Cancer Research and Treatment

Review Article

Redefining HER2 in Breast Cancer: From Conventional Positivity to Low and Ultralow in the New Era of Antibody-Drug Conjugates: Jiwon Koh, Seock-Ah Im; Cancer Res Treat. 2026;58(1):15-25. Published online December 18, 2025; DOI: https://doi.org/10.4143/crt.2025.1182

Abstract PDF PubReader ePub: Human epidermal growth factor receptor 2 (HER2) has evolved from a poor prognostic factor to one of the most impactful predictive biomarkers in oncology. The introduction of trastuzumab established HER2 as a binary determinant of therapy, with HER2 immunohistochemistry (IHC) becoming the treatment-guiding diagnostic assay. However, the emergence of antibody-drug conjugates (ADCs), particularly trastuzumab deruxtecan, has challenged this paradigm by demonstrating activity in tumors with low and even ultralow HER2 expression. This review outlines the evolution of HER2 testing, from its historical discovery and early assay variability to the ADC era, where categories such as HER2-low and HER2-ultralow have emerged. We highlight key challenges: poor reproducibility at the lower end of IHC scoring, instability of HER2 status across timepoints and between primary and metastatic tumors, and no consistent biological distinction between low, ultralow, and null. Efforts to improve reliability—including structured training, high-sensitivity assays, RNA-based methods, and artificial intelligence-assisted pathology—are summarized. Finally, we reconsider the therapeutic implications of ADCs, with the question of whether the benefit parallels HER2 expression or extends into HER2-null disease. HER2 exemplifies how biomarker interpretation evolves with drug development. As new ADCs target additional antigens, pathologists must balance trial-driven categories with biologic reproducibility to ensure diagnostics remain aligned with therapeutic advances.

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Original Articles

ITGB2 Gene Gain as a Prognostic Marker for Early Recurrence in Luminal HER2-Negative High Proliferative Breast Cancer: Chun-Yu Liu, Ji-Lin Chen, Yi-Fang Tsai, Ta-Chung Chao, Wan-Lun Wang, Pei-Ju Lien, Chih-Yi Hsu, Jiun-I Lai, Chi-Cheng Huang, Jen-Hwey Chiu, Ling-Ming Tseng; Received June 23, 2025 Accepted December 3, 2025 Published online December 4, 2025; DOI: https://doi.org/10.4143/crt.2025.651 [Accepted]

Abstract PDF: Purpose
Early recurrence reflects aggressive disease and poor prognosis, with patterns varying across breast cancer subtypes. Early recurrence is a major challenge in luminal HER2-negative high proliferative breast cancer, yet reliable biomarkers remain limited. Identifying biomarkers associated with early recurrence is therefore of significant interest.
Materials and Methods
Forty-two patients with stage I–III luminal HER2-negative, high-proliferative breast cancer were enrolled in the VGHTPE cohort and underwent targeted next-generation sequencing using the ACTOnco Comprehensive Cancer Panel. Findings were validated in The Cancer Genome Atlas (TCGA) and METABRIC datasets, and in vitro experiments were conducted to assess cell aggressiveness.
Results
We examined 42 patients, including 15 who experienced recurrence within five years and 27 who did not. Next-generation sequencing revealed that the most prevalent alterations in this luminal HER2-negative, high-proliferative breast cancer cohort were mutations in PIK3CA and TP53, and amplifications/gains in MCL1, MYC, and KLF6. Patients with recurrence within five years exhibited a higher frequency of ITGB2 gain compared with non-recurrent patients. Validation in the TCGA and METABRIC cohorts confirmed the prognostic significance of ITGB2 gain in ER+/HER2– breast cancers. Gene Set Enrichment Analysis indicated that high ITGB2 expression was enriched in KRAS and EMT pathways. In vitro experiments further demonstrated that ITGB2 knockdown led to inactivation of Akt and ERK signaling and suppression of cell aggressiveness in ER+/HER2– breast cancer cells.
Conclusion
ITGB2 gain represents an unfavorable prognostic marker for early recurrence in luminal HER2-negative high proliferative breast cancer, with potential therapeutic implications.

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Alteration of HER2 Status Following Neoadjuvant Chemotherapy in Breast Cancer: A Clinicopathological Analysis Focusing on HER2-Low Status: Hyun-Jung Sung, Hyun Jung Kwon, Kyungah Bai, Yul Ri Chung, Hee-Chul Shin, Eun-Kyu Kim, Koung Jin Suh, Se Hyun Kim, Jee Hyun Kim, So Yeon Park; Received July 22, 2025 Accepted September 18, 2025 Published online September 19, 2025; DOI: https://doi.org/10.4143/crt.2025.761 [Accepted]

Abstract PDF

Purpose
This study aimed to investigate alteration of HER2 status after neoadjuvant chemotherapy (NAC) in breast cancer and its impact on clinical outcomes of patients, focusing on HER2-low status.
Materials and Methods
We retrospectively reviewed clinicopathological data of 1,063 breast cancer patients who underwent NAC between 2013 and 2020. Using paired samples of 670 patients with residual disease after NAC, we analyzed HER2 discordance rates between pre- and post-NAC samples, relationships between HER2 discordance and clinicopathological characteristics of tumors, and clinical outcomes of the patients.
Results
Pre-NAC HER2-low status was associated with a lower pathological complete response rate and higher Residual Cancer Burden class compared with HER2-zero and HER2-positive status. However, in subgroup analysis by hormone receptor (HR) status, no statistical differences were found in chemo-responsiveness between them. Following NAC, the overall HER2 discordance rate was 21.2% (κ = 0.676), and the most common type of alteration was zero-to-low (11.5%) conversion, followed by low-to-positive (3.6%) conversion. HER2 discordance was significantly associated with lower HER2 levels and HR positivity before NAC, as well as lymphovascular invasion, higher ypT stage, and axillary node metastasis in residual disease after NAC. In survival analyses, HER2 discordance was found to be an independent prognostic factor for poor disease-free survival of the patients, particularly within the HR-positive subgroup.
Conclusion
Given the prognostic implications of HER2 discordance which primarily involves zero-to-low conversion and the therapeutic benefits of newly developed antibody-drug conjugates in HER2-low breast cancers, HER2 status should be re-evaluated in surgical resection specimens following NAC.

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HER2-Low Breast Cancer: Biological Framework and Determinants of HER2 Instability
Alina-Mihaela Gurau, Daniela Mihalache, Catalin-Bogdan Satala, Ana Maria Rață, Laura-Florentina Rebegea
Medicina.2026; 62(2): 304. CrossRef

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DNA damage and Nuclear Anaplasia Induced by Trastuzumab Deruxtecan in Cancer Cells with Variable HER2 Expression and Homologous Recombination Deficiency Status: So Hyeon Kim, Yoonjung Park, Ahrum Min, Hye Yeon Park, Yu-Jin Kim, Sujin Ham, Jiwon Koh, Seongyeong Kim, Dae-Won Lee, Han Suk Ryu, Jin-Soo Kim, Kyung-Hun Lee, Seock-Ah Im; Received February 21, 2025 Accepted June 2, 2025 Published online August 4, 2025; DOI: https://doi.org/10.4143/crt.2025.201 [Accepted]

Abstract PDF

Purpose
Human epidermal growth factor receptor 2 (HER2) is amplified or overexpressed in various malignancies, including breast and gastric cancers, and is associated with poor prognosis. Although HER2-targeted therapies, such as trastuzumab, improve outcomes in HER2-positive tumors, resistance often develops, and HER2-low tumors remain largely untargeted. Trastuzumab deruxtecan (T-DXd; DS-8201a) is a HER2-targeted antibody-drug conjugate with potent activity in HER2-positive and HER2-low tumors. This study evaluates its antitumor mechanisms and efficacy in HER2-positive, HER2-low, and homologous recombination deficiency (HRD)-associated models.
Materials and Methods
Effects of T-DXd were assessed in cancer cell lines with diverse HER2 expression and HRD status. In vivo efficacy was evaluated using a xenograft model derived from HER2-low SNU-601 gastric cancer cells.
Results
T-DXd reduced HER2 phosphorylation and downstream signaling (AKT, ERK) in HER2-positive cells. It induced DNA damage accumulation, as evidenced by increased γH2AX and p-Chk1 expression, and triggered apoptosis through cleaved PARP and caspase-3 activation, confirmed by annexin V staining. Similar effects were observed in HER2-low cells, with greater sensitivity in HRD cells. In xenografts, T-DXd reduced tumor volume by up to 80% at 4 mg/kg and 10 mg/kg. Histological analyses showed decreased Ki-67 and increased apoptosis. Furthermore, T-DXd induced G2/M cell cycle arrest and nuclear anaplasia, suggesting disruption of chromosomal stability as a potential antitumor mechanism. No significant toxicity, including body weight loss, was observed.
Conclusion
These findings highlight T-DXd’s effectiveness in HER2-low and HRD tumors, supporting its broader clinical application, including strategies targeting DNA damage repair pathways.

