美国国家综合癌症网络乳腺癌指南更新
前情提要
时隔131天，正值徐志摩诞辰123周年、马丁·路德·金诞辰91周年、遵义会议85周年、中美签署第一阶段经贸协议之际，美国国家综合癌症网络（NCCN）于美国东部时间2020年1月15日悄然将乳腺癌临床实践指南更新至2020年第1版，全文由216页增至223页，免费注册后仍可免费下载：
NCCN为非国立、非营利、全国综合癌症中心联盟组织，1993年11月正式成立，1995年1月31日宣布成为全国联盟，其总部于2018年9月28日由宾夕法尼亚州华盛顿堡迁至普利茅斯米庭，由最初13个至目前28个美国知名综合癌症中心组成：
关于本版（2020年第1版）NCCN乳腺癌临床实践指南，其架构仍为临床路径＋循证解读＋参考文献，其依据仍来自权威学术期刊最新发表的大样本多中心随机对照三期临床研究结果。本版更新较多，具体如下：
整体修改
General
将「多基因测定」全部改为「基因表达测定」。
Changed "multigene assays" to "gene expression assays" throughout the guidelines.
将乳腺浸润癌（BINV）各个页面的脚注修改或增加如下：
The following footnotes have been added/modified on various BINV pages:
修改脚注y：删除「髓样癌和微乳头状癌亚型」改为「根据世界卫生组织（WHO）乳腺肿瘤组织学分类，非特殊类型（NST）癌包含多种形式，包括髓样癌、神经内分泌表达癌以及其他罕见形式」。
Footnote y modified: This includes medullary and micropapillary subtypes. According to WHO, carcinoma of no special type (NST) encompasses multiple patterns including medullary pattern, cancers with neuroendocrine expression, and other rare patterns.
增加脚注z：罕见的化生癌亚型（例如低分级腺鳞状细胞癌和低分级纤维瘤样癌）被认为预后良好，即使未进行术后辅助全身治疗。
Footnote z added: There are rare subtypes of metaplastic carcinoma (eg, low-grade adenosquamous and low-grade fibromatosis-like carcinoma) that are considered to have a favorable prognosis without adjuvant systemic therapies.
增加脚注aa：与良好预后相关的良好组织学类型应为单纯（占手术切除标本>90%，而非仅仅根据粗针穿刺活检）非高分级且HER2阴性。如果存在不典型病理或临床特征，考虑作为导管癌或非特殊类型（NST）癌进行治疗（参见BINV-4）。
Footnote aa added: To be associated with favorable prognosis, the favorable histologic type should be pure (>90% as classified on the surgical excision, not core biopsy alone), not high grade and HER2 negative. If non-typical pathologic or clinical features are present, consider treating as ductal/NST (see BINV-4).
增加脚注bb：如果检查结果异常、不一致或模棱两可，那么应该关注组织学与激素受体和HER2状态的关联。参见生物标志检查原则（BINV-A）。
Footnote bb added: Correlation of histology, hormone receptor, and HER2 status should always be done with awareness of unusual/discordant or borderline results. See Principles of Biomarker Testing (BINV-A).
修改脚注cc：删除「乳腺癌的雌激素受体（ER）和孕激素受体（PR）表达范围可从低水平（1%～10%）到高水平」改为「ER/PR低表达乳腺癌的生物学行为可能与ER/PR阴性乳腺癌更相似，故术后辅助治疗决策时应予考虑。虽然ER免疫组织化学（IHC）染色为1%～100%的乳腺癌患者被认为ER阳性且适合进行内分泌治疗，但是关于ER弱阳性（1%～10%）结果的乳腺癌症亚组数据极少。根据研究报告，ER弱阳性乳腺癌的生物学行为通常与ER阴性乳腺癌相似，其他辅助治疗和总体治疗路径决策应予考虑。参见生物标志检查原则（BINV～A）。
Footnote cc modified: The expression of ER and PR in breast cancer can range from low (1%-10%) to high levels. The biologic behavior of ER/PR low-expressing tumors may be more similar to ER/PR-negative cancers and this should be considered in decision-making for adjuvant therapy. Although patients with cancers with 1%-100% ER IHC staining are considered ER-positive and eligible for endocrine therapies, there are more limited data on the subgroup of cancers with ER-low-positive (1%-10%) results. The ER-low-positive group is heterogeneous with reported biologic behavior often similar to ER-negative cancers. This should be considered in decisionmaking for other adjuvant therapy and overall treatment pathway. See Principles of Biomarker Testing (BINV-A).
乳腺导管原位癌术后治疗与监测/随访（DCIS-2）
Noninvasive Breast Cancer: DCIS Postsurgical Treatment and Surveillance/Follow-up (DCIS-2)
从流程和脚注删除指向NCCN减少乳腺癌风险指南的链接。
Removed links to NCCN Guidelines for Breast Risk Reduction from algorithm and footnote.
乳腺浸润癌临床分期与检查（BINV-1）
Invasive Breast Cancer: Clinical Stage, Workup (BINV-1)
注明该路径适用于不考虑术前全身治疗的患者。
Clarified that this pathway is for those not considering preoperative systemic therapy.
将腋窝评定检查移至BINV-11。
Moved axillary assessment with exam to BINV-11.
修改脚注k：乳房磁共振成像（MRI）可能有助于分析腋窝和/或乳房内侧（内乳）淋巴结病变。参见乳房MRI专用检查原则（BINV-B）。
Footnote k modified: Breast MRI may be useful for characterizing axillary and/or internal mammary nodal disease. See Principles of Dedicated Breast MRI Testing (BINV-B).
增加链接指向妊娠期乳腺癌检查（PREG-1）。
Added link to PREG-1 for patients preganat at time of workup.
将「如果考虑对T0-4,N1-3,M0或T2-4,N0,M0进行术前全身治疗」改为「如果考虑对≥T2或≥N1进行术前全身治疗（术前全身治疗指征）」并增加指向BINV-M的链接获得更多信息。
Revised criteria for consideration of preoperative systemic therapy to ≥T2 or ≥N1, and added a link to BINV-M for more information.
