[1] |
Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2021,71(3):209-249.
|
[2] |
Chuaychai A, Sriplung H. A rapid rise in hormone receptor-positive and HER2-positive breast cancer subtypes in Southern Thai women: a population-based study in Songkhla[J]. PLoS One, 2022,17(3):e265417.
|
[3] |
Fendereski A, Hajizadeh E, Haghighat S, et al. Long-term outcomes of non-metastatic breast cancer patients by molecular subtypes[J]. BMC Womens Health, 2022,22(1):268.
|
[4] |
Pereira C, Martis M, D’Souza R, et al. Correlation of clinicopathological features of breast cancer with molecular subtypes taking ki-67 into consideration: single institution experience over 5 years[J]. Curr Health Sci J, 2021,47(3):348-352.
|
[5] |
Dang C, Ewer MS, Delaloge S, et al. BERENICE final analysis: cardiac safety study of neoadjuvant pertuzumab, trastuzumab, and chemotherapy followed by adjuvant pertuzumab and trastuzumab in HER2-positive early breast cancer[J]. Cancers (Basel), 2022,14(11):2596.
|
[6] |
Xu B, Li W, Zhang Q, et al. Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase Ⅲ,randomized, double-blind, placebo-controlled study[J]. Breast Cancer Res Treat, 2023,197(3):503-513.
|
[7] |
Shao Z, Tseng LM, Huang CS, et al. Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study[J]. Jpn J Clin Oncol, 2021,51(3):345-353.
|
[8] |
Arpino G, de la Haba-Rodriguez J, Ferrero JM, et al. Pertuzumab, trastuzumab, and an aromatase inhibitor for HER2-positive and hormone receptor-positive metastatic/locally advanced breast cancer: PERTAIN final analysis[J]. Clin Cancer Res, 2023,29(8):1468-1476.
|
[9] |
Xu B, Yan M, Ma F, et al. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial[J]. Lancet Oncol, 2021,22(3):351-360.
|
[10] |
Xie Y, Li Y, Ting L, et al. Pyrotinib plus vinorelbine versus lapatinib plus capecitabine in patients with previously treated HER2-positive metastatic breast cancer: a multicenter, retrospective study[J]. Front Oncol, 2021,11:699 333.
|
[11] |
Chan A, Moy B, Mansi J, et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase Ⅲ ExteNET trial[J]. Clin Breast Cancer, 2021,21(1):80-91.
|
[12] |
Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ib study[J]. J Clin Oncol, 2020,38(17):1887-1896.
|
[13] |
Tan R, Ong WS, Lee KH, et al. HER2 expression, copy number variation and survival outcomes in HER2-low non-metastatic breast cancer: an international multicentre cohort study and TCGA-METABRIC analysis[J]. BMC Med, 2022,20(1):105.
|
[14] |
Alves FR, Gil L, Vasconcelos DML, et al. Impact of human epidermal growth factor receptor 2 (HER2) low status in response to neoadjuvant chemotherapy in early breast cancer[J]. Cureus, 2022,14(2):e22330.
|
[15] |
Xin L, Wu Q, Zhan C, et al. Multicenter study of the clinicopathological features and recurrence risk prediction model of early-stage breast cancer with low-positive human epidermal growth factor receptor 2 expression in China (Chinese Society of Breast Surgery 021)[J]. Chin Med J (Engl), 2022,135(6):697-706.
|
[16] |
Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer[J]. J Clin Oncol, 2007,25(1):118-145.
|
[17] |
Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update [J]. Arch Pathol Lab Med, 2014,138(2):241-256.
|
[18] |
Wolff AC, Hammond ME, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline focused update[J]. Arch Pathol Lab Med, 2018,142(11):1364-1382.
|
[19] |
商久妍,刘畅,刘月平. 2019版乳腺癌HER-2检测指南对FISH可疑阳性病例判读及其预后分析[J]. 临床与实验病理学杂志,2021,37(9):1021-1025.
|
[20] |
Onsum MD, Geretti E, Paragas V, et al. Single-cell quantitative HER2 measurement identifies heterogeneity and distinct subgroups within traditionally defined HER2-positive patients[J]. Am J Pathol, 2013,183(5):1446-1460.
|
[21] |
Schettini F, Prat A. Dissecting the biological heterogeneity of HER2-positive breast cancer[J]. Breast, 2021,59:339-350.
|
[22] |
Paik S, Kim C, Wolmark N. HER2 status and benefit from adjuvant trastuzumab in breast cancer[J]. N Engl J Med, 2008,358(13):1409-1411.
|
[23] |
Perez EA, Reinholz MM, Hillman DW, et al. HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial[J]. J Clin Oncol, 2010,28(28):4307-4315.
|
[24] |
中国抗癌协会乳腺癌专业委员会. 中国抗癌协会乳腺癌诊治指南与规范(2021年版)[J]. 中国癌症杂志,2021,31(10):954-1040.
|
[25] |
Denkert C, Seither F, Schneeweiss A, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials[J]. Lancet Oncol, 2021,22(8):1151-1161.
|
[26] |
Mutai R, Barkan T, Moore A, et al. Prognostic impact of HER2-low expression in hormone receptor positive early breast cancer[J]. Breast, 2021,60:62-69.
|
[27] |
Li Y, Abudureheiyimu N, Mo H, et al. In real life, low-level HER2 expression may be associated with better outcome in HER2-negative breast cancer: a study of the national cancer center, China[J]. Front Oncol, 2022,11:774577.
|
[28] |
Agostinetto E, Rediti M, Fimereli D, et al. HER2-low breast cancer: molecular characteristics and prognosis[J]. Cancers (Basel), 2021,13(11):2824.
|
[29] |
Schettini F, Chic N, Braso-Maristany F, et al. Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer[J]. NPJ Breast Cancer, 2021,7(1):1.
|
[30] |
Gampenrieder SP, Rinnerthaler G, Tinchon C, et al. Landscape of HER2-low metastatic breast cancer (MBC): results from the Austrian AGMT_MBC-Registry[J]. Breast Cancer Res, 2021,23(1):112.
|
[31] |
Hein A, Hartkopf AD, Emons J, et al. Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status[J]. Eur J Cancer, 2021,155:1-12.
|
[32] |
Jacot W, Maran-Gonzalez A, Massol O, et al. Prognostic value of HER2-low expression in non-metastatic triple-negative breast cancer and correlation with other biomarkers[J]. Cancers (Basel), 2021,13(23):6059.
|
[33] |
Horisawa N, Adachi Y, Takatsuka D, et al. The frequency of low HER2 expression in breast cancer and a comparison of prognosis between patients with HER2-low and HER2-negative breast cancer by HR status.[J]. Breast Cancer, 2022,29(2):234-241.
|
[34] |
Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1[J]. Clin Cancer Res, 2016,22(20):5097-5108.
|
[35] |
Ogitani Y, Hagihara K, Oitate M, et al. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity[J]. Cancer Sci, 2016,107(7):1039-1046.
|
[36] |
Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer [J]. N Engl J Med, 2022,387(1):9-20.
|
[37] |
van der Lee MM, Groothuis PG, Ubink R, et al. The preclinical profile of the duocarmycin-based HER2-targeting ADC SYD985 predicts for clinical benefit in low HER2-expressing breast cancers[J]. Mol Cancer Ther, 2015,14(3):692-703.
|
[38] |
Banerji U, van Herpen C, Saura C, et al. Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study[J]. Lancet Oncol, 2019,20(8):1124-1135.
|
[39] |
Li L, Xu MZ, Wang L, et al. Conjugating MMAE to a novel anti-HER2 antibody for selective targeted delivery[J]. Eur Rev Med Pharmacol Sci, 2020,24(24):12929-12937.
|
[40] |
Chen Z, Yuan J, Xu Y, et al. From AVATAR mice to patients: RC48-ADC exerted promising efficacy in advanced gastric cancer with HER2 expression[J]. Front Pharmacol, 2022,12:757994.
|
[41] |
Wang J, Liu Y, Zhang Q, et al. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: A pooled analysis of two studies [J]. J Clin Oncol,2021,39(15_suppl):1022.
|
[42] |
Li H, Zhang X, Xu Z, et al. Preclinical evaluation of MRG002, a novel HER2-targeting antibody-drug conjugate with potent antitumor activity against HER2-positive solid tumors[J]. Antib Ther, 2021,4(3):175-184.
|
[43] |
Jiang Z, Sun T, Wang X, et al. A multiple center, open-label, single-arm, phase II clinical trial of MRG002, an HER2-targeted antibody-drug conjugate, in patients with HER2-low expressing advanced or metastatic breast cancer [J]. J Clin Oncol, 2022,40(16_suppl):1102.
|
[44] |
Nagaraja Shastri P, Zhu J, Skidmore L, et al. Nonclinical development of next-generation site-specific HER2-targeting antibody-drug conjugate (ARX788) for breast cancer treatment[J]. Mol Cancer Ther, 2020,19(9):1822-1832.
|
[45] |
Skidmore L, Sakamuri S, Knudsen NA, et al. ARX788, a site-specific anti-HER2 antibody-drug conjugate, demonstrates potent and selective activity in HER2-low and T-DM1-resistant breast and gastric cancers[J]. Mol Cancer Ther, 2020,19(9):1833-1843.
|
[46] |
Schmid P, Cortés J, Marmé F, et al. 214MO Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase Ⅲ TROPiCS-02 study[J]. Ann Oncol, 2022,33:S635-S636.
|
[47] |
Nordstrom J L, Gorlatov S, Zhang W, et al. Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties[J]. Breast Cancer Res, 2011,13(6):R123.
|
[48] |
Rugo HS, Im SA, Cardoso F, et al. Margetuximab versus trastuzumab in patients with previously treated her2-positive advanced breast cancer (SOPHIA): final overall survival results from a randomized phase 3 trial[J]. J Clin Oncol, 2023,41(2):198-205.
|
[49] |
Barbara P, Hans W, Erika P H, et al. Clinical activity of MCLA-128 (zenocutuzumab) in combination with endocrine therapy (ET) in ER+/HER2-low, non-amplified metastatic breast cancer (MBC) patients (pts) with ET-resistant disease who had progressed on a CDK4/6 inhibitor (CDK4/6i)[J]. J Clin Oncol, 2020,38(15_suppl):1037.
|
[50] |
Mittendorf EA, Lu B, Melisko M, et al. Efficacy and safety analysis of nelipepimut-S vaccine to prevent breast cancer recurrence: a randomized, multicenter, phase Ⅲ clinical trial[J]. Clin Cancer Res, 2019,25(14):4248-4254.
|
[51] |
Kan S, Koido S, Okamoto M, et al. Gemcitabine treatment enhances HER2 expression in low HER2-expressing breast cancer cells and enhances the antitumor effects of trastuzumab emtansine[J]. Oncol Rep, 2015,34(1):504-510.
|