PDF(Pubmed)
Abstract：
UNASSIGNED: Significant progress has been made in immunotherapy of breast cancer (BC) with the approval of multiple immune checkpoint inhibitors (ICIs), particularly in early and metastatic triple-negative breast cancer (TNBC) settings. Most guidelines have recommended immune therapy as the important approach in BC, yet several critical aspects still require further clarification, including proper patient selection, treatment duration, optimized chemotherapy partner, predictive biomarkers, and specific considerations for Chinese patients.
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.
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.
摘要：
■随着多种免疫检查点抑制剂（ICIs）的批准，乳腺癌（BC）的免疫治疗取得了重大进展，特别是在早期和转移性三阴性乳腺癌（TNBC）设置。大多数指南都推荐免疫疗法作为BC的重要方法，然而，几个关键方面仍需要进一步澄清，包括适当的病人选择，治疗持续时间,优化的化疗伙伴，预测性生物标志物，以及对中国患者的具体考虑。
■(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。
■(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。