删除脚注：参见术前全身治疗原则（BINV-M）参见检查（BINV-11）。
Footnote removed: See Principles of Preoperative Systemic Therapy (BINV-M) amd See Workup (BINV-11).
增加链接指向炎症性乳腺癌（IBC-1）。
Added a link to IBC-1 for those diagnosed with inflammatory breast cancer.
乳腺浸润癌T1-3,N0-1,M0病变局部区域治疗：乳房肿块切除手术腋窝分期（BINV-2）
Invasive Breast Cancer: Locoregional Treatment of T1-3,N0-1,M0 Disease: Lumpectomy with surgical axillary staging (BINV-2)
删除术前全身治疗指征并链接至BINV-11。
Removed criteria for preoperative systemic therapy and link to BINV-11.
增加脚注s：对于符合ACOSOG Z0011指征的患者应该考虑切线野或高位切线野放疗。
Footnote s added: Consider tangents/high tangents for patients who meet ACOSOG Z0011 criteria.
乳腺浸润癌T1-3,N0-1,M0病变局部区域治疗：乳房全部切除手术腋窝分期（BINV-3）
Invasive Breast Cancer: Locoregional Treatment of T1-3,N0-1,M0 Disease: Total mastectomy with surgical axillary staging (BINV-3)
增加脚注w：对于微转移（0.2～2.0毫米）且未腋窝清扫的病例，考虑放疗时应该评估其他的患者风险因素。
Footnote w added: In the case of a micrometastasis (>0.2 to ≤2.0 mm), and no axillary dissection, evaluate other patient risk factors when considering RT.
乳腺浸润癌：组织学、激素受体状态、HER2状态与全身辅助治疗（BINV-4）
Invasive Breast Cancer: Histology, Hormone Receptor Status, HER2 Status, Systemic Adjuvant Treatment
组织学分类：增加非特殊类型（NST）癌、微乳头状癌，增加有利的组织学类型：纯管状癌、纯黏液样癌、纯筛状（多孔）癌、包膜或实体乳头状癌、其他罕见类型
Histologies modified/clarified. (Also on subsequent pages)
乳腺浸润癌：全身辅助治疗：激素受体阳性、HER2阳性病变（BINV-5）
Invasive Breast Cancer: Systemic Adjuvant Treatment: Hormone Receptor-Positive HER2-Positive Disease (BINV-5)
删除脚注：对于乳腺小叶与导管混合癌，应该根据导管成分进行分级，并根据该分级进行治疗。对于化生癌，组织学分级的预后价值尚不明确。不过，当化生癌组织学亚型成分占肿瘤的10%以上时，该亚型为独立的预后因素。
Footnote removed: Mixed lobular and ductal carcinoma should be graded based on the ductal component and treated based on this grading. For metaplastic carcinoma, the prognostic value of the histologic grading is uncertain. However, when a specific histologic subtype of metaplastic carcinoma is present and accounts for more than 10% of the tumor, the subtype is an independent prognostic variable.
乳腺浸润癌：全身辅助治疗：淋巴结阴性、激素受体阳性、HER2阴性病变（BINV-6）
Invasive Breast Cancer: Systemic Adjuvant Treatment: Node-Negative Hormone Receptor-Positive HER2-Negative Disease (BINV-6)
修改脚注kk：其他具有预后作用的「多基因测定」改为其他具有预后作用的「基因表达测定」
Footnote kk modified: Other prognostic multigene gene expression assays may be considered to help assess risk of recurrence but have not been validated to predict response to chemotherapy. See...
修改脚注ll：「组织学分级低的T1b期乳腺癌患者应予单纯内分泌治疗」改为「组织学分级低且无淋巴管浸润的T1b期乳腺癌患者应予单纯内分泌治疗」
Footnote ll modified: Patients with T1b tumors with low-grade histology and no lymphovascular invasion should be treated with endocrine monotherapy as the TAILORx trial did not include patients with such tumors.
修改脚注mm：对于年龄≤50岁且复发评分为16～25的女性，根据TAILORx研究初步分析表明考虑术后辅助化疗年轻患者对化疗可能获益。参见讨论。对于年龄≤50岁的随机化疗女性，远处复发较少。
Footnote mm modified: Consider the use of adjuvant chemotherapy In women 50 years of age or younger with a recurrence score of 16-25, based on an exploratory analysis from the TAILORx study demonstrated a potential benefit to chemotherapy in younger patients. See Discussion. lower distant recurrences in women 50 years of age or younger randomized to chemotherapy.
乳腺浸润癌：全身辅助治疗：激素受体阴性、HER2阴性病变（BINV-9）
Invasive Breast Cancer: Systemic Adjuvant Treatment: Hormone Receptor-Negative HER2-Negative Disease (BINV-9)
增加脚注ss：对于某些具有高风险特征的患者（例如组织学分级较高的年轻女性）可以考虑术后辅助化疗（2B类证据）。参见（BINV-L）。
Footnote ss added: In select patients with high-risk features (eg, very young women with high-grade histology), adjuvant chemotherapy may be considered (category 2B). See (BINV-L).
乳腺浸润癌：全身辅助治疗：有利的组织学类型（BINV-10）
Invasive Breast Cancer: Systemic Adjuvant Treatment: Favorable Histologies (BINV-10)
对于ER阴性和PR阴性的HER2阴性病变（三阴性乳腺癌）增加推荐意见：现有少量数据支持仅对淋巴结阳性疾病全身/靶向治疗情况下进行局部治疗。
Bottom pathway modified. For ER-negative and PR-negative, HER2 negative disease the following recommendation has been added: Limited available data support local therapy only with consideration for systemic/targeted therapies only in node-positive disease.
