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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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- Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies
- Yong Wha Moon, Seung Ki Kim, Keun Seok Lee, Moon Hee Lee, Yeon Hee Park, Kyong Hwa Park, Gun Min Kim, Seungtaek Lim, Seung Ah Lee, Jae Duk Choi, Eunhye Baek, Hyesun Han, Seungjae Baek, Seock-Ah Im
- Cancer Res Treat. 2023;55(3):766-777. Published online January 19, 2023
- DOI: https://doi.org/10.4143/crt.2022.987
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
Materials and Methods
Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.
Results
Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.
Conclusion
This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population. -
Citations
Citations to this article as recorded by
- The hidden costs of PEG-rhG-CSF in autologous stem cell transplantation for newly diagnosed multiple myeloma
Ruiqi Wang, Hao Tian, Zhenxing Zhu, Dan Cong, Yuansong Bai, Wenlong Zhang
Scientific Reports.2025;[Epub] CrossRef - Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial
Dongmei Ji, Shufang Wang, Wei Yao, Denny Hou, Xiaoyan Wang, Changsheng Ye, Hongsheng Li, Hongjian Yang, Jilin Yi, Jinsong Lu, Haibo Wang, Xiaohong Xu, Dongyan Cai, Xiaoan Liu, Xi Yan, Jianyun Nie, Shude Cui, Hongchuan Jiang, Junning Cao
Clinical Drug Investigation.2025; 45(11): 889. CrossRef - Comparison of Prophylactic Efficacy of Eflapegrastim and Pegteograstim for Chemotherapy-induced Neutropenia in Pancreatic Cancer Patients Receiving FOLFIRINOX/mFOLFIRINOX
Eui Seon Lee, Min Jung Geum, Jong Hee Ko, Jae Song Kim, Eun Sun Son, Yun Mi Yu
Journal of Korean Society of Health-System Pharmacists.2024; 41(3): 253. CrossRef
- The hidden costs of PEG-rhG-CSF in autologous stem cell transplantation for newly diagnosed multiple myeloma
- 8,806 View
- 317 Download
- 2 Web of Science
- 3 Crossref
- Risk Factors for a False-Negative Result of Sentinel Node Biopsy in Patients with Clinically Node-Negative Breast Cancer
- Seung Ah Lee, Hak Min Lee, Hak Woo Lee, Ban Seok Yang, Jong Tae Park, Sung Gwe Ahn, Joon Jeong, Seung Il Kim
- Cancer Res Treat. 2018;50(3):625-633. Published online July 31, 2017
- DOI: https://doi.org/10.4143/crt.2017.089
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
Although sentinel lymph node biopsy (SLNB) can accurately represent the axillary lymph node (ALN) status, the false-negative rate (FNR) of SLNB is the main concern in the patients who receive SLNB alone instead of ALN dissection (ALND).
Materials and Methods
We analyzed 1,886 patientswho underwent ALNDafter negative results of SLNB,retrospectively. A logistic regression analysis was used to identify risk factors associated with a falsenegative (FN) result. Cox regression model was used to estimate the hazard ratio of factors affecting disease-free survival (DFS).
Results
Tumor located in the upper outer portion of the breast, lymphovascular invasion, suspicious node in imaging assessment and less than three sentinel lymph nodes (SLNs) were significant independent risk factors for FN in SLNB conferring an adjusted odds ratio of 2.10 (95% confidence interval [CI], 1.30 to 3.39), 2.69 (95% CI, 1.47 to 4.91), 2.59 (95% CI, 1.62 to 4.14), and 2.39 (95% CI, 1.45 to 3.95), respectively. The prognostic factors affecting DFS were tumor size larger than 2 cm (hazard ratio [HR], 1.86; 95% CI, 1.17 to 2.96) and FN of SLNB (HR, 2.51; 95% CI, 1.42 to 4.42) in SLN-negative group (FN and true-negative), but in ALN-positive group (FN and true-positive), FN of SLNB (HR, 0.64; 95% CI, 0.33 to 1.25) did not affect DFS.
