2024年中国乳腺癌重要临床研究成果

doi:10.19401/j.cnki.1007-3639.2025.02.003

摘要/Abstract

摘要：

乳腺癌是全球女性患者发病率最高的癌症，严重威胁女性的健康。2024年，中国学者在乳腺癌临床研究的各个方面都有很好的进展：在外科手术方面，新型光学成像技术为手术边缘的准确评估助力，靶向腋窝淋巴结清扫（target axillary dissection，TAD）继续为手术降阶梯治疗提供循证医学证据，影像组学联合人工智能（artificial intelligence，AI）也有助于手术决策。在靶向治疗方面，酪氨酸激酶抑制剂（tyrosine kinase inhibitor，TKI）类药物表现出优秀的临床结局，其中PILHLE-001研究探索了吡咯替尼新的用药亚型，为管腔型/人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）低表达乳腺癌提供新的治疗思路，安罗替尼和阿帕替尼的疗效和安全性也均可靠；双重靶向HER2方案用于早期HER2阳性患者的新辅助治疗（neoadjuvant therapy，NAT）及辅助治疗较单靶方案组显著获益，提高了患者的生存率；各类抗体药物偶联物（antibody-drug conjugate，ADC）也均展现出良好的临床应用价值，明显改善了患者的生存获益，同时，中国自己研发的新药也走向国际舞台，国际影响力日益增大；此外，免疫治疗和基于复旦分型的精准治疗也均显示出不同程度的生存改善。在化疗方面，研究者探索了不同的NAT策略。在内分泌治疗方面，进一步巩固了CDK4/6抑制剂（CDK4/6 inhibitor，CDK4/6i）在晚期激素受体阳性/HER2阴性乳腺癌中的重要地位，并探讨了既往尚未确定的促性腺激素释放激素激动剂（gonadotrophin releasing hormone analogue，GnRHa）用药剂型等问题。在放疗方面，局部放疗联合靶向治疗显著延长了HER2阳性脑转移乳腺癌患者的生存期，还针对放疗相关心脏毒性不良反应等问题进行了优化。在此，本文总结2024年中国乳腺癌领域重要的临床研究进展，为相关领域的学者提供参考。

关键词: 乳腺癌, 临床研究, 临床试验

Abstract:

Breast cancer, is the cancer type with highest incidence rate in women globally. To improve the treatment for breast cancer patients, Chinese scientists have done extensive research on breast cancer. Reviewing the progress made in 2024, Chinese scholars have achieved significant advancements in various aspects of breast cancer research. In the field of surgery, new optical imaging techniques have aided the accurate assessment of surgical margins, and targeted axillary dissection (TAD) continues to provide evidence-based support for de-escalation therapy in surgery. Radiomics combined with artificial intelligence (AI) also assists in surgical decision-making. In targeted therapy, tyrosine kinase inhibitors (TKIs) have shown excellent clinical outcomes. The PILHLE-001 study explored new subtypes for the use of pyrotinib, offering new therapeutic approaches for luminal/human epidermal growth factor receptor 2 (HER2) low breast cancer. The efficacy and safety of anlotinib and apatinib are also reliable. Dual-targeted HER2 regimens in neoadjuvant therapy (NAT) and adjuvant therapy for early HER2-positive patients have demonstrated significant benefits over single-target regimens, improving survival rates. Various antibody-drug conjugates (ADCs) have shown significant clinical applicability, enhancing patient survival benefits, and novel drugs developed in China are making their way onto the international stage, increasing their global influence. Additionally, immunotherapy and precision treatment based on Fudan subtypes have shown varied degrees of survival improvement. In chemotherapy, different NAT strategies have been explored, offering more treatment options for doctors and patients. In endocrine therapy, the critical role of CDK4/6 inhibitors (CDK4/6i) in advanced hormone receptor positive/HER2-negative breast cancer has been further solidified, and issues concerning previously undetermined drug formulations of gonadotrophin releasing hormone analogue (GnRHa) have been examined. In radiotherapy, local radiotherapy combined with targeted therapy has significantly extended the survival of HER2-positive breast cancer patients with brain metastases, and optimizations have been made regarding the cardiotoxic side effects associated with radiotherapy. This article summarized the key clinical research on breast cancer in China in 2024, providing a reference for scholars and experts in related fields.

Key words: Breast cancer, Clinical research, Clinical trial

中图分类号:

R737.9

杨鑫, 史钱枫, 刘强. 2024年中国乳腺癌重要临床研究成果[J]. 中国癌症杂志, 2025, 35(2): 167-175.

YANG Xin, SHI Qianfeng, LIU Qiang. Progress of important clinical research on breast cancer in China in 2024[J]. China Oncology, 2025, 35(2): 167-175.

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