ArticleThe oncologist2025
Survival analysis of pyrotinib in HER2-positive metastatic breast cancer: a multicenter real-world study.
Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Overall Survival With Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer: A Single-Center Pooled Analysis.Thoracic cancer · 2026Article
- Rare overlap of subtype and phenotype: HER2-positive pleomorphic invasive lobular carcinoma presenting with an inflammatory breast cancer phenotype: a case report and targeted treatment strategy.Frontiers in oncology · 2026Article
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Authors and funding
13 authors.
Funding
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Abstract
backgroundIn previous clinical trials, pyrotinib has shown good antitumor activity and manageable toxicity in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). However, real-world data on pyrotinib remain limited. In this study, we reported the latest real-world data on the efficacy and safety of pyrotinib in HER2-positive MBC.
methodsThis multicenter retrospective study included 337 HER2-positive MBC patients treated with pyrotinib between October 2016 and October 2024. We reported the analysis of the efficacy and safety of pyrotinib in HER2-positive MBC. The primary endpoints were progression-free survival (PFS) and overall survival (OS).
resultsAs of April 1, 2025, the median follow-up duration was 42.6 months (range, 2.0-92.7). The median line of treatment was two. The median PFS was 15.3 months (95% CI, 12.9-17.6). By treatment line, the median PFS was 21.4 months (95% CI, 10.1-32.6) for first-line treatment, 14.8 months (95% CI, 11.4-18.1), and 10.9 months (95% CI, 8.1-13.7) for second-line and third-line or above treatment. The 3-year OS rate was 54.6% overall, with 63.2%, 61.1%, and 37.7% for first-line, second-line, and third-line or above treatment. The ORR, DCR, and CBR were 41.5%, 91.2%, and 80.0%. We further analyzed 57 patients with brain metastases (BM). The result showed that the median duration of response (DoR) and time to response (IQR) of radiotherapy-naïve ones were 12.6 months (95% CI, 6.8-18.4) and 1.7 months (95% CI, 1.3-2.2), respectively. The most frequent grade 3 or 4 adverse event was diarrhea. No treatment-related deaths were reported.
conclusionThe updated analysis demonstrated that pyrotinib could be a promising treatment option in HER2-positive MBC with acceptable toxicity in the real world. Survival is still under assessment with longer follow-up.
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