Cancer Res Treat.  2024 Apr;56(2):513-521. 10.4143/crt.2023.786.

Pyrotinib Combined with Vinorelbine in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Single-Arm, Prospective Study

• Jiang K
• Hong R
• Xia W
• Lu Q
• Li L
• Huang J
• Shi Y
• Yuan Z
• Zheng Q
• An X
• Xue C
• Huang J
• Bi X
• Chen M
• Zhang J
• Xu F
• Wang S

• KMID: 2554340
• DOI: http://doi.org/10.4143/crt.2023.786

Abstract

Purpose
This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice.
Materials and Methods
This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m² intravenously or 60-80 mg/m² orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety.
Results
A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%).
Conclusion
Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.

Keyword

Breast Neoplasms; Pyrotinib; Vinorelbine; Tyrosine Protein Kinase Inhibitors

Figure

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  Fig. 1. Trial profile.

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  Fig. 2. Progression-free survival. CI, confidence interval.

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  Fig. 3. Tumor response assessment with waterfall plot (n=33).

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  Fig. 4. Kaplan-Meier plot for progression-free survival of patients with or without prior pertuzumab exposure.

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  Fig. 5. Kaplan-Meier plot for progression-free survival of patients treated with oral or intravenous vinorelbine

Reference

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