增加脚注tt：不伴明确浸润的包被乳头状癌（EPC）由于生物学行为与乳腺导管原位癌（DCIS）相似，被美国癌症联合委员会分期为病理原位癌（pTis）。实体乳头状癌（SPC）应该按照世界卫生组织乳腺肿瘤组织学分类指定为原位癌或浸润癌，不过两种类型的结局均良好。
Footnote tt added: Encapsulated papillary carcinoma (EPC) without associated conventional invasion is staged as pTis because behavior is similar to DCIS (per AJCC). Solid papillary carcinoma (SPC) should be specified as in situ or invasive based on WHO criteria but both forms have favorable outcomes.
乳腺浸润癌：术前全身治疗前检查（BINV-11）
Invasive Breast Cancer: Workup Prior to Preoperative Systemic Therapy (BINV-11)
修改临床分期：「T0-4,N1-3,M0或T2-4,N0,M0」改为「≥T2,M0或≥N1,M0」
Modified clinical stage: ≥T2,M0 or ≥N1,M0.
增加腋窝评定检查，包括考虑超声检查、可疑淋巴结的经皮穿刺活检。
Added axillary assessment with exam, including consider ultrasound, and percutaneous biopsy of suspicious nodes.
为妊娠患者增加指向PREG-1的链接。
Added link to PREG-1 for pregnant patients.
将乳房MRI（可选）移至「其他研究考虑」。
Moved breast MRI (optional) under "additional studies consider."
将检查后的「对于潜在可手术的乳腺癌」改为「对于可手术的乳腺癌」
Following workup, changed "for potentially operable breast cancer" to "for operable breast cancers..."
修改脚注vv：腋窝淋巴结活检时，应该用夹子或纹身进行标记，以便最终手术时确定活检阳性淋巴结已被切除。
Footnote vv modified: At the time of axillary node sampling, a clip or tattoo should be placed to permit verification that the biopsy-positive lymph node has been removed at the time of definitive surgery.
乳腺浸润癌：可手术病变术前全身治疗前乳房和腋窝评估（BINV-12）
Invasive Breast Cancer: Operable Disease: Breast and Axillary Evaluation Prior to Preoperative Systemic Therapy (BINV-12)
关于腋窝淋巴结评估/活检的建议已被移至BINV-D。
This page has been significantly modified. Recommendations regarding axillary lymph node evaluation/biopsy have been moved to BINV-D.
增加脚注ww：如果确定淋巴结状态将影响手术和/或全身治疗的选择，那么可于术前全身治疗之前考虑进行前哨淋巴结活检。
Footnote ww added: Sentinel node biopsy can be considered prior to preoperative systemic therapy if the determination of nodal status will influence surgical and/or systemic therapy choices.
乳腺浸润癌：可手术病变术前全身治疗后手术治疗和辅助治疗（BINV-13）
Invasive Breast Cancer: Operable Disease: Surgical Treatment and Adjuvant Therapy after Preoperative Systemic Treatment (BINV-13)
标题修改：潜在可手术病变术前全身治疗和后手术治疗和辅助治疗
Title modified: Potentially Operable Disease: Preoperative Systemic Therapy and Surgical Treatment and Adjuvant Therapy After Preoperative Systemic Treatment
增加辅助治疗选择并链接至BINV-15，以获取关于辅助全身治疗选择的更多信息。
Added adjuvant therapy options with link to BINV-15 for additional information on adjuvant systemic therapy options.
修改脚注xx：精准评定乳房内肿瘤或区域淋巴结对术前全身治疗的效果较难，并且应该包括体格检查和影像检查（乳腺X线和/或乳腺超声和/或乳腺MRI）
Footnote xx modified: The accurate assessment of in-breast tumor or regional lymph node response to preoperative systemic therapy is difficult, and should include physical examination and performance of imaging studies (mammogram and/or breast ultrasound and/or breast MRI) that were abnormal...
增加脚注yy：完成术前未完成的化疗方案计划疗程。
Footnote yy added: Complete planned chemotherapy regimen course if not completed preoperatively. (Also on BINV-14)
乳腺浸润癌：不可手术或局部晚期病变（非炎性）术前全身治疗及其后续治疗（BINV-14）
Invasive Breast Cancer: Inoperable or Locally Advanced Disease (non-inflammatory): Preoperative Systemic Therapy and Subsequent Treatment (BINV-14)
修改标题：不可手术或局部晚期病变（非炎性）术前全身治疗及其后续治疗
Title modified: Inoperable or Locally Advanced Disease (Non- Inflammatory): Preoperative Systemic Therapy and Subsequent Treatment
增加辅助治疗选择并链接至BINV-15，以获取关于辅助全身治疗选择的更多信息。
Top pathway: Added adjuvant therapy options with link to BINV-15 for additional information on adjuvant systemic therapy options.
乳腺浸润癌：术前全身治疗后全身辅助治疗（BINV-15）
Invasive Breast Cancer: Adjuvant Systemic Therapy After Preoperative Systemic Therapy (BINV-15)
该页已经重大修改，增加根据术前治疗效果选择术后全身辅助治疗方案。
Page significantly modified to include adjuvant systemic therapy options based on response to preoperative treatment.
该页面适用于可手术和不可手术病变的术前全身治疗后全身辅助治疗（原BINV-14和BINV-16已被该新流程替换）。
This page applies to adjuvant systemic therapy after preoperative systemic therapy for both operable and inoperable disease. (Former pages BINV-14 and BINV-16 have been replaced with this new algorithm.)
增加脚注ccc：如果HER2靶向治疗和/或内分泌治疗有指征，可与放疗同时进行。如果卡培他滨有指征，应于放疗完成后用药。
Footnote ccc added: If HER2-targeted therapy and/or endocrine therapy is indicated, it may be administered concurrently with radiation. If indicated, capecitabine should follow completion of RT.
乳腺浸润癌：监测/随访（BINV-16）
Invasive Breast Cancer: Surveillance/Follow-Up (BINV-16)
脚注eee增加：地舒单抗停药后有自发骨折的病例报告。
Line added to footnote eee: There are case reports of spontaneous fractures after denosumab discontinuation.
