Application consensus of peripheral blood HER2 gene amplification detection (digital PCR) in anti-HER2 therapy

doi:10.19401/j.cnki.1007-3639.2022.01.012

Abstract

CLC Number:

R737.9

LU Renquan, LIU Guangyu, YANG Wentao, GUO Lin, GUAN Ming, SHAO Zhimin, XU Dazhi, NI Ming, TANG Feng, WANG Chaofu, LOU Jiatao, SUN Fenyong, XING Jinliang, PAN Yueyin. Application consensus of peripheral blood HER2 gene amplification detection (digital PCR) in anti-HER2 therapy[J]. China Oncology, 2022, 32(1): 90-96.

Figures/Tables 2

References 25

[1]	中国医药教育协会乳腺癌个案管理师分会. 乳腺癌靶向药物静脉输注规范专家共识[J]. 中华医学杂志, 2021, 101(16): 1143-1148.
	China Association for Breast Cancer Case Management Division. Consensus on guidelines for intravenous infusion of targeted drugs in breast cancer[J]. Natl Med J China, 2021, 101(16): 1143-1148.
[2]	江泽飞, 邵志敏, 徐兵河. 人表皮生长因子受体2阳性乳腺癌临床诊疗专家共识[J]. 中华肿瘤杂志, 2010, 32(2): 158-160.
	JIANG ZEFEI, SHAO ZHIMIN, XU BINGHE. Consensus on clinical diagnosis and treatment of human epidermal growth factor receptor 2 positive breast cancer[J]. Chin J Oncol, 2010, 32(2): 158-160.
[3]	中国临床肿瘤学会乳腺癌专家委员会, 中国抗癌协会乳腺癌专业委员会. 人表皮生长因子受体2阳性乳腺癌临床诊疗专家共识(2021版)[J]. 中华医学杂志, 2021, 8(17): 1226-1231.
	Breast Cancer Expert Committee of Chinese Society of Clinical Oncology, Breast Cancer Professional Committee of Chinese Anti-Cancer Association. Consensus on clinical diagnosis and treatment of human epidermal growth factor receptor 2 positive breast cancer (2021 edition)[J]. Natl Med J China, 2021, 8(17): 1226-1231.
[4]	中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会乳腺癌诊疗指南2019[M]. 北京: 人民卫生出版社, 2019.
	Guidelines Working Committee of Chinese Society of Clinical Oncology. The breast cancer guidelines 2019 of Chinese Society of Clinical Oncology[M]. Beijing: People’s Med Publ House, 2019.
[5]	中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会乳腺癌诊疗指南2020[M]. 北京: 人民卫生出版社, 2019.
	Guidelines Working Committee of Chinese Society of Clinical Oncology. The breast cancer guidelines 2020 of Chinese Society of Clinical Oncology[M]. Beijing: People’s Med Publ House, 2019.
[6]	《乳腺癌HER2检测指南(2019版)》编写组. 乳腺癌HER2检测指南(2019版)[J]. 中华病理学杂志, 2019, 48(3): 169-175.
	Guideline for HER2 detection of breast cancer (2019 edition) compiling group. Guideline for HER2 detection of breast cancer (2019 edition)(2019版)[J]. Chin J Pathol, 2019, 48(3): 169-175.
[7]	WOLFF A C, HAMMOND M E H, ALLISON K H, et al. HER 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline focused update summary[J]. J Oncol Pract, 2018, 14(7): 437-441. doi: 10.1200/JOP.18.00206
[8]	张众, 王华新, 谢丰培. 乳腺癌异质性及其临床意义[J]. 临床与实验病理学杂志, 2014, 30(5): 473-477.
	ZHANG Z, WANG H X, XIE F P. Heterogeneity of breast cancer and its clinical significance[J]. Chin J Clin Exp Pathol, 2014, 30(5): 473-477.
[9]	王歆光, 刘毅强, 何英剑, 等. 同侧多原发灶乳腺癌病灶间异质性的研究[J]. 中国癌症杂志, 2017, 27(10): 809-814.
	WANG X G, LIU Y Q, HE Y J, et al. Intertumoral heterogeneity in patients with ipsilateral multifocal/multicentric breast cancer diagnosed by core needle biopsy[J]. China Oncol, 2017, 27(10): 809-814.
[10]	LOWER E E, GLASS E, BLAU R, et al. HER-2/neu expression in primary and metastatic breast cancer[J]. Breast Cancer Res Treat, 2009, 113(2): 301-306. doi: 10.1007/s10549-008-9931-6
[11]	HYUN C L, LEE H E, KIM K S, et al. The effect of chromosome 17 polysomy on HER-2/neu status in breast cancer[J]. J Clin Pathol, 2007, 61(3): 317-321. doi: 10.1136/jcp.2007.050336
[12]	DAWSON S J, TSUI D W, MURTAZA M, et al. Analysis of circulating tumor DNA to monitor metastatic breast cancer[J]. N Engl J Med, 2013, 368(13): 1199-1209. doi: 10.1056/NEJMoa1213261
