The efficacy and safety of pyrotinib in treating HER2‐positive breast cancer patients with brain metastasis: A multicenter study

Gao, Min; Fu, Chao; Li, Shanshan; Chen, Fang; Yang, Yongteng; Wang, Chunjian; Qin, Jie; Liu, Shuaishuai; Ranran, Zhang; Wang, Changyuan; Zong, Jingfeng; Meng, Liping; Meng, Xiangjiao

doi:10.1002/cam4.4481

Cited by 15 publications

(9 citation statements)

References 26 publications

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“… 16–18 Thus, we consider ADCs and TKIs are both favorable options for this kind of patient. In this real-world study, pyrotinib-based therapy resulted in an mPFS of 11.6 months in patients with brain metastases, which is highly consistent with that of 11.3 months and 11.1 months reported in the PERMEATE study and by Gao et al for pyrotinib plus capecitabine in patients with brain metastases from HER2-positive MBC, 19 , 20 respectively. Although the prognosis of patients with brain metastases remains poor, treatment strategies range from local to systemic anti-HER2 therapies.…”

Section: Discussionsupporting

confidence: 89%

Real-World Outcome and Prognostic Factors Among HER2-Positive Metastatic Breast Cancer Patients Receiving Pyrotinib-Based Therapy: A Multicenter Retrospective Analysis

Liu¹,

Sun²,

Du³

et al. 2022

BCTT

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To explore the efficacy, safety, and potential factors influencing efficacy and outcome of pyrotinib-based therapy in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in complex clinical practice. Methods: Real-world data for HER2-positive MBC patients treated with pyrotinib-based regimens from 6 hospitals in Northern Anhui, China, from September 2018 to February 2022, were retrospectively collected, and clinicopathological features, efficacy, prognosis, and safety were analyzed. Potential influencing factors including baseline serum vascular endothelial growth factor-A (VEGF-A) for evaluating pyrotinib's treatment response and outcome were also explored. Results: A total of 169 patients with HER2-positive MBC were enrolled. The objective response rate (ORR), disease control rate (DCR), and median progression-free survival (mPFS) of the overall cohort were 65.1%, 87.6%, and 12.4 months, respectively. Pyrotinib is highly beneficial as different treatment lines and appears to be a feasible strategy both in combination with chemotherapeutic drugs and alone. The mPFS values were 16.5 months, 12.4 months, and 9.3 months in the first, second, and third-or-higher lines of anti-HER2 therapy, respectively (P=0.027). The most common adverse event (AE) was diarrhea (88.2%), and patients with < grade 3 diarrhea achieved a longer mPFS than patients with ≥ grade 3 diarrhea (13.3 months vs 6.9 months, P=0.007). Among the patients with available baseline VEGF-A data, the ORR was 43.5% in patients with a high level of VEGF-A, compared to 81.5% in patients with a low level of VEGF-A (P=0.005). Moreover, patients in the VEGF-A-high group exhibited a shorter mPFS time than those in the VEGF-A-low group (7.8 months vs 19.1 months, P=0.004). Further analysis demonstrated AE of diarrhea and VEGF-A at baseline to be independent prognostic factors for PFS. Conclusion: Pyrotinib-based regimens showed promising efficacy, with manageable tolerance, and AE occurrence of severe diarrhea and baseline level of serum VEGF-A are helpful in predicting the treatment outcome of pyrotinib in HER2-positive MBC.

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Section: Discussionsupporting

confidence: 89%

Real-World Outcome and Prognostic Factors Among HER2-Positive Metastatic Breast Cancer Patients Receiving Pyrotinib-Based Therapy: A Multicenter Retrospective Analysis

Liu¹,

Sun²,

Du³

et al. 2022

BCTT

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“…In this meta-analysis, 9 studies investigating pyrotinib in a total of 321 Asian patients were included ( Table 4 ); 1 double blind phase 3 study [ 71 ], 1 single arm phase 2 trial [ 78 ] and 7 retrospective studies [ 70 , 72 , 73 , 74 , 75 , 76 , 77 ]. Pooled ORR was 43% (95% CI 27–59%; I 2 80%) ( Figure 2 E).…”

