[1]
|
Sung, H., Ferlay, J., Siegel, R.L., et al. (2021) Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, 71, 209-249.
https://doi.org/10.3322/caac.21660
|
[2]
|
Schechter, A.L., Hung, M.C., et al. (1985) The Neu Gene: An erbB-Homologous Gene Distinct from and Unlinked to the Gene Encoding the EGF Receptor. Science, 229, 976-978. https://doi.org/10.1126/science.2992090
|
[3]
|
Xu, Y., Wang, Y., Gong, J., et al. (2021) Phase I Study of the Re-combinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate RC48-ADC in Patients with HER2-Positive Advanced Solid Tumors. Gastric Cancer, 24, 913-925. https://doi.org/10.1007/s10120-021-01168-7
|
[4]
|
Modi, S., Park, H., Murthy, R.K., et al. (2020) Antitumor Activ-ity and Safety of Trastuzumab Deruxtecan in Patients with HER-2-Low-Expressing Advanced Breast Cancer: Results from a Phase Ib Study. Journal of Clinical Oncology, 38, 1887-1896. https://doi.org/10.1200/JCO.19.02318
|
[5]
|
Banerji, U., van Herpen, C.M.L., Saura, C., et al. (2019) Trastuzumab Duocarmazine in Locally Advanced and Metastatic Solid Tumours and HER-2-Expressing Breast Cancer: A Phase 1 Dose-Escalation and Dose-Expansion Study. The Lancet Oncology, 20, 1124-1135. https://doi.org/10.1016/S1470-2045(19)30328-6
|
[6]
|
Hanna, W.M. and Kwok, K. (2006) Chromogenic In-Situ Hybridization: A Viable Alternative to Fluorescence In-Situ Hybridization in the HER-2 Testing Algorithm. Modern Pa-thology, 19, 481-487.
https://doi.org/10.1038/modpathol.3800555
|
[7]
|
张瑰红, 施达仁, 梁晓曼, 等. 显色原位杂交和免疫组织化学检测乳腺癌HER-2/neu基因状况和蛋白表达的对照性研究[J]. 中华病理学杂志, 2006, 35(10): 580-583.
|
[8]
|
应建明, 郭蕾, 刘秀云, 等. 全自动银增强原位杂交检测乳腺癌患者人表皮生长因子受体2基因状态[J]. 中华医学杂志, 2010, 90(24): 1674-1677.
|
[9]
|
许燕, 杨文涛, 杨飞, 等. 双色银染原位杂交与荧光原位杂交在乳腺癌HER-2基因状态评估中的比较[J]. 中华病理学杂志, 2014, 43(4): 226-230.
|
[10]
|
Wolff, A.C., Hammond, M.E.H., Allison, K.H., et al. (2018) Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Journal of Clinical Oncology, 36, 2105-2122. https://doi.org/10.1200/JCO.2018.77.8738
|
[11]
|
Murthy, R.K., Loi, S., Okines, A., et al. (2020) Tucatinib, Trastuzumab, and Capecitabine for HER-2-Positive Metastatic Breast Cancer. The New England Jour-nal of Medicine, 382, 597-609. https://doi.org/10.1056/NEJMoa1914609
|
[12]
|
Tarantino, P., Hamilton, E., Tolaney, S.M., et al. (2020) HER-2-Low Breast Cancer: Pathological and Clinical Landscape. Journal of Clinical Oncology, 38, 1951-1962. https://doi.org/10.1200/JCO.19.02488
|
[13]
|
刘月平, 薛卫成, 杨文涛, 步宏. 乳腺癌HER-2低表达病理检测进展及挑战[J]. 中华病理学杂志, 2022, 51(9): 799-802.
|
[14]
|
《乳腺癌HER-2检测指南(2019版)》编写组. 乳腺癌HER-2检测指南(2019版) [J]. 中华病理学杂志, 2019, 48(3): 169-175.
|
[15]
|
Schalper, K.A., Kumar, S., Hui, P., et al. (2014) A Retrospective Population-Based Comparison of HER-2 Immunohistochemistry and Fluorescence in Situ Hybridization in Breast Carcinomas: Impact of 2007 American Society of Clinical Oncology/College of American Pathologists Criteria. Archives of Pathology & Laboratory Medicine, 138, 213-219. https://doi.org/10.5858/arpa.2012-0617-OA
|
[16]
|
Fernandez, A.I., Liu, M., Bellizzi, A., et al. (2022) Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue. JAMA Oncology, 8, 607-614. https://doi.org/10.1001/jamaoncol.2021.7239
|
[17]
|
Schettini, F., Chic, N., Brasó-Maristany, F., et al. (2021) Clini-cal, Pathological, and PAM50 Gene Expression Features of HER-2-Low Breast Cancer. NPJ Breast Cancer, 7, 1. https://doi.org/10.1038/s41523-020-00208-2
|
[18]
|
Lim, S.K., Lee, M.H., Park, I.H., et al. (2016) Impact of Molec-ular Subtype Conversion of Breast Cancers after Neoadjuvant Chemotherapy on Clinical Outcome. Cancer Research and Treatment, 48, 133-141.
