Background: The treatment landscape in HR+/HER2− metastatic breast cancer (mBC) is continuously evolving, with evidence on new agents and combinations published almost every year. Despite updated therapeutic guidelines, second-line (2L) selection may be challenging due to clinical factors, biomarker status, and available agents.Methods: A two-round Delphi consensus was organized in July 2024, gathering input from 10 experts in research, diagnosis, and treatment of HR+/HER2− mBC on optimal 2L and beyond choice, considering the available biomarkers and results from published clinical trials. Consensus was defined as 70% agreement or disagreement.Results: The experts considered initially a list of 39 statements, structured into the following four sections: biomarker testing; selection of 2L treatment at progression of disease on first line endocrine therapy (ET) + CDK4/6i at ≥6 months after initiation of ET for mBC; selection of 2L treatment at disease progression on ET + CDK4/6i, at <6 months after initiation of ET for mBC, whilst on ET; and selection of post-2L treatment options. After a discussion, the experts decided to remove four statements, refine ten, and include three new ones. The final list consisted of 38 statements, and consensus was achieved in 37.Conclusions: The panel recommends next-generation sequencing as the method of choice for genomic characterization at disease progression on first line. The optimal agent or treatment class is indicated depending on the presence of specific mutations; however, the panel admits that the strategy is different in clinical practice, where novel therapies might not be available or reimbursed.
背景：HR+/HER2−转移性乳腺癌的治疗格局持续演变，每年均有新药及联合方案的研究证据发表。尽管治疗指南不断更新，但由于临床因素、生物标志物状态及可用药物等因素，二线治疗方案的选择仍具挑战性。 方法：2024年7月组织了两轮德尔菲共识研究，汇集了10位HR+/HER2−转移性乳腺癌研究、诊断与治疗领域的专家意见，基于现有生物标志物及已发表临床试验结果，探讨最佳二线及后续治疗方案选择。共识定义为70%及以上的一致同意或反对。 结果：专家们最初审议了包含39条声明的清单，内容分为四个部分：生物标志物检测；一线内分泌治疗联合CDK4/6抑制剂治疗转移性乳腺癌≥6个月后疾病进展时的二线治疗选择；一线内分泌治疗联合CDK4/6抑制剂治疗转移性乳腺癌不足6个月时疾病进展（且仍处于内分泌治疗期间）的二线治疗选择；以及二线后治疗方案选择。经讨论，专家决定删除4条声明，修改10条，并新增3条。最终清单包含38条声明，其中37条达成共识。 结论：专家小组推荐在一线治疗疾病进展时采用新一代测序技术进行基因组特征分析。根据特定突变的存在情况可明确最佳药物或治疗类别；但专家组亦承认，在临床实践中若新型疗法不可及或未纳入医保，治疗策略将有所不同。
Treatment Sequencing in Metastatic HR+/HER2− Breast Cancer: A Delphi Consensus
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