2022年中国乳腺癌重要临床试验成果及最新进展

doi:10.19401/j.cnki.1007-3639.2023.02.002

中国癌症杂志 ›› 2023, Vol. 33 ›› Issue (2): 103-109.doi: 10.19401/j.cnki.1007-3639.2023.02.002

2022年中国乳腺癌重要临床试验成果及最新进展

邵志博¹^,²(), 杨犇龙¹^,², 吴炅¹^,²()

1.复旦大学附属肿瘤医院乳腺外科，复旦大学上海医学院肿瘤学系，上海 200032
2.中国上海肿瘤医学协同创新中心，上海 200032

收稿日期:2023-01-09 修回日期:2023-02-11 出版日期:2023-02-28 发布日期:2023-03-22
通信作者: 吴炅（ORCID: 0000-0002-8103-0505），博士，主任医师，复旦大学附属肿瘤医院副院长。
作者简介:邵志博（ORCID: 0000-0001-8152-8250），复旦大学附属肿瘤医院博士研究生。
吴炅，主任医师，教授，博士研究生导师，复旦大学附属肿瘤医院副院长，药物临床试验机构主任。学术任职包括：中国抗癌协会乳腺癌专业委员会主任委员，中国医师协会外科医师分会乳腺外科医师专业委员会副主任委员，中国医师协会肿瘤医师分会副主任委员，中华医学会肿瘤学分会常委，中华医学会外科分会乳腺外科学组副组长，上海市医学会肿瘤专科分会候任主任委员，上海市抗癌协会乳腺癌专业委员会荣誉主任委员，上海市医学会肿瘤靶分子专科分会前任主任委员。擅长乳腺癌的综合治疗，特别是新的外科诊疗技术在乳腺疾病中的应用，包括乳腺癌保乳手术、乳腺癌前哨淋巴结活检、乳腺癌一期乳房重建手术。作为Ⅰ期临床研究负责人，牵头主持8项抗肿瘤新药Ⅰ期注册研究。主持编撰了《乳腺肿瘤整形与乳房重建专家共识（2018年版）》、《保留乳房治疗专家共识（2020年版）》和《乳腺肿瘤整形与乳房重建专家共识（2022年版）》，并连续12年主办上海市乳房重建论坛。以第一作者及通信作者在SCI收录期刊上发表论文70余篇；主编《乳腺癌术后乳房重建》、《乳腺癌的乳房重建手术》、Reconstruction Surgery in Breast Cancer，参编《现代乳腺肿瘤学进展》、《肿瘤外科手术学》、《乳腺肿瘤学》等专著。曾被授予上海市卫生局首批“医苑新星”、上海市卫生局先进工作者、复旦大学“世纪之星”，获得上海市科技启明星、上海市教委曙光计划、上海市科委优秀学术带头人计划等人才基金。目前承担国家重大慢病非传染性疾病防控研究课题及国家自然科学基金面上项目等。2004年以第三完成人获国家科技进步二等奖（乳腺癌的临床和基础研究），并多次以主要完成人获得多项上海市科技进步奖；以第一完成人获得上海市临床医学成果奖。

Progress of important clinical trials of breast cancer in China in 2022

SHAO Zhibo¹^,²(), YANG Benlong¹^,², WU Jiong¹^,²()

1. Department of Breast Surgery, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
2. Department of Collaborative Innovation Center for Cancer Medicine, Fudan University, Shanghai 200032, China

Received:2023-01-09 Revised:2023-02-11 Published:2023-02-28 Online:2023-03-22
Contact: WU Jiong

摘要/Abstract

摘要：

乳腺癌已经成为全球发病率最高的恶性肿瘤，严重危害广大女性的身心健康，对于临床肿瘤的防治也是一个巨大挑战。随着对乳腺癌发病、转移机制研究的深入，以及多组学技术和肿瘤免疫等转化研究的发展，已经证明乳腺癌是一种分子分型和临床特征高度异质性的肿瘤，不同亚型乳腺癌临床治疗方式既有差异又存在联系，乳腺癌临床研究领域的成果层出不穷。2022年，针对不同亚型乳腺癌均有重要的临床试验成果。在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性乳腺癌的新辅助治疗方面，PHEDRA研究为患者提供了新的治疗选择；对于HER2阳性转移性乳腺癌，PHILA研究和SYSUCC-002研究结果为临床医师提供了参考；而对于脑转移的患者，PERMEATE研究显示，吡咯替尼联合卡培他滨方案有望成为HER2阳性脑转移人群，尤其是未经局部放疗的脑转移患者的优选治疗方案。在激素受体阳性乳腺癌中，阿贝西利、达尔西利、瑞波西利等药物的多项临床研究（monarchE研究、DAWNA-1研究、MONALEESA系列研究等）证实了其对内脏转移的疗效。对于三阴性乳腺癌，亦有多项临床试验正在进行中。本文就过去的一年中乳腺癌治疗领域临床研究的新进展进行回顾。

关键词: 乳腺癌, 临床试验, 重要成果, 人表皮生长因子受体2, 激素受体, 三阴性乳腺癌, 靶向治疗, 化疗, 联合治疗, 免疫治疗

Abstract:

Breast cancer has become the most common type of cancer in the world, harming the majority of women's physical and mental health and challenging clinical prevention and treatment of tumors. With the in-depth research on the pathogenesis and metastasis mechanism of breast cancer, as well as the development of translational research such as multiomics technology and tumor immunity, it has been proved that breast cancer has highly heterogeneous molecular and clinical characteristics. The clinical treatment methods of different subtypes of breast cancer are different and related, and the achievements in the field of breast cancer clinical research are fruitful. In 2022, results of important clinical trials have achieved for different subtypes of breast cancer. For the neo-adjuvant treatment of human epidermal growth factor receptor 2 (HER2) positive breast cancer, the PHEDRA study provided new adjuvant treatment options for HER2 positive breast cancer patients; And for the HER2 positive metastatic breast cancer, PHILA study and SYSUCC-002 study results provided reference for clinicians. For patients with brain metastasis, PERMEATE study showed that pyrrolitinib combined with capecitabine regimen was to become the preferred treatment scheme for HER2 positive brain metastasis population, especially for patients with brain metastasis without local radiotherapy. In hormone receptor positive breast cancer, a number of clinical trials (monarchE study, DAWNA-1 study, MONALEESA series of studies, etc.) of arbacilli, daracilli, rebosilli and others reported their efficacy on visceral metastasis. For triple-negative breast cancer, many clinical trials are under way. This paper aimed to review the recent advances in clinical research on breast cancer in the past year.

Key words: Breast cancer, Clinical trials, Important achievements, Human epidermal growth factor receptor 2, Hormone receptor, Triple-negative breast cancer, Targeted therapy, Chemotherapy, Combination therapy, Immunotherapy

中图分类号:

R737.9

邵志博, 杨犇龙, 吴炅. 2022年中国乳腺癌重要临床试验成果及最新进展[J]. 中国癌症杂志, 2023, 33(2): 103-109.

SHAO Zhibo, YANG Benlong, WU Jiong. Progress of important clinical trials of breast cancer in China in 2022[J]. China Oncology, 2023, 33(2): 103-109.

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2022年中国乳腺癌重要临床试验成果及最新进展

Progress of important clinical trials of breast cancer in China in 2022

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