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- Impact of High Lymph Node Burden on Brain Metastases in Patients Who Achieved Pathological Complete Response after Neoadjuvant Chemotherapy in HER2-Positive Breast Cancer
- Seung Ah Lee, Ki Jo Kim, Do Youn Woen, Su Min Lee, Kawon Oh, Cho Eun Lee, Woong Ki Park, Ji Won Yoo, Dong Seung Shin, Jai Min Ryu, Se Kyung Lee, Byung Joo Chae, Jonghan Yu, Seok Won Kim, Seok Jin Nam, Ji-Yeon Kim, Yeon Hee Park, Eun Young Ko, Eun Sook Ko, Jeong Eon Lee
- Cancer Res Treat. 2026;58(3):780-789. Published online July 8, 2025
- DOI: https://doi.org/10.4143/crt.2025.219
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Abstract
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Supplementary Material
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ePub - Purpose
This study aims to investigate the clinical characteristics, outcomes, and predictors of brain metastases in human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer patients who achieved pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). This research seeks to inform surveillance strategies and optimize management for high-risk subgroups.
Materials and Methods
A retrospective analysis of 1,757 patients (2008-2022) classified them into pCR (n=914) and non-pCR (n=843) groups post-NAC. Collected data included demographics, clinical features, and metastasis parameters. Survival outcomes and brain metastasis predictors were assessed using Kaplan-Meier curves, Cox models, and logistic regression.
Results
Among pCR patients, brain metastases accounted for 54.2% of distant metastases, significantly affecting overall survival (p < 0.001). Median distant metastasis-free survival was shorter for brain metastases (13.4 months) compared to extracranial metastases (31.1 months) in the pCR group (p=0.005). Positive supraclavicular node (SCN) fine needle aspiration (FNA) and clinical N3 (cN3) category were the strongest predictors of brain metastases (SCN FNA: odds ratio [OR], 12.9; p < 0.001; cN3: OR, 12.1; p < 0.001). Multivariable Cox regression analysis revealed that positive SCN FNA and cN3 category were strong predictors of reduced distant metastasis-free survival (SCN FNA: hazard ratio, 2.5; 95% confidence interval [CI], 1.3 to 3.6; p < 0.001; cN3: hazard ratio, 11.3; 95% CI, 4.9 to 33.0; p < 0.001).
Conclusion
This study highlights the challenges of brain metastases in HER2-positive pCR patients, emphasizing the need for tailored therapeutic strategies and enhanced surveillance. High lymph node burden prior to NAC is a significant factor in risk assessment. Therefore, it may be advisable to recommend post-surgery surveillance for high-risk patients.
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- Real World Evidence of Neoadjuvant Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) in Patients with HER2-Positive Early or Locally Advanced Breast Cancer: A Single-Institutional Clinical Experience
- Ji-Yeon Kim, Seok Jin Nam, Jeong Eon Lee, Jonghan Yu, Byung Joo Chae, Se Kyung Lee, Jai Min Ryu, Jin Seok Ahn, Young-Hyuck Im, Seok Won Kim, Yeon Hee Park
- Cancer Res Treat. 2022;54(4):1091-1098. Published online January 10, 2022
- DOI: https://doi.org/10.4143/crt.2021.901
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
Docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP) regimen is frequently used to treat early and locally advanced human epidermal growth factor receptor 2 (HER2)–positive breast cancer (BC) in neoadjuvant setting. However, large-scaled real-world evidence did not exist.
Materials and Methods
We retrospectively reviewed medical records of patients with early or locally advanced HER2-positive BC who underwent neoadjuvant TCHP followed by curative surgery at Samsung Medical Center between January 2016 and August 2020.
