对于早期乳腺癌，术后全身治疗（化疗、内分泌治疗和靶向治疗）又称辅助治疗，可减少术后复发转移风险，目前已经成为治疗常规；术前全身治疗又称新辅助治疗，可提高手术的可行性和成功率，目前仍然存在五大临床问题：哪些乳腺癌患者适合进行新辅助全身治疗？新辅助化疗患者应如何衡量疗效？对于三阴性乳腺癌患者推荐什么新辅助全身治疗方案？对于HER2阴性激素受体阳性乳腺癌患者推荐什么新辅助治疗？对于HER2阳性乳腺癌患者推荐什么新辅助治疗方法？
2021年1月28日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表美国国家癌症研究所、美国临床肿瘤学会、北卡罗来纳大学莱恩伯格综合癌症中心、西雅图抗癌联盟、弗吉尼亚癌症中心、杜克大学、西北大学、纽约纪念医院斯隆凯特林癌症中心、迈阿密大学米勒医学院西尔维斯特综合癌症中心、哈佛大学达纳法伯癌症研究所、罗文大学库珀医学院MD安德森癌症中心、德克萨斯大学MD安德森癌症中心、哥伦比亚大学赫伯特欧文综合癌症中心、德国乳腺癌协作组联合起草的美国临床肿瘤学会指南：乳腺癌新辅助化疗、内分泌治疗和靶向治疗，对五大临床问题提供了推荐意见，全文共计23页。
美国临床肿瘤学会指南专家组首先对2000年1月1日～2020年8月31日发表的乳腺癌新辅助治疗文献进行系统检索评审，并提供治疗方案推荐意见。结果，共计41篇论文符合入选标准，并为指南推荐意见提供了证据基础。指南草案于2020年8月28日～2020年9月8日公开征求意见，并于2020年12月4日正式提交。该指南主要推荐意见如下：
进行新辅助治疗的患者应由多学科医疗团队管理。
新辅助治疗合适候选者包括炎性乳腺癌患者、不可切除或局部晚期病灶可能转为可切除者、高风险HER2阳性或三阴性乳腺癌残留病灶可能指导治疗改变者。
新辅助治疗也可用于减少局部治疗（保乳手术、腋窝淋巴结清扫）范围或缩短手术延迟时间（例如术前需要基因检测指导治疗决策或考虑乳房重建方案）。
虽然应常规采用肿瘤组织学、分级、分期、雌孕激素受体和HER2表达指导临床决策，但是尚无充分证据支持采用其他免疫化学或形态学标志物（例如肿瘤浸润淋巴细胞）或基因组检测。
临床淋巴结阳性和（或）肿瘤大于1厘米（≥T1c）三阴性乳腺癌患者应予蒽环类和紫杉类化疗方案；临床肿瘤大小0.1～0.5厘米或0.5～1厘米且淋巴结阴性（cT1a或cT1bN0）三阴性乳腺癌患者不应常规进行新辅助治疗。
三阴性乳腺癌患者可予卡铂，以提高病理完全缓解。
当前将免疫检查点抑制剂加入标准化疗的证据不足。
对于激素受体阳性HER2阴性乳腺癌患者，若无需手术病理数据和（或）肿瘤基因组检测即可决定化疗方案，则新辅助化疗可用于取代辅助化疗。
对于激素受体阳性HER2阴性绝经后患者，新辅助内分泌治疗＋芳香酶抑制剂可用于降低分期，以增加局部区域治疗选择；如无手术意向，内分泌治疗可用于控制病灶。
对于淋巴结阳性或高风险淋巴结阴性、HER2阳性乳腺癌患者，应予新辅助化疗并联合HER2靶向治疗。
肿瘤大小0.1～1厘米且淋巴结阴性（T1aN0和T1bN0）HER2阳性乳腺癌患者不应常规进行新辅助治疗。
J Clin Oncol. 2021 Jan 28. Online ahead of print.
Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline.
Korde LA, Somerfield MR, Carey LA, Crews JR, Denduluri N, Hwang ES, Khan SA, Loibl S, Morris EA, Perez A, Regan MM, Spears PA, Sudheendra PK, Symmans WF, Yung RL, Harvey BE, Hershman DL.
National Cancer Institute, Bethesda, MD; American Society of Clinical Oncology, Alexandria, VA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Seattle Cancer Care Alliance, Seattle, WA; US Oncology Network, Virginia Cancer Specialists, Arlington, VA; Duke University, Durham, NC; Northwestern University, Chicago, IL; German Breast Group, Neu-Isenburg, Germany; Memorial Sloan Kettering Cancer Center, New York, NY; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Plantation, FL; Dana Farber Cancer Institute, Boston, MA; MD Anderson Cooper University Health Care, Camden, NJ; MD Anderson Cancer Center, Houston, TX; Herbert Irving Comprehensive Cancer Center at Columbia University, New York, NY.
PURPOSE: To develop guideline recommendations concerning optimal neoadjuvant therapy for breast cancer.
METHODS: ASCO convened an Expert Panel to conduct a systematic review of the literature on neoadjuvant therapy for breast cancer and provide recommended care options.
RESULTS: A total of 41 articles met eligibility criteria and form the evidentiary basis for the guideline recommendations.
RECOMMENDATIONS: Patients undergoing neoadjuvant therapy should be managed by a multidisciplinary care team. Appropriate candidates for neoadjuvant therapy include patients with inflammatory breast cancer and those in whom residual disease may prompt a change in therapy. Neoadjuvant therapy can also be used to reduce the extent of local therapy or reduce delays in initiating therapy. Although tumor histology, grade, stage, and estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) expression should routinely be used to guide clinical decisions, there is insufficient evidence to support the use of other markers or genomic profiles. Patients with triple-negative breast cancer (TNBC) who have clinically node-positive and/or at least T1c disease should be offered an anthracycline- and taxane-containing regimen; those with cT1a or cT1bN0 TNBC should not routinely be offered neoadjuvant therapy. Carboplatin may be offered to patients with TNBC to increase pathologic complete response. There is currently insufficient evidence to support adding immune checkpoint inhibitors to standard chemotherapy. In patients with hormone receptor (HR)-positive (HR-positive), HER2-negative tumors, neoadjuvant chemotherapy can be used when a treatment decision can be made without surgical information. Among postmenopausal patients with HR-positive, HER2-negative disease, hormone therapy can be used to downstage disease. Patients with node-positive or high-risk node-negative, HER2-positive disease should be offered neoadjuvant therapy in combination with anti-HER2-positive therapy. Patients with T1aN0 and T1bN0, HER2-positive disease should not be routinely offered neoadjuvant therapy.
PMID: 33507815
DOI: 10.1200/JCO.20.03399
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