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 immunotherapy as an 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.
Methods
Establishment of expert group: The expert group consists of 32 experts from departments such as medical oncology, breast surgery, and pathology.
Literature search: It is 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 the search cutoff date of April 23, 2024.
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.
Consensus formulation: On March 2, 2024, the content of the consensus was thoroughly discussed through an online consensus meeting, and opinions from all experts were solicited.
Results
The consensus put forward 15 detailed recommendations. The core suggestions are that programmed cell death protein 1 (PD - 1) inhibitors can be considered for early - stage II - III TNBC and first - line metastatic TNBC (mTNBC). However, there is insufficient evidence to support the application of immunotherapy in hormone receptor - positive/human epidermal growth factor receptor 2 - negative BC (HR⁺/HER2⁻ BC), HER2⁺ BC, and mTNBC in later - line therapy.
Conclusions
This consensus comprehensively covers the relevant content of breast cancer immunotherapy, including immunotherapy for early and advanced breast cancer, the management of immune - related adverse events, biomarkers of immunotherapy, and future development directions. These discussions are summarized into 15 evidence - based recommendations, which can help clinicians scientifically and systematically carry out the clinical application of immunotherapy.