Results
Of 447 patients, 316 (70.7%) received breast-conserving surgery and 131 (29.3%) received total mastectomy. In terms of neoadjuvant chemotherapy response, pathologic complete response (pCR) and residual cancer burden (RCB) score were analyzed. The rate of pCR was 64% a class of RCB 0 was observed in 65% of cases, RCB class I in 12%, RCB class II in 14%, and RCB class III in 2%. The 3-year event-free survival rate was 90.6%, BC with pCR occurred in 92.8%, and BC with non-pCR in 86.3% (p=0.016). In terms of distant metastasis, the 3-year distant recurrence-free survival rate was 93.5%; BC with pCR occurred in 95.9% and BC with non-pCR in 89.2% (p=0.013). Mucositis (85.2%), pain (83.2%), and diarrhea (70.5%) were the most common non-hematologic adverse events. In terms of hematologic adverse events, anemia (89.9%) was the most commonly observed adverse events followed by thrombocytopenia (29.8%).
Conclusion
Neoadjuvant TCHP therapy had a pCR rate of 64% and a 3-year event-free survival of 90% in real world experience. In terms of toxicity profile, anemia was frequently observed and adequate management including occasional transfusion was required. -
Citations
Citations to this article as recorded by
- Efficacy, safety, and biomarkers of neoadjuvant trastuzumab and pertuzumab combined with chemotherapy in Chinese patients with HER2-positive breast cancer: a multicenter retrospective cohort study
Xiaowei Qi, Hong Hu, Pengfei Qiu, Wenlin Chen, Xiaochun Wang, Qiyun Shi, Yan Xu, Shu Liu, Yanman Fang, Taolang Li, Jia Ming, Sihai Zhou, Fan Chai, Yueyang Liang, Yuanming Fan, Peng Tang, Li Chen, Shushu Wang, Jun Jiang, Mengyuan Wang, Yi Zhang, Jianyun Ni
International Journal of Surgery.2026; 112(1): 1318. CrossRef - Systemic Treatment for Patients with Early-Stage Breast Cancer
Hee Kyung Ahn
The Korean Journal of Medicine.2026; 101(2): 70. CrossRef - Bridging Clinical Trials to Real-World Clinical Practice: TCHP Neoadjuvant Therapy Outcomes in HER2-Positive Breast Cancer
Baha Sharaf, Alaa Seif, Hira Bani Hani, Maha Alhasan, Rnad Khader, Maram Al-Yag'oub, Ameed Ghanem, Jinan Bani Ata, Batool Ajlouni, Qutaiba Jawarneh, Adel Jaffal, Faris Tamimi, Sharif Jehad, Haneen Al-Abdallat, Osama Mahafdah, Hikmat Abdel-razeq
Breast Cancer: Targets and Therapy.2026; Volume 18: 1. CrossRef - Response-Adapted Surgery for Residual Calcifications in HER2-Positive Breast Cancer After Neoadjuvant Chemotherapy
Jeong Eon Lee, Cho Eun Lee, Seok Jin Nam, Seok Won Kim, Jonghan Yu, Byung Joo Chae, Se Kyung Lee, Jai Min Ryu, Eun Young Ko, Ji Soo Choi, Eun Sook Ko, Jeongmin Lee, Boo-Kyung Han, Woong Ki Park
Journal of Breast Cancer.2026; 29(3): 299. CrossRef - Tumors >2 cm in node-negative, HER2-positive breast cancer: comparing neoadjuvant dual-targeted versus adjuvant single-targeted treatment pathways in real-world practice
Xiaoduo Li, Kexuan Feng, Junjie Liu, Xiaoqian Li, Rui Zhang, Huimin Zhang
Therapeutic Advances in Medical Oncology.2026;[Epub] CrossRef - Neoadjuvant anthracycline-free versus anthracycline-containing chemotherapy combined with dual HER2 blockade in HER2-positive breast cancer: a real-world comparative study
Asli Buyukkuscu, Zehra Sucuoglu Isleyen, Omer Burak Ekinci, Tugay Atasever, Kubra Akkaya, Okan Aydin, Gamze Kulduk, Emir Celik, Kayhan Erturk, M. Mustafa Atci
Breast Cancer Research.2026;[Epub] CrossRef - Decluttering chemotherapy agents for HER2+early breast cancer: Do we still need carboplatin?