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Redefining HER2 in Breast Cancer: From Conventional Positivity to Low and Ultralow in the New Era of Antibody-Drug Conjugates
Jiwon Koh, Seock-Ah Im
Cancer Research and Treatment.2026; 58(1): 15. CrossRef

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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; Received February 24, 2025 Accepted July 6, 2025 Published online July 8, 2025; DOI: https://doi.org/10.4143/crt.2025.219 [Accepted]

Abstract PDF: Purpose
This study aims to investigate the clinical characteristics, outcomes, and predictors of brain metastases in 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 OS (p<0.001). Median DMFS 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) stage were the strongest predictors of brain metastases (SCN FNA: OR=12.9, p<0.001; cN3: OR=12.1, p<0.001). Multivariable Cox regression analysis revealed that positive SCN FNA and cN3 stage were strong predictors of reduced DMFS (SCN FNA: HR=2.5, 95% CI: 1.3–3.6, p < 0.001; cN3: HR=11.3, 95% CI: 4.9–33.0, 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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Differences in Responses to Neoadjuvant Anti-HER2 Therapy between HER2 2+/ISH+ and HER2 3+ in HER2-Positive Breast Cancer: Lingjun Ma, Ran Zheng, Lingyun Xu, Ying Zhu, Hong Yin, Xiaoqing Zhang, Rong Deng, Jue Wang, Xiaoming Zha; Received December 12, 2024 Accepted April 20, 2025 Published online April 21, 2025; DOI: https://doi.org/10.4143/crt.2024.1200 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Purpose
Dual anti–human epidermal growth factor receptor 2 (HER2) drugs have become the standard regimen for neoadjuvant systemic treatment (NST) to HER2-positive breast cancer patients. However, the efficacy varies greatly among patients with different HER2 protein expression levels.
Materials and Methods
A total of 575 HER2-positive breast cancer patients from multiple centers throughout China from 2013 to 2022 were retrospectively analyzed. We compared clinicopathological features in different HER2 immunohistochemistry classes (HER2 2+/in situ hybridization [ISH] + or HER2 3+), and their difference in response to NST and survival with single or dual anti-HER2 drugs. Drug sensitivity assays were used to evaluate different efficacy of anti-HER2 drugs in vitro.
Results
Compared to HER2 3+ subgroup, the HER2 2+/ISH+ group had a higher proportion of hormone receptor–positive status (48.7% vs. 76.1%, p < 0.001), more HER2 protein loss after NST, lower pathological complete response (pCR) rate (46.07% vs. 16.24%, p < 0.001), and tended to have worse disease-free survival (DFS). In HER2 2+/ISH+ patients, treated with pertuzumab and trastuzumab in combination had no significant improvement in pCR (19.12% vs. 12.24%, p=0.287) and DFS (p=0.908) than using alone. Drug sensitivity assay showed poor efficacy with dual anti-HER2 drugs in HER2 2+/ISH+ cell lines; however, fam-trastuzumab deruxtecan drugs had a satisfactory effect.
Conclusion
Owing to the differences in clinicopathological features and treatment efficacy, we considered the HER2 2+/ISH+ group to be a distinct subtype and defined it as the HER2-moderate–positive subgroup. In this subgroup, dual anti-HER2 drugs did not exert significant improvement in pCR and DFS. Therefore, treatment optimization is warranted, with antibody-drug conjugate drugs as potential options.

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Breast cancer

Ten-Year Follow-up Clinical Outcomes and the Role of Adjuvant Chemotherapy in HER2-Positive Patients with Microinvasive Breast Cancer: Yeokyeong Shin, Soo-Young Lee, Hyehyun Jeong, Jin-Hee Ahn, Kyung Hae Jung, Sung-Bae Kim, Hee Jeong Kim, Jong Won Lee, Byung Ho Son, BeomSeok Ko, Ji Sun Kim, Il Yong Chung, Hee Jin Lee, Gyungyub Gong, Sae Byul Lee, Jae Ho Jeong; Cancer Res Treat. 2026;58(1):151-158. Published online March 5, 2025; DOI: https://doi.org/10.4143/crt.2024.1120

Abstract PDF Supplementary Material PubReader ePub

Purpose
Although human epidermal growth factor receptor 2 (HER2) positivity is prevalent in microinvasive breast cancer (MIBC), data focused on HER2-positive MIBC are limited. We investigated the clinical course and long-term outcomes of HER2-positive MIBC and evaluated the role of adjuvant chemotherapy.
Materials and Methods
The study included patients with curatively resected pT1mi pN0 HER2-positive breast cancer between January 2000 and January 2020. Treatments and survival outcomes, including invasive breast cancer-free survival (IBCFS), distant recurrence-free survival (DRFS), and overall survival (OS) were analyzed.
Results
The analysis included 799 female patients. The median age was 51 years (range, 23 to 79 years), and 51.6% (n=412) were premenopausal. Multifocality was confirmed in 17.3% (n=138), and estrogen receptor (ER) positivity in 29.8% (n=238). Adjuvant chemotherapy was administered to 17.5% (n=140), with doxifluridine in 96.4% of cases. One patient (0.1%) received trastuzumab. With a median follow-up of 119.0 months (95% confidence interval [CI], 114.0 to 127.0), the 8-year IBCFS, DRFS, and OS were 91.2% (95% CI, 89.1 to 93.3), 97.5% (95% CI, 96.4 to 98.7), and 98.8% (95% CI, 98.0 to 99.6), respectively. No significant differences were observed between patients with and without adjuvant chemotherapy. The lack of differences in IBCFS by chemotherapy was consistent across subgroups, including pre-/postmenopausal patients, grade 1-2/3 tumors, and ER-negative disease.
Conclusion
A clinically meaningful proportion of HER2-positive MIBC patients experience IBCFS events with long-term follow-up. Adjuvant chemotherapy did not improve survival, potentially due to the use of an outdated, ineffective regimen. The role of modern adjuvant regimens, particularly those incorporating HER2-targeted therapy, warrants further exploration.

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Microinvasive carcinoma of the breast
Rachel Han, Edi Brogi
Human Pathology.2025; 162: 105856. CrossRef

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Gastrointestinal cancer

The Histone Deacetylase Inhibitor Entinostat Mediates HER2 Downregulation in Gastric Cancer, Providing the Basis for Its Particular Efficacy in HER2-Amplified Tumors and in Combination Therapies: Tamara Zenz, Robert Jenke, René Thieme, Tim Kahl, Hannes Borchardt, Ines Gockel, Finn K. Hansen, Achim Aigner, Thomas R. H. Büch; Cancer Res Treat. 2025;57(3):781-802. Published online December 10, 2024; DOI: https://doi.org/10.4143/crt.2024.546

Abstract PDF Supplementary Material PubReader ePub

Purpose
Human epidermal growth factor receptor 2 (HER2) inhibition represents a therapeutic approach with proven clinical efficacy in gastric cancer. However, resistance against HER2-directed therapeutics highlights the need for alternative approaches or drug combinations. Histone deacetylase inhibitors (HDACi) display a broad spectrum of antitumor properties, which may include effects on receptor tyrosine kinases.
Materials and Methods
We analyzed the effects of the class I HDACi entinostat in a panel of HER2-amplified and non-amplified gastric adenocarcinoma cells in 2D cell culture as well as in tumor slice models ex vivo and in patient-derived xenografts in vivo. Effects on protein expression/signal transduction were evaluated by immunoblotting and quantitative reverse transcription polymerase chain reaction.
Results
HDAC inhibition reduced HER2 protein expression independently of initial HER2 expression levels. This was associated with the upregulation of the HER2-inhibiting microRNA miR-205. The downregulation of HER2 resulted in reduced AKT phosphorylation, apoptosis induction and antiproliferative effects, with particularly high efficiency in HER2-amplified gastric cancer cells. Inhibiting HER2 by a specific kinase inhibitor in gastric cancer cells with low basal HER2 expression led to HER2 upregulation. This was reversed by entinostat treatment and provided the basis for synergistic cell inhibition upon double treatment.
Conclusion
We describe the downregulation of HER2 in gastric carcinoma cells upon HDACi treatment. Concomitantly, cells with high basal or treatment-induced HER2 expression showed most profound sensitivities towards HDACi. These findings may thus provide the basis for HDACi treatment as a therapeutic option particularly valuable in HER2-amplified gastric cancer and particularly useful in combination therapies with HER2 inhibitors.

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Acquired vulnerability against EGF receptor inhibition in gastric cancer promoted by class I histone deacetylase inhibitor entinostat
Tamara Zenz, Robert Jenke, Denys Oliinyk, Sandra Noske, René Thieme, Tim Kahl, Ines Gockel, Florian Meier-Rosar, Achim Aigner, Thomas RH Büch
Neoplasia.2025; 60: 101121. CrossRef

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1 Crossref

Review Article

The Era of Antibody Drug Conjugates in Lung Cancer: Trick or Threat?: Mariona Riudavets, David Planchard; Cancer Res Treat. 2025;57(2):293-311. Published online November 28, 2024; DOI: https://doi.org/10.4143/crt.2024.714

Abstract PDF PubReader ePub

Antibody drug conjugates (ADCs) are a novel class of therapeutics that structurally are composed by an antibody directed to a tumor epitope connected via a linker to a cytotoxic payload, and that have shown significant antitumor activity across a range of malignancies including lung cancer. In this article we review the pharmacology and design of ADCs, as well as we describe the results of different studies evaluating ADCs in lung cancer directed to several targets including HER2, HER3, TROP2, MET, CEACAM5 and DLL3.

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Evaluating the efficacy and safety of antibody–drug conjugates in non-small cell lung cancer: a systematic review and meta-analysis
Linling Zhang, Hongyuan Jia, Bin Niu
BMC Cancer.2026;[Epub] CrossRef

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Original Articles

Breast cancer

A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of ¹⁸F-FES PET-CT and Metabolites with Treatment Response: Qing Shao, Ningning Zhang, Xianjun Pan, Wenqi Zhou, Yali Wang, Xiaoliang Chen, Jing Wu, Xiaohua Zeng; Cancer Res Treat. 2025;57(1):126-139. Published online July 9, 2024; DOI: https://doi.org/10.4143/crt.2023.1251

Abstract PDF Supplementary Material PubReader ePub

Purpose
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (¹⁸F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received ¹⁸F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of ¹⁸F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. ¹⁸F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.