[13]	中国抗癌协会肿瘤标志专业委员会遗传性肿瘤标志物协作组, 中国抗癌协会肿瘤标志专业委员会乳腺癌标志物协作组. 复发/转移性乳腺癌标志物临床应用专家共识(2019年版)[J]. 中国癌症防治杂志, 2019, 11(5): 363-374.
	Genetic Tumor Markers Collaborative Group of Tumor Markers Professional Committee of China Anti-Cancer Association, Breast Cancer Markers Collaborative Group of Tumor Markers Professional Committee of China Anti-Cancer Association. Expert consensus on clinical application of markers for recurrent/metastatic breast cancer (2019 edition)[J]. Chin J of Oncol Prev and Treat, 2019, 11(5): 363-374.
[14]	徐兵河, 王树森, 江泽飞, 等. 中国晚期乳腺癌维持治疗专家共识[J]. 中华医学杂志, 2018, 98(2): 87-90.
	XU B H, WANG S S, JIANG Z F, et al. Expert consensus on maintenance therapy for advanced breast cancer in China[J]. Natl Med J China, 2018, 98(2): 87-90.
[15]	ZHOU R F, YUAN P, ZHANG L H, et al. Using digital PCR to detect HER2 amplification in breast and gastric cancer patients[J]. Front Lab Med, 2018, 2(3): 102-108. doi: 10.1016/j.flm.2018.11.002
[16]	WHALE A S, HUGGETT J F, COWEN S, et al. Comparison of microfluidic digital PCR and conventional quantitative PCR for measuring copy number variation[J]. Nucleic Acids Res, 2012, 40(11): e82. doi: 10.1093/nar/gks203
[17]	母予馨, 张频, 马飞, 等. 乳腺癌原发灶和转移灶受体表达的异质性及其临床意义[J]. 中华肿瘤杂志, 2018, 40(7): 506-511.
	MU Y X, ZHANG P, MA F, et al. Heterogeneity of receptor expression in primary and metastatic breast cancer and its clinical significance[J]. Chin J Oncol, 2018, 40(7): 506-511.
[18]	YI Z B, YU P, ZHANG S, et al. Profile and outcome of receptor conversion in breast cancer metastases: a nation-wide multicenter epidemiological study[J]. Int J Cancer, 2021, 148(3): 692-701. doi: 10.1002/ijc.v148.3
[19]	MA C X, BOSE R, GAO F, et al. Neratinib efficacy and circulating tumor DNA detection of HER2 mutations in HER2 nonamplified metastatic breast cancer[J]. Clin Cancer Res, 2017, 23(19): 5687-5695. doi: 10.1158/1078-0432.CCR-17-0900
[20]	MA F, ZHU W J, GUAN Y F, et al. ctDNA dynamics: a novel indicator to track resistance in metastatic breast cancer treated with anti-HER2 therapy[J]. Oncotarget, 2016, 7(40): 66020-66031. doi: 10.18632/oncotarget.v7i40
[21]	GUAN X, LIU B, NIU Y, et al. Longitudinal HER2 amplification tracked in circulating tumor DNA for therapeutic effect monitoring and prognostic evaluation in patients with breast cancer[J]. Breast, 2020, 49: 261-266. doi: 10.1016/j.breast.2019.12.010
[22]	中国临床肿瘤学会抗肿瘤药物安全管理专家委员会, 中国抗癌协会胃癌专业委员会, 中国抗癌协会肿瘤病理专业委员会. HER2阳性晚期胃癌分子靶向治疗的中国专家共识(2016版)[J]. 临床肿瘤学杂志, 2016, 21(9): 831-389.
	Expert Committee on Safety Management of Anti-Tumor Drugs of Chinese Society of Clinical Oncology, Gastric Cancer Professional Committee of China Anti-Cancer Association, Tumor Pathology Professional Committee of China Anti-Cancer Association. Chinese expert consensus on molecular targeted therapy for HER2 positive advanced gastric cancer (2016 edition)[J]. Chin Clin Oncol, 2016, 21(9): 831-389.
[23]	BANG Y J, VAN CUTSEM E, FEYEREISLOVA A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial[J]. Lancet, 2010, 376(9742): 687-697. doi: 10.1016/S0140-6736(10)61121-X
[24]	TSURUTANI J, IWATA H, KROP I, et al. Targeting HER2 with trastuzumab deruxtecan: a dose-expansion, phase Ⅰ study in multiple advanced solid tumors[J]. Cancer Discov, 2020, 10(5): 688-701. doi: 10.1158/2159-8290.CD-19-1014
[25]	HURVITZ S A, MARTIN M, SYMMANS W F, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial[J]. Lancet Oncol, 2018, 19(1): 115-126. doi: 10.1016/S1470-2045(17)30716-7

Detection result of dPCR	Detection results of gold standard for tissue sample detection (ICH combined with FISH)		Total
Detection result of dPCR	Positive	Negative	Total
Positive	42	20	62
Negative	54	106	160
Total	96	126	222