Conclusion
In patients with risk factors for a FN such as suspicious node in imaging assessment, upper outer breast cancer, less than three harvested nodes, we need attention to find another metastatic focus in non-SLNs during the operation. It may contribute to provide an exact prognosis and optimizing adjuvant treatments. -
Citations
Citations to this article as recorded by- Axillary staging with 18F-FDG PET/CT in early breast cancer: impact of tumor subtypes
Abdullah Gunes, Nuray Colapkulu-Akgul, Caner Akgul, Ibrahim Unlu, Saffet Cinar
Annals of Saudi Medicine.2025; 45(3): 145. CrossRef - Establishment of Prediction Model of Axillary Lymph Node Metastasis Before Operation for Early-Stage Breast Cancer
Xinhua Zhang, Chuang Zhang, Jian Zhang, Xiuming Zhang, Xiaowen Dou
Cancer Control.2025;[Epub] CrossRef - Potential factors of false-negative sentinel lymph node biopsy for breast cancer and clinical decision-making value of axillary lymph node dissection
Jianghai Li, Dong Meng
BMC Surgery.2025;[Epub] CrossRef - Detection of presence or absence of metastasis in WSI patches of breast cancer using the dual-enhanced convolutional ensemble neural network
Ruigang Ge, Guoyue Chen, Kazuki Saruta, Yuki Terata
Machine Learning with Applications.2024; 17: 100579. CrossRef - Ultrasound radiomics based on axillary lymph nodes images for predicting lymph node metastasis in breast cancer
Yu-Long Tang, Bin Wang, Tao Ou-Yang, Wen-Zhi Lv, Shi-Chu Tang, An Wei, Xin-Wu Cui, Jiang-Sheng Huang
Frontiers in Oncology.2023;[Epub] CrossRef - Future Directions in the Assessment of Axillary Lymph Nodes in Patients with Breast Cancer
Filippo Pesapane, Luciano Mariano, Francesca Magnoni, Anna Rotili, Davide Pupo, Luca Nicosia, Anna Carla Bozzini, Silvia Penco, Antuono Latronico, Maria Pizzamiglio, Giovanni Corso, Enrico Cassano
Medicina.2023; 59(9): 1544. CrossRef - Axillary Lymph Node Dissection Can Be Omitted in Breast Cancer Patients With Mastectomy and False-Negative Frozen Section in Sentinel Lymph Node Biopsy
Jing Si, Rong Guo, Huan Pan, Xiang Lu, Zhiqin Guo, Chao Han, Li Xue, Dan Xing, Wanxin Wu, Caiping Chen
Frontiers in Oncology.2022;[Epub] CrossRef - False-negative frozen section of sentinel nodes in early breast cancer (cT1-2N0) patients
Zhu-Jun Loh, Kuo-Ting Lee, Ya-Ping Chen, Yao-Lung Kuo, Wei-Pang Chung, Ya-Ting Hsu, Chien-Chang Huang, Hui-Ping Hsu
World Journal of Surgical Oncology.2021;[Epub] CrossRef - What Is High-risk Breast Cancer With Pathologically Negative Lymph Nodes for Regional Recurrence?
