NCCN乳腺癌临床实践指南更新！
前情提要
仅仅时隔34天，正值国际圆周率日、爱因斯坦生日、霍金忌日、白色情人节之际，美国国家综合癌症网络（NCCN）于美国东部时间2019年3月14日悄然将《乳腺癌临床实践指南》更新至2019年第1版，全文仍为215页，免费注册后可免费下载：
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（2019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III期大样本多中心随机对照研究结果，更新较多，具体如下：
小叶原位癌（LCIS-1）
由于2018年1月1日开始正式执行的美国癌症联合委员会（AJCC）癌症分期手册第8版TNM分期已将小叶原位癌删除，故将本页从NCCN乳腺癌临床实践指南删除；参见NCCN乳腺癌筛查诊断指南。
General: Recommendations for Lobular Carcinoma in Situ (LCIS-1) were removed from the NCCN Guidelines for Breast Cancer; see the NCCN Guidelines for Breast Cancer Screening and Diagnosis.
导管原位癌的诊断、检查、基本治疗（DCIS-1）
修改：若患者遗传性乳腺癌风险高则进行遗传咨询 → 若患者有遗传性乳腺癌风险则进行遗传咨询（亦适用于BINV-1、BINV-11、BINV-18、IBC-1）
Modified bullet: Genetic counseling if patient is at high risk for hereditary breast cancer. (also applies to BINV-3, -11, and -18)
新增：淋巴结不手术的乳房肿块切除术＋乳房局部加速放疗（ABPI）作为基本治疗选择之一
Added Lumpectomy without lymph node surgery + accelerated partial breast irradiation (APBI) as an option for primary therapy.
修改脚注j：乳房肿块切除术后全乳放疗可将DCIS复发率减少大约50%。复发大约一半为浸润癌、一半为DCIS。若干因素决定了局部复发风险：肿块可触及、肿块较大、分级较高、切缘接近或阳性、年龄<50岁。如果患者和医师认为个体风险“低”，那么某些患者可以仅仅接受切除治疗。评估三种局部治疗的数据表明患者生存相似 → 选择可能适合APBI的低风险DCIS患者，低风险DCIS的定义来自RTOG9804研究，包括DCIS由筛查检出、细胞核分级低至中级、肿瘤大小≤2.5厘米、手术阴性切缘>3毫米。
Modified footnote j: Whole-breast radiation therapy following lumpectomy reduces recurrence rates in DCIS by about 50%. Approximately half of the recurrences are invasive and half are DCIS. A number of factors determine local recurrence risk: palpable mass, larger size, higher grade, close or involved margins, and age <50 years. If the patient and physician view the individual risk as "low," some patients may be treated by excision alone. Data evaluating the three local treatments show no differences in patient survival. Select patients with low-risk DCIS may be considered suitable for APBI if they meet all aspects of the definition of low-risk DCIS from the RTOG 9804 trial, including screen-detected DCIS, low to intermediate nuclear grade, tumor size ≤2.5 cm and surgical resection with margins negative at >3 mm.
乳腺浸润癌：临床分期、检查（BINV-1）
本页的临床分期和检查部分已经重新调整。
The Clinical Stage and Workup sections of this page have been reorganized.
新增：腋窝检查评定；必要时进行超声波或其他影像学检查，以及可疑淋巴结经皮活检。
Added bullet: Axillary assessment with exam; ultrasound or other imaging as necessary, and percutaneous biopsy of suspicious nodes.
修改脚注a：有助于老年患者优化评定和管理的工具。参见NCCN老年肿瘤患者指南。
Modified footnote a: For tools to aid optimal assessment and management of older adults. See NCCN Guidelines for Older Adult Oncology.
乳腺浸润癌（T1-3 N0-1 M0）：局部和引流区域治疗（BINV-2）
腋窝淋巴结阴性，修改：全乳放疗±瘤床放疗，对于乳房中心或内侧肿瘤或肿瘤大于2厘米伴其他高风险特征（年轻或广泛淋巴血管浸润）患者，除了腋窝清扫部位，考虑引流区域淋巴结放疗。
Negative axillary nodes, modified: Radiation therapy to whole breast with or without boost to tumor bed, and consider regional nodal irradiation with exclusion of the dissected portion of the axilla in patients with central/medial tumors or tumors >2 cm with other high-risk features (young age or extensive lymphovascular invasion [LVI]).
乳腺浸润癌（T1-3 N0-1 M0）：局部和引流区域治疗（BINV-3）
新增脚注v：参见男性乳腺癌特殊事项（BINV-J）（亦适用于BINV-5～BINV-10、BINV-22、BINV-N）
Added a new footnote: See Special Considerations for Breast Cancer in Men (BINV-J) (also applies to pages BINV-5 through -10, and -22).
乳腺浸润癌：组织学、激素受体状态、HER2状态、全身辅助治疗（BINV-4）
组织学，新增：乳头状
Histology, added: Papillary.