https://doi.org/10.4143/crt.2014.262
|
[19]
|
白冰, 张艾佳, 郭新, 等. HER2低表达乳腺癌的临床病理特征和预后因素分析[J]. 中国医科大学学报, 2023, 52(6): 494-498.
|
[20]
|
Prat, A., Bardia, A., Curigliano, G., et al. (2022) An Overview of Clinical Development of Agents for Metastatic or Advanced Breast Cancer without ERBB2 Amplification (HER2-Low). JAMA Oncology.
https://doi.org/10.1001/jamaoncol.2022.4175
|
[21]
|
Denkert, C., Seither, F., Schneeweiss, A., et al. (2021) Clinical and Molecular Characteristics of HER-2-Low-Positive Breast Cancer: Pooled Analysis of Individual Patient Data from Four Prospective, Neoadjuvant Clinical Trials. The Lancet Oncology, 22, 1151-1161. https://doi.org/10.1016/S1470-2045(21)00301-6
|
[22]
|
Zhang, H., Katerji, H., Turner, B.M., et al. (2022) HER-2-Low Breast Cancers: Incidence, HER-2 Staining Patterns, Clinicopathologic Features, MammaPrint and Blue-Print Genomic Profiles. Modern Pathology, 35, 1075-1082.
https://doi.org/10.1038/s41379-022-01019-5
|
[23]
|
Alves, F.R., Gil, L., Vasconcelos de Matos, L., et al. (2022) Im-pact of Human Epidermal Growth Factor Receptor 2 (HER-2) Low Status in Response to Neoadjuvant Chemotherapy in Early Breast Cancer. Cureus, 14, e22330.
https://doi.org/10.7759/cureus.22330
|
[24]
|
Li, Y., Abudureheiyimu, N., Mo, H., et al. (2022) In Real Life, Low-Level HER-2 Expression May Be Associated with Better Outcome in HER-2-Negative Breast Cancer: A Study of the National Cancer Center, China. Frontiers in Oncology, 11, Article ID: 774577. https://doi.org/10.3389/fonc.2021.774577
|
[25]
|
Gilcrease, M.Z., Woodward, W.A., Nicolas, M.M., et al. (2009) Even Low-Level HER-2 Expression May Be Associated with Worse Outcome in Node-Positive Breast Cancer. The American Journal of Surgical Pathology, 33, 759- 767. https://doi.org/10.1097/PAS.0b013e31819437f9
|
[26]
|
Agostinetto, E., Rediti, M., Fimereli, D., et al. (2021) HER-2-Low Breast Cancer: Molecular Characteristics and Prognosis. Cancers (Basel), 13, Article No. 2824. https://doi.org/10.3390/cancers13112824
|
[27]
|
Fehrenbacher, L., Cecchini, R.S., Geyer, C.E., et al. (2020) NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy with or without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER-2 by FISH and with IHC 1+ or 2. Journal of Clinical Oncology, 38, 444-453.
https://doi.org/10.1200/JCO.19.01455
|
[28]
|
Ergun, Y., Ucar, G. and Akagunduz, B. (2023) Comparison of HER-2-Zero and HER-2-Low in Terms of Clinicopathological Factors and Survival in Early-Stage Breast Cancer: A Systematic Review and Meta-Analysis. Cancer Treatment Reviews, 115, Article ID: 102538. https://doi.org/10.1016/j.ctrv.2023.102538
|
[29]
|
Rossi, V., Sarotto, I., Maggiorotto, F., et al. (2012) Moderate Im-munohistochemical Expression of HER-2 (2+) without HER-2 Gene Amplification Is a Negative Prognostic Factor in Early Breast Cancer. Oncologist, 17, 1418-1425.