Sang-Won Kim, Won Kyung Cho, Doo Ho Choi, Haeyoung Kim, Oyeon Cho, Won Park, Mison Chun
International Journal of Radiation Oncology*Biology*Physics.2021; 111(4): 992. CrossRef - Validating the ACOSOG Z0011 Trial Result: A Population-Based Study Using the SEER Database
Jiwoong Jung, Byoung Hyuck Kim, Jongjin Kim, Sohee Oh, Su-jin Kim, Chang-Sup Lim, In Sil Choi, Ki-Tae Hwang
Cancers.2020; 12(4): 950. CrossRef - Retrospectively validating the results of the ACOSOG Z0011 trial in a large Asian Z0011-eligible cohort
Jiwoong Jung, Wonshik Han, Eun Sook Lee, So-Youn Jung, Jai Hong Han, Dong-Young Noh, Yumi Kim, Hee Jun Choi, Jeong Eon Lee, Seok Jin Nam, Jong Won Lee, Hee Jeong Kim, Eunhae Um, Joo Heung Kim, Seho Park, Young Up Cho
Breast Cancer Research and Treatment.2019; 175(1): 203. CrossRef - Preliminary study of contrast-enhanced ultrasound in combination with blue dye vs. indocyanine green fluorescence, in combination with blue dye for sentinel lymph node biopsy in breast cancer
Yidong Zhou, Yan Li, Feng Mao, Jing Zhang, Qingli Zhu, Songjie Shen, Yan Lin, Xiaohui Zhang, He Liu, Mengsu Xiao, Yuxin Jiang, Qiang Sun
BMC Cancer.2019;[Epub] CrossRef
- Axillary staging with 18F-FDG PET/CT in early breast cancer: impact of tumor subtypes
- 17,505 View
- 362 Download
- 13 Web of Science
- 12 Crossref
- Prospective Evaluation of the Feasibility of Sentinel Lymph Node Biopsy in Breast Cancer Patients with Negative Axillary Conversion after Neoadjuvant Chemotherapy
- Hy-De Lee, Sung Gwe Ahn, Seung Ah Lee, Hak Min Lee, Joon Jeong
- Cancer Res Treat. 2015;47(1):26-33. Published online August 29, 2014
- DOI: https://doi.org/10.4143/crt.2013.208
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Abstract
PDFPubReaderePub
- Purpose
Tumor response to neoadjuvant chemotherapy (NAC) may adversely affect the identification and accuracy rate of sentinel lymph node biopsy (SLNB). This study was conducted to evaluate the feasibility of SLNB in node-positive breast cancer patients with negative axillary conversion after NAC. Materials and Methods Ninety-six patients with positive nodes at presentation were prospectively enrolled. 18Fluorodeoxyglucose-positron emission tomography (18F-FDG PET) and ultrasonography were performed before and after NAC. A metastatic axillary lymph node was defined as positive if it was positive upon both 18F-FDG PET and ultrasonography, while it was considered negative if it was negative upon both 18F-FDG PET and ultrasonography. Results After NAC, 55 cases (57.3%) became clinically node-negative, while 41 cases (42.7%) remained node-positive. In the entire cohort, the sentinel lymph node (SLN) identification and false-negative rates were 84.3% (81/96) and 18.4% (9/49), respectively. In the negative axillary conversion group, the results of SLNB showed an 85.7% (48/55) identification rate and 16.7% (4/24) false-negative rate. Conclusion For breast cancer patients with clinically positive nodes at presentation, it is difficult to conclude whether the SLN accurately represents the metastatic status of all axillary lymph nodes, even after clinically negative node conversion following NAC. -
Citations
Citations to this article as recorded by- Performance of sentinel lymph node biopsy after neoadjuvant chemotherapy in clinically node-positive breast cancer patients: systematic review and meta-analysis
Mariam Zahwe, Abir Ghzaiel, Ahmad Najia, Lara Soueid, Khalil El Asmar, Malak Ghezzawi, Sarah El Iskandarani, Marwa Diab, Miryam El Jibbawi, Reem Hoteit, Eman Sbaity
International Journal of Surgery.2025; 111(4): 3040. CrossRef - Feasibility of Sentinel Lymph Node Biopsy in Breast Cancer Patients with Axillary Conversion after Neoadjuvant Chemotherapy—A Single-Tertiary Centre Experience and Review of the Literature
Alexandra Maria Lazar, Mario-Demian Mutuleanu, Paula Monica Spiridon, Cristian Ioan Bordea, Tatiana Lucia Suta, Alexandru Blidaru, Mirela Gherghe
