UNASSIGNED: (I) Establishment of expert group: the expert group consists of 32 experts from departments such as medical oncology, breast surgery, and pathology; (II) literature search: mainly conducted in English databases (such as PubMed, Embase, and Cochrane Library) and Chinese databases (such as China National Knowledge Infrastructure, China Biology Medicine disc, and Wanfang Database), with a search cutoff date of April 23, 2024; (III) assessment of evidence quality and recommendation strength: evidence quality and recommendation opinions are graded based on the evidence category and recommendation level of the Chinese Society of Clinical Oncology (CSCO) guidelines; (IV) consensus formulation: on the March 2, 2024, through online consensus meeting, the consensus content is thoroughly discussed, and opinions from all experts are solicited.
UNASSIGNED: The consensus meeting has resulted in 15 detailed recommendations, providing clearer guidance on the clinical application of immunotherapy in BC management. The core suggestions are as follows: for early-stage II-III TNBC and metastatic TNBC (mTNBC) in the first-line setting, programmed cell death protein 1 (PD-1) inhibitors can be considered. However, for hormone receptor-positive/human epidermal growth factor receptor 2-negative BC (HR+/HER2- BC), HER2+ BC, and mTNBC in later lines of therapy, evidence is lacking to support the use of immunotherapy.
UNASSIGNED: This consensus provides a comprehensive overview of BC immunotherapy, including immunotherapy for early-stage BC and late-stage BC, immune related adverse event (irAE) management, biomarkers of immunotherapy, and future directions. The consensus consolidates these deliberations into 15 evidence-based recommendations, serving as a practical guide for clinicians to more scientifically and systematically manage the clinical application of immunotherapy.
■(一)专家组成立:专家组由32名来自内科肿瘤等科室的专家组成,乳房手术,和病理学;(二)文献检索:主要在英文数据库(如PubMed,Embase,和Cochrane图书馆)和中文数据库(如中国国家知识基础设施,中国生物医药光盘,和万方数据库),搜索截止日期为2024年4月23日;(三)证据质量和推荐力度评估:根据中国临床肿瘤学会(CSCO)指南的证据类别和推荐水平对证据质量和推荐意见进行分级;(四)共识制定:2024年3月2日,通过在线共识会议,对共识内容进行了深入讨论,并征求所有专家的意见。
■共识会议提出了15项详细建议,为免疫治疗在BC管理中的临床应用提供更清晰的指导。核心建议如下:对于一线设置的早期II-III期TNBC和转移性TNBC(mTNBC),程序性细胞死亡蛋白1(PD-1)抑制剂可以考虑。然而,对于激素受体阳性/人表皮生长因子受体2阴性BC(HR/HER2-BC),HER2+BC,和mTNBC在后来的治疗中,缺乏支持使用免疫治疗的证据.
■这一共识提供了BC免疫治疗的全面概述,包括早期BC和晚期BC的免疫疗法,免疫相关不良事件(irAE)管理,免疫疗法的生物标志物,和未来的方向。协商一致意见将这些审议合并为15项基于证据的建议,作为临床医生更科学,更系统地管理免疫治疗的临床应用的实践指南。