What is it about?

This study aimed to observe the efficacy and safety of inetetamab and pyrotinib in combination with vinorelbine in second-line therapy and beyond in HER2-positive metastatic breast cancer (MBC). 52 patients were included; 13 patients received 2nd-line treatment and 39 patients received ≥3rd-line treatment. The median PFS (mPFS) for all patients treated with inetetamab + pyrotinib + vinorelbine was 7 months. The mPFS of the 2nd-line subgroup was significantly better than that of the ≥3rd-line subgroup (17 vs. 5 months, P = 0.001). The mPFS of the subgroups that received trastuzumab (H) or trastuzumab and pertuzumab (HP) only was significantly better than that of the H or HP and tyrosine kinase inhibitor (TKI) subgroups (8 vs. 5 months, P = 0.030). The mPFS of the HER2 resistance subgroup was better than that of the HER2 refractoriness subgroup (14 vs. 7 months, P = 0.025). Cox regression analysis showed that the treatment line (2nd-line more so than ≥3rd-line) was an independent prognostic factor for PFS. In addition, the ORR and CBR of 2nd-line patients were significantly higher than those of ≥3rd-line patients (69.2% vs. 30.8% and 92.3% vs. 64.1%, respectively). The most common hematological toxicities were leukopenia and neutropenia, and the most common nonhematological toxicity was diarrhea.

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Why is it important?

For HER2-positive metastatic breast cancer patients who cannot use antibody‒drug conjugates (ADCs) as a standard second-line therapy due to cost‒benefit ratios and those who receive third-line therapy and beyond, with no preferred regimens according to the National Comprehensive Cancer Network (NCCN) guidelines, it is necessary to explore new anti-HER2-targeted therapies to meet their clinical needs. Here, we provide evidence to support the efficacy and safety of inetetamab and pyrotinib combined with vinorelbine in a real-world setting. The median progression-free survival (mPFS) for all patients treated with inetetamab + pyrotinib + vinorelbine was 7 months. The mPFS of the 2nd-line subgroup was significantly better than that of the ≥3rd-line subgroup (17 vs. 5 months, P = 0.001). The ORR and CBR of 2nd-line patients were significantly higher than those of ≥3rd-line patients (69.2% vs. 30.8% and 92.3% vs. 64.1%, respectively). The most common adverse events were leukopenia, neutropenia and diarrhea, which were mostly Grade 1-2, and no patients discontinued medication due to adverse reactions.

Perspectives

To our knowledge, this study represents the first and largest observational case series available to date. We report a promising regimen in HER2-positive metastatic breast cancer, especially in second-line patients who cannot use ADCs, providing a theoretical basis for a prospective study.

Fan Wu
Cancer Hospital of Fujian Province

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This page is a summary of: The Efficacy and Safety of Inetetamab and Pyrotinib in Combination with Vinorelbine for Second-line Therapy and Beyond in HER2-positive Metastatic Breast Cancer: A Single-institution Clinical Experience, Current Cancer Drug Targets, May 2024, Bentham Science Publishers,
DOI: 10.2174/0115680096248592231016065117.
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