Fabio Conforti, Jacopo Canzian, Benedetta Tinterri, Laura Pala, Marzia Bendoni, Marzia Locatelli, Tommaso De Pas, Aldo Caltavituro, James C. Dickerson, Carmen Criscitiello, Francesco Schettini, Aleix Prat, Javier Cortes, Giuseppe Viale, Martine Piccart, R
European Journal of Cancer.2026; 247: 117015. CrossRef - Decrease in Calcifications After Neoadjuvant Treatment Predicts Invasive Tumor Response but Not Complete DCIS Eradication: Systematic Review and Meta-Analysis
Noam Weiner, Yaron Niv, Eran Sharon
Clinical Breast Cancer.2025; 25(7): e990. CrossRef - Comparison of T-DM1 and trastuzumab-pertuzumab in HER2-positive breast cancer patients with residual disease after neoadjuvant therapy: a retrospective study
Junxiao Wang, Yushuai Yu, Qisheng Lin, Xin Wang
World Journal of Surgical Oncology.2025;[Epub] CrossRef - Pertuzumab/Docetaxel/Carboplatin/Trastuzumab Regimen in Human Epidermal Growth Factor Receptor 2–Positive Early, Locally Advanced, and Oligometastatic Breast Cancer: Real-World Outcomes From India
Ajay Gogia, Atul Batra, Ashutosh Mishra, Kamal Kataria, Surendra K. Saini, Sandeep Mathur, Chandra P. Prasad, Hari Krishna Raju Sagiraju
JCO Global Oncology.2025;[Epub] CrossRef - De-escalation of neoadjuvant taxane and carboplatin therapy in HER2-positive breast cancer with dual HER2 blockade: a multicenter real-world experience in China
Song Wu, Li Bian, Haibo Wang, Shaohua Zhang, Tao Wang, Zhigang Yu, Jianbin Li, Feng Li, Kun Wang, Zefei Jiang
World Journal of Surgical Oncology.2024;[Epub] CrossRef - Distinct ER and PR expression patterns significantly affect the clinical outcomes of early HER2-positive breast cancer: A real-world analysis of 871 patients treated with neoadjuvant therapy
Haizhu Chen, Xiujuan Gui, Ziwei Zhou, Fengxi Su, Chang Gong, Shunrong Li, Wei Wu, Nanyan Rao, Qiang Liu, Herui Yao
The Breast.2024; 75: 103733. CrossRef - Impact of adding pertuzumab to trastuzumab plus chemotherapy in neoadjuvant treatment of HER2 positive breast cancer patients: a multicenter real-life HER2PATH study
Ahmet Bilici, Omer Fatih Olmez, Muhammed Ali Kaplan, Berna Oksuzoglu, Ahmet Sezer, Nuri Karadurmus, Erdem Cubukcu, Mehmet Ali Nahit Sendur, Sercan Aksoy, Dilek Erdem, Gul Basaran, Burcu Cakar, Abdallah T. M. Shbair, Cagatay Arslan, Ahmet Taner Sumbul, Sem
Acta Oncologica.2023; 62(4): 381. CrossRef - Pathologic Complete Response Achieved in Early-Stage HER2-Positive Breast Cancer After Neoadjuvant Therapy With Trastuzumab and Chemotherapy vs. Trastuzumab, Chemotherapy, and Pertuzumab: A Systematic Review and Meta-Analysis of Clinical Trials
Faizan Fazal, Muhammad Nauman Bashir, Maham Leeza Adil, Usama Tanveer, Mansoor Ahmed, Taha Zahid Chaudhry, Ali Ahmad Ijaz, Muhammad Haider
Cureus.2023;[Epub] CrossRef - Trends of axillary surgery in breast cancer patients with axillary lymph node metastasis: a comprehensive single-center retrospective study
Yeon Jin Kim, Hye Jin Kim, Soo Yeon Chung, Se Kyung Lee, Byung Joo Chae, Jonghan Yu, Jeong Eon Lee, Seok Won Kim, Seok Jin Nam, Jai Min Ryu
Annals of Surgical Treatment and Research.2023; 105(1): 10. CrossRef - Anthracyclines versus No Anthracyclines in the Neoadjuvant Strategy for HER2+ Breast Cancer: Real-World Evidence