乳腺浸润癌：复发或IV期（M1）病变（BINV-17）
Invasive Breast Cancer: Recurrent/Stage IV (M1) Disease (BINV-17)
增加检查项目：进行生物标志检查以确定其他靶向治疗的可选药物，参见复发或IV期（M1）病变的其他靶向治疗及其相关生物标志检查。
Workup, bullet added: For biomarker testing to identify candidates for additional targeted therapies, see Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease.
删除检查项目：对于考虑化疗的HER2阴性肿瘤患者，强烈考虑进行生殖细胞BRCA1/2检查。
Removed bullet: For patients with HER2-negative tumors under consideration for chemotherapy, strongly consider germline BRCA1/2 testing.
修改并移至BINV-R：对于激素受体阳性/HER2阴性乳腺癌，通过肿瘤活检或液体活检对PIK3CA突变进行评定，以确定适合阿吡利塞/阿培利司＋氟维司群的患者。对于三阴性乳腺癌，对肿瘤浸润免疫细胞PD-L1表达生物标志状态进行评估，以确定最有可能获益于阿特利珠单抗＋白蛋白结合紫杉醇的患者。
Modified and moved the following bullets to BINV-R: For HR-positive/HER2-negative breast cancer, assess for PIK3CA mutations with tumor or liquid biopsy identify candidates for alpelisib plus fulvestrant. For triple-negative breast cancer (TNBC), assess PD-L1 expression biomarker status on tumor-infiltrating immune cells to identify patients most likely to benefit from candidates for atezolizumab plus albumin-bound paclitaxel.
该脚注移至BINV-R：可对肿瘤组织或外周血液循环肿瘤DNA（液体活检）进行PIK3CA突变检查。
Footnote moved to BINV-R: PIK3CA mutation testing can be done on tumor tissue or ctDNA in peripheral blood (liquid biopsy).
如果液体活检阴性，那么推荐进行肿瘤组织检查。
If liquid biopsy is negative, tumor tissue testing is recommended.
增加脚注jjj：关于脑转移的治疗，参见《NCCN中枢神经系统癌症指南》。
Footnote jjj added: For the treatment of brain metastases, see NCCN Guidelines for Central Nervous System Cancers.
乳腺浸润癌：复发或IV期（M1）病变全身治疗（BINV-19）
Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease (BINV-19)
修改脚注qqq：唑来膦酸的最佳疗程为每月×12，随后每季度每12周。
Last line of footnote qqq modified: The optimal schedule for zoledronic acid is every 12 weeksmontly x 12, then quarterly.
乳腺浸润癌：复发或IV期（M1）激素受体阳性、HER2阴性病变全身治疗（BINV-20）
Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-negative (BINV-20)
无内脏转移且1年内曾经进行内分泌治疗，绝经前和绝经后：将「不同的内分泌治疗±CDK4/6或mTOR抑制剂」改为「全身治疗」
No visceral crisis and prior endocrine therapy within 1 y, premenopausal and postmenopausal Changed "different endocrine therapy ± CDK4/6 or mTOR inhibitor" to "systemic therapy"
无内脏转移且1年内未曾进行内分泌治疗：绝经前首选卵巢切除或抑制＋「内分泌治疗±CDK4/6抑制剂」改为「全身治疗」；绝经后治疗方案改为「全身治疗」
No visceral crisis and no prior endocrine therapy within 1 y: Premenopausal, modified first option: Ovarian ablation or suppression plus endocrine therapy ± CDK4/6 inhibitor lll + systemic therapy Postmenopausal, replaced options with: Systemic therapy
增加脚注uuu：如果初始内分泌治疗失败，转换至其他内分泌治疗方案。
Footnote uuu added: If progression on initial endocrine therapy, switch to a different endocrine therapy option.
删除脚注并移至BINV-P：两项一线治疗随机对照研究证实氟维司群＋CDK4/6抑制剂（哌柏西利、瑞波西利）优于氟维司群单药。
Footnote removed, addressed on BINV-P: Fulvestrant has been combined with CDK4/6 inhibitors (palbociclib, ribociclib) in the first-line setting in two randomized trials.
乳腺浸润癌：复发或IV期（M1）激素受体阳性、HER2阴性病变全身治疗（BINV-21）
Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-negative (BINV-21)
疾病进展或毒性反应无法耐受，修改首选治疗方案：如果内分泌治疗有效，考虑其他内分泌治疗方案±靶向治疗方案（参见BINV-P二线治疗方案）
Progression or unacceptable toxicity, modified first option: If not endocrine therapy refractory, consider additional line of endocrine therapy ± targeted therapy (see second-line therapy options on BINV-P).
修改脚注www：如果CDK4/6抑制剂治疗时疾病进展，那么无有少量数据支持其他下一步治疗方法...
Modified footnote www: If there is disease progression while on CDK4/6 inhibitor therapy, there are no limited data to support an additional line of therapy...
乳腺浸润癌：复发或IV期（M1）激素受体阴性、HER2阴性病变全身治疗（BINV-25）
Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-negative; HER2-negative (BINV-25)
增加脚注ffff：对于三阴性乳腺癌，对肿瘤浸润免疫细胞PD-L1表达进行评定，以确定适合阿特珠单抗＋白蛋白结合紫杉醇的患者。对生殖细胞BRCA1/2突变进行评定，以确定适合PARP抑制剂单药治疗的患者。参见复发或IV期（M1）病变其他靶向治疗及其相关生物标志检查（BINV-R）。
Footnote ffff added: For triple-negative breast cancer (TNBC), assess PD-L1 expression on tumor-infiltrating immune cells to identify candidates for atezolizumab plus albumin-bound paclitaxel. Assess germline BRCA1/2 mutations to identify candidates for PARP-inhibitor monotherapy. See Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease (BINV-R).
乳腺浸润癌：生物标志检查原则（BINV-A）
Invasive Breast Cancer: Principles of Biomarker Testing (BINV-A)
增加激素受体检查
New page added on Principles of Biomarker Testing Hormone Receptor Testing.