Section: Resultsmentioning

confidence: 99%

Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis

Werter

Remmelzwaal

Burchell

et al. 2022

Cancers

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Aim: Patients with HER2-positive (HER2+) metastatic breast cancer (mBC) develop brain metastases (BM) in up to 30% of cases. Treatment of patients with BM can consist of local treatment (surgery and/or radiotherapy) and/or systemic treatment. We undertook a systematic review and meta-analysis to determine the effect of different systemic therapies in patients with HER2+ mBC and BM. Methods: A systematic search was performed in the databases PubMed, Embase.com, Clarivate Analytics/Web of Science Core Collection and the Wiley/Cochrane Library. Eligible articles included prospective or retrospective studies reporting on the effect of systemic therapy on objective response rate (ORR) and/or median progression free survival (mPFS) in patients with HER2+ mBC and BM. The timeframe within the databases was from inception to 19 January 2022. Fixed-effects meta-analyses were used. Quality appraisal was performed using the ROBINS-I tool. Results: Fifty-one studies were included, involving 3118 patients. Most studies, which contained the largest patient numbers, but also often carried a moderate-serious risk of bias, investigated lapatinib and capecitabine (LC), trastuzumab-emtansine (T-DM1) or pyrotinib. The best quality data and/or highest ORR were described with tucatinib (combined with trastuzumab and capecitabine, TTC) and trastuzumab-deruxtecan (T-DXd). TTC demonstrated an ORR of 47.3% in patients with asymptomatic and/or active BM. T-DXd achieved a pooled ORR of 64% (95% CI 43–85%, I2 0%) in a heavily pretreated population with asymptomatic BM (3 studies, n = 96). Conclusions: Though our meta-analysis should be interpreted with caution due to the heterogeneity of included studies and a related serious risk of bias, this review provides a comprehensive overview of all currently available systemic treatment options. T-Dxd and TTC that appear to constitute the most effective systemic therapy in patients with HER2+ mBC and BM, while pyrotinib might be an option in Asian patients.

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“…Another real-world study reported various efficacy indicators of pyrotinib-based therapy in 42 patients with ABC suffering from brain metastases. ORR was 40.4%, disease control was obtained in 92.8% of cases, improvement in intracranial symptoms was noted in all patients, the median duration of intracranial improvement was 15 months, the median time to relieve brain metastases was 43 days, the median time to relieve other metastases was 50 days, the median time to progression of brain metastases was 16.6 months, and the median time to disease progression was 11.1 months [ 67 ]. In a retrospective study involving 61 HER2-positive patients with brain metastases treated by pyrotinib-based regimens, median PFS was 8.6 months, median OS was 18.0 months, and the combination of pyrotinib with nab-paclitaxel was superior to the combination with capecitabine and vinorelbine with respect to PFS and OS.…”

Section: Clinical Evidence Of Pyrotinib In Abcmentioning

confidence: 99%

Pyrotinib-based therapeutic approaches for HER2-positive breast cancer: the time is now

Qi,

Shi,

Xuhong

et al. 2023

Breast Cancer Res

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Human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) is a highly aggressive subtype associated with poor prognosis. The advent of HER2-targeted drugs, including monoclonal antibodies, tyrosine-kinase inhibitors (TKIs) and antibody–drug conjugates, has yielded improved prognosis for patients. Compared with widely used monoclonal antibodies, small-molecule TKIs have unique advantages including oral administration and favorable penetration of blood–brain barrier for brain metastatic BC, and reduced cardiotoxicity. Pyrotinib is an irreversible TKI of the pan-ErbB receptor, and has recently been shown to be clinically effective for the treatment of HER2-positive BC in metastatic and neoadjuvant settings. This review highlights the development on the application of pyrotinib-based therapeutic approaches in the clinical settings of HER2-positive BC.

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The efficacy and safety of pyrotinib in treating HER2‐positive breast cancer patients with brain metastasis: A multicenter study

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 15 publications

References 26 publications

Real-World Outcome and Prognostic Factors Among HER2-Positive Metastatic Breast Cancer Patients Receiving Pyrotinib-Based Therapy: A Multicenter Retrospective Analysis

Real-World Outcome and Prognostic Factors Among HER2-Positive Metastatic Breast Cancer Patients Receiving Pyrotinib-Based Therapy: A Multicenter Retrospective Analysis

Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis

Pyrotinib-based therapeutic approaches for HER2-positive breast cancer: the time is now

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