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Application of Multimodal Radiomics in Assessing Neoadjuvant Therapeutic Efficacy for Breast Cancer
聪刘
Journal of Clinical Personalized Medicine.2026; 05(01): 324. CrossRef
Novel molecular imaging approaches in oncology: towards a more accurate estimation of tumour response
Amy Rose Sharkey, Anum Pervez, Gary J.R. Cook
Current Opinion in Oncology.2025; 37(5): 522. CrossRef
Novel Molecular Imaging Approaches: Towards a Better Estimation of Response in Breast Cancer
Amy R Sharkey, Gary JR Cook
British Journal of Hospital Medicine.2025; 86(11): 1. CrossRef

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Gastrointestinal cancer

Varlitinib and Paclitaxel for EGFR/HER2 Co-expressing Advanced Gastric Cancer: A Multicenter Phase Ib/II Study (K-MASTER-13): Dong-Hoe Koo, Minkyu Jung, Yeul Hong Kim, Hei-Cheul Jeung, Dae Young Zang, Woo Kyun Bae, Hyunki Kim, Hyo Song Kim, Choong-kun Lee, Woo Sun Kwon, Hyun Cheol Chung, Sun Young Rha; Cancer Res Treat. 2024;56(4):1136-1145. Published online April 29, 2024; DOI: https://doi.org/10.4143/crt.2023.1324

Abstract PDF Supplementary Material PubReader ePub

Purpose
Varlitinib is a pan-human epidermal growth factor receptor (HER) inhibitor targeting epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. We present a phase Ib/II study of a combination of varlitinib and weekly paclitaxel as a second-line treatment for patients with EGFR/HER2 co-expressing advanced gastric cancer (AGC).
Materials and Methods
Patients whose tumors with EGFR and HER2 overexpression by immunohistochemistry (≥ 1+) were enrolled. Varlitinib and paclitaxel were investigated every 4 weeks. After determining the recommended phase II dose (RP2D) in phase Ib, a phase II study was conducted to evaluate the antitumor activity.
Results
RP2D was treated with a combination of varlitinib (300 mg twice daily) and paclitaxel. Among 27 patients treated with RP2D, the median progression-free survival and overall survival (OS) were 3.3 months (95% confidence interval [CI], 1.7 to 4.9) and 7.9 months (95% CI, 5.0 to 10.8), respectively, with a median follow-up of 15.7 months. Among 16 patients with measurable disease, the objective response rate (ORR) and disease control rate were 31% and 88%, respectively. Patients with strong HER2 expression (n=8) had a higher ORR and longer OS, whereas those with strong EGFR expression (n=3) had poorer outcomes. The most common adverse events (AEs) of any grade were neutropenia (52%), diarrhea (27%), aspartate aminotransferase/alanine transaminase elevation (22%), and nausea (19%). No treatment-related deaths or unexpected AEs resulting from treatment cessation were observed in patients with RP2D.
Conclusion
A combination of varlitinib and paclitaxel displayed manageable toxicity and modest antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy.

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Human Epidermal Growth Factor Receptor 2 Positive Advanced Gastric or Esophagogastric Adenocarcinoma: Reflecting on the Past to Gain a New Insights
Yu Aoki, Izuma Nakayama, Kohei Shitara
Current Oncology Reports.2025; 27(1): 15. CrossRef
Pharmacotherapy for previously treated gastric cancer patients: current options and future developments
Seiya Sato, Izuma Nakayama, Kohei Shitara
Expert Review of Clinical Pharmacology.2025; 18(8): 607. CrossRef
Unraveling the future: Innovative design strategies and emerging challenges in HER2-targeted tyrosine kinase inhibitors for cancer therapy
Sixiang Zheng, Ruixian Chen, Lele Zhang, Lun Tan, Lintao Li, Fangyi Long, Ting Wang
European Journal of Medicinal Chemistry.2024; 276: 116702. CrossRef

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Breast cancer

A Nationwide Study on HER2-Low Breast Cancer in South Korea: Its Incidence of 2022 Real World Data and the Importance of Immunohistochemical Staining Protocols: Min Chong Kim, Eun Yoon Cho, So Yeon Park, Hee Jin Lee, Ji Shin Lee, Jee Yeon Kim, Ho-chang Lee, Jin Ye Yoo, Hee Sung Kim, Bomi Kim, Wan Seop Kim, Nari Shin, Young Hee Maeng, Hun Soo Kim, Sun Young Kwon, Chungyeul Kim, Sun-Young Jun, Gui Young Kwon, Hye Jeong Choi, So Mang Lee, Ji Eun Choi, Ae Ri An, Hyun Joo Choi, EunKyung Kim, Ahrong Kim, Ji-Young Kim, Jeong Yun Shim, Gyungyub Gong, Young Kyung Bae; Cancer Res Treat. 2024;56(4):1096-1104. Published online March 6, 2024; DOI: https://doi.org/10.4143/crt.2024.092

Abstract PDF Supplementary Material PubReader ePub

Purpose
Notable effectiveness of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)–low advanced breast cancer (BC) has focused pathologists’ attention. We studied the incidence and clinicopathologic characteristics of HER2-low BC, and the effects of immunohistochemistry (IHC) associated factors on HER2 IHC results.
Materials and Methods
The Breast Pathology Study Group of the Korean Society of Pathologists conducted a nationwide study using real-world data on HER2 status generated between January 2022 and December 2022. Information on HER2 IHC protocols at each participating institution was also collected.
Results
Total 11,416 patients from 25 institutions included in this study. Of these patients, 40.7% (range, 6.0% to 76.3%) were classified as HER2-zero, 41.7% (range, 10.5% to 69.1%) as HER2-low, and 17.5% (range, 6.7% to 34.0%) as HER2-positive. HER2-low tumors were associated with positive estrogen receptor and progesterone receptor statuses (p < 0.001 and p < 0.001, respectively). Antigen retrieval times (≥ 36 minutes vs. < 36 minutes) and antibody incubation times (≥ 12 minutes vs. < 12 minutes) affected on the frequency of HER2 IHC 1+ BC at institutions using the PATHWAY HER2 (4B5) IHC assay and BenchMark XT or Ultra staining instruments. Furthermore, discordant results between core needle biopsy and subsequent resection specimen HER2 statuses were observed in 24.1% (787/3,259) of the patients.
Conclusion
The overall incidence of HER2-low BC in South Korea concurs with those reported in previously published studies. Significant inter-institutional differences in HER2 IHC protocols were observed, and it may have impact on HER2-low status. Thus, we recommend standardizing HER2 IHC conditions to ensure precise patient selection for targeted therapy.

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Redefining HER2 in Breast Cancer: From Conventional Positivity to Low and Ultralow in the New Era of Antibody-Drug Conjugates
Jiwon Koh, Seock-Ah Im
Cancer Research and Treatment.2026; 58(1): 15. CrossRef
Evaluating the Effectiveness of Neoadjuvant Therapy in Her2-Positive Invasive Breast Cancer: A Comprehensive Analysis of 167 Cases in Romania
Bogdan Pop, Carmen Popa, Nicoleta Zenovia Antone, Patriciu-Andrei Achimas-Cadariu, Ioan-Cătălin Vlad, Gabriela Morar-Bolba, Daniela Laura Martin, Carmen Lisencu, Călin Cainap, Roxana Pintican, Annamaria Fulop, Cosmin Ioan Lisencu, Codruț Cosmin Nistor-Ciu
Cancers.2025; 17(14): 2312. CrossRef
Impact of immunohistochemistry staining conditions on the incidence of human epidermal growth factor receptor 2 (HER2)-low breast cancer
Min Chong Kim, Sun Young Kwon, Hye Ra Jung, Young Kyung Bae
Virchows Archiv.2024; 485(6): 1117. CrossRef
Breast Cancer: Extracellular Matrix and Microbiome Interactions
Lourdes Herrera-Quintana, Héctor Vázquez-Lorente, Julio Plaza-Diaz
International Journal of Molecular Sciences.2024; 25(13): 7226. CrossRef

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Lung and Thoracic cancer

Comparison of Clinicopathogenomic Features and Treatment Outcomes of EGFR and HER2 Exon 20 Insertion Mutations in Non–Small Cell Lung Cancer: Single-Institution Experience: So Heun Lee, Hyehyun Jeong, Deok Hoon Kim, Se Jin Jang, Sang-We Kim, Shinkyo Yoon, Dae Ho Lee; Cancer Res Treat. 2024;56(3):774-784. Published online January 30, 2024; DOI: https://doi.org/10.4143/crt.2023.1177

Abstract PDF PubReader ePub

Purpose
Exon 20 insertion mutations (E20ins) in epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2) in non–small cell lung cancer (NSCLC) patients has become more important with emergence of novel agents targeting E20ins.
Materials and Methods
Advanced/Metastatic NSCLC patients with E20ins were included. EGFR E20ins was identified by two methods, next-generation sequencing (NGS) or real-time polymerase chain reaction (PCR), while HER2 E20ins was done by NGS only.
Results
Between December 2013 and July 2021, E20ins were identified in 107 patients at Asan Medical Center; 67 EGFR E20ins and 40 HER2 E20ins. Out of 32 patients with EGFR E20ins who had tested both PCR and NGS, 17 were identified only through NGS and the other 15 through both tests, giving a discordance rate of 53.1%. There was no clinically significant difference in clinicopathologic features between EGFR and HER2 E20ins; both were observed more frequently in adenocarcinoma, female and never-smokers. Brain metastases were evident at diagnosis in 31.8% of EGFR E20ins and 27.5% of HER2 E20ins, respectively. Platinum-based doublets demonstrated objective response rates (ORR) of 13.3% with a median progression-free survival (PFS) of 4.2 months for EGFR E20ins and 35.3% with 4.7 months for HER2 E20ins, respectively. In contrast, novel EGFR E20ins-targeted agents exhibited an ORR of 46.2% with a median PFS of 5.4 months, while HER2-targeted agents showed an ORR of 50% with that of 7.0 months.
Conclusion
Identification of EGFR and HER2 E20ins is more important as their targeted therapies improved outcomes. Upfront NGS test as a comprehensive molecular approach is strongly warranted.

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Review Article

HER2-Low Breast Cancer: Now and in the Future: Sora Kang, Sung-Bae Kim; Cancer Res Treat. 2024;56(3):700-720. Published online January 30, 2024; DOI: https://doi.org/10.4143/crt.2023.1138

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Breast cancer is a heterogeneous disease, and its subtypes are characterized by hormone receptor and human epidermal growth factor receptor 2 (HER2) expression status. “HER2-low” tumors, which exhibit a low level of HER2 expression (immunohistochemistry 1+ or 2+ without gene amplification), were conventionally considered not amenable to anti-HER2 targeting agents based on the results of a phase III trial of trastuzumab. However, this perspective is being challenged by the emergence of novel anti-HER2 antibody-drug conjugates, such as trastuzumab-deruxtecan. These innovative therapies have demonstrated remarkable efficacy against HER2-low breast cancer, shedding new light on a previously overlooked category of breast cancer. Such promising results highlight the need for in-depth investigations of the biology and prognostic implications of HER2-low tumors. In this review, we comprehensively summarize the current evidence surrounding this topic and highlight areas that warrant further exploration and research in the future.