乳腺浸润癌：生育和节育（BINV-C）
Invasive Breast Cancer: Fertility and Birth Control (BINV-C)
修改第四点：放疗、化疗、内分泌治疗期间，以及曲妥珠单抗或帕妥珠单抗治疗期间或治疗完成6个月内，患者应该避免妊娠。
Fourth bullet modified: Patients should not become pregnant during treatment with RT, chemotherapy, endocrine therapy, or during or within 6 months of completing trastuzumab or pertuzumab.
修改第八点：不推荐化疗和内分泌治疗期间、曲妥珠单抗或帕妥珠单抗治疗完成6个月内进行母乳喂养。
Eighth bullet modified: Breastfeeding is not recommended during active treatment with chemotherapy and endocrine therapy or within 6 months of completing trastuzumab or pertuzumab.
乳腺浸润癌：腋窝手术分期（BINV-D）
Invasive Breast Cancer: Surgical Axillary Staging (BINV-D)
该页已经重大修改，增加术前化疗患者腋窝分期推荐意见。
This page has been significantly revised to include axillary staging recommendations for patients who have received preoperative chemotherapy.
乳腺浸润癌：腋窝淋巴结分期（BINV-E）
Invasive Breast Cancer: Axillary Lymph Node Staging (BINV-E)
结尾增加：淋巴水肿是腋窝淋巴结手术治疗后淋巴系统损伤可能引起的副作用。淋巴水肿的早期发现/诊断，是优化治疗的关键。考虑对有淋巴水肿风险因素的患者进行治疗前双臂测量。参见NCCN生存指南：淋巴水肿（SLYMPH-1）。
Last paragraph added: Lymphedema is a potential side effect after the treatment of axillary lymph node surgery resulting from damage to the lymphatic system. Early detection/diagnosis of lymphedema is key for optimal management. Consider pretreatment measurement of both arms as a baseline for patients with risk factors for lymphedema. See NCCN Guidelines for Survivorship: Lymphedema (SLYMPH-1).
乳腺浸润癌：放疗原则（BINV-I）
Invasive Breast Cancer: Principles of Radiation Therapy (BINV-I)
个体化放疗的优化：修改第四小点：俯卧位可能有助于进一步减少邻近正常组织，尤其心肺以及邻近正常组织的放疗剂量。修改第六点：在特殊情况下当采用某些技术（例如胸部俯卧）时，可以适当增加影像检查频次。不推荐常规进行每天影像检查。
Optimizing delivery of individual therapy: Fourth sub-bullet modified: ...prone positioning may be used to try to further reduce dose to adjacent [normal tissues, in particular] heart and lung and adjacent normal tissue. Sixth sub-bullet modified: [In certain circumstances] When using certain techniques (ie, prone breast), more frequent imaging may be appropriate. Routine use of daily imaging is not recommended.
区域淋巴结放疗：修改第二小点：根据乳房切除术后放疗随机对照研究和最新研究，区域淋巴结放疗时强烈推荐内乳淋巴结放疗，包括第1～3肋间隙。内乳淋巴结放疗时应该评估淋巴结体积以制定放疗剂量计划应该采用剂量体积直方图（DVH）对正常组织、尤其心肺放疗剂量以及剂量限制放疗剂量限制、正常组织（心肺）放疗剂量以及放疗计划靶区（PTV）进行评估。
Regional Nodal Radiation: Second sub-bullet modified: Based on the post-mastectomy radiation randomized studies and recent trials, RT of the internal mammary lymph nodes nodal chain to include the first 3 intercostal spaces should be strongly considered when delivering regional nodal irradiation. [CT treatment planning should be utilized] When treating the internal mammary [lymph nodal volume to evaluate dose to] nodes, dose-volume histograms (DVHs) should be used to evaluate dose constraints, dose to normal tissues (heart, lung), and planned target volumes (PTVs). [normal tissues, especially the heart and lung, and dose constraints respected.]
快速部分乳房放疗（APBI）修改第一点：初步研究表明，APBI与标准全乳放疗（WBRT）相比，某些低风险早期乳腺癌患者的局部控制率可能相似。不过，与标准WBRT相比，若干最新研究表明APBI美观结局较差。随访数据有限，研究正在进行。
Accelerated Partial Breast Irradiation: First bullet modified: [Preliminary] Studies of APBI suggest that rates of local control in selected low-risk patients with early-stage breast cancer may be comparable to those treated with standard WBRT. However, compared to standard whole breast radiation, several recent studies document an inferior cosmetic outcome with APBI. Follow-up is limited and studies are ongoing.
修改术前全身治疗：对于术前全身治疗患者，根据乳腺癌诊断时（术前全身治疗之前）病变最高分期（例如临床分期、病理分期、肿瘤特征）和术前全身治疗后的病理结果进行术后辅助放疗。
Preoperative Systemic Therapy Bullet modified: In patients treated with preoperative systemic therapy, adjuvant RT is based on the maximal disease stage (ie, clinical stage, pathologic stage, tumor characteristics) at diagnosis (before preoperative systemic therapy) and pathology results after preoperative systemic therapy.
乳腺浸润癌：男性乳腺癌特殊注意点（BINV-J 1 OF 2）
Invasive Breast Cancer: Special Considerations for Breast Cancer in Men (BINV-J 1 OF 2)
修改第一点：乳腺癌临床研究的男性患者专门针对男性乳腺癌的临床研究极少。
First bullet modified: Few men have been included in breast cancer trials. Few clinical trials have specifically focused on male breast cancer.
修改第二点：虽然男性与女性的乳腺癌之间存在某些生物学和临床差异，但是男性乳腺癌的治疗总体而言与女性乳腺癌的治疗相似，不过男性患者存在若干特殊注意点。
Second bullet modified: Although there are some biologic and clinical differences between breast cancer in men and women, [Overall,] management of breast cancer in men is similar overall to management of breast cancer in women, with the following special considerations pertinent to male patients.
