Li Jianbin, Hao Chunfang, Wang Kun, Zhang Jian, Chen Jiayi, Liu Yueping, Nie Jianyun, Yan Min, Liu Qiang, Geng Cuizhi, Wang Xiaojia, Wang Haibo, Wang Shusen, Wu Jiong, Yin Yongmei, Song Erwei, Jiang Zefei
Senior Department of Oncology, Fifth Medical Center of PLA General Hospital, Beijing, China.
Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Transl Breast Cancer Res. 2024 Jul 25;5:18. doi: 10.21037/tbcr-24-31. eCollection 2024.
Developing guidelines for the diagnosis and treatment of common cancers in China based on the evidence-based practice, the availability of diagnosis and treatment products, and the up-to-date advances in precision medicine is one of the basic tasks of the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Committee.
Protocols with high evidence level and good availability are used as the Level I recommendations; protocols with relatively high evidence level but slightly lower expert consensus or with poor availability are used as the Level II recommendations; and protocols that are clinically applicable but with low evidence level are regarded as the Level III recommendations. Based on the findings of clinical research at home and abroad and the opinions of CSCO BC experts, the CSCO BC guidelines determine the levels of recommendations for clinical application.
For human epidermal growth factor receptor 2 (HER2)-positive breast cancer, a combination of trastuzumab and pertuzumab regimen were recommended as Level I recommendation for neoadjuvant and first line metastatic breast cancer. Pyrotinib is also recommended as Level I recommendation in first line and second line therapy according to the latest studies conducted in China. Antibody drug conjugates was also recommended for patients with trastuzumab progression. For triple negative breast cancer, immunotherapy in early and metastatic breast cancer was highlighted and listed as new chapters in this version of guideline. For hormone receptor (HR)-positive breast cancer, cyclin dependent kinase 4/6 (CDK4/6) was recommended in different stages, especially in adjuvant therapy. There was also a new chapter for HER2-low breast cancer stratified by HR status.
We firmly believe that evidence-based, availability-concerned, and consensus-based guidelines will be more feasible for clinical practice in China and in other countries with similar situations.
基于循证实践、诊断和治疗产品的可及性以及精准医学的最新进展，制定中国常见癌症的诊断和治疗指南是中国临床肿瘤学会乳腺癌（CSCO BC）委员会的基本任务之一。
具有高证据水平和良好可及性的方案用作I级推荐；证据水平相对较高但专家共识稍低或可及性较差的方案用作II级推荐；临床适用但证据水平较低的方案视为III级推荐。基于国内外临床研究结果以及CSCO BC专家的意见，CSCO BC指南确定临床应用的推荐级别。
对于人表皮生长因子受体2（HER2）阳性乳腺癌，曲妥珠单抗和帕妥珠单抗联合方案被推荐作为新辅助和一线转移性乳腺癌的I级推荐。根据中国开展的最新研究，吡咯替尼在一线和二线治疗中也被推荐为I级推荐。对于曲妥珠单抗进展的患者，也推荐使用抗体药物偶联物。对于三阴性乳腺癌，早期和转移性乳腺癌的免疫治疗被重点突出，并在本版指南中列为新章节。对于激素受体（HR）阳性乳腺癌，细胞周期蛋白依赖性激酶4/6（CDK4/6）在不同阶段被推荐，尤其是在辅助治疗中。对于按HR状态分层的HER2低表达乳腺癌也有新章节。
我们坚信，基于证据、关注可及性且基于共识的指南对中国及其他情况类似国家的临床实践将更具可行性。
