2023年中国乳腺癌重要临床研究成果及最新进展

doi:10.19401/j.cnki.1007-3639.2024.02.001

中国癌症杂志 ›› 2024, Vol. 34 ›› Issue (2): 135-142.doi: 10.19401/j.cnki.1007-3639.2024.02.001

2023年中国乳腺癌重要临床研究成果及最新进展

张琪¹(), 修秉虬¹, 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:2024-01-16 修回日期:2024-01-30 出版日期:2024-02-29 发布日期:2024-03-14
通信作者: 吴炅
作者简介:张琪（ORCID: 0000-0003-0876-7495），博士，复旦大学附属肿瘤医院博士后
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、乳腺癌即刻乳房重建手术。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14年主办上海市乳房重建论坛。以第一作者及通讯作者在SCI收录期刊上发表论文100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、上海市科学技术委员会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 research of breast cancer in China in 2023

ZHANG Qi¹(), XIU Bingqiu¹, 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:2024-01-16 Revised:2024-01-30 Published:2024-02-29 Online:2024-03-14
Contact: WU Jiong

摘要/Abstract

摘要：

乳腺癌是全球女性发病率最高的恶性肿瘤，严重威胁女性健康。随着乳腺癌分期分型诊治原则的确立和新型抗肿瘤药物的研发与应用，乳腺癌患者的生存情况和生活质量不断得到改善。中国乳腺癌患者基数大，具有独特的发病特征，需要不断探索更合适的治疗策略；临床研究的体量和水平也在不断提升。2023年，针对不同亚型乳腺癌均有重要的临床研究成果。在外科治疗方面，关于靶向腋窝淋巴结清扫的临床试验和对侧乳腺癌风险预测BRCA-CRisk模型的建立为外科降阶梯治疗提供了更多的证据；在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性乳腺癌方面，吡咯替尼在晚期乳腺癌治疗中显示出明显疗效；在三阴性乳腺癌方面，精准分型治疗和免疫治疗持续改善患者的生存情况；在激素受体阳性乳腺癌方面，对低风险患者豁免化疗以及探索内分泌治疗耐药后的可选方案均有重要研究成果；在BRCA突变方面，BGB-290-201临床研究进一步确认了多腺苷二磷酸核糖聚合酶[poly(ADP-ribose) polymerase，PARP]抑制剂用于中国人群的治疗效果和安全性，对晚期HER2阴性携带BRCA胚系（germline BRCA，gBRCA）1/2突变的乳腺癌患者，帕米帕利将会是一个理想的治疗选择。本文对2023年中国乳腺癌领域的重要临床研究进行回顾，总结关键结果，以期为未来的临床研究提供参考。

关键词: 乳腺癌, 临床研究, 临床试验, 研究进展

Abstract:

Breast cancer is the most prevalent malignant tumor among women globally, posing a serious threat to women's health. With the establishment of staging and typing principles for breast cancer diagnosis and treatment, and the development and application of novel antitumor drugs, the survival and quality of life of breast cancer patients have been continuously improving. In China, the large base of breast cancer patients possesses unique incidence characteristics, necessitating ongoing exploration of more appropriate treatment strategies; the volume and level of clinical research are also continuously advancing. In 2023, significant clinical research results were reported for different subtypes of breast cancer. In surgical treatment, clinical trials on targeted axillary lymph node dissection and the establishment of a predictive model BRCA-CRisk for contralateral breast cancer risk provide more evidence for de-escalation in surgical treatment. In the area of human epidermal growth factor receptor 2 (HER2)-positive breast cancer, pyrotinib has shown significant efficacy in advanced breast cancer treatment. In triple-negative breast cancer, precision subtype treatment and immunotherapy continue to improve patient survival. For hormone receptor-positive breast cancer, significant research results were obtained in exempting low-risk patients from chemotherapy and exploring alternative options after resistance to endocrine therapy. In the aspect of BRCA mutations, BGB-290-201 further confirmed the therapeutic efficacy and safety of poly(ADP-ribose) polymerase (PARP) inhibitors for the Chinese population. For advanced HER2-negative patients carrying germline BRCA (gBRCA)1/2 mutations, pamiparib will be an ideal treatment choice. This article reviews the important clinical research in the field of breast cancer in China in 2023, summarizes key results, and aims to provide reference ideas for future clinical research.

Key words: Breast cancer, Clinical research, Clinical trials, Research progress

中图分类号:

R737.9

张琪, 修秉虬, 吴炅. 2023年中国乳腺癌重要临床研究成果及最新进展[J]. 中国癌症杂志, 2024, 34(2): 135-142.

