2023年改变晚期乳腺癌临床实践的重要研究成果及进展

doi:10.19401/j.cnki.1007-3639.2024.02.002

中国癌症杂志 ›› 2024, Vol. 34 ›› Issue (2): 143-150.doi: 10.19401/j.cnki.1007-3639.2024.02.002

2023年改变晚期乳腺癌临床实践的重要研究成果及进展

张思源(), 江泽飞()

解放军总医院第五医学中心肿瘤医学部，北京 100071

收稿日期:2024-01-25 修回日期:2024-02-18 出版日期:2024-02-29 发布日期:2024-03-14
通信作者: 江泽飞
作者简介:张思源（ORCID: 0009-0001-1742-9183），硕士。
江泽飞，主任医师，教授，博士研究生导师，解放军总医院肿瘤医学部副主任。担任中国临床肿瘤学会（CSCO）副理事长兼秘书长，St. Gallen国际早期乳腺癌专家共识团成员，2011年成为首位St. Gallen国际早期乳腺治疗共识专家团的中国专家。从事肿瘤内科临床工作三十余年，担任中央军委保健工作和中央保健会诊专家任务。执笔完成《中国版NCCN乳腺癌治疗指南》、《CSCO乳腺癌诊疗指南》、《CSCO常见恶性肿瘤指南》等指南和共识的撰写。先后承担十余项国家科技专项、国家自然科学基金、军队和北京市科研课题，研究成果多次在国内外重要会议上汇报。以第一作者或通信作者在Nature Medicine、Lancet Oncology、JAMA Oncology、《中华医学杂志》等国内外学术期刊发表论文200余篇。

Important research progress in clinical practice for advanced breast cancer in 2023

ZHANG Siyuan(), JIANG Zefei()

Senior Department of Oncology, the Fifth Medical Center of PLA General Hospital, Beijing 100071, China

Received:2024-01-25 Revised:2024-02-18 Published:2024-02-29 Online:2024-03-14
Contact: JIANG Zefei

摘要/Abstract

摘要：

晚期乳腺癌的综合诊疗已进入“精准分类、精确分层”时代，并迈向个体化精准医学之路。2023年晚期乳腺癌不同分子分型研究领域取得了多项突破性进展，其研究结果影响临床指南，改变临床实践。激素受体阳性晚期乳腺癌的研究重点在于细胞周期蛋白依赖性激酶4和6（cyclin-dependent kinase 4 and 6，CDK4/6）抑制剂治疗失败患者的治疗选择。人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）低表达晚期乳腺癌已成为一个新兴治疗方向，而T-DXd是其重要的治疗选择。PHILA研究结果的公布，开启了HER2阳性晚期乳腺癌一线治疗的新纪元。同时T-DXd已成为临床治疗实践中酪氨酸激酶抑制剂治疗失败后的首选。晚期三阴性乳腺癌（triple-negative breast cancer，TNBC）中免疫治疗和靶向治疗相关研究也如火如荼，TORCHILIGHT研究、BEGONIA研究等取得了阳性结果。与此同时，探索TNBC精准治疗的“复旦分型”的系列临床研究也在持续进行中，有望改变目前的治疗模式。本文对2023年晚期乳腺癌的重大临床研究进展按照不同分子分型进行梳理和总结，以期更好地为临床治疗提供参考和指导。

关键词: 晚期乳腺癌, 临床研究, 研究进展

Abstract:

The comprehensive diagnosis and treatment of advanced breast cancer has entered the era of "accurate classification and precise stratification", and is moving towards the road of personalized precision medicine. In 2023, significant breakthroughs have been achieved in the research on different molecular classifications of advanced breast cancer, influencing clinical guidelines and transforming clinical practice. The primary focus of research for hormone receptor positive advanced breast cancer lies in selecting appropriate treatments for patients who have failed cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors. Advanced breast cancer with low human epidermal growth factor receptor 2 (HER2) expression has emerged as a promising treatment direction, with T-DXd being an important therapeutic option. With the release of results from the PHILA study, a new era has begun for first-line treatment of HER2-positive advanced breast cancer. Simultaneously, T-DXd has become the preferred choice in clinical practice following tyrosine kinase inhibitor failure. Research related to immune and targeted therapy for advanced triple-negative breast cancer (TNBC) is also progressing rapidly, yielding positive outcomes in studies such as TORCHILIGHT and BEGONIA. Additionally, ongoing clinical studies on precision treatment based on the "Fudan classification" for TNBC are expected to revolutionize current treatment approaches. This paper summarized major advancements in clinical research on advanced breast cancer in 2023 according to various molecular classifications, aiming to provide improved reference and guidance for clinical management.

Key words: Advanced breast cancer, Clinical study, Research progress

中图分类号:

R737.9

张思源, 江泽飞. 2023年改变晚期乳腺癌临床实践的重要研究成果及进展[J]. 中国癌症杂志, 2024, 34(2): 143-150.

ZHANG Siyuan, JIANG Zefei. Important research progress in clinical practice for advanced breast cancer in 2023[J]. China Oncology, 2024, 34(2): 143-150.

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参考文献 27

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Item	TORCHLIGHT (n= 531)		KEYNOTE-355 (n = 847)			IMpassion130 (n = 902)		IMpassion131 (n = 943)		BEGONIA Arm 7
Treatment	Toripalimab + nab-paclitaxelvs placebo + nab-paclitaxel		Pembrolizumab + chemotherapy vsplacebo + chemotherapy			Atezolizumab + nab-paclitaxel vsplacebo + nab-paclitaxel		Atezolizumab + paclitaxel vsplacebo + paclitaxel		Dato-DXd + durvalumab
	Previously untreated or no more than one previous systemic chemotherapy regimen		Completion of treatment with curative inten t≥6 months prior to first disease recurrence			No prior therapy for advanced setting (prior RT or CT in curative setting allowed if ≥12 months DFI)		No prior therapy for advanced setting (prior RT or CT in curative setting allowed if ≥12 months DFI)		No prior treatment for stage Ⅳ TNBC or 212 months since prior taxane therapy
PD-L1 IHC staining assay	JS311		22C3			SP142		SP142		SP263, 22C3
End points	PFS		PFS, OS			PFS, OS		PFS		PFS, OS and DoR
Grouping	ITT	PD-L1⁺ (CPS≥1)	ITT	PD-L1⁺		ITT	PD-L1⁺SP142 IC≥1%	ITT	PD-L1⁺SP142 IC≥1%	Regardless of PD-L1 expression level
Grouping	ITT	PD-L1⁺ (CPS≥1)	ITT	CPS≥10	CPS≥1	ITT	PD-L1⁺SP142 IC≥1%	ITT	PD-L1⁺SP142 IC≥1%	Regardless of PD-L1 expression level
mPFS	8.4 vs6.9	8.4 vs 5.6	7.5vs5.6	9.7 vs5.6	7.6 vs5.6	7.2 vs5.5	7.5 vs5.0	5.7 vs5.6	6.0 vs5.7	13.8
mOS	33.1 vs23.5	32.8 vs19.5	17.2vs15.5	23.0 vs16.1	17.6 vs16.0	21.0 vs18.7	25.4 vs17.9	19.2 vs22.8	22.1 vs28.3
Domestic indications	Submitted the first-line indication application for advanced triple-negative breast cancer in May 2023		Unapproved			Unapproved		Negative result

2023年改变晚期乳腺癌临床实践的重要研究成果及进展

Important research progress in clinical practice for advanced breast cancer in 2023

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