中国实用外科杂志

中国实用外科杂志 ›› 2024, Vol. 44 ›› Issue (01): 98-102.DOI: 10.19538/j.cjps.issn1005-2208.2024.01.16

• 论著 • 上一篇    下一篇

中国118家三级医院早期HER2阳性乳腺癌新辅助治疗现状调查报告

辛    灵1，周思成1，江泽飞2，刘荫华1，中国临床肿瘤学会乳腺癌专业委员会，中华医学会外科学分会乳腺外科学组   

  1. 1北京大学第一医院甲状腺乳腺外科，北京100034；2中国人民解放军第五医学中心肿瘤内科，北京100039
  • 出版日期:2024-01-01 发布日期:2024-02-23

  • Online:2024-01-01 Published:2024-02-23

摘要： 目的    调查中国早期人类表皮生长因子受体2（HER2）阳性乳腺癌病人新辅助治疗现状。方法    采用问卷调查的方式，登记2023年1月1日至6月30日各医院经治的乳腺癌病例，调查内容包括病理实验室资质、HER2检测试剂、收治早期乳腺癌例数、HER2阳性乳腺癌例数、接受含抗HER2靶向药物的新辅助治疗例数和新辅助治疗结局。结果    全国13个省、自治区和直辖市118家三级医院参加调查并提供病例资料，包括99家综合性医院和19家肿瘤专科医院。其中85家（72%）医院具备病理实验室资质认证并使用经国家药品监督管理局批准的HER2检测试剂认证，33家（28%）医院未能提供病理实验室资质或检测试剂。118家医院共收治39 014例早期乳腺癌病例，其中，HER2阳性乳腺癌9160例，HER2阳性率23.5%。3222例（35.2%）病人接受了双靶方案新辅助治疗，病理完全缓解（pCR）率为51.3%。具有HER2检测资质认证的医院双靶新辅助治疗pCR率显著高于未提供资质认证医院（56.2% vs. 48.0%，P=0.046）。结论    规范和推广病理实验室资质及HER2检测试剂认证是改善乳腺癌临床同质化诊治水平的重要举措。

关键词: 乳腺癌, HER2阳性, 新辅助治疗, 病理质控

Abstract: A questionnaire-based investigation on the status of neoadjuvant therapy for early-stage HER2-positive breast cancer in 118 tertiary hospitals in China        XIN Ling*,ZHOU Si-cheng,JIANG Ze-fei，et al.*Department of Thyroid and Breast Surgery, Peking University First Hospital, Beijing100034, China
Corresponding authors：JIANG Ze-fei,E-mail:jiangzefei@csco.org.cn；LIU Yin-hua,E-mail:liuyinhua7520@163.com
XIN Ling and ZHOU Sicheng are the first authors who contributed equally to the article.
Abstract    Objective    To investigate the status of neoadjuvant therapy for early HER2-positive breast cancer in China.Methods    A questionnaire-based survey was conducted to investigate the treatment of patients with breast cancer from January 1，2023 to June 30，2023.The investigation content included the qualification of pathological department，certification of HER2 test reagent，the number of early breast cancer cases，the number of HER2-positive breast cancer cases，the number of cases receiving neoadjuvant therapy with anti-HER2 therapy and the pathological result after neoadjuvant therapy. Results    A total of 118 tertiary hospitals from 13 provinces participated in the investigation，including 99 general hospitals and 19 oncology hospitals.Among them，85 hospitals（72%）had both pathological department qualification and certificated HER2 test reagent approved by the National Medical Products Administration，and 33 hospitals（28%）failed to provide pathological department qualification or reagent certification.A total of 39014 cases of patients with early-stage breast cancer were admitted in 118 hospitals.9160（23.5%）cases were HER2-positive breast cancer.3222（35.2%）patients received neoadjuvant therapy with dual HER2-targeted regimen，with pCR rate of 51.3%.The pCR rate after neoadjuvant therapy with dual HER2-targeted regimen in hospitals with qualification was significantly higher than that those hospitals without certification（56.2% vs 48.0%，P=0.046）. Conclusion    To improve the qualification of pathological department and HER2 test certification is an important measure to achieve clinical homogenization of diagnosis and treatment for breast cancer.

Key words: breast cancer, HER2 positive, neoadjuvant therapy, pathological quality control