Diagnostics.2023; 13(18): 3000. CrossRef - AGO-Empfehlungen zur operativen Therapie der Axilla nach neoadjuvanter Chemotherapie: Update 2021
Michael Friedrich, Thorsten Kühn, Wolfgang Janni, Volkmar Müller, Maggie Banys-Paluchowski, Cornelia Kolberg-Liedtke, Christian Jackisch, David Krug, Ute-Susann Albert, Ingo Bauerfeind, Jens Blohmer, Wilfried Budach, Peter Dall, Eva M. Fallenberg, Peter A
Senologie - Zeitschrift für Mammadiagnostik und -therapie.2022; 19(01): 56. CrossRef - The value of sentinel lymph-node biopsy in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy: a systematic review
Juan C. Vázquez, Antonio Piñero, Francisco J. de Castro, Ana Lluch, Miguel Martín, Agustí Barnadas, Emilio Alba, Álvaro Rodríguez-Lescure, Federico Rojo, Julia Giménez, Ivan Solá, Maria J. Quintana, Xavier Bonfill, Gerard Urrutia, Pedro Sánchez-Rovira
Clinical and Translational Oncology.2022; 25(2): 417. CrossRef - Outcomes of Sentinel Node Biopsy for Women with Breast Cancer After Neoadjuvant Therapy: Systematic Review and Meta-Analysis of Real-World Data
Shi-Qian Lin, Nguyen-Phong Vo, Yu-Chun Yen, Ka-Wai Tam
Annals of Surgical Oncology.2022; 29(5): 3038. CrossRef - Feasibility and reliability of sentinel lymph node biopsy after neoadjuvant chemotherapy in breast cancer patients with positive axillary nodes at initial diagnosis: An up-to-date meta-analysis of 3,578 patients
Siyang Cao, Xia Liu, Junwei Cui, Xiaoling Liu, Jieyu Zhong, Zijian Yang, Desheng Sun, Wei Wei
The Breast.2021; 59: 256. CrossRef - AGO Recommendations for the Surgical Therapy of the Axilla After Neoadjuvant Chemotherapy: 2021 Update
Michael Friedrich, Thorsten Kühn, Wolfgang Janni, Volkmar Müller, Maggie Banys-Paluchowski, Cornelia Kolberg-Liedtke, Christian Jackisch, David Krug, Ute-Susann Albert, Ingo Bauerfeind, Jens Blohmer, Wilfried Budach, Peter Dall, Eva M. Fallenberg, Peter A
Geburtshilfe und Frauenheilkunde.2021; 81(10): 1112. CrossRef - Therapiealgorithmen für das Mammakarzinom
J.-U. Blohmer, A. Schneeweiss, I. Bauerfeind, T. Fehm, V. Müller, C. Thomssen, I. Witzel, A. Wöckel, W. Janni
Der Onkologe.2021; 27(12): 1165. CrossRef - Axillary response according to neoadjuvant single or dual human epidermal growth factor receptor 2 (HER2) blockade in clinically node‐positive, HER2‐positive breast cancer
Chihwan Cha, Sung Gwe Ahn, Dooreh Kim, Janghee Lee, Soeun Park, Soong June Bae, Jee Ye Kim, Hyung Seok Park, Seho Park, Seung Il Kim, Byeong‐Woo Park, Joon Jeong
International Journal of Cancer.2021; 149(8): 1585. CrossRef - Assessment of sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer in two subgroups: Initially node negative and node positive converted to node negative – A systemic review and meta-analysis
Alireza Shirzadi, Habibollah Mahmoodzadeh, Mostafa Qorbani
Journal of Research in Medical Sciences.2019;[Epub] CrossRef - The Accuracy of Sentinel Lymph Node Biopsy Following Neoadjuvant Chemotherapy in Clinically Node Positive Breast Cancer Patients: A Single Institution Experience
Hossein Yahyazadeh, Maria Hashemian, Mojtaba Rajabpour, Saina Aminmozaffari, Maryam Zaree, Ahmad R Mafi, Hossein Pourtavakoli, Narges Sistany Allahabadi, Marzieh Beheshti
International Journal of Cancer Management.2018;[Epub] CrossRef - A survey of current surgical treatment of early stage breast cancer in China
Xin Zhang, Ying Wang
Oncoscience.2018; 5(7-8): 239. CrossRef - Predictive Factors for Nonsentinel Lymph Node Metastasis in Patients With Positive Sentinel Lymph Nodes After Neoadjuvant Chemotherapy: Nomogram for Predicting Nonsentinel Lymph Node Metastasis
Jai Min Ryu, Se Kyung Lee, Ji Young Kim, Jonghan Yu, Seok Won Kim, Jeong Eon Lee, Se Hwan Han, Yong Sik Jung, Seok Jin Nam
Clinical Breast Cancer.2017; 17(7): 550. CrossRef
- Performance of sentinel lymph node biopsy after neoadjuvant chemotherapy in clinically node-positive breast cancer patients: systematic review and meta-analysis
- 25,109 View
- 134 Download
- 13 Web of Science
- 13 Crossref
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