https://doi.org/10.1634/theoncologist.2012-0194
|
[30]
|
Wang, J., Xu, B., Yuan, P., et al. (2014) HER-2 as a Predic-tive Factor for Successful Neoadjuvant Anthracycline Chemotherapy of Locally Advanced and Early Breast Cancer. The International Journal of Biological Markers, 29, e187- e192. https://doi.org/10.5301/jbm.5000094
|
[31]
|
Pinhel, I., Hills, M., Drury, S., Salter, J., et al. (2012) ER and HER-2 Expression Are Positively Correlated in HER-2 Non-Overexpressing Breast Cancer. Breast Cancer Research, 14, R46. https://doi.org/10.1186/bcr3145
|
[32]
|
Zhang, G., Ren, C., Li, C., et al. (2022) Distinct Clinical and Somatic Muta-tional Features of Breast Tumors with High-, Low-, or Non-Expressing Human Epidermal Growth Factor Receptor 2 Status. BMC Medicine, 20, Article No. 142. https://doi.org/10.1186/s12916-022-02346-9
|
[33]
|
Horisawa, N., Adachi, Y., Takatsuka, D., et al. (2022) The Frequency of Low HER-2 Expression in Breast Cancer and a Comparison of Prognosis between Patients with HER-2-Low and HER-2-Negative Breast Cancer by HR Status. Breast Cancer, 29, 234-241. https://doi.org/10.1007/s12282-021-01303-3
|
[34]
|
Pegram, M., Hsu, S., Lewis, G., et al. (1999) Inhibito-ry Effects of Combinations of HER-2/Neu Antibody and Chemotherapeutic Agents Used for Treatment of Human Breast Cancers. Oncogene, 18, 2241-2251.
https://doi.org/10.1038/sj.onc.1202526
|
[35]
|
Friess, T.S. and Bauer, A.M.B. (2002) In Vivo Activity of Recombi-nant Humanized Monoclonal Antibody 2C4 in Xenografts Is Independent of Tumor Type and Degree of HER-2 Over-expression. European Journal of Cancer, 38, S149.
https://doi.org/10.1016/S0959-8049(02)81150-9
|
[36]
|
Gianni, L., Lladó, A., Bianchi, G., et al. (2010) Open-Label, Phase II, Multicenter, Randomized Study of the Efficacy and Safety of Two Dose Levels of Pertuzumab, a Human Epi-dermal Growth Factor Receptor 2 Dimerization Inhibitor, in Patients with Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. Journal of Clinical Oncology, 28, 1131-1137. https://doi.org/10.1200/JCO.2009.24.1661
|
[37]
|
Beck, A., Goetsch, L., Dumontet, C., et al. (2017) Strategies and Challenges for the Next Generation of Antibody-Drug Conjugates. Nature Reviews Drug Discovery, 16, 315-337. https://doi.org/10.1038/nrd.2016.268
|
[38]
|
Ferraro, E., Drago, J.Z. and Modi, S. (2021) Implementing Anti-body-Drug Conjugates (ADCs) in HER-2-Positive Breast Cancer: State of the Art and Future Directions. Breast Cancer Research, 23, Article No. 84.
https://doi.org/10.1186/s13058-021-01459-y
|
[39]
|
Burris, H.A., Tibbitts, J., Holden, S.N., et al. (2011) Trastuzumab Emtansine (T-DM1): A Novel Agent for Targeting HER-2+ Breast Cancer. Clinical Breast Cancer, 11, 275-282. https://doi.org/10.1016/j.clbc.2011.03.018
|
[40]
|
Verma, S., Miles, D., Gianni, L., et al. (2012) Trastuzumab Emtansine for HER-2-Positive Advanced Breast Cancer. The New England Journal of Medicine, 367, 1783-1791. https://doi.org/10.1056/NEJMoa1209124
|
[41]
|
Yver, A., Agatsuma, T. and Soria, J.C. (2020) The Art of Innovation: Clinical Development of Trastuzumab Deruxtecan and Redefining How Antibody-Drug Conjugates Target HER-2-Positive Cancers. Annals of Oncology, 31, 430- 434. https://doi.org/10.1016/j.annonc.2019.11.019
|
[42]
|
Sahin, U., Hartmann, F., Senter, P., Pohl, C., Engert, A., Diehl, V. and Pfreundschuh, M. (1990) Specific Activation of the Prodrug Mitomycin Phosphate by a Bispecific An-ti-CD30/Anti-Alkaline Phosphatase Monoclonal Antibody. Cancer Research, 50, 6944-6948.