ZHANG Qi, XIU Bingqiu, WU Jiong. Progress of important clinical research of breast cancer in China in 2023[J]. China Oncology, 2024, 34(2): 135-142.

参考文献 39

[1]	SUNG H, FERLAY J, SIEGEL R L, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2021, 71(3): 209-249. doi: 10.3322/caac.v71.3
[2]	XIA C F, DONG X S, LI H, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants[J]. Chin Med J, 2022, 135(5): 584-590. doi: 10.1097/CM9.0000000000002108
[3]	BOILEAU J F, POIRIER B, BASIK M, et al. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study[J]. J Clin Oncol, 2015, 33(3): 258-264.
[4]	KUEHN T, BAUERFEIND I, FEHM T, et al. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study[J]. Lancet Oncol, 2013, 14(7): 609-618. doi: 10.1016/S1470-2045(13)70166-9 pmid: 23683750
[5]	CAUDLE A S, YANG W T, KRISHNAMURTHY S, et al. Improved axillary evaluation following neoadjuvant therapy for patients with node-positive breast cancer using selective evaluation of clipped nodes: implementation of targeted axillary dissection[J]. J Clin Oncol, 2016, 34(10): 1072-1078. doi: 10.1200/JCO.2015.64.0094 pmid: 26811528
[6]	WU S Y, LI J W, WANG Y J, et al. Clinical feasibility and oncological safety of non-radioactive targeted axillary dissection after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: a prospective diagnostic and prognostic study[J]. Int J Surg, 2023, 109(7): 1863-1870.
[7]	HARTMANN L C, SELLERS T A, SCHAID D J, et al. Efficacy of bilateral prophylactic mastectomy in BRCA1 and BRCA2 gene mutation carriers[J]. J Natl Cancer Inst, 2001, 93(21): 1633-1637. doi: 10.1093/jnci/93.21.1633
[8]	SUN J, CHU F T, PAN J N, et al. BRCA-CRisk: a contralateral breast cancer risk prediction model for BRCA carriers[J]. J Clin Oncol, 2023, 41(5): 991-999. doi: 10.1200/JCO.22.00833
[9]	LI X, YANG C Y, WAN H, et al. Discovery and development of pyrotinib: a novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer[J]. Eur J Pharm Sci, 2017, 110: 51-61. doi: S0928-0987(17)30043-X pmid: 28115222
[10]	MA F, YAN M, LI W, et al. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial[J]. BMJ, 2023, 383: e076065.
[11]	CAO J, TENG Y E, LI H P, et al. Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial[J]. BMC Med, 2023, 21(1): 300. doi: 10.1186/s12916-023-02999-0 pmid: 37559142
[12]	JIANG K K, HONG R X, XIA W, et al. Pyrotinib combined with vinorelbine in patients with previously treated HER2-positive metastatic breast cancer: a multicenter, single-arm, prospective study[J]. Cancer Res Treat, 2023. Online ahead of print.
[13]	HUA X, BI X W, ZHAO J L, et al. Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for patients with hormone receptor-positive and HER2-positive metastatic breast cancer (SYSUCC-002)[J]. Clin Cancer Res, 2022, 28(4): 637-645. doi: 10.1158/1078-0432.CCR-21-3435
[14]	HU Z Y, YAN M, XIONG H H, et al. Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM): a multicenter, single-arm, phase Ⅱ trial[J]. BMC Med, 2023, 21(1): 226. doi: 10.1186/s12916-023-02943-2
[15]	ZHANG J, MENG Y C, WANG B Y, et al. PLEASURABLE: results and biomarkers analysis from the phase Ⅱ study of dalpiciclib combined with pyrotinib and endocrine therapy (ET) in women with dual-receptor positive (ER+/HER2+) metastatic breast cancer (MBC)[J]. J Clin Oncol, 2023, 41(16_suppl): 1046.
[16]	BIANCHINI G, BALKO J M, MAYER I A, et al. Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease[J]. Nat Rev Clin Oncol, 2016, 13(11): 674-690. doi: 10.1038/nrclinonc.2016.66 pmid: 27184417
[17]	JIANG Y Z, MA D, SUO C, et al. Genomic and transcriptomic landscape of triple-negative breast cancers: subtypes and treatment strategies[J]. Cancer Cell, 2019, 35(3): 428-440.e5. doi: 10.1016/j.ccell.2019.02.001
[18]	LIU Y, ZHU X Z, XIAO Y, et al. Subtyping-based platform guides precision medicine for heavily pretreated metastatic triple-negative breast cancer: the FUTURE phase Ⅱ umbrella clinical trial[J]. Cell Res, 2023, 33(5): 389-402. doi: 10.1038/s41422-023-00795-2
[19]	FAN L, WANG Z H, MA L X, et al. Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial[J]. Lancet Oncol, 2024: S1470-S2045(23)00579-X.
[20]	BURSTEIN H J, CURIGLIANO G, LOIBL S, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen international consensus guidelines for the primary therapy of early breast cancer 2019[J]. Ann Oncol, 2019, 30(10): 1541-1557. doi: S0923-7534(19)60978-6 pmid: 31987446
[21]	SCHMID P, CORTES J, PUSZTAI L, et al. Pembrolizumab for early triple-negative breast cancer[J]. N Engl J Med, 2020, 382(9): 810-821. doi: 10.1056/NEJMoa1910549
[22]	MITTENDORF E A, ZHANG H, BARRIOS C H, et al. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial[J]. Lancet, 2020, 396(10257): 1090-1100. doi: 10.1016/S0140-6736(20)31953-X pmid: 32966830
[23]	LIU J Q, LIU Q, LI Y, et al. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase Ⅱ trial[J]. J Immunother Cancer, 2020, 8(1): e000696. doi: 10.1136/jitc-2020-000696
[24]	CHEN L, JIANG Y Z, WU S Y, et al. Famitinib with camrelizumab and nab-paclitaxel for advanced immunomodulatory triple-negative breast cancer (FUTURE-C-plus): an open-label, single-arm, phase Ⅱ trial[J]. Clin Cancer Res, 2022, 28(13): 2807-2817. doi: 10.1158/1078-0432.CCR-21-4313
[25]	WANG C Z, LIU Z Z, CHEN X C, et al. Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: a single-arm phase Ⅱ trial[J]. Nat Commun, 2023, 14(1): 6654. doi: 10.1038/s41467-023-42479-w
[26]	JIANG Z F, OUYANG Q C, SUN T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial[J]. Nat Med, 2024, 30(1): 249-256. doi: 10.1038/s41591-023-02677-x pmid: 38191615
[27]	GOLDENBERG D M, CARDILLO T M, GOVINDAN S V, et al. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC)[J]. Oncotarget, 2015, 6(26): 22496-22512. pmid: 26101915
[28]	BARDIA A, MAYER I A, VAHDAT L T, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer[J]. N Engl J Med, 2019, 380(8): 741-751. doi: 10.1056/NEJMoa1814213
[29]	BARDIA A, TOLANEY S M, PUNIE K, et al. Biomarker analyses in the phase Ⅲ ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer[J]. Ann Oncol, 2021, 32(9): 1148-1156. doi: 10.1016/j.annonc.2021.06.002
[30]	XU B H, MA F, WANG T, et al. A phase Ⅱb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments[J]. Int J Cancer, 2023, 152(10): 2134-2144. doi: 10.1002/ijc.v152.10
[31]	WANG X G, FAN Z Q, WANG X, et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study[J]. Breast Cancer Res Treat, 2022, 195(3): 301-310. doi: 10.1007/s10549-022-06686-1
[32]	BRAAL C L, JONGBLOED E M, WILTING S M, et al. Inhibiting CDK4/6 in breast cancer with palbociclib, ribociclib, and abemaciclib: similarities and differences[J]. Drugs, 2021, 81(3): 317-331. doi: 10.1007/s40265-020-01461-2 pmid: 33369721
[33]	XU B H, ZHANG Q Y, ZHANG P, et al. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial[J]. Nat Med, 2021, 27(11): 1904-1909. doi: 10.1038/s41591-021-01562-9 pmid: 34737452
[34]	ZHANG P, ZHANG Q Y, TONG Z S, et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial[J]. Lancet Oncol, 2023, 24(6): 646-657. doi: 10.1016/S1470-2045(23)00172-9
[35]	LIU M, XIE F, LIU M Y, et al. Association between BRCA mutational status and survival in patients with breast cancer: a systematic review and meta-analysis[J]. Breast Cancer Res Treat, 2021, 186(3): 591-605. doi: 10.1007/s10549-021-06104-y
[36]	LITTON J K, RUGO H S, ETTL J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation[J]. N Engl J Med, 2018, 379(8): 753-763. doi: 10.1056/NEJMoa1802905
[37]	ROBSON M, IM S A, SENKUS E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation[J]. N Engl J Med, 2017, 377(6): 523-533. doi: 10.1056/NEJMoa1706450
[38]	XU B H, SUN T, SHI Y X, et al. Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase Ⅱ study[J]. Breast Cancer Res Treat, 2023, 197(3): 489-501. doi: 10.1007/s10549-022-06785-z
[39]	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. doi: 10.19401/j.cnki.1007-3639.2023.02.002
	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. doi: 10.19401/j.cnki.1007-3639.2023.02.002

