Abstract
Purpose
Pertuzumab (Per) is a humanized monoclonal antibody used in combination with trastuzumab (Tra) in the treatment of human epidermal growth factor receptor-2 (HER2)-positive breast cancer. The administration of biologics, such as Tra and Per, frequently causes infusion reactions (IRs) with fever and chills. This study aimed to clarify the characteristics of and risk factors for IRs in Tra + Per combination therapy.
Methods
Between March 2013 and December 2019, 64 patients with breast cancer who started Tra + Per combination therapy were included in the study. The severity of IRs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results
The incidence of IRs in the Tra + Per combination therapy was 48.4% (31/64). The severity of IRs in the Tra + Per combination therapy was Grade 1 (9 patients) and Grade 2 (22 patients). Lymphocyte counts were significantly different between the IR and non-IR groups in patients receiving Tra + Per combination therapy (univariate analysis, p = 0.006; multivariate analysis, p = 0.050). ROC curve analysis found the cutoff value of lymphocyte counts were 1.60 (× 103/µL). The incidence of IRs in the lymphocyte counts ≥ 1.60 group was significantly higher than that in the lymphocyte counts < 1.60 group (p < 0.001).
Conclusion
Our study indicates that the severity of IRs in most patients is moderate or less and the risk of IRs is higher in patients with higher lymphocyte counts (≥ 1.60 × 103/µL).
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Availability of data and material
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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All authors contributed to the conception and design of the study. Data collection and analysis were performed by Yusuke Tabuchi and Kosuke Yamamoto. The first draft of the manuscript was written by Yusuke Tabuchi, and all authors commented on the previous versions of the manuscript. All authors read and approved the final manuscript.
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Department of Endocrine and Breast Surgery, to which Koichi Sakaguchi belongs, has received a scholarship donation from Chugai Pharmaceutical Co. Keisuke Shikata has received honorarium from Chugai Pharmaceutical Co. Other authors have no relevant financial or non-financial interests to disclose.
Ethical approval
The Medical Ethics Review Committee of Kyoto Prefectural University of Medicine (approval no. ERB-C-2013) and the Medical Ethics Review Committee of Kyoto Pharmaceutical University (approval no. E21-013) approved this study.
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Since this study was a retrospective study, the informed consent of the individual participants who were included in this study was waived in accordance with the Medical Ethics Review Committee of Kyoto Prefectural University of Medicine and Kyoto Pharmaceutical University.
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Tabuchi, Y., Tsujimoto, M., Yamamoto, K. et al. Incidence and risk factors of infusion reactions in patients with breast cancer administered trastuzumab plus pertuzumab-based regimen. Cancer Chemother Pharmacol 91, 25–31 (2023). https://doi.org/10.1007/s00280-022-04492-6
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DOI: https://doi.org/10.1007/s00280-022-04492-6