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Original Articles

Breast cancer

Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study: Ruyan Zhang, Xiaoran Liu, Guohong Song, Yan Zhang, Huiping Li; Cancer Res Treat. 2024;56(3):795-801. Published online December 20, 2023; DOI: https://doi.org/10.4143/crt.2023.1151

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Purpose
This study aims to evaluate the efficacy and safety of trastuzumab biosimilar (HLX02) in combination with pertuzumab and chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) after progression of trastuzumab.
Materials and Methods
In this prospective, single-arm, phase II study, patients with HER2-positive MBC after progression of trastuzumab received pertuzuamb, HLX02, and chemotherapy in Beijing Cancer Hospital from March 2020 to December 2022. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The study was registered with ClinicalTrials.gov (NCT05188495).
Results
A total of 45 patients were included in this study. Twelve patients (26.7%) were treated in second-line and 33 patients (73.3%) were in third-line and later setting. Eighty percent and 15.5% patients had previously received pyrotinib/lapatinib and T-DM1, respectively. With a median follow-up of 24.4 months (range, 1.2 to 43.9 months), the median PFS was 7.6 months (95% confidence interval, 4.3 to 10.9), OS was not reached, the ORR was 31.1%, and DCR was 91.1%. The treatment was well tolerated.
Conclusion
The combination of trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy exhibited promising efficacy and a favorable safety profile as second- and beyond-line treatment in HER2-positive MBC.

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Efficacy and safety of biosimilar trastuzumab (HLX02) in patients with HER2-positive advanced breast cancer: a retrospective real-world analysis
Xuan Ye, Linlin Wang, Wensheng Liu, Mengmeng Wang, Zihan Guo, Han Shan, Qing Zhai, Qiong Du
Frontiers in Oncology.2025;[Epub] CrossRef

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Gastrointestinal cancer

First-in-Human Phase 1 Study of a B Cell– and Monocyte-Based Immunotherapeutic Vaccine against HER2-Positive Advanced Gastric Cancer: Minkyu Jung, Jii Bum Lee, Hyo Song Kim, Woo Sun Kwon, Hyun Ok Kim, Sinyoung Kim, Myunghwan Park, Wuhyun Kim, Ki-Young Choi, Taegwon Oh, Chang-Yuil Kang, Hyun Cheol Chung, Sun Young Rha; Cancer Res Treat. 2024;56(1):208-218. Published online June 28, 2023; DOI: https://doi.org/10.4143/crt.2022.1328

Abstract PDF Supplementary Material PubReader ePub

Purpose
BVAC-B is an autologous B cell– and monocyte-based immunotherapeutic vaccine that contains cells transfected with a recombinant human epidermal growth factor receptor 2 (HER2) gene and loaded with the natural killer T cell ligand alpha-galactosylceramide. Here, we report the first BVAC-B study in patients with HER2-positive advanced gastric cancer.
Materials and Methods
Patients with advanced gastric cancer refractory to standard treatment with HER2+ immunohistochemistry ≥ 1 were eligible for treatment. Patients were administered low (2.5×10⁷ cells/dose), medium (5.0×10⁷ cells/dose), or high dose (1.0×10⁸ cells/dose) of BVAC-B intravenously four times every 4 weeks. Primary endpoints included safety and maximum tolerated BVAC-B dose. Secondary endpoints included preliminary clinical efficacy and BVAC-B-induced immune responses.
Results
Eight patients were treated with BVAC-B at low (n=1), medium (n=1), and high doses (n=6). No dose-limiting toxicity was observed, while treatment-related adverse events (TRAEs) were observed in patients treated with medium and high doses. The most common TRAEs were grade 1 (n=2) and grade 2 (n=2) fever. Out of the six patients treated with high-dose BVAC-B, three had stable disease with no response. Interferon gamma, tumor necrosis factor-α, and interleukin-6 increased after BVAC-B treatment in all patients with medium and high dose, and HER2-specific antibody was detected in some patients.
Conclusion
BVAC-B monotherapy had a safe toxicity profile with limited clinical activity; however, it activated immune cells in heavily pretreated patients with HER2-positive gastric cancer. Earlier treatment with BVAC-B and combination therapy is warranted for evaluation of clinical efficacy.

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GASTric Cancer HER2 Re-Assessment Study 2 (GASTHER2): HER2 Re-assessment for Initially HER2-Negative Advanced Gastric Cancer Patients after Progression on First-Line Treatment: Jaewon Hyung, Hyung-Don Kim, Min-Hee Ryu, Young Soo Park, Meesun Moon, Yoon-Koo Kang; Cancer Res Treat. 2024;56(1):199-207. Published online June 20, 2023; DOI: https://doi.org/10.4143/crt.2023.490

Abstract PDF Supplementary Material PubReader ePub

Purpose
Heterogeneous human epidermal growth factor receptor 2 (HER2) overexpression in gastric cancer may lead to a misdiagnosis of HER2 status. Accurate assessment of HER2 status is essential for optimal treatment as novel HER2-directed agents are being investigated in various clinical settings. We evaluated the usefulness of HER2 re-assessment following progression on first-line treatment in initially HER2-negative advanced gastric cancer (AGC) patients.
Materials and Methods
We enrolled 177 patients with baseline HER2-negative AGC and performed HER2 re-assessment after progression on first-line treatment from February 2012 to June 2016 at Asan Medical Center, Seoul, Korea. The re-assessed HER2 status was analyzed with baseline HER2 status and clinical characteristics.
Results
The median age was 54 years (range, 24 to 80 years), and 123 patients (69.5%) were men. Seven patients (4.0%) were HER2-positive on the re-assessment. Patients with baseline HER2 negativity confirmed by a single test (n=100) had a higher HER2-positive re-assessment rate compared to those who had repeated baseline testing (n=77) (5.0% vs. 2.6%). Among the patients with single baseline HER2 testing, the rate was higher in patients with baseline HER2 immunohistochemistry (IHC) 1+ compared to those with IHC 0 (13.4% vs. 3.6%).
Conclusion
Overall, 4.0% of patients with baseline HER2-negative AGC were HER2-positive on re-assessment, and the HER2-positive re-assessment rate was higher among patients who had a single test at baseline. HER2 re assessment may be considered for initially HER2-negative patients to determine their eligibility for HER2-directed therapy, particularly if their HER2 negativity was determined by a single test, especially if they had a single baseline HER2 IHC 1+ test.

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Breast cancer

Prognostic Value of the Evolution of HER2-Low Expression after Neoadjuvant Chemotherapy: Youzhao Ma, Mingda Zhu, Jingyang Zhang, Minhao Lv, Xiuchun Chen, Zhenzhen Liu; Cancer Res Treat. 2023;55(4):1210-1221. Published online April 4, 2023; DOI: https://doi.org/10.4143/crt.2022.1633

Abstract PDF PubReader ePub

Purpose
Patients with human epidermal growth factor receptor 2 (HER2)–low advanced breast cancer can benefit from trastuzumab deruxtecan. Given the unclear prognostic characteristics of HER2-low breast cancer, we investigated the prognostic characteristics of HER2-low expression from primary tumor to residual disease after neoadjuvant chemotherapy (NACT).
Materials and Methods
The data of HER2-negative patients receiving NACT at our center were collected. Pathological complete response (pCR) rate were compared between HER2-0 and HER2-low patients. The evolution of HER2 expression from primary tumor to residual disease and its impact on disease-free survival (DFS) were examined.
Results
Of the 690 patients, 494 patients had HER2-low status, of which 72.3% were hormone receptor (HR)–positive (p < 0.001). The pCR rates of HER2-low and HER2-0 patients (14.2% vs. 23.0%) showed no difference in multivariate analysis regardless of HR status. No association was observed between DFS and HER2 status. Of the 564 non-pCR patients, 57 (10.1%) changed to HER2-positive, and 64 of the 150 patients (42.7%) with HER2-0 tumors changed to HER2-low. HER2-low (p=0.004) and HR-positive (p=0.010) tumors before NACT were prone to HER2 gain. HER2 gain patients had a better DFS compared with HER2-negative maintained patients (87.9% vs. 79.5%, p=0.048), and the DFS of targeted therapy group was better than that of no targeted therapy group (92.4% vs. 66.7%, p=0.016).
Conclusion
Although HER2-low did not affect the pCR rate and DFS, significant evolution of HER2-low expression after NACT creates opportunities for targeted therapy including trastuzumab.