Inês Soares de Pinho, Paulo Luz, Lucy Alves, Raquel Lopes-Brás, Vanessa Patel, Miguel Esperança-Martins, Lisa Gonçalves, Ritas Freitas, Diana Simão, Maria Roldán Galnares, Isabel Fernandes, Silvia Artacho Criado, Salvador Gamez Casado, Jose Baena Cañada,
Clinical Drug Investigation.2023; 43(9): 691. CrossRef - Benefit of postoperative regional nodal irradiation in patients receiving preoperative systemic therapy with docetaxel/carboplatin/trastuzumab/pertuzumab for HER2-positive breast cancer
Nalee Kim, Ji-Yeon Kim, Won Park, Won Kyung Cho, Tae Gyu Kim, Young-Hyuck Im, Jin Seok Ahn, Jeong Eon Lee, Seok Jin Nam, Seok Won Kim, Jonghan Yu, Byung Joo Chae, Sei Kyung Lee, Jai-Min Ryu, Yeon Hee Park, Haeyoung Kim
The Breast.2023; 72: 103594. CrossRef - Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer
Hee Kyung Ahn, Sung Hoon Sim, Koung Jin Suh, Min Hwan Kim, Jae Ho Jeong, Ji-Yeon Kim, Dae-Won Lee, Jin-Hee Ahn, Heejung Chae, Kyung-Hun Lee, Jee Hyun Kim, Keun Seok Lee, Joo Hyuk Sohn, Yoon-La Choi, Seock-Ah Im, Kyung Hae Jung, Yeon Hee Park
JAMA Oncology.2022; 8(9): 1271. CrossRef
- Efficacy, safety, and biomarkers of neoadjuvant trastuzumab and pertuzumab combined with chemotherapy in Chinese patients with HER2-positive breast cancer: a multicenter retrospective cohort study
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- 649 Download
- 18 Web of Science
- 18 Crossref
- Real-World Data of Pyrotinib-Based Therapy in Metastatic HER2-Positive Breast Cancer: Promising Efficacy in Lapatinib-Treated Patients and in Brain Metastasis
- Ying Lin, Mingxi Lin, Jian Zhang, Biyun Wang, Zhonghua Tao, Yiqun Du, Sheng Zhang, Jun Cao, Leiping Wang, Xichun Hu
- Cancer Res Treat. 2020;52(4):1059-1066. Published online April 24, 2020
- DOI: https://doi.org/10.4143/crt.2019.633
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
Pyrotinib is a newly-developed irreversible pan-ErbB receptor tyrosine kinase inhibitor. This study reported the first real-world data of pyrotinib-based therapy in metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC), focusing on efficacy in lapatinib-treated patients and in brain metastasis.
Materials and Methods
One hundred thirteen patients with metastatic HER2-positive BC treated with pyrotinib-based therapy in Fudan University Shanghai Cancer Center under non-clinical trial settings from September 1, 2018 to March 1, 2019 were included.
Results
Over half patients have received more than two lines of systematic therapy and exposed to two or more kinds of anti-HER2 agents. Most patients received a combined therapy, commonly of pyrotinib plus capecitabine, or vinorelbine or trastuzumab. Median progression-free survival (PFS) was 6.3 months (range, 5.54 to 7.06 months) and objective response rate (ORR) was 29.5%, with two patients (1.9%) achieving complete response. Lapatinib-naïve patients had significantly longer PFS than lapatinib-treated patients (9.0 months vs. 5.4 months, p=0.001). ORR for lapatinib-treated patients was 23.2%. Thirty-one of 113 patients have brain metastasis. Median PFS was 6.7 months and intracranial ORR was 28%. For patients without concurrent radiotherapy and/or brain surgery, the ORR was very low (6.3%). But for patients receiving concurrent radiotherapy and/or brain surgery, the ORR was 66.7%, and three patients achieved complete response. Most common adverse event was diarrhea.