乳腺浸润癌（激素受体阳性、HER2阳性）：全身辅助治疗（BINV-5）
肿瘤≤0.5厘米，删除：包括微浸润（亦适用于BINV-8、BINV-9）
Tumor ≤0.5 cm, removed: including microinvasive. (also applies to BINV-8, -9)
修改脚注ff：雌激素受体阴性 → 激素受体阴性，雌激素受体阳性 → 激素受体阳性
Modified footnote ff: Changed ER-negative to hormone receptor-negative and ER-positive to hormone receptor-positive.
乳腺浸润癌：淋巴结阴性、激素受体阳性、HER2阴性（BINV-6）
强烈推荐21基因逆转录聚合酶链反应检测，新增：（I类证据）
Strongly consider 21-gene RT-PCR assay, added (category 1).
乳腺浸润癌：术前全身治疗前检查（BINV-11）
修改标题：可手术病变术前全身治疗前检查 → 术前全身治疗前检查
Modified page title from "Operable Disease" to "Workup Prior to Preoperative Systemic Therapy."
更新临床分期，纳入符合术前全身治疗指征的所有分期，包括 T0-4 N1-3 M0、T2-4 N0 M0（合并原BINV-11的T2 N0-1 M0、T3 N0-1 M0和BINV-15的T0-3 N2 M0、T4 N0-2 M0、T0-4 N3 M0）
Updated clinical stage to include all stages eligible for consideration of preoperative systemic therapy (Former pages BINV-11 and BINV-15 were combined).
修改：对于可手术乳腺癌 → 对于可能可手术乳腺癌，参见术前全身治疗：乳房和腋窝评估（BINV-12）
Modified link: For potentially operable breast cancers, See Preoperative Systemic Therapy: Breast and Axillary Evaluation (BINV-12).
新增：对于不可手术乳腺癌，参见术前全身治疗（BINV-15）
Added a link: For inoperable breast cancers, See Preoperative Systemic Therapy (BINV-15).
删除以下内容，移至乳腺浸润癌的术前全身治疗原则（BINV-M）：对于可能无法进行保乳手术但是需要化疗的患者，术前全身治疗仍然是可以接受的选择。这对于术前全身治疗有效患者（T2-3 N1 M0、T3 N0-1 M0）避免腋窝淋巴结清扫可能有益。参见ST-1。
Removed the following bullet from this page, it is included in the Principles of Preoperative Systemic Therapy (BINV-M): "In cases where breast-conserving surgery may not be possible but patient will need chemotherapy, preoperative systemic treatment remains an acceptable option. This may be of benefit for patients who may be able to avoid ALND with a good response to therapy (T2N1M0, T3N0M0, T3N1M0). See ST-1"
乳腺浸润癌：术前全身治疗前乳房和腋窝评估（BINV-12）
修改标题：可手术病变 → 可能可手术病变
Modified page title: Potentially Operable Disease: Breast and Axilllary Evaluation Prior to Preoperative Systemic Therapy.
乳腺浸润癌：术前全身治疗和手术治疗效果（BINV-13）
可手术病变 → 可能可手术病变
Modified page title: Potentially Operable Disease: Preoperative Systemic Therapy and Surgical Treatment.
任何时间确认的进展病变，新增：乳房肿块切除术不可能
"Confirmed progressive disease at any time," added "lumpectomy not possible."
乳腺浸润癌：术前全身治疗后辅助治疗（BINV-14）
修改标题：可手术病变辅助治疗 → 可能可手术病变的术前全身治疗后辅助治疗
Modified page title: Potentially Operable Disease: Adjuvant Therapy After Preoperative Systemic Therapy.
乳房肿块切除术后：乳房肿块切除术后全乳辅助放疗，新增：±瘤床放疗
Post lumpectomy: "Adjuvant radiation post-lumpectomy is indicated to the whole breast," added "with or without boost to the tumor bed."
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（BINV-15）
修改：有效 → 对术前全身治疗有效并且肿瘤可手术
Modified: Response to preoperative systemic therapy and tumor is operable.
修改：无效 → 对术前全身治疗无效并且肿瘤不可手术
Modified: No response to preoperative systemic therapy and tumor remains inoperable.
乳腺浸润癌：不可手术或局部晚期病变（非炎性）术前全身治疗后辅助治疗（BINV-16）
修改标题：辅助治疗 → 术前全身治疗后辅助治疗
Modified page title: Inoperable or Locally Advanced Disease (Non-Inflammatory): Adjuvant Therapy After Preoperative Systemic Therapy.
乳腺浸润癌：监测或随访（BINV-17）
对监测或随访推荐意见进行归类：
身体检查
基因筛查
术后管理
影像检查
转移筛查
内分泌治疗
生活方式
沟通：新增推荐意见（鼓励初级医疗提供者与专科医师之间的医疗协调。此外，推荐个体化生存治疗计划，包括可能的长期毒性个体化治疗概述和明确的随访推荐意见。参见NCCN生存指南）
参与：新增推荐意见（患者需要经常随访鼓励以提高继续筛查和坚持用药的依从性）
Surveillance/follow-up recommendations were organized by category:
Exam
Genetic screening
Post surgical management
Imaging
Screening for metastases
Endocrine therapy
Lifestyle
Communication - with new recommendation (Coordination of care between the primary care provider and specialists is encouraged. Additionally, a personalized survivorship treatment plan including personalized treatment summary of possible long-term toxicity and clear follow-up recommendations is recommended. See NCCN Guidelines for Survivorship)
Engagement - with new recommendation (Patients frequently require follow-up encouragement in order to improve adherence to ongoing screening and medication adherence).