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The Modified Neo-Bioscore System for Staging Breast Cancer Treated with Neoadjuvant Therapy Based on Prognostic Significance of HER2-Low Expression
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Mei Liu, Qin Xiang, Fengsheng Dai, Yixiao Yuan, Zhongjun Wu, Tingxiu Xiang
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Yingying Zhao, Xinru Chen, Yaohui Wang, Xueqing Zhang, Yumei Ye, Shuguang Xu, Liheng Zhou, Yanping Lin, Jingsong Lu, Wenjin Yin
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Gastrointestinal cancer

Trastuzumab Combined with Irinotecan in Patients with HER2-Positive Metastatic Colorectal Cancer: A Phase II Single-Arm Study and Exploratory Biomarker Analysis: Ting Xu, Xicheng Wang, Ying Xin, Zhenghang Wang, Jifang Gong, Xiaotian Zhang, Yanyan Li, Congcong Ji, Yu Sun, Feilong Zhao, Depei Huang, Yuezong Bai, Jian Li, Lin Shen; Cancer Res Treat. 2023;55(2):626-635. Published online December 23, 2022; DOI: https://doi.org/10.4143/crt.2022.1058

Abstract PDF Supplementary Material PubReader ePub

Purpose
The human epidermal growth factor receptor 2 (HER2) is an established therapeutic target for various kinds of solid tumors. HER2 amplification occurs in approximately 1% to 6% of colorectal cancer. In this study, we aimed to assess the efficacy and safety of trastuzumab in combination with chemotherapy in HER2-positive metastatic colorectal cancer (mCRC).
Materials and Methods
An open-label, phase II trial (Clinicaltrials.gov: NCT03185988) was designed to evaluate the antitumor activity of trastuzumab and chemotherapy in HER2-positive digestive cancers excluding gastric cancer in 2017. Patients from this trial with HER2-positive, KRAS/BRAF wild-type, unresectable mCRC were analyzed in this manuscript. Eligible patients were treated with trastuzumab (8 mg/kg loading dose and then 6 mg/kg every 3 weeks) and irinotecan (120 mg/m² days 1 and 8 every 3 weeks). The primary endpoint was the objective response rate.
Results
Twenty-one HER2-positive mCRC patients were enrolled in this study. Seven patients (33.3%) achieved an objective res-ponse, and 11 patients (52.4%) had stable disease as their best response. The median progression-free survival (PFS) was 4.3 months (95% confidence interval, 2.7 to 5.9). Four of the 21 patients (19.0%) had grade 3 adverse events, including leukopenia, neutropenia, urinary tract infection, and diarrhea. No treatment-related death was reported. Exploratory analyses revealed that high tumor tissue HER2 copy number was associated with better therapeutic response and PFS. Alterations in the mitogen-activated protein kinase pathway, HER2 gene, phosphoinositide 3-kinase/AKT pathway, and cell cycle control genes were potential drivers of trastuzumab resistance in mCRC.
Conclusion
Trastuzumab combined with chemotherapy is a potentially effective and well-tolerated therapeutic regimen in mCRC with a high HER2 copy number.

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Breast cancer

PIK3CA Mutation is Associated with Poor Response to HER2-Targeted Therapy in Breast Cancer Patients: Ju Won Kim, Ah Reum Lim, Ji Young You, Jung Hyun Lee, Sung Eun Song, Nam Kwon Lee, Seung Pil Jung, Kyu Ran Cho, Cheol Yong Kim, Kyong Hwa Park; Cancer Res Treat. 2023;55(2):531-541. Published online September 7, 2022; DOI: https://doi.org/10.4143/crt.2022.221

Abstract PDF Supplementary Material PubReader ePub

Purpose
Mutations in the PIK3CA gene occur frequently in breast cancer patients. Activating PIK3CA mutations confer resistance to human epidermal growth factor receptor 2 (HER2)-targeted treatments. In this study, we investigated whether PIK3CA mutations were correlated with treatment response or duration in patients with HER2-positive (HER2+) breast cancer.
Materials and Methods
We retrospectively reviewed the clinical information of patients with HER2+ breast cancer who received HER2-targeted therapy for early-stage or metastatic cancers. The pathologic complete response (pCR), progression-free survival (PFS), and overall survival were compared between patients with wild-type PIK3CA (PIK3CAw) and those with mutated PIK3CA (PIK3CAm). Next-generation sequencing was combined with examination of PFS associated with anti-HER2 monoclonal antibody (mAb) treatment.
Results
Data from 90 patients with HER2+ breast cancer were analyzed. Overall, 34 (37.8%) patients had pathogenic PIK3CA mutations. The pCR rate of the PIK3CAm group was lower than that of the PIK3CAw group among patients who received neoadjuvant chemotherapy for early-stage cancer. In the metastatic setting, the PIK3CAm group showed a significantly shorter mean PFS (mPFS) with first-line anti-HER2 mAb. The mPFS of second-line T-DM1 was lower in the PIK3CAm group than that in the PIK3CAw group. Sequencing revealed differences in the mutational landscape between PIK3CAm and PIK3CAw tumors.
Conclusion
Patients with HER2+ breast cancer with activating PIK3CA mutations had lower pCR rates and shorter PFS with palliative HER2-targeted therapy than those with wild-type PIK3CA. Precise targeted-therapy is needed to improve survival of patients with HER2+/PIK3CAm breast cancer.

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Kyoungmin Lee, Jongwon Lee, Jungmin Choi, Sung Hoon Sim, Jeong Eun Kim, Min Hwan Kim, Yeon Hee Park, Jee Hyun Kim, Su-Jin Koh, Kyong Hwa Park, Myoung Joo Kang, Mi Sun Ahn, Kyoung Eun Lee, Hee-Jun Kim, Hee Kyung Ahn, Han Jo Kim, Keon Uk Park, In Hae Park
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Ioanna Akrida, Francesk Mulita
Medical Oncology.2022;[Epub] CrossRef

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Real-World Evidence of Trastuzumab, Pertuzumab, and Docetaxel Combination as a First-Line Treatment for Korean Patients with HER2-Positive Metastatic Breast Cancer: Yong-Pyo Lee, Min-Sang Lee, HongSik Kim, Ji-Yeon Kim, Jin Seok Ahn, Young-Hyuck Im, Yeon Hee Park; Cancer Res Treat. 2022;54(4):1130-1137. Published online January 17, 2022; DOI: https://doi.org/10.4143/crt.2021.1103

Abstract PDF Supplementary Material PubReader ePub

Purpose
Trastuzumab has markedly improved the survival outcomes of patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer, and dual blockade of HER2 using trastuzumab and pertuzumab in combination with taxanes (THP) has become a standard of care for HER2-positive metastatic breast cancer (MBC) worldwide since the CLEOPATRA trial. We assessed the outcomes of THP as a first-line treatment for Korean HER2-positive MBC patients in the real-world setting.
Materials and Methods
Between August 2008 and October 2020, we identified 228 HER2-positive MBC patients who received THP as a first-line palliative chemotherapy. We analyzed survival outcomes, efficacy, and adverse events of THP retrospectively.
Results
After a median follow-up duration of 28.7 months, median overall survival and progression-free survival were 58.3 months (95% confidence interval [CI], 36.6 to 80.0) and 19.1 months (95% CI, 16.2 to 21.9), respectively. Better survival outcomes were observed in patient who received docetaxel for more than six cycles. Patients exposed to anti-HER2 directed therapies in a perioperative setting had poor survival outcomes. The overall response rate was 86.8% with a complete response (CR) rate of 17.7%. Among responders, 16.7% of patients sustained THP over 35 months and showed better survivals and higher CR rates. Adverse events were comparable to those reported in previous studies.
Conclusion
In a real-world context, clinical outcomes of Korean HER2-positive MBC patients treated with THP were similar to those of patients in the CLEOPATRA trial. Much longer follow-up results would be warranted.

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Trastuzumab deruxtecan: Redefining precision oncology across HER2-driven cancers
Pooya Jalali, Azhar Saeed, Sahar Taher, Anwaar Saeed
Critical Reviews in Oncology/Hematology.2026; 217: 105019. CrossRef
Pertuzumab in Combination with Trastuzumab and Docetaxel as Adjuvant Doublet Therapy for HER2-Positive Breast Cancer: A Systematic Review
Ignacio Ventura, Nerea Pinilla Salcedo, Marcelino Pérez-Bermejo, Javier Pérez-Murillo, Manuel Tejeda-Adell, Francisco Tomás-Aguirre, María Ester Legidos-García, María Teresa Murillo-Llorente
International Journal of Molecular Sciences.2025; 26(5): 1908. CrossRef
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Yi Guo, Gang Zheng, Yu Fan, Liangchang Li, Yang Sun
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From intravenous to subcutaneous pertuzumab/trastuzumab in breast cancer: Clinical and pharmacoeconomic drivers and barriers to switching
Mariangela Gaudio, Anna Floreani, Greta Schivardi, Domiziana Alaimo, Vera Basilico, Isabella Lorenzetti, Cristina Crepaldi, Benedetta Tinterri, Antonella Panzardi, Daniela Strada, Giuseppe Saltalamacchia, Flavia Jacobs, Chiara Benvenuti, Riccardo Gerosa,
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Real-world impact of dual anti-HER2 antibodies on cardiac function in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer
Kelvin KH. Bao, Jeffrey CH. Chan, Jocelyn G. Chan, Leone Sutanto, Ka Man Cheung, Harry HY. Yiu
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Bilateral inflammatory recurrence of HER-2 positive breast cancer: a unique case report and literature review
Rong Qin, Xiangyang Wang, Tingting Fan, Ting Wu, Chao Lu, Xun Shao, Liang Yin
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Cancer Cell International.2022;[Epub] CrossRef

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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

Abstract PDF Supplementary Material PubReader ePub

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.

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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
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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
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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

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Clinical Significance of Major Angiogenesis-Related Effectors in Patients with Metastatic Breast Cancer Treated with Trastuzumab-Based Regimens: Helen P. Kourea, Foteinos-Ioannis Dimitrakopoulos, Georgia-Angeliki Koliou, Anna Batistatou, Kyriaki Papadopoulou, Mattheos Bobos, Anthoula Asimaki-Vlachopoulou, Sofia Chrisafi, Kitty Pavlakis, Kyriakos Chatzopoulos, Eleni Galani, George Pentheroudakis, Dimitrios Pectasides, Dimitrios Bafaloukos, Eleni Res, Pavlos Papakostas, Angelos Koutras, Vassiliki Kotoula, George Fountzilas; Cancer Res Treat. 2022;54(4):1053-1064. Published online November 17, 2021; DOI: https://doi.org/10.4143/crt.2021.748

Abstract PDF Supplementary Material PubReader ePub

Purpose
Angiogenesis is a crucial phenomenon in the development and progression of breast cancer (BC), but the clinical significance of angiogenesis-related proteins in metastatic BC remains unknown. This study investigates the prognostic value of vascular endothelial growth factor receptors 1, 2, 3 (VEGFR1, VEGFR2, VEGFR3) as well as vascular endothelial growth factors A and C (VEGFA and VEGFC) in metastatic BC patients treated with trastuzumab-based regimens.
Materials and Methods
Two hundred female patients were included. Protein and mRNA expression of the studied angiogenesis-related factors were evaluated by immunohistochemistry and quantitative polymerase chain reaction, respectively.
Results
High expression of VEGFA, VEGFC, VEGFR1, VEGFR2, and VEGFR3 in the tumor cells was observed in 43.5%, 24.2%, 36%, 29.5%, and 43%, respectively. Stromal elements expressed high levels of VEGFA, VEGFC, VEGFR1, VEGFR2, and VEGFR3 in 78.9%, 93.3%, 90.7%, 90.2%, and 74.8% of tumors with available data. High tumor cell expression of VEGFR1 was a favorable prognosticator for survival among patients with human epidermal growth factor receptor 2 (HER2)–positive tumors (hazard ratio [HR], 0.55; p=0.013). A trend towards longer progression-free survival was detected univariately for patients with HER2-negative tumors and high expression of VEGFR2 (HR, 0.60; p=0.059).
Conclusion
VEGFR1 and VEGFR2 seem to have significant prognostic value in BC patients with metastatic disease treated with trastuzumab-based regimens.