Conclusion
Pyrotinib-based therapy demonstrated promising effects in metastatic HER2-positive BC and showed activity in lapatinib-treated patients. For patients with brain metastasis, pyrotinib-based regimen without radiotherapy showed limited efficacy, but when combined with radiotherapy it showed promising intracranial control. -
Citations
Citations to this article as recorded by- Treatment of HER2-Positive Brain Metastasis from Cervical Cancer Using Multimodal Therapy Including Pyrotinib: A Case Report
Yuanping Chen, Ting Wen, Xinglin Wen, Zhihua Lai
International Journal of Women's Health.2026; Volume 18: 1. CrossRef - Comparison of the prognostic effect of pyrotinib plus trastuzumab and chemotherapy different lines therapy in HER2-positive advanced breast cancer
Yangqingqing Zhou, Hui Wang, Jiao Yang, Fan Wang, Danfeng Dong, Xiaoai Zhao, Le Wang, Ruiyuan He, Zhiping Ruan, Jin Yang
Journal of Chemotherapy.2025; 37(2): 135. CrossRef - Pyrotinib-assisted whole brain radiotherapy alleviates HER2-positive advanced breast cancer and brain metastases: a prospective study in patients
Fulin Zhou, Cui Zhang, Mingyuan He, Yu Ren, Hongshuang Yue, Zhihua Tan, Shaolin Zhang, Yong Li, Shu Liu
Frontiers in Neurology.2025;[Epub] CrossRef - Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting
Jian Zhang, Yuxin Mu, Hui Zhang, Chao Deng, Jiao Yang, Lu Gan, Qingmo Yang, Xuefeng Xu, Wanping Liang, Xiaowei Qi, Liang Xu
Frontiers in Oncology.2025;[Epub] CrossRef - Neurotoxicity-sparing radiotherapy for brain metastases in breast cancer: a narrative review
Dagmara Buczek, Renata Zaucha, Jacek Jassem
Frontiers in Oncology.2024;[Epub] CrossRef - HER2-positive metastatic breast cancer with brain metastases responds favorably to pyrotinib and trastuzumab-based treatment: A case report and literature review
Min-long Chen, Wenjie Yu, Binbin Cui, Yijian Yu, Zhaosheng Ma
Frontiers in Oncology.2023;[Epub] CrossRef - Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer: a real-world retrospective study in China
Xiaoyu Liu, Peng Zhang, Chao Li, Xiang Song, Zhaoyun Liu, Wenna Shao, Sumei Li, Xinzhao Wang, Zhiyong Yu
Frontiers in Oncology.2023;[Epub] CrossRef - Evolving management of HER2+ breast cancer brain metastases and leptomeningeal disease
Matthew N. Mills, Whitney King, Aixa Soyano, Yolanda Pina, Brian J. Czerniecki, Peter A. Forsyth, Hatem Soliman, Hyo S. Han, Kamran A. Ahmed
Journal of Neuro-Oncology.2022; 157(2): 249. CrossRef - Temporal Heterogeneity of HER2 Expression and Spatial Heterogeneity of 18F-FDG Uptake Predicts Treatment Outcome of Pyrotinib in Patients with HER2-Positive Metastatic Breast Cancer
Chengcheng Gong, Cheng Liu, Zhonghua Tao, Jian Zhang, Leiping Wang, Jun Cao, Yannan Zhao, Yizhao Xie, Xichun Hu, Zhongyi Yang, Biyun Wang
Cancers.2022; 14(16): 3973. CrossRef - Cost-Effectiveness of Pyrotinib Plus Capecitabine versus Lapatinib Plus Capecitabine for the Treatment of HER2-Positive Metastatic Breast Cancer in China: A Scenario Analysis of Health Insurance Coverage