Item	Newly diagnosed stage Ⅲ patients (n=70)	Newly diagnosed stage Ⅳ patients (n=93)	Patients with recurrence and metastasis (n=59)
Sensitivity	37.93% (11/29)	41.67% (15/36)	51.61% (16/31)
Specificity	92.68% (38/41)	85.96% (49/57)	67.86% (19/28)
Total consistent rate	70.00% (49/70)	68.82% (64/93)	59.32% (35/59)
Kappa	0.331 2	0.296 0	0.192 7

Application consensus of peripheral blood HER2 gene amplification detection (digital PCR) in anti-HER2 therapy

RichHTML

PDF

Knowledge

Abstract

Cite this article

share this article

Figures/Tables 2

References 25

Related Articles 15

Recommended Articles

Metrics

Comments

[1]	Committee of Integrated Rehabilitation for Urogenital Tumors, Chinese Anti-Cancer Association. Chinese expert consensus on perioperative integrated rehabilitation for radical prostatectomy (2024 edition) [J]. China Oncology, 2024, 34(9): 890-902.
[2]	Cancer Assessment Society of China Anti-Cancer Association, Cancer Pain Society of Fujian Anti-Cancer Association. Chinese expert consensus on whole-process management of oxaliplatin-induced hypersensitivity reactions (2024 edition) [J]. China Oncology, 2024, 34(8): 785-805.
[3]	Cancer Nuclear Medicine Committee of China Anti-Cancer Association, Chinese Association of Nuclear Medicine Physicians. Expert consensus of ¹⁷⁷Lu-labeled PSMA radioligand therapy for clinical practice of prostate cancer (2024 edition) [J]. China Oncology, 2024, 34(7): 702-714.
[4]	Urologic Chinese Oncology Group. Expert consensus on early diagnosis and treatment of bladder cancer (2024 edition) [J]. China Oncology, 2024, 34(6): 607-618.
[5]	Professional Committee on Gastric Cancer of Shanghai Anticancer Association , Professional Committee on Gastrointestinal Cancer of China Association for Promotion of Health Science and Technology . Chinese expert consensus on clinical practice of locally advanced gastric cancer invading adjacent organs (2024 edition) [J]. China Oncology, 2024, 34(5): 517-526.
[6]	GUO Ye, ZHANG Chenping. Expert consensus on immune checkpoint inhibitors treatment for recurrent/metastatic head and neck squamous cell carcinoma (2024 edition) [J]. China Oncology, 2024, 34(4): 425-438.
[7]	Committee of Breast Cancer Society, China Anti-Cancer Association. Expert consensus on clinical applications of ovarian function suppression for Chinese women with early breast cancer (2024 edition) [J]. China Oncology, 2024, 34(3): 316-333.
[8]	WANG Zhaobu, LI Xing, YU Xinmiao, JIN Feng. Important research progress in clinical practice for early breast cancer in 2023 [J]. China Oncology, 2024, 34(2): 151-160.
[9]	China Anti-Cancer Association Tumor Biomarker Professional Committee, Shanghai Anti-Cancer Association Tumor Biomarker Professional Committee. Expert consensus on population-based BRCA germline mutation screening in China (2024 edition) [J]. China Oncology, 2024, 34(2): 220-238.
[10]	WANG Shanshan, YE Dingwei, YANG Li, CHENG Fan, YANG Tiejun, ZHANG Xiaoping, YU Zhixian, ZHANG Qingyun, YANG Yong. Correlation of HER2 expression and clinicopathological characteristics in patients with urothelial carcinoma in China [J]. China Oncology, 2024, 34(11): 1011-1019.
[11]	ZHAO Junxiu, ZHU Yi, SONG Xiaoyu, ZHE Chao, XIAO Yuhan, LIU Yunduo, LI Linhai, XIAO Bin. Circ-0007766 acts as a miR-1972 sponge to promote breast cancer cell migration and invasion via upregulation of HER2 [J]. China Oncology, 2024, 34(10): 915-930.
[12]	Cancer Rehabilitation and Palliative Professional Committee of Shanghai Anti-Cancer Association , Cancer Drug Clinical Research Committee of Shanghai Anti-Cancer Association , Cancer Prevention and Clinical Research Committee of Chinese Aging Well Association . Shanghai expert consensus on whole-process management of antineoplastic-induced nausea and vomiting (2024 edition) [J]. China Oncology, 2024, 34(1): 104-134.
[13]	XUE Liqiong, GUO Ye, CHEN Libo. Expert consensus on the management of adverse events in patients receiving targeted agents for advanced thyroid cancer (2023 edition) [J]. China Oncology, 2023, 33(9): 879-888.
[14]	KANG Yinnan, CHEN Shun, XIE Youcheng, ZHENG Ying, HE Yujing, LI Chuyi, YU Xiaohui. Application and research progress of antibody drug conjugates in HER2 positive advanced gastric cancer [J]. China Oncology, 2023, 33(8): 790-800.
[15]	WANG Ruoxi, JI Peng, GONG Yue, CHEN Sheng. Response rate and clinical outcome of HER2-low breast cancer after neoadjuvant therapy: a single-center retrospective study [J]. China Oncology, 2023, 33(7): 686-692.