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Multi-parametric MRI radiomics predicts different HER2 expression in breast cancer
Siqi Zhao, Fan Wei, Yuanfei Li, Yueqi Wu, Moyun Zhang, Shuo Wang, Xinyue Yin, Zhitian Guo, Jie Yang, Xue Gao, Haonan Guan, Hui Liu, Lina Zhang
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Sevda Jafari, Alireza Ostadrahimi, Afsaneh Farjami, Soheila Montazersaheb
Scientific Reports.2025;[Epub] CrossRef
Apatinib beyond first progression is associated with prolonged overall survival in patients with advanced breast cancer: Results from an observational study
Jing Wang, Jinghao Jia, Jingjing Liu, Xuemin Yao, Zhiyong Yuan
Experimental and Therapeutic Medicine.2024;[Epub] CrossRef

7,268 View
113 Download
5 Web of Science
3 Crossref

Breast Cancer

Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA Trial: Kyung-Hun Lee, Joohyuk Sohn, Annabel Goodwin, Tiziana Usari, Silvana Lanzalone, Seock-Ah Im, Sung-Bae Kim; Cancer Res Treat. 2021;53(4):1084-1095. Published online March 24, 2021; DOI: https://doi.org/10.4143/crt.2020.1381

Abstract PDF Supplementary Material PubReader ePub

Purpose
We evaluated study outcomes in patients enrolled in Asian regions in the phase III EMBRACA trial of talazoparib vs. chemotherapy.
Materials and Methods
Patients with human epidermal growth factor receptor 2–negative germline BRCA1/2-mutated advanced breast cancer who received prior chemotherapy were randomized 2:1 to talazoparib 1 mg/day or chemotherapy (physician’s choice). Primary endpoint was progression-free survival (PFS) per independent central review in the intent-to-treat (ITT) population. This post-hoc analysis evaluated efficacy/safety endpoints in the ITT population of patients enrolled in Asian regions.
Results
Thirty-three patients were enrolled at Asian sites (talazoparib, n=23; chemotherapy, n=10). Baseline characteristics were generally comparable with the overall EMBRACA population. In Asian patients, median PFS was 9.0 months (95% confidence interval [CI] 3.0, 15.2) for talazoparib and 7.1 months (95% CI, 1.2, not reached) for chemotherapy (hazard ratio [HR] 0.74 [95% CI, 0.22, 2.44]). Objective response rate was numerically higher for talazoparib vs. chemotherapy (62.5% [95% CI, 35.4, 84.8] vs. 25.0% [95% CI, 3.2, 65.1]). Median overall survival was 20.7 months (95% CI, 9.4, 40.1) versus 21.2 months (95% CI, 2.7, 35.0) months (HR, 1.41 [95% CI, 0.49, 4.05]). In Asian patients, fewer grade 3/4 adverse events (AEs), serious AEs (SAEs), grade 3/4 SAEs, and AEs resulting in dose reduction/discontinuation occurred with talazoparib than chemotherapy; for talazoparib, the frequency of these events was lower in Asian patients versus overall EMBRACA population.
Conclusion
In this subgroup analysis, talazoparib numerically improved efficacy versus chemotherapy and was generally well tolerated in Asian patients, with fewer grade 3/4 TEAEs, SAEs, and TEAEs leading to dose modification vs. the overall EMBRACA population.

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Mufei Tang, Peiyan Liu, Linzhe Du, Yuanyuan Li, Jinjin Chen, Yang Li
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Breast cancer

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

Abstract PDF Supplementary Material PubReader ePub

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.

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BioPATH: A Biomarker Study in Asian Patients with HER2+ Advanced Breast Cancer Treated with Lapatinib and Other Anti-HER2 Therapy: Sung-Bae Kim, In-Gu Do, Janice Tsang, Tae-You Kim, Yoon-Sim Yap, Gerardo Cornelio, Gyungyub Gong, Soonmyung Paik, Suee Lee, Ting-Ying Ng, Sarah Park, Ho-Suk Oh, Joanne Chiu, Joohyuk Sohn, Moonhee Lee, Young-Jin Choi, Eun Mi Lee, Kyong-Hwa Park, Christos Nathaniel, Jungsil Ro; Cancer Res Treat. 2019;51(4):1527-1539. Published online June 4, 2019; DOI: https://doi.org/10.4143/crt.2018.598

Abstract PDF PubReader ePub

Purpose
BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. Materials and Methods Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored.
Results
p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib.
Conclusion
The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.

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PIK3CA Mutation is Associated with Poor Response to HER2-Targeted Therapy in Breast Cancer Patients
Ju Won Kim, Ah Reum Lim, Ji Young You, Jung Hyun Lee, Sung Eun Song, Nam Kwon Lee, Seung Pil Jung, Kyu Ran Cho, Cheol Yong Kim, Kyong Hwa Park
Cancer Research and Treatment.2023; 55(2): 531. CrossRef
Discordance of PIK3CA mutational status between primary and metastatic breast cancer: a systematic review and meta-analysis
Justus Rosin, Ella Svegrup, Antonios Valachis, Ioannis Zerdes
Breast Cancer Research and Treatment.2023; 201(2): 161. CrossRef
Association of PIK3CA mutation with outcomes in HER2-positive breast cancer treated with anti-HER2 therapy: A meta-analysis and bioinformatic analysis of TCGA‑BRCA data
Haizhu Chen, Xingbin Hu, Daquan Wang, Ying Wang, Yunfang Yu, Herui Yao
Translational Oncology.2023; 37: 101738. CrossRef
Comparison of PIK3CA Mutation Prevalence in Breast Cancer Across Predicted Ancestry Populations
Jessica W. Chen, Karthikeyan Murugesan, Justin Y. Newberg, Ethan S. Sokol, Heidi M. Savage, Thomas J. Stout, Sophia L. Maund, Katherine E. Hutchinson
JCO Precision Oncology.2022;[Epub] CrossRef
Breast Cancer: A Molecularly Heterogenous Disease Needing Subtype-Specific Treatments
Ugo Testa, Germana Castelli, Elvira Pelosi
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Case Report

Effective Treatment of Solitary Pituitary Metastasis with Panhypopituitarism in HER2-Positive Breast Cancer by Lapatinib: Youngmok Park, Hyemin Kim, Eui-Hyun Kim, Chang-Ok Suh, Soohyeon Lee; Cancer Res Treat. 2016;48(1):403-408. Published online February 16, 2015; DOI: https://doi.org/10.4143/crt.2014.165

Abstract PDF PubReader ePub

Brain metastasis affects one third of patients with HER2-positive breast cancer after treatment with trastuzumab. Surgical resection and radiation therapy are often unsuccessful at accomplishing complete control of metastasis. Lapatinib is presumed to cross the blood-brain barrier, and exhibits clinical activities for treatment of HER2- positive breast cancer. A 43-year-old woman was treated for early breast carcinoma with total mastectomy, axillary lymph-node dissection, and adjuvant chemotherapy with cyclophosphamide plus doxorubicin. After the end of adjuvant trastuzumab therapy, she was diagnosed with panhypopituitarism due to pituitary metastasis. Surgical removal and whole brain radiation therapy were performed, but a portion of viable tumor remained. Only taking lapatinib, the size of the metastatic lesion began to shrink. Trastuzumab may have controlled the micro-metastasis of breast cancer, but it was unable to control its progression to the central nervous system. Lapatinib is a possible option for HER2-positive metastatic breast cancer patients with brain metastasis.

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Breast cancer metastasis in sellar and suprasellar region. A rare presentation, and the ideal clinical management
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Hajrullah Ahmeti, Eva Jüttner, Christoph Röcken, Olav Jansen, Matthias Laudes, Michael Synowitz
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Pituitary metastases: a case series and scoping review
Kaiyun Yang, Sabrina L. Begley, Daniel Lynch, Vincent Ye, Jasleen Saini, Enrique Gutierrez, Jaclyn Vialet, Barbara-Ann Millar, Tatianna Conrad, Normand Laperriere, Mark Bernstein, Gelareh Zadeh, David B. Shultz, Paul N. Kongkham
Pituitary.2023; 26(5): 538. CrossRef
Early and isolated breast cancer metastasis to the pituitary: A case report and systematic review
Neilen P Rasiah, Abdulrahman Albakr, Suzanne Kosteniuk, Yves Starreveld
Surgical Neurology International.2022; 13: 462. CrossRef
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Xiaohai Liu, Renzhi Wang, Mingchu Li, Ge Chen
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Mostafa Shahein, Thiago Albonette-Felicio, Ricardo L. Carrau, Daniel M. Prevedello
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Capecitabine/lapatinib/paclitaxel

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Original Articles

Prognostic Role of Interleukin-6, Interleukin-8, and Leptin Levels According to Breast Cancer Subtype: Young Ae Cho, Mi-Kyung Sung, Jee-Young Yeon, Jungsil Ro, Jeongseon Kim; Cancer Res Treat. 2013;45(3):210-219. Published online September 30, 2013; DOI: https://doi.org/10.4143/crt.2013.45.3.210