修改第二小点：乳房手术：根据历史数据，乳腺癌男性的乳房切除术多于保乳手术。不过，男性保乳治疗越来越多，并且不断变化的数据表明，男性保乳与乳房切除术的效果相似，并且安全可行。对于男性，应该按照与女性相似的标准进行保乳或乳房切除术的决策。虽然某些男性乳腺癌病例可以进行部分乳房切除术，但是通常仅用于合并症严重的老年男性，或者男性患者希望保留乳头并且愿意进行放疗，如同相似病变女性的指征
Second sub-bullet modified: Breast surgery: Historically, men with breast cancer have undergone mastectomy more often than BCS. However, breast-conserving therapy is increasingly being performed in men and evolving data indicated that breast conservation in men is associated with equivalent outcomes to mastectomy and that it is safe and feasible. Decisions about breast conservation versus mastectomy in men should be made according to similar criteria as for women. While partial mastectomy can be performed in selected cases of male breast cancer, it generally has been reserved for older men with significant comorbid disease or in cases where the male patient is hoping to achieve nipple preservation and is willing to undergo radiation treatment as would be indicated in women with similar disease.
修改第八小点：晚期病变的全身治疗：男性晚期乳腺癌的治疗与女性相似。不过，给予芳香酶抑制剂时，应该同时给予促性腺激素释放激素类似物。现有数据表明，氟维司群对于男性的效果与女性相似。乳腺癌男性临床研究尚未对CDK4/6抑制剂＋芳香酶抑制剂或氟维司群、mTOR抑制剂和PIK3CA抑制剂等新药进行系统评估。不过，现有真实世界数据表明其有效性和安全性相似，故根据主要由晚期乳腺癌女性参加的研究数据推断，向男性推荐这些药物是合理的。虽然尚未对CDK4/6抑制剂和mTOR抑制剂等新药用于男性进行评估，但是根据来自晚期乳腺癌女性研究的数据，向男性推荐这些新药是合理的。
Last sub-bullet modified: Systemic therapy for advanced disease: Management of advanced breast cancer in men is similar to that in women; however, it is preferred that when an aromatase inhibitor is used, a GnRH analog should be given concurrently. Available data suggest single-agent fulvestrant has similar efficacy in men as in women. Newer agents such as CDK4/6 inhibitors in combination with an aromatase inhibitor or fulvestrant, mTOR inhibitors, and PIK3CA inhibitors have not been systematically evaluated in clinical trials in men with breast cancer. However, available real-world data suggest comparable efficacy and safety profiles and it is reasonable to recommend these agents to men based on extrapolation of data from studies comprised largely of female participants with advanced breast cancer. Newer agents such as CDK 4/6 inhibitors and mTOR inhibitors have not been evaluated in men, but it is reasonable to recommend them in men based on data from studies of women with advanced breast cancer.
乳腺浸润癌：男性乳腺癌特殊注意点（BINV-J 2 OF 2）
Invasive Breast Cancer: Special Considerations for Breast Cancer in Men (BINV-J 2 OF 2)
参考文献更新。
References have been updated.
乳腺浸润癌：术后内分泌辅助治疗（BINV-K）
Invasive Breast Cancer: Adjuvant Endocrine Therapy (BINV-K)
芳香酶抑制剂辅助治疗5年之后，对于乳腺癌诊断时已绝经患者，推荐维持芳香酶抑制剂治疗延长时间由5年改为3～5年。
Following adjuvant therapy with an aromotase inhibitor for 5 y, the recommended duration to continue an aromatase inhibitor has been modified from an additional 5 y to an additional 3-5 y for patients that were postmenopausal at diagnosis.
增加脚注：如果患者未绝经，推荐先评估激素状态，再考虑其他内分泌药物。
Footnote a added: If patient is not postmenopausal, sequential evaluation of hormonal status is recommended to consider an alternative endocrine agent.
乳腺浸润癌：术前新辅助或术后辅助治疗方案（BINV-L 1 of 6）
Invasive Breast Cancer: Preoperative/Adjuvant Therapy Regimens (BINV-L 1 of 6)
对于某些三阴性乳腺癌患者，增加其他被推荐的术前新辅助治疗方案：每周紫杉醇＋卡铂、多西他赛＋卡铂。
Other recommended preoperative therapy regimens added for select patients with triple-negative breast cancer: Weekly paclitaxel + carboplatin, Docetaxel + carboplatin.
增加脚注j：铂类药物用于三阴性乳腺癌术前新辅助化疗仍存在争议。若干研究表明，加入铂类与否相比，病理完全缓解（pCR）率较高。不过，长期结局仍然未知。对于大多数患者（包括BRCA突变携带者），不推荐铂类药物常规用于三阴性乳腺癌术前新辅助治疗，但是可以考虑用于某些患者（例如需要获得较好局部控制者）。不推荐铂类药物用于术后辅助治疗。如果将铂类药物加入蒽环类化疗方案，那么化疗最佳顺序以及紫杉类药物选择尚未确定。
Footnote j added: The inclusion of platinum agents as neoadjuvant chemotherapy for triple-negative breast cancer remains controversial. Several studies have shown improved pCR rates with incorporation of platinum. However, longterm outcomes remain unknown. The routine use of platinum agents as part of neoadjuvant therapy for triple-negative breast cancer is not recommended for most patients (including BRCA mutation carriers), but it may be considered in select patients (such as those for whom achieving better local control is necessary). The use of platinum agents in the adjuvant setting is not recommended. If platinum agents are included in an anthracycline based regimen, the optimal sequence of chemotherapy and choice of taxane agent is not established.
乳腺浸润癌：术前新辅助或术后辅助治疗方案（BINV-L 3 of 6）
Invasive Breast Cancer: Preoperative/Adjuvant Therapy Regimens (BINV-L 3 of 6)
剂量信息更新，并增加治疗方案。
Dosing information updated with regimens added.
乳腺浸润癌：术前新辅助或术后辅助治疗方案（BINV-L 6 of 6）
Invasive Breast Cancer: Preoperative/Adjuvant Therapy Regimens (BINV-L 6 of 6)
参考文献更新。
References updated.