2023年中国乳腺癌重要临床研究成果及最新进展

Progress of important clinical research of breast cancer in China in 2023

RichHTML

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献 39

相关文章 15

编辑推荐

Metrics

本文评价

[1]	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.
[2]	王昭卜, 黎星, 于鑫淼, 金锋. 2023年改变早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): 151-160.
[3]	罗扬, 孙涛, 邵志敏, 崔久嵬, 潘跃银, 张清媛, 程颖, 李惠平, 杨燕, 叶长生, 于国华, 王京芬, 刘运江, 刘新兰, 周宇红, 柏玉举, 谷元廷, 王晓稼, 徐兵河, 宋礼华. AK-HER2与参照药治疗HER2阳性转移性乳腺癌患者的疗效、体内代谢特征、安全性和免疫原性比较：一项多中心、随机、双盲Ⅲ期等效性临床试验[J]. 中国癌症杂志, 2024, 34(2): 161-175.
[4]	陈远香, 余涛, 杨诗雨, 曾涛, 魏兰, 张彦. KDM4A通过下调BMP9促进乳腺癌细胞MDA-MB-231的迁移和侵袭[J]. 中国癌症杂志, 2024, 34(2): 176-184.
[5]	胡晓钰, 蔡毓文, 叶富贵, 邵志敏, 胡伟刚, 余科达. BRCA1/2胚系突变对三阴性乳腺癌患者放疗后第二原发肿瘤的影响[J]. 中国癌症杂志, 2024, 34(2): 185-190.
[6]	李天骄, 叶龙云, 金凯舟, 吴伟顶, 虞先濬. 2023年度胰腺癌研究及诊疗新进展[J]. 中国癌症杂志, 2024, 34(1): 1-12.
[7]	金奕滋, 林明曦, 张剑. 乳腺癌原发灶与肝转移灶受体表达差异研究[J]. 中国癌症杂志, 2023, 33(9): 834-843.
[8]	杨忠毅, 许晓平, 王明伟, 张勇平, 杨建伟, 陈跃, 徐文贵, 李亚明, 章英剑, 宋少莉. 乳腺癌¹⁸F-FES雌激素受体PET技术和应用标准[J]. 中国癌症杂志, 2023, 33(8): 801-808.
[9]	王若曦, 吉芃, 龚悦, 陈盛. HER2低表达乳腺癌新辅助化疗效果及其预后特征：一项单中心回顾性研究[J]. 中国癌症杂志, 2023, 33(7): 686-692.
[10]	邬思雨, 李俊杰, 邵志敏. 乳腺癌前哨淋巴结活检术的发展历史及研究进展[J]. 中国癌症杂志, 2023, 33(6): 551-559.
[11]	毕钊, 王永胜. 1~2枚前哨淋巴结阳性早期乳腺癌患者治疗策略降阶梯新理念[J]. 中国癌症杂志, 2023, 33(6): 560-565.
[12]	赵谦, 凌云霄, 柳光宇. 乳腺癌患者保乳手术后再次前哨淋巴结活检的最新研究进展及展望[J]. 中国癌症杂志, 2023, 33(6): 566-573.
[13]	丛斌斌, 曹晓珊, 王春建, 邱鹏飞, 孙晓, 陈鹏, 刘雁冰, 赵桐, 张朝蓬, 石志强, 毕钊, 王永胜. 临床查体阴性但超声检查及穿刺确诊腋窝淋巴结转移的乳腺癌前哨淋巴结活检的可行性分析[J]. 中国癌症杂志, 2023, 33(6): 574-580.
[14]	任恒宇, 郝爽, 陈嘉健, 杨犇龙, 曹阿勇, 柳光宇, 邵志敏, 吴炅. 国内外乳房重建研究的现状和重点：一项文献计量学研究[J]. 中国癌症杂志, 2023, 33(6): 581-588.
[15]	渠宁, 王钰婷, 马奔, 王宇. 2022年度甲状腺癌研究及诊疗新进展[J]. 中国癌症杂志, 2023, 33(5): 423-430.