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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2024, Vol. 18 ›› Issue (01) : 1 -10. doi: 10.3877/cma.j.issn.1674-0807.2024.01.001

指南与共识

三阴性乳腺癌新辅助铂类应用专家共识(2023版)
广东省医学会乳腺病学分会(广东省医学会乳腺病学分会青年委员会), 长江学术带乳腺联盟, 重庆市医学会乳腺病分会, 广东省预防医学会乳腺癌防治专业委员会   
  1. 1. 510080　南方医科大学附属广东省人民医院（广东省医学科学院）乳腺肿瘤科
  • 收稿日期:2024-01-10 出版日期:2024-02-01

Experts consensus on platinum-based neoadjuvant therapy for triple negative breast cancer (2023 version)

Breast Disease Branch of Guangdong Medical Association (Youth Committee of Breast Disease Branch of Guangdong Medical Association);, Breast Cancer Study Group Along the Yangtze River (YBCSG);, Breast Disease Branch of Chongqing Medical Association;, Breast Cancer Prevention and Treatment Committee of Guangdong Preventive Medicine Association   

  1. 1. Department of Breast Cancer, Cancer Center, Guangdong Provincial People’s Hospital/Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou 510080, China
  • Received:2024-01-10 Published:2024-02-01
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引用本文：

广东省医学会乳腺病学分会(广东省医学会乳腺病学分会青年委员会), 长江学术带乳腺联盟, 重庆市医学会乳腺病分会, 广东省预防医学会乳腺癌防治专业委员会. 三阴性乳腺癌新辅助铂类应用专家共识(2023版)[J]. 中华乳腺病杂志(电子版), 2024, 18(01): 1-10.

Breast Disease Branch of Guangdong Medical Association (Youth Committee of Breast Disease Branch of Guangdong Medical Association);, Breast Cancer Study Group Along the Yangtze River (YBCSG);, Breast Disease Branch of Chongqing Medical Association;, Breast Cancer Prevention and Treatment Committee of Guangdong Preventive Medicine Association. Experts consensus on platinum-based neoadjuvant therapy for triple negative breast cancer (2023 version)[J]. Chinese Journal of Breast Disease(Electronic Edition), 2024, 18(01): 1-10.

新辅助治疗是早期高危三阴性乳腺癌(TNBC)的标准处理方式，在新辅助方案中添加铂类药物能显著提高病理学完全缓解率和远期生存率。然而，目前国内外指南对铂类在TNBC新辅助治疗中的应用推荐仍存在差异。因此，由乳腺外科、乳腺内科、肿瘤科等相关领域专家组成的专家组成员综合参考国内外指南以及重要文献，共同编写本共识，对TNBC新辅助治疗方案、铂类药物作用机制、铂类在TNBC新辅助治疗和辅助治疗中的应用价值、铂类疗效预测因子及治疗相关不良反应等进行循证证据分析，提炼核心观点，并进行了专家组意见投票，以期对铂类在TNBC新辅助治疗中的临床应用提供建议和指导。

关键词: 三阴性乳腺癌, 铂类, 新辅助治疗, 共识

Neoadjuvant therapy is the standard approach for early-stage high-risk triple negative breast cancer (TNBC) and the addition of platinum-based drugs to neoadjuvant regimens significantly improves pathological complete response rates and long-term survival of patients. However, there are still discrepancies in the recommendations for the application of platinum-based drugs in neoadjuvant therapy for TNBC between domestic and international guidelines. Therefore, a consensus panel of experts from the departments of breast surgery, internal medicine and oncology has compiled this consensus, integrating domestic and international guidelines and important literature. This consensus provides evidence-based analysis, key opinion extraction, and expert opinion voting on topics including neoadjuvant therapy regimens for TNBC, the mechanism of platinum-based drug action, the application value of platinum-based drugs in neoadjuvant therapy and adjuvant therapy for TNBC, predictive factors for platinum efficacy, and treatment-related adverse reactions, aiming to provide recommendations and guidances for the clinical application of platinum-based drugs in neoadjuvant therapy for TNBC.

Key words: Triple negative breast neoplasms, Platinum, Neoadjuvant therapy, Consensus
表1 早期三阴性乳腺癌含铂新辅助化疗相关临床研究
研究名称 研究分期 组别方案 样本量 pCR (%) P值 生存率(%) P值
GEICAM/2006-03[17] 2 EC→DCb 48 30 0.606 － －
    EC→D 46 35      
GeparSixto GBG66[18,31] 2 P＋Dox＋Bev＋Cb 158 53.2 0.005 86.1a 0.024 4
    P＋Dox＋Bev 157 36.9   75.8a  
CALGB 40603(Alliance)[19,32] 2 P＋Cb±Bev→ddAC 221 54 0.002 9 70.4b 0.721 0
    P±Bev→ddAC 212 41   70.1b  
ChiCTR-TRC-14005019[20,33] 2 DEL 62 38.7 0.001 89.9c 0.028
    DE 63 12.7   80.2c  
BrighTNess[21,30] 3 PCb→AC 160 58 <0.001 79.3d 0.02
    P→AC 158 31   68.5d  
NCT03168880[23] 3 PCb→AC/EC 361 55.2 0.000 4 70.6e 0.073
    P→AC/EC 356 41.5   64.5e  
NCT0205986[24] 2 PCb 14 57.14 － － －
NCT02302742[25] － DCb 190 55 － － －
NCT01276769[26] 2 PCb 47 38.6 0.014 77.6f 0.043
    PE 44 14.0   56.2f  
NeoSTOP[27] 2 CbD 52 54 0.974 － －
    CbP→AC 48 54      
NeoCART[28] 2 DCb 44 61.4 0.004 90.8g 0.683
    EC-D 44 38.6   88.3g  
WSG-ADAPT-TN[29] 2 Nab-P＋Cb 146 45.9 0.002 72.6h 0.856
    Nab-P＋Gem 178 28.7   73.7h  
表2 早期TNBC新辅助免疫化疗相关临床研究
研究名称 研究分期 组别方案 样本量 是否含铂 pCR (%) P值 生存率(%) P值
KN-522[36,37] 3 (PCb→AC)＋Pembrolizumab→Pembrolizumab 1 174 是 64.8 <0.001 91.3a <0.05
    PCb→AC     51.2   85.3a  
NeoTRIP[38] 3 PCb＋Atezolizumab 280 是 48.6 0.480 － －
    PCb     44.4      
NeoPACT[39] 2 TCb＋Pembrolizumab 150 是 58 － 89.0b －
GeparNuevo[58] 2 (PCb→AC)＋Durvalumab 174 是 53.4 0.287 85.6c 0.036
    PCb→AC     44.2   77.2c  
IMpassion031[59] 3 (P→AC)＋Atezolizumab 333 否 58 0.004 4 － －
    P→AC     41      
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