Pyrotinib with trastuzumab and aromatase inhibitors as first-line treatment for HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer: study protocol of a randomized controlled trial

Wang, Changjun; Yang, Lin; Zhou, Yidong; Mao, Feng; Zhu, Hong; Guan, Jinghong; Zhang, Xiaohui; Shen, Songjie; Huang, Xin; Chen, Chang; Yao, Ru; Zhao, Jialin; Sun, Qiang

doi:10.1186/s12885-020-07143-2

Cited by 10 publications

(18 citation statements)

References 18 publications

(19 reference statements)

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“…The marketed pyrotinib in 2018 is a multi-target tyrosine kinase inhibitor targeting HER1, HER2 and HER4 intracellular kinase regions independently developed in China. The current phase II and III clinical studies [10,11] have encouraging results. In the multicenter randomized controlled study of MA et al [12], it was shown that pyrotinib combined with capecitabine had a high objective response rate of 78.5% and progression-free survival of 18.1 months in the treatment of HER2-positive advanced breast cancer.…”

Section: Introductionmentioning

confidence: 88%

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Wang¹,

Meng²,

LI³

et al. 2021

annhematoloncol

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Background: Pyrotinib is a molecular and irreversible tyrosine kinase inhibitor independently developed in China, and its efficacy against HER2- positive breast cancer in the real world is not clear. In this study, we evaluated the efficacy and safety of pyrotinib in the treatment of HER2-positive advanced breast cancer based on real-world evidence. Materials and Methods: We designed a prospective observational study. Thirty-six patients with HER2-positive advanced breast cancer from a single medical center were included in the study from December 2018 to February 2021. All patients received the oral HER2 receptor inhibitor pyrotinib and received concurrent chemotherapy or endocrinotherapy. The follow-up endpoint is set as April 1, 2021. The primary endpoint is Objective Response Rate (ORR) and Disease Control Rate (DCR), and the secondary endpoint is Progression- Free Survival (PFS) and related side effects. Results: By the end point of follow-up, a total of 17 patients had progressed (including 6 deaths), and the progression-free survival rate was 52.78%. The median PFS was 13months (PFS range: 3-22 months). As the best response, 4 patients achieved CR, 20 patients achieved PR, 9 patients achieved SD, and 3 patient developed PD. The ORR was 66.67% and DCR was 91.67%. In the analysis, first-line pyrotinib treatment appeared to have higher ORR (88.88% vs 59.26%), but there was no significant difference. In addition, pyrotinib showed significant efficacy in patients with brain metastases, with an ORR of 42.85%. In terms of safety, the incidence of diarrhea was 80.55%, but only 4 patients had grade 3 diarrhea, which was tolerable after the drug dose was reduced; 1 patient had grade 4 neutropenia and grade 3 and thrombocytopenia, which were considered to be related to the chemotherapy drugs. The incidence of other adverse reactions was low, and all were grade 1 to 2. Conclusion: Pyrotinib combined with chemotherapy has a significant effect on HER2-positive breast cancer, and there is still a high ORR in patients who fail multiple lines of treatment. Side effects are overall controllable and safe.

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Section: Introductionmentioning

confidence: 88%

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Wang¹,

Meng²,

LI³

et al. 2021

annhematoloncol

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“…Letrozole, an aromatase inhibitor (AI), has been Case Report Significant response to the combination of pyrotinib and letrozole in a patient with metastatic HER2-positive and hormone receptor-positive breast cancer: a case report proven to have better clinical efficacy when combined with trastuzumab compared with hormonal therapy alone (10,11). Although a similar treatment regimen has been reported previously, the effect and safety profile of pyrotinib plus letrozole in the treatment for HER2-positive/HR-positive patients have not yet been demonstrated (12).…”

Section: Introductionmentioning

confidence: 93%

Significant response to the combination of pyrotinib and letrozole in a patient with metastatic HER2-positive and hormone receptor-positive breast cancer: a case report

Shui

Ouyang

2021

Ann Palliat Med

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Breast cancer is the most commonly diagnosed malignant tumor and the leading cause of cancerrelated death in women worldwide. Previous studies have demonstrated that patients with human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor (HR)-positive metastatic breast cancer can benefit from HER2-targeted therapy. Pyrotinib, an irreversible tyrosine kinase inhibitor (TKI), has been demonstrated to be effective and safe in treating HER2-positive breast cancer patients. Letrozole is an aromatase inhibitor (AI) which has shown better clinical efficacy when combined with HER2 inhibitors in treating patients with HER2-positive and HR-positive breast cancer than has hormonal therapy alone. However, the effect of combination therapy with pyrotinib plus letrozole in HER2-positive/HRpositive metastatic breast cancer patients has not yet been investigated. In this case report, a 57-year-old female patient with HER2-positive/HR-positive breast cancer received modified radical mastectomy and experienced subsequent relapse and metastasis. She was diagnosed with relapsed right breast cancer, a right chest bone mass accompanied by bone destruction, and metastases in the chest wall and both lungs. She was then enrolled in a phase II clinical trial and was treated with pyrotinib plus letrozole, and achieved a durable clinical response. Our case shows that combination therapy with pyrotinib plus letrozole may provide significant clinical benefit for patients with HER2-positive/HR-positive metastatic breast cancer, with tolerable adverse events.

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“…Pyrotinib combined with trastuzumab, paclitaxel and cisplatin exhibited favorable results (pCR) in HER2-positive locally advanced BC in published case reports (52), while study protocols for randomized trials including pyrotinib are currently under development (53). Clinical trials assessing the effects of TKIs in breast cancer are included in Table I.…”

Section: Clinical Trialsmentioning

confidence: 99%

Tyrosine kinase inhibitors in breast cancer (Review)

et al. 2021

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Anti-epider mal growth factor receptor (EGFR)-targeted therapy has been intensely researched in the last years, motivated by the favorable results obtained with monoclonal antibodies in HER2-enriched breast cancer (BC) patients. Most researched alternatives of anti-EGFR agents were tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. However, excluding monoclonal antibodies trastuzumab and pertuzumab, the remaining anti-EGFR molecules have exhibited disappointing results, due to the lack of specificity and frequent adverse side effects. TKIs have several advantages, including reduced cardiotoxicity, oral administration and favorable penetration of blood-brain barrier for brain metastatic BC. Lapatinib and neratinib and recently pyrotinib (approved only in China) are the only TKIs from dozens of molecules researched over the years that were approved to be used in clinical practice with limited indications, in a subset of BC patients, single or in combination with other chemotherapy or hormonal therapeutic agents. Improved identification of BC subtypes and improved characterization of aggressive forms (triple negative BC or inflammatory BC) should lead to advancements in shaping of targeted agents to improve the outcome of patients. Contents 1. Introduction 2. Tyrosine kinase inhibitors (TKIs) used in breast cancer (BC) therapy 3. Limitations and challenges of TKI use in BC chemotherapy 4. Conclusions

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Pyrotinib with trastuzumab and aromatase inhibitors as first-line treatment for HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer: study protocol of a randomized controlled trial

Cited by 10 publications

References 18 publications

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Efficacy and Side Effects in HER2-Positive Advanced Breast Cancer Patients Treated with Pyrrotinib: A Real-World Study in China

Significant response to the combination of pyrotinib and letrozole in a patient with metastatic HER2-positive and hormone receptor-positive breast cancer: a case report

Tyrosine kinase inhibitors in breast cancer (Review)

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