinib-Based Therapy in Metastatic HER2-Positive Breast Cancer: Promising Efficacy in Lapatinib-Treated Patients and in Brain Metastasis

• Lin Y
• Lin M
• Zhang J
• Wang B
• Tao Z
• Du Y
• Zhang S
• Cao J
• Wang L
• Hu X

• KMID: 2507933
• DOI: http://doi.org/10.4143/crt.2019.633

Abstract

Purpose
Pyrotinib is a newly-developed irreversible pan-ErbB receptor tyrosine kinase inhibitor. This study reported the first real-world data of pyrotinib-based therapy in metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC), focusing on efficacy in lapatinib-treated patients and in brain metastasis.
Materials and Methods
One hundred thirteen patients with metastatic HER2-positive BC treated with pyrotinib-based therapy in Fudan University Shanghai Cancer Center under non-clinical trial settings from September 1, 2018 to March 1, 2019 were included.
Results
Over half patients have received more than two lines of systematic therapy and exposed to two or more kinds of anti-HER2 agents. Most patients received a combined therapy, commonly of pyrotinib plus capecitabine, or vinorelbine or trastuzumab. Median progression-free survival (PFS) was 6.3 months (range, 5.54 to 7.06 months) and objective response rate (ORR) was 29.5%, with two patients (1.9%) achieving complete response. Lapatinib-naïve patients had significantly longer PFS than lapatinib-treated patients (9.0 months vs. 5.4 months, p=0.001). ORR for lapatinib-treated patients was 23.2%. Thirty-one of 113 patients have brain metastasis. Median PFS was 6.7 months and intracranial ORR was 28%. For patients without concurrent radiotherapy and/or brain surgery, the ORR was very low (6.3%). But for patients receiving concurrent radiotherapy and/or brain surgery, the ORR was 66.7%, and three patients achieved complete response. Most common adverse event was diarrhea.
Conclusion
Pyrotinib-based therapy demonstrated promising effects in metastatic HER2-positive BC and showed activity in lapatinib-treated patients. For patients with brain metastasis, pyrotinib-based regimen without radiotherapy showed limited efficacy, but when combined with radiotherapy it showed promising intracranial control.

Keyword

Pyrotinib; HER2-positive breast cancer; Tyrosine kinase inhibitor; Lapatinib-treated; Brain metastasis

Figure

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  Fig. 1. Kaplan-Meier plot of progression-free survival and log-rank analysis of predictors of pyrotinib-based treatment. (A) Kaplan-Meier plot of progression-free survival of all patients treated with pyrotinib-based treatment. (B) Kaplan-Meier plot of progression-free survival for patients with ≤ 2 metastatic sites and > 2 metastatic sites. (C) Kaplan-Meier plot of progression-free survival for patients with and without prior lapatinib exposure. mPFS, median progression-free survival.

Reference

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