乳腺浸润癌：术前全身治疗原则（BINV-M 1 of 2）
Invasive Breast Cancer: Principles of Preoperative Systemic Therapy (BINV-M 1 of 2)
将术前全身治疗的获益和标准从第2页移至第1页。
Moved benefits and criteria for preoperative systemic therapy from page 2 to page 1.
术前全身治疗指征：修改第二点：对于可手术乳腺癌患者，术前全身治疗适用于：
Candidates for Preoperative Systemic Therapy, Modified second bullet: In patients with operable breast cancer, preoperative systemic therapy is preferred for those with:
增加：HERT2阳性和三阴性乳腺癌，如果T≥2或N≥1。
Added: HER2-positive disease and triple-negative breast cancer, if T ≥2 or N ≥1.
增加：如果需要时间决定手术方案。
Added: If time needed to decide surgical options.
乳腺浸润癌：术前全身治疗原则（BINV-M 2 of 2）
Invasive Breast Cancer: Principles of Preoperative Systemic Therapy (BINV-M 2 of 2)
修改第六点：HER2阳性乳腺癌患者术前应予曲妥珠单抗全身治疗至少9周。
Sixth bullet modified: Patients with HER2-positive tumors should be treated with preoperative systemic therapy incorporating trastuzumab for at least 9 weeks of preoperative therapy.
修改第八点：术前治疗期间应通过临床检查和影像检查对肿瘤缓解情况进行常规评定（参见BINV-13脚注tt）。
Eighth bullet modified: Tumor response should be routinely assessed by clinical exam and imaging studies (see footnote tt on BINV-13) during delivery of preoperative therapy.
乳腺浸润癌：有助于决定术后内分泌辅助治疗±全身辅助化疗的基因表达测定（BINV-N）
Invasive Breast Cancer: Gene Expression Assays for Consideration of Addition of Adjuvant Systemic Chemotherapy to Adjuvant Endocrine Therapy (BINV-N)
表格简化
Table reformatted.
乳腺浸润癌：有助于决定术后内分泌辅助治疗±全身辅助化疗的基因表达测定（BINV-N 3 of 4）
Invasive Breast Cancer: Gene Expression Assays for Consideration of Addition of Adjuvant Systemic Chemotherapy to Adjuvant Endocrine Therapy (BINV-N 3 of 4)
增加12基因对治疗的意义：根据对3746例淋巴结阴性或淋巴结阳性乳腺癌内分泌治疗±化疗女性队列的激素受体阳性HER2阴性T1-T3期肿瘤病理标本前瞻分析，该风险评分可预测化疗获益。
Added to 12-gene treatment implications: The risk score is predictive of chemo-benefit based on a prospective analysis of 3,746 archived, HR-positive, HER2-negative, T1-T3 tumors from chemo-endocrine and endocrine-only cohorts, that included women with lymph node-negative and lymph nodepositive disease.
增加乳腺癌指数（BCI）对治疗的意义：aTTom研究二次分析结果表明，对于激素受体阳性、淋巴结阳性乳腺癌患者，高BCI（HOXB13/IL17BR，H/I）患者与低BCI（H/I）患者相比，术后他莫昔芬辅助治疗从5年延长至10年获益显著。
Added to Breast Cancer Index treatment implications: Results of a secondary analysis of the aTTom trial demonstrated that in patients with hormone-receptor positive, node-positive breast cancer, patients with a high BCI (HOXB13/IL17BR) (H/I) derived significant benefit from extending tamoxifen therapy to 10 years versus 5 years. In contrast, BCI (H/I) low pts derived no benefit from extended adjuvant therapy.
乳腺浸润癌：有助于决定术后内分泌辅助治疗±全身辅助化疗的基因表达测定（BINV-N 4 of 4）
Invasive Breast Cancer: Gene Expression Assays for Consideration of Addition of Adjuvant Systemic Chemotherapy to Adjuvant Endocrine Therapy (BINV-N 4 of 4)
参考文献更新
References updated.
乳腺浸润癌：激素受体阳性复发或IV期（M1）病变全身治疗（BINV-P）
Invasive Breast Cancer: Systemic Therapy for ER- and/or PR-Positive Recurrent or Stage IV (M1) Disease (BINV-P)
HER2阴性和绝经后或绝经前接受卵巢切除或抑制：将「推荐方案」拆分为「一线治疗推荐方案」和「二线及后续治疗推荐方案」。一线治疗推荐方案增加：选择性ER下调剂（氟维司群，1类证据）±非甾体芳香酶抑制剂（阿那曲唑、来曲唑，1类证据）。特殊情况可选方案删除：瑞波西利＋他莫昔芬（1类证据）
HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression: Separated preferred regimens for first-line therapy from preferred regimens for second- and subsequent-line therapy. Preferred first-line option added: Selective ER down-regulator (fulvestrant, category 1) ± non-steroidal aromatase inhibitor (anastrozole, letrozole) (category 1). Useful in certain circumstances, option removed: ribociclib + tamoxifen (category 1)
删除脚注：CDK4/6抑制剂（阿贝西利、哌柏西利、瑞波西利）＋芳香酶抑制剂（阿那曲唑、来曲唑、依西美坦）或氟维司群可以作为绝经后或绝经前（LHRH激动剂抑制或切除卵巢）激素受体阳性、HER2阴性乳腺转移癌女性一线治疗方案。氟维司群＋CDK4/6抑制剂（即哌柏西利，瑞波西利）已被两项随机对照研究用于一线治疗。
Footnote removed: CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) in combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) or fulvestrant may be considered as a treatment option for first-line therapy for women who are postmenopausal or premenopausal (receiving ovarian suppression or ablation with an LHRH agonist) with hormone-receptor positive, HER2- negative metastatic breast cancer. Fulvestrant has been combined with CDK4/6 inhibitors (ie, palbociclib, ribociclib) in the first-line setting in two randomized trials.
修改脚注b：阿那曲唑±氟维司群相比，至进展时间和总生存显著较长。
Footnote b modified: ...addition of fulvestrant to anastrozole resulted in prolongation of time to progression and overall survival.