|
[43]
|
Tadokoro, J., Kakihata, K., Shimazaki, M., et al. (2011) Post-Marketing Surveillance (PMS) of All Patients Treated with Irinotecan in Japan: Clinical Experience and ADR Profile of 13,935 Patients. Japanese Journal of Clinical Oncology, 41, 1101-1111. https://doi.org/10.1093/jjco/hyr105
|
[44]
|
van der Lee, M.M., Groothuis, P.G., Ubink, R., et al. (2015) The Preclini-cal Profile of the Duocarmycin-Based HER-2-Targeting ADC SYD985 Predicts for Clinical Benefit in Low HER-2-Expressing Breast Cancers. Molecular Cancer Therapeutics, 14, 692-703. https://doi.org/10.1158/1535-7163.MCT-14-0881-T
|
[45]
|
Zhu, Y., Zhu, X., Wei, X., et al. (2021) HER-2-Targeted Therapies in Gastric Cancer. Biochimica et Biophysica Acta (BBA)—Reviews on Cancer, 1876, Article ID: 188549. https://doi.org/10.1016/j.bbcan.2021.188549
|
[46]
|
Wang, J.Y., et al. (2021) RC48-ADC, a HER-2-Targeting Anti-body-Drug Conjugate, in Patients with HER-2-Positive and HER-2-Low Expressing Advanced or Metastatic Breast Cancer: A Pooled Analysis of Two Studies. Journal of Clinical Oncology, 39, 1022-1022. https://doi.org/10.1200/JCO.2021.39.15_suppl.1022
|
[47]
|
Shi, F., Liu, Y., Zhou, X., et al. (2022) Disitamab Ve-dotin: A Novel Antibody-Drug Conjugates for Cancer Therapy. Drug Delivery, 29, 1335-1344. https://doi.org/10.1080/10717544.2022.2069883
|
[48]
|
Le Joncour, V., Martins, A., Puhka, M., et al. (2019) A Novel Anti-HER-2 Antibody-Drug Conjugate XMT-1522 for HER-2-Positive Breast and Gastric Cancers Resistant to Trastuzumab Emtansine. Molecular Cancer Therapeutics, 18, 1721-1730. https://doi.org/10.1158/1535-7163.MCT-19-0207
|
[49]
|
Hamilton, E.P., et al. (2018) Phase 1 Dose Escalation of XMT-1522, a Novel HER-2-Targeting Antibody-Drug Conjugate (ADC), in Patients (pts) with HER-2-Expressing Breast, Lung and Gastric Tumors. Journal of Clinical Oncology, 36, 2546-2546.
|
[50]
|
Modi, S., et al. (2019) A Phase III, Multicenter, Randomized, Open Label Trial of [fam-] Trastuzumab Deruxtecan (DS-8201a) versus Investigator’s Choice in HER-2-Low Breast Cancer. Journal of Clinical Oncology, 37, TPS1102.
https://doi.org/10.1200/JCO.2019.37.15_suppl.TPS1102
|
[51]
|
Bardia, A., et al. (2021) Trastuzumab Deruxtecan (T-DXd, DS-8201) vs Investigator’s Choice of Chemotherapy in Patients with Hormone Receptor-Positive (HR+), HER-2 Low Metastatic Breast Cancer Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting: A Randomized, Global Phase 3 Trial (DESTINY-Breast06). Cancer Research, 81, OT-03-09. https://doi.org/10.1158/1538-7445.SABCS20-OT-03-09
|
[52]
|
朱艺, 肖斌, 刘嘉慧, 等. Circ-0003910在HER-2阳性乳腺癌中的表达、定位、生物学作用及蛋白质组学研究[J]. 中国癌症杂志, 2022, 32(10): 979-989. https://doi.org/10.19401/j.cnki.1007-3639.2022.10.006
|
[53]
|
Fehrenbacher, L., Cecchini, R.S., Geyer, C.E., et al. (2019) NSABP B-47/NRG Oncology Phase II Randomized Trial Comparing Adjuvant Chemotherapy with or without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER-2 by FISH and with IHC 1+ or 2.
|
[54]
|
Xu, K., Bayani, J., Mallon, E., et al. (2022) Discordance between Immunohistochemistry and Erb-B2 Receptor Tyrosine Kinase 2 mRNA to Determine Human Epidermal Growth Factor Receptor 2 Low Status for Breast Cancer. The Journal of Molec-ular Diagnostics, 24, 775-783. https://doi.org/10.1016/j.jmoldx.2022.04.002
|
[55]
|
Hicks, D.G., Buscaglia, B., Goda, H., et al. (2018) A Novel Detection Methodology for HER-2 Protein Quantitation in Formalin-Fixed, Paraffin Embedded Clinical Samples Using Fluorescent Nanoparticles: An Analytical and Clinical Validation Study. BMC Can-cer, 18, Article No. 1266. https://doi.org/10.1186/s12885-018-5172-1
|
[56]
|
Harigopal, M., Barlow, W.E., Tedeschi, G., et al. (2010) Multiplexed Assessment of the Southwest Oncology Group-Directed Intergroup Breast Cancer Trial S9313 by AQUA Shows That both High and Low Levels of HER-2 Are Associated with Poor Outcome. The American Journal of Pathology, 176, 1639-1647.
https://doi.org/10.2353/ajpath.2010.090711
|
[57]
|
Won, H.S., Ahn, J., Kim, Y., et al. (2022) Clinical Significance of HER-2-Low Expression in Early Breast Cancer: A Nationwide Study from the Korean Breast Cancer Society. Breast Cancer Research, 24, Article No. 22.
https://doi.org/10.1186/s13058-022-01519-x
|