Abstract PDF PubReader ePub

PURPOSE
Inflammation within the tumor microenvironment has been reported to show an association with poor prognosis in breast cancer. However, the associations may differ according to breast cancer subtype. In this study, we investigated the association between inflammation-related markers and breast cancer recurrence according to patients' tumor subtypes.
MATERIALS AND METHODS
This prospective study included 240 patients who underwent surgery for management of newly diagnosed breast cancer. Levels of inflammation-related markers (interleukin [IL]-1beta, IL-6, IL-8, monocyte chemoattractant protein-1 [MCP-1], leptin, and adiponectin) were measured at diagnosis, and the associations between these markers and breast cancer recurrence during a six-year follow-up period were examined using the Kaplan-Meier statistical method.
RESULTS
Overall, inflammation-related markers showed no association with breast cancer recurrence. However, when data were stratified by tumor subtype, higher levels of some mediators showed an association with poor prognosis among patients with particular subtypes. Compared to patients without recurrence, patients with recurrence had higher levels of circulating IL-6 (p=0.024) and IL-8 (p=0.016) only among those with HER2- tumors and had higher levels of leptin (p=0.034) only among those with estrogen receptor (ER)+/progesterone receptor (PR)+ tumors. Results of survival analyses revealed an association of high levels of IL-6 (p=0.016) and IL-8 (p=0.022) with poor recurrence-free survival in patients with HER2- tumors. In addition, higher leptin levels indicated shorter recurrence-free survival time only among patients with ER+/PR+ tumors (p=0.022).
CONCLUSION
We found that certain cytokines could have a differential prognostic impact on breast cancer recurrence according to breast cancer subtype. Conduct of additional large studies will be required in order to elucidate the precise roles of these cytokines in breast cancer progression.

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Correlation of AR, EGFR, and HER2 Expression Levels in Prostate Cancer: Immunohistochemical Analysis and Chromogenic In Situ Hybridization: Kwang Hyun Baek, Min Eui Hong, Yoon Yang Jung, Chung Hun Lee, Tae Jin Lee, Eon Sub Park, Mi Kyung Kim, Jae Hyung Yoo, Soo Whan Lee; Cancer Res Treat. 2012;44(1):50-56. Published online March 31, 2012; DOI: https://doi.org/10.4143/crt.2012.44.1.50

Abstract PDF PubReader ePub

PURPOSE
The androgen receptor (AR) plays a central role in prostate cancer. Evidence from several groups indicates that epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) may enhance AR activity in prostate cancer cell lines. This study was designed to investigate the protein expression of AR, EGFR, and HER2 and to determine whether the EGFR and HER2 genes are amplified in prostate cancer tissues.
MATERIALS AND METHODS
The protein expression levels of AR, EGFR, and HER2 in a tissue microarray block of 66 prostate cancer samples were investigated by immunohistochemical analysis and chromogenic in situ hybridization was used to determine whether the EGFR and HER2 genes were amplified in these tissues.
RESULTS
The AR and EGFR proteins were expressed in 59.1% and 40.9% of prostate cancers, respectively, but their expression levels were not significantly associated with clinicopathologic factors. Of the cases in which tissues were negative for EGFR protein expression, 69.2% were positive for AR protein expression; however, AR protein expression was significantly reduced (44.4%) in tissues in which EGFR protein was expressed. HER2 expression was detected in only 1 case (1.5%). No amplification of the EGFR or HER2 genes was found in prostate cancer specimens.
CONCLUSION
This study was limited by small number of subjects, but it can still be inferred that the expression levels of the AR and EGFR proteins are inversely correlated in prostate cancer patients. The potential utility of EGFR and HER2 as prognostic factors or therapeutic targets warrants further study.

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Implications of Bone-Only Metastases in Breast Cancer: Favorable Preference with Excellent Outcomes of Hormone Receptor Positive Breast Cancer: Su Jin Lee, Silvia Park, Hee Kyung Ahn, Jun Ho Yi, Eun Yoon Cho, Jong Mu Sun, Jeong Eon Lee, Seok Jin Nam, Jung-Hyun Yang, Yeon Hee Park, Jin Seok Ahn, Young-Hyuck Im; Cancer Res Treat. 2011;43(2):89-95. Published online June 30, 2011; DOI: https://doi.org/10.4143/crt.2011.43.2.89

Abstract PDF PubReader ePub

PURPOSE
The aim of the current study was to determine the incidence, clinical presentation, and treatment outcomes of "bone-only metastases" in patients with breast cancer and to analyze the impact of hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status on prognosis.
MATERIALS AND METHODS
Between 1994 and 2007, of 968 patients with metastatic breast cancer who underwent palliative management at Samsung Medical Center, 565 (57%) relapsed with distant metastases. Of the 968, 146 (15%) had bone-only metastases during a median follow-up period of 75 months. Among the 146 patients with bone-only metastases, 122 (84%) were relapsed patients after curative surgery and 24 (26%) were initially metastatic cases.
RESULTS
The median time from primary surgery to bone-only metastases of the 122 patients was 37 months (95% confidence interval [CI], 27 to 46 months). Bone-only metastases were more common in the HR-positive group than in the other subtypes (85% for HR+; 8.2% for HER2+; 6.8% for triple negative. Among all 146 patients, 75 (51%) were treated with hormone therapy. The median post-relapse progression-free survival was 15 months (95%CI, 13 to 17 months). The median overall survival was much longer in the HR+ patients than the HER2+ and triple negative breast cancer patients with marginal statistical significance (65 vs. 40 vs. 40 months, p=0.077).
CONCLUSION
Breast cancer patients with "bone-only metastases" had excellent clinical outcomes. Further study is now warranted to reveal the underlying biology that regulates the behavior of this indolent tumor, as it should identify 'favorable tumor characteristics' in addition to 'favorable preferential metastatic site.'

