Efficacy and Safety of Pyrotinib in Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: A Multicenter, Retrospective, Real-World Study

Abstract

Xiaoling Zhang1 *, Zhaohui Li2 *, Linlin Han3 *, Zheng Lv,4 Yuee Teng,5 Xiujie Cui,6 Caiyun Zhou,7 Hongwei Wu,8 Wei Fang,8 Lingzhi Xu,1 Shanshan Zhao,1 Chen Song,1 Yuanyuan Zheng,1 Tianqi Gao,1 Man Li1 1Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, People’s Republic of China; 2Department of Oncology, Anshan Cancer Hospital, Anshan, People’s Republic of China; 3Health Management Center, The Second Hospital of Dalian Medical University, Dalian, People’s Republic of China; 4Department of Oncology, The First Hospital of Jilin University, Changchun, People’s Republic of China; 5Department of Oncology, The First Hospital of China Medical University, Shenyang, People’s Republic of China; 6Department of Oncology, Chaoyang Center Hospital, Chaoyang, People’s Republic of China; 7Department of Oncology, Huludao Center Hospital, Huludao, People’s Republic of China; 8Department of Oncology, Yingkou Center Hospital, Yingkou, People’s Republic of China*These authors contributed equally to this workCorrespondence: Man Li, Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, Liaoning, People’s Republic of China, Tel [phone], Fax [phone], Email [email protected]: Pyrotinib, a novel human epidermal growth factor receptor 2 (HER2)-targeted tyrosine kinase inhibitor (TKI), has led to remarkable survival outcomes in HER2-positive advanced breast cancer (ABC) in clinical trials and was approved for second-line standards of treatment for HER2+ ABC in China. However, the clinical trials could not fully reflect reality of clinical practice, and predictive factors were still lacking. This study aimed to assess the actual efficacy and safety of pyrotinib in HER2+ ABC in real-world setting.Patients and Methods: In this multicenter, retrospective, observational real-world study, we analyzed 171 patients with HER2+ ABC, who received pyrotinib-based treatment from November 2017 to November 2020. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety.Results: Up to November 30, 2021, the median PFS (mPFS) was 12.0 months for all patients. One hundred and sixty-two patients (94.7%) with measurable lesions had been included in efficacy assessment. The ORR and CBR were 45.1% and 81.5%, respectively. A significantly longer PFS was reported in patients who received pyrotinib as first-line treatment, had the ECOG-PS of 0– 1, as well as those who were lapatinib-naive. In addition, multivariable analysis indicated that ECOG-PS of 2– 4, positive hormone receptor (HR) status, and presence of visceral metastasis were independent negative predictors of PFS. As far as we know, this study first reported the survival outcome of pyrotinib cross-line treatment, with a mPFS of 5.0 months. All grades of adverse events (AEs) occurred in 171 patients (100%), and the most common AE was diarrhea (86.5%).Conclusion: This study further demonstrated the outstanding efficacy and safety of pyrotinib and reported the potential predictors of survival in HER2+ ABC.Keywords: breast cancer, tyrosine kinase inhibitors, prognostic factor, targeted therapy

Keywords

• breast cancer
• tyrosine kinase inhibitors
• prognostic factor
• target therapy