增加脚注：参见复发或IV期（M1）病变其他靶向治疗及其相关生物标志检查（BINV-R）
Footnote added: See Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease (BINV-R).
删除脚注：由于存在心电图QTc间期延长的风险，不推荐瑞波西利＋他莫昔芬一线治疗，但是特殊情况可以考虑作为激素受体阳性、HER2阴性乳腺转移癌绝经前卵巢抑制或切除患者一线治疗方案。
Footnote removed: Ribociclib + tamoxifen is not considered a preferred first-line therapy due to QTc prolongation risk but may be considered in certain circumstances as a treatment option for first-line therapy with ovarian suppression or ablation for premenopausal patients with hormone-receptor positive, HER2-negative metastatic breast cancer.
乳腺浸润癌：复发或IV期（M1）病变全身治疗方案（BINV-Q 1 of 6）
Invasive Breast Cancer: Systemic Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q 1 of 6)
HER2阴性乳腺癌：将靶向治疗方案移至BINV-R并链接至该页治疗方案表。特殊情况治疗方案增加卡铂＋紫杉醇或白蛋白结合紫杉醇
HER2-Negative: Moved targeted therapy options to BINV-R and linked to that page in the table of options. Added regimen under useful in certain circumstances: Carboplatin + paclitaxel or albumin-bound paclitaxel
HER2阳性乳腺癌：其他推荐治疗方案增加奈拉替尼＋卡培他滨（2B类证据）
HER2-Positive Disease, other recommended regimen added: Neratinib + capecitabine (category 2B)
删除脚注：对于三阴性乳腺癌患者，评定肿瘤浸润免疫细胞PD-L1生物标志状态，可以确定最有可能获益于阿特利珠单抗＋白蛋白结合紫杉醇的患者。
Footnote removed: Patients with TNBC, assess PD-L1 biomarker status on tumor-infiltrating immune cells to identify patients most likely to benefit from atezolizumab plus albumin-bound paclitaxel.
增加脚注：参见复发或IV期（M1）病变其他靶向治疗及其相关生物标志检查（BINV-R）。关于脑转移的治疗，参见《NCCN中枢神经系统癌症指南》。
Footnotes added: See Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease (BINV-R). For treatment of brain metastases, see NCCN Guidelines for Central Nervous System Cancers.
乳腺浸润癌：复发或IV期（M1）病变全身治疗方案（BINV-Q 2 of 6）
Invasive Breast Cancer: Systemic Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q 2 of 6)
为新的治疗方案增加剂量信息。
Dosing information added for new regimens.
靶向治疗剂量移至BINV-R。
Dosing for targeted therapies moved to BINV-R.
乳腺浸润癌：复发或IV期（M1）病变全身治疗方案（BINV-Q 4 of 6）
Invasive Breast Cancer: Systemic Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q 4 of 6)
为曲妥珠单抗＋长春瑞滨治疗方案修改长春瑞滨剂量。
Vinorelbine dosing modified for trastuzumab + vinorelbine regimen.
为新的治疗方案增加剂量信息。
Dosing added for new regimens.
乳腺浸润癌：复发或IV期（M1）病变全身治疗方案（BINV-Q 5 of 6）
Invasive Breast Cancer: Systemic Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q 5 of 6)
参考文献更新。
References updated.
乳腺浸润癌：复发或IV期（M1）病变其他靶向治疗及其相关生物标志检查（BINV-R）
Invasive Breast Cancer: Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease (BINV-R)
新增章节，标题：复发或IV期（M1）病变其他靶向治疗及其相关生物标志检查
New section added, titled "Additional Targeted Therapies and Associated Biomarker Testing for Recurrent or Stage IV (M1) Disease."
增加FDA批准药物用于特殊情况：拉罗替尼（2A类证据）恩曲替尼（2A类证据）喷洛利珠单抗（2A类证据）
The following FDA approved agents have been added as useful in certain circumstances options: Larotrectinib (category 2A) Entrectinib (category 2A) Pembrolizumab (category 2A)
乳腺浸润癌：转移病变监测原则（BINV-S）
Invasive Breast Cancer: Principles of Monitoring Metastatic Disease (BINV-S)
增加监测内容：临床医师应与患者共同决策，充分考虑患者偏好。
Components of monitoring, added: Clinicians should take into account patient preferences through a shared decision making process.
特殊情况：叶状肿瘤（PHYLL-1）
Special Considerations: Phyllodes Tumor (PHYLL-1)
未行腋窝分期的广泛切除术后，增加「临床随访3年」。
Following wide excision without axillary staging, added "clinical follow-up for 3 y."
修改脚注c：对于恶性或中性病变，广泛切除意味着手术切缘≥1厘米。
Footnote c modified: For malignant or borderline disease, wide excision means excision with the intention of obtaining surgical margins ≥1 cm.
特殊情况：妊娠期乳腺癌（PREG-1）
Special Considerations: Breast Cancer During Pregnancy (PREG-1)
增加检查
Added workup.
增加脚注a：CT扫描和核成像禁用于妊娠期。
Added footnote a: CT scans and nuclear imaging are contraindicated during pregrnancy.
修改脚注b：妊娠前三个月不应进行化疗，并且妊娠期不应进行放疗。推荐肿瘤科与产科团队合作，计划妊娠期全身治疗的最佳时机。
Modified footnote: ...Chemotherapy should not be administered during the first trimester of pregnancy, and RT should not be administered during any trimester of pregnancy. Coordination is recommended between the oncology and obstetrics teams to plan the optimal timing of systemic therapy administration during pregnancy. Most experience...
特殊情况：炎性乳腺癌（IBC-1）
Special Considerations: Inflammatory Breast Cancer (IBC-1)
修改检查第一点：由多学科团队进行病史询问、体格检查并获取医学影像
Modified first bullet: History and physical exam by multidisciplinary team and obtain medical photography
删除：胸部CT造影（如果出现肺部症状）
Removed bullet: Chest diagnostic CT with contrast (if pulmonary symptoms are present)