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Clinical Breast Cancer.2020; 20(1): e54. CrossRef
Radiation therapy for bone-only metastases in breast cancer patients: A GOCO survey of current clinical practice
Marta Bonet, Virginia García, Núria Farré, Manel Algara, Blanca Farrús, Jaume Fernandez, Victoria Reyes, Arancha Eraso, Ana Álvarez, Maria José Cambra, Agustí Pedro, Jordi Vayreda, Claire Lemansky, Françoise Izar, Meritxell Arenas
Reports of Practical Oncology & Radiotherapy.2020; 25(1): 113. CrossRef
MicroRNA-429 inhibits bone metastasis in breast cancer by regulating CrkL and MMP-9
Xinxin Zhang, Xiying Yu, Zhenguo Zhao, Zhennan Yuan, Peiqing Ma, Zhibin Ye, Liping Guo, Songfeng Xu, Libin Xu, Ting Liu, Huanmei Liu, Shengji Yu
Bone.2020; 130: 115139. CrossRef
Metastatic Presentations of Previously Treated Early-Stage Breast Cancer Patients and Association With Survival
Najla Itani, Nicole Grogan, Sarah Mott, Sneha Phadke
Clinical Breast Cancer.2020; 20(3): 209. CrossRef
Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer
Cynthia Huang Bartlett, Jack Mardekian, Matthew James Cotter, Xin Huang, Zhe Zhang, Christina M. Parrinello, Ariel Bulua Bourla, Apar Kishor Ganti
PLOS ONE.2020; 15(4): e0227256. CrossRef
International Framework for Red Flags for Potential Serious Spinal Pathologies
Laura M. Finucane, Aron Downie, Christopher Mercer, Susan M. Greenhalgh, William G. Boissonnault, Annelies L. Pool-Goudzwaard, Jason M. Beneciuk, Rachel L. Leech, James Selfe
Journal of Orthopaedic & Sports Physical Therapy.2020; 50(7): 350. CrossRef
Prognostic Value of Modified IHC4 Score in Patients with Estrogen Receptor-Positive Metastatic Breast Cancer
Liang Jin, Kai Chen, Cui Tan, Jianbin Li, Jiayue Luo, Yaping Yang, Yudong Li, Shunying Li, Liling Zhu, Yue Hu, Fengtao Liu, Qiuting You, Min Peng, Zefei Jiang, Qiang Liu
The Oncologist.2020; 25(8): e1170. CrossRef
Imaging diagnosis of metastatic breast cancer
Filippo Pesapane, Kate Downey, Anna Rotili, Enrico Cassano, Dow-Mu Koh
Insights into Imaging.2020;[Epub] CrossRef
Tamoxifen Rechallenge Decreases Metastatic Potential but Increases Cell Viability and Clonogenicity in a Tamoxifen-Mediated Cytotoxicity-Resistant Subline of Human Breast MCF7 Cancer Cells
Yung-Chieh Chang, Chun Hei Antonio Cheung, Yao-Lung Kuo
Frontiers in Cell and Developmental Biology.2020;[Epub] CrossRef
Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials
Richard S. Finn, Massimo Cristofanilli, Johannes Ettl, Karen A. Gelmon, Marco Colleoni, Carla Giorgetti, Eric Gauthier, Yuan Liu, Dongrui R. Lu, Zhe Zhang, Cynthia Huang Bartlett, Dennis J. Slamon, Nicholas C. Turner, Hope S. Rugo
Breast Cancer Research and Treatment.2020; 184(1): 23. CrossRef
Innovative Options for Bone Metastasis Treatment: An Extensive Analysis on Biomaterials-Based Strategies for Orthopedic Surgeons
Ania Naila Guerrieri, Monica Montesi, Simone Sprio, Roberta Laranga, Laura Mercatali, Anna Tampieri, Davide Maria Donati, Enrico Lucarelli
Frontiers in Bioengineering and Biotechnology.2020;[Epub] CrossRef
The influence of breast cancer subtype on survival after palliative radiation for osseous metastases
Mohamed K. Abdelhakiem, Candice Johnstone, Carmen Bergom, Adam Currey, Jared R. Robbins
Cancer Medicine.2020; 9(23): 8979. CrossRef
Racial/ethnic differences in the outcomes of patients with metastatic breast cancer: contributions of demographic, socioeconomic, tumor and metastatic characteristics
Jin-Xiao Ren, Yue Gong, Hong Ling, Xin Hu, Zhi-Ming Shao
Breast Cancer Research and Treatment.2019; 173(1): 225. CrossRef
Metastatic pattern discriminates survival benefit of primary surgery for de novo stage IV breast cancer: A real-world observational study
Kang Wang, Yang Shi, Zhu-Yue Li, Ye-Lei Xiao, Jie Li, Xiang Zhang, Hong-Yuan Li
European Journal of Surgical Oncology.2019; 45(8): 1364. CrossRef
The CXCL5/CXCR2 axis is sufficient to promote breast cancer colonization during bone metastasis
Ricardo Romero-Moreno, Kimberly J. Curtis, Thomas R. Coughlin, Maria Cristina Miranda-Vergara, Shourik Dutta, Aishwarya Natarajan, Beth A. Facchine, Kristen M. Jackson, Lukas Nystrom, Jun Li, William Kaliney, Glen L. Niebur, Laurie E. Littlepage
Nature Communications.2019;[Epub] CrossRef
Single-Agent Oral Vinorelbine as First-Line Chemotherapy for Endocrine-Pretreated Breast Cancer With Bone Metastases and No Visceral Involvement: NORBREAST-228 Phase II Study
Guenther G. Steger, Adriana Dominguez, Natalia Dobrovolskaya, Francesco Giotta, Nicole Tubiana-Mathieu, Martin Pecherstorfer, Antonio Ardizzoia, Maria Blasinska-Morawiec, Enrique Espinosa, Gustavo Villanova
Clinical Breast Cancer.2018; 18(1): e41. CrossRef
Differential presentation and survival of de novo and recurrent metastatic breast cancer over time: 1990–2010
Judith A. Malmgren, Musa Mayer, Mary K. Atwood, Henry G. Kaplan
Breast Cancer Research and Treatment.2018; 167(2): 579. CrossRef
Breast cancer bone metastases: pathogenesis and therapeutic targets
Naomi Brook, Emily Brook, Arun Dharmarajan, Crispin R. Dass, Arlene Chan
The International Journal of Biochemistry & Cell Biology.2018; 96: 63. CrossRef
Incidence, risk factors and prognostic characteristics of bone metastases and skeletal-related events (SREs) in breast cancer patients: A systematic review of the real world data
Hongwei Zhang, Wei Zhu, Ewelina Biskup, Weige Yang, Ziang Yang, Hong Wang, Xiaochun Qiu, Chengjiao Zhang, Guangxia Hu, Guangfu Hu
Journal of Bone Oncology.2018; 11: 38. CrossRef
Breast osteoblast-like cells: a new biomarker for the management of breast cancer
Manuel Scimeca, Nicoletta Urbano, Rita Bonfiglio, Orazio Schillaci, Elena Bonanno
British Journal of Cancer.2018; 119(9): 1129. CrossRef
Post-relapse survival in patients with the early and late distant recurrence in estrogen receptor-positive HER2-negative breast cancer
Akiko Ogiya, Kieko Yamazaki, Rie Horii, Tadahiko Shien, Yoshiya Horimoto, Norikazu Masuda, Touko Inao, Mitsuchika Hosoda, Naoko Ishida, Tomofumi Osako, Masato Takahashi, Yumi Endo, Yuichiro Miyoshi, Hiroyuki Yasojima, Nobumoto Tomioka, Hiroko Yamashita
Breast Cancer.2017; 24(3): 473. CrossRef
Pattern of metastatic spread and subcategories of breast cancer
Catharina Bartmann, Manfred Wischnewsky, Tanja Stüber, Roland Stein, Mathias Krockenberger, Sebastian Häusler, Wolfgang Janni, Rolf Kreienberg, Maria Blettner, Lukas Schwentner, Achim Wöckel, Joachim Diessner
Archives of Gynecology and Obstetrics.2017; 295(1): 211. CrossRef
Osteonecrosis of the Jaw in a Breast Cancer Patient Treated with Everolimus and a Single Dose of Zoledronic Acid
Claudia Omarini, Maria E. Filieri, Roberta Depenni, Giulia Grizzi, Stefano Cascinu, Federico Piacentini
The Breast Journal.2017; 23(5): 610. CrossRef
The critical role of the ZNF217 oncogene in promoting breast cancer metastasis to the bone
Aurélie Bellanger, Caterina F Donini, Julie A Vendrell, Jonathan Lavaud, Irma Machuca‐Gayet, Maëva Ruel, Julien Vollaire, Evelyne Grisard, Balázs Győrffy, Ivan Bièche, Olivier Peyruchaud, Jean‐Luc Coll, Isabelle Treilleux, Véronique Maguer‐Satta, Véroniqu
The Journal of Pathology.2017; 242(1): 73. CrossRef
Estrogen receptors in breast and bone: from virtue of remodeling to vileness of metastasis
I Bado, Z Gugala, S A W Fuqua, X H-F Zhang
Oncogene.2017; 36(32): 4527. CrossRef
Which red flags aid the early detection of metastatic bone disease in back pain?
Laura Finucane, Susan Greenhalgh, James Selfe
Physiotherapy Practice and Research.2017; 38(2): 73. CrossRef
Prognostic utility of FDG PET/CT and bone scintigraphy in breast cancer patients with bone-only metastasis
Soyeon Park, Joon-Kee Yoon, Su Jin Lee, Seok Yun Kang, Hyunee Yim, Young-Sil An
Medicine.2017; 96(50): e8985. CrossRef
Tolerability of Therapies Recommended for the Treatment of Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
Shinji Ohno
Clinical Breast Cancer.2016; 16(4): 238. CrossRef
Quality of life and symptom burden in patients with metastatic breast cancer
Christine Ecclestone, Ronald Chow, Natalie Pulenzas, Liying Zhang, Angela Leahey, Julia Hamer, Carlo DeAngelis, Gillian Bedard, Rachel McDonald, Anchal Bhatia, Janet Ellis, Eileen Rakovitch, Sherlyn Vuong, Edward Chow, Sunil Verma
Supportive Care in Cancer.2016; 24(9): 4035. CrossRef
Evaluation of clinical parameters influencing the development of bone metastasis in breast cancer
Joachim Diessner, Manfred Wischnewsky, Tanja Stüber, Roland Stein, Mathias Krockenberger, Sebastian Häusler, Wolfgang Janni, Rolf Kreienberg, Maria Blettner, Lukas Schwentner, Achim Wöckel, Catharina Bartmann
BMC Cancer.2016;[Epub] CrossRef
Prolactin receptor in breast cancer: marker for metastatic risk
Carrie S Shemanko
Journal of Molecular Endocrinology.2016; 57(4): R153. CrossRef
Clinical Characteristics and Outcome of Bone-Only Metastasis in Inflammatory and Noninflammatory Breast Cancers
Megumi Kai, Takahiro Kogawa, Diane D. Liu, Tamer M. Fouad, Kazuharu Kai, Naoki Niikura, Limin Hsu, Jie S. Willey, Richard L. Theriault, Vicente Valero, Naoto T. Ueno
Clinical Breast Cancer.2015; 15(1): 37. CrossRef
Loading Dose Ibandronate Versus Standard Oral Ibandronate in Patients With Bone Metastases From Breast Cancer
Iain R. Macpherson, Caroline Bray, Carol Hopkins, Rosemary A. Hannon, Liz-Anne Lewsley, Diana M. Ritchie, Peter Canney
Clinical Breast Cancer.2015; 15(2): 117. CrossRef
Assessing response to treatment of bone metastases from breast cancer: what should be the standard of care?
D.K. Woolf, A.R. Padhani, A. Makris
Annals of Oncology.2015; 26(6): 1048. CrossRef
Survival time according to the year of recurrence and subtype in recurrent breast cancer
Masahiro Nakano, Mamiko Fujisue, Rumiko Tashima, Yasuhiro Okumura, Yasuyuki Nishiyama, Tomofumi Ohsako, Yasuo Toyozumi, Nobuyuki Arima, Reiki Nishimura
The Breast.2015; 24(5): 588. CrossRef
Cases of Bone-only Metastasis in Recurrent Breast Cancer
Yoko MAEKAWA, Shintaro TAKAO, Koichi HIROKAGA, Mayuko MIKI, Sachiko YOSHIDA
Nihon Rinsho Geka Gakkai Zasshi (Journal of Japan Surgical Association).2014; 75(6): 1484. CrossRef
Efficacy of Exemestane in Korean Patients with Metastatic Breast Cancer after Failure of Nonsteroidal Aromatase Inhibitors
June Koo Lee, Seock-Ah Im, Daewon Lee, Ji-Yeon Kim, Yoojoo Lim, Eunyoung Lee, Hyeong-Gon Moon, Tae-Yong Kim, Sae-Won Han, Do-Youn Oh, Se-Hoon Lee, Wonshik Han, Dong-Wan Kim, Tae-You Kim, Dong-Young Noh
Journal of Breast Cancer.2013; 16(1): 66. CrossRef
Incidence, consequences and treatment of bone metastases in breast cancer patients—Experience from a single cancer centre
I. Kuchuk, B. Hutton, P. Moretto, T. Ng, C.L. Addison, M. Clemons
Journal of Bone Oncology.2013; 2(4): 137. CrossRef
Zooming in on the schedule of bone-modifying drugs
Miguel Martin, Sara López-Tarruella
The Lancet Oncology.2013; 14(7): 575. CrossRef
Bone metastases: assessment, management and treatment options
Carole Farrell
British Journal of Nursing.2013; 22(Sup7): S4. CrossRef
Limites de la scintigraphie osseuse dans le suivi des métastases osseuses du carcinome mammaire : étude du centre tunisien
K. Chatti, A. Harrabi, I. Chabchoub, T. Kamoun, R. Sfar, M. Nouira, M.B. Fredj, N. Ayachi, S.B. Ahmed, H. Essabbah
Médecine Nucléaire.2012; 36(10): 574. CrossRef

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