Yuwen Bao, Zhuolin Zhang, Xuan He, Lele Cai, Xiao Wang, Xin Li
Current Oncology.2022; 29(9): 6053. CrossRef - An Insight into Molecular Targets of Breast Cancer Brain Metastasis
Mohammed Kaleem, Mahmood Hassan Dalhat, Lubna Azmi, Turky Omar Asar, Wasim Ahmad, Maimonah Alghanmi, Amal Almostadi, Torki A. Zughaibi, Shams Tabrez
International Journal of Molecular Sciences.2022; 23(19): 11687. CrossRef - Real-World Outcome and Prognostic Factors Among HER2-Positive Metastatic Breast Cancer Patients Receiving Pyrotinib-Based Therapy: A Multicenter Retrospective Analysis
Jing Liu, Xianglu Sun, Qianyu Du, Jinghao Yao, Mengfen Dai, Qianqian Cheng, Han Xu, Yawei Li, Xiuli Liu, Mingliang Zhang, Yongchun Zhou, Yan Yang
Breast Cancer: Targets and Therapy.2022; Volume 14: 491. CrossRef - Eribulin Efficacy on Brain Metastases in Heavily Pretreated Patients with Metastatic Breast Cancer
Renaud Sabatier, Johan Martin, Cécile Vicier, Mathilde Guérin, Audrey Monneur, Magali Provansal, Louis Tassy, Carole Tarpin, Jean-Marc Extra, Frédéric Viret, Anthony Goncalves
Journal of Clinical Medicine.2021; 10(6): 1272. CrossRef - Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study
Yi Li, Yixuan Qiu, Huihui Li, Ting Luo, Wei Li, Hong Wang, Bin Shao, Biyun Wang, Rui Ge
Frontiers in Oncology.2021;[Epub] CrossRef - Multiple Administrations of Itraconazole Increase Plasma Exposure to Pyrotinib in Chinese Healthy Adults
Yueyue Liu, Qian Zhang, Chao Lu, Wei Hu
Drug Design, Development and Therapy.2021; Volume 15: 2485. CrossRef - Brain Metastases in HER2-Positive Breast Cancer: Current and Novel Treatment Strategies
Alejandro Garcia-Alvarez, Andri Papakonstantinou, Mafalda Oliveira
Cancers.2021; 13(12): 2927. CrossRef - Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Retrospective Study
Yizhao Xie, Yi Li, Luo Ting, Die Sang, Peng Yuan, Wei Li, Huihui Li, Rui Ge, Biyun Wang
Frontiers in Oncology.2021;[Epub] CrossRef - The Efficacy of Pyrotinib as a Third- or Higher-Line Treatment in HER2-Positive Metastatic Breast Cancer Patients Exposed to Lapatinib Compared to Lapatinib-Naive Patients: A Real-World Study
D. J Ouyang, Q. T Chen, M. Anwar, N. Xie, Q. C. Ouyang, P. Z. Fan, L. Y. Qian, G. N. Chen, E. X. Zhou, L. Guo, X. W. Gu, B. N. Ding, X. H. Yang, L. P. Liu, C. Deng, Z. Xiao, J. Li, Y. Q. Wang, S. Zeng, Shouman Wang, Wenjun Yi
Frontiers in Pharmacology.2021;[Epub] CrossRef - Updates on Molecular Targeted Therapies for Intraparenchymal CNS Metastases
Akanksha Sharma, Lauren Singer, Priya Kumthekar
Cancers.2021; 14(1): 17. CrossRef
- Treatment of HER2-Positive Brain Metastasis from Cervical Cancer Using Multimodal Therapy Including Pyrotinib: A Case Report
- 13,120 View
- 430 Download
- 44 Web of Science
- 19 Crossref
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