乳腺浸润癌：复发或IV期（M1）病变（BINV-18）
新增：对于三阴性乳腺癌，评定肿瘤浸润免疫细胞的PD-L1生物标志状态，以确定最有可能对阿特利珠单抗＋白蛋白结合型紫杉醇获益的患者。
New bullet: For triple negative breast cancer, assess PD-L1 biomarker status on tumor-infiltrating immune cells to identify patients most likely to benefit from atezolizumab plus albuminbound paclitaxel.
修改：对于符合条件单药治疗的正在考虑化疗的HER2阴性肿瘤患者，强烈推荐生殖细胞BRCA1/2检测。
Modified bullet: For patients with HER2-negative tumors under consideration for chemotherapy, eligible for single-agent therapy, strongly consider germline BRCA1/2 testing.
修改：参见NCCN支持治疗指南 → 参见NCCN姑息治疗（缓和照顾）指南和NCCN支持治疗指南
Modified footnote: See NCCN Guidelines for Palliative Care and NCCN Guidelines for Supportive Care.
相关阅读
乳腺浸润癌：复发或IV期（M1）病变的全身治疗（BINV-20）
修改：IV期（M1）全身治疗 → 复发或IV期（M1）病变全身治疗
Modified: Systemic treatment of recurrent or stage IV (M1) disease.
修改：激素受体阳性、HER2阳性，过去1年内接受内分泌治疗
Modified: ER and/or PR positive; HER2 positive, Prior endocrine therapy within 1 y.
删除：激素受体阳性、HER2阳性，过去未接受内分泌治疗
Removed: "ER and/or PR positive; HER2 positive, No prior endocrine therapy." The pages were combined.
乳腺浸润癌：复发或IV期（M1）激素受体阳性HER阴性病变的全身治疗（BINV-21）
修改：将内脏转移单独列出
Reorganized the page for clarification.
新增脚注n：考虑PARP抑制剂单药疗法作为HER2阴性肿瘤和生殖细胞BRCA1/2突变患者的选择之一（亦适用于BINV-22）
New footnote n: "Consider PARP-inhibitor monotherapy as an option for patients with HER2-negative tumors and germline BRCA1/2 mutations." (Also for BINV-22)
绝经前推荐意见，删除：对于绝经后女性
Removed "as for postmenopausal women" from premenopausal recommendations.
乳腺浸润癌：复发或IV期（M1）激素受体阳性HER阴性病变的全身治疗（BINV-22）
修改：ECOG体力状态评分≥3分或连续三线化疗后无临床获益 → 大多数患者有指征进行多线全身治疗以缓解晚期乳腺癌。每次重新评定时，临床医师应该通过医患共同决策流程，评定现行治疗的意义、更换化疗方案的风险和获益、患者体力状态、患者个人偏好。
Replaced "No clinical benefit after 3 sequential lines of chemotherapy or ECOG performance status ≥3" with "Most patients will be candidates for multiple lines of systemic therapy to palliate advanced breast cancer. At each reassessment clinicians should assess value of ongoing treatment, the risks and benefits of an additional line of chemotherapy, patient performance status, and patient preferences through a shared decision-making process."
修改脚注qqq：更换化疗方案的潜在副作用可能超过体力状态不佳患者的任何临床获益，新增：必须考虑患者个人偏好。
Modified footnote: The potential side effects of additional chemotherapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account."
乳腺浸润癌：复发或IV期（M1）激素受体阳性HER阳性病变的全身治疗（BINV-23）
简化：合并绝经前、绝经后
Simplified this page following changes to BINV-21.
新增：内分泌治疗±HER2靶向治疗（如绝经前，考虑卵巢切除或抑制）
Added: Endocrine therapy ± HER2-targeted therapy (if premenopausal, consider ovarian ablation or suppression).
新增脚注rrr：如果治疗以化疗＋曲妥珠单抗＋帕妥珠单抗开始，并且化疗停止，内分泌治疗可以加入曲妥珠单抗＋帕妥珠单抗。
Added three new footnotes: If treatment was initiated with chemotherapy and trastuzumab + pertuzumab, and the chemotherapy was stopped, endocrine therapy may be added to the trastuzumab + pertuzumab.
新增脚注uuu：对于绝经前女性，单纯选择性雌激素受体调节剂（不切除或抑制卵巢）＋HER2靶向治疗也是一种选择。
For premenopausal women, selective selective ER modulators alone (without ovarian ablation/suppression) + HER2-targeted therapy is also an option.
新增脚注ttt：如果过去1年内接受内分泌治疗，考虑其他内分泌治疗方案
If prior endocrine therapy within 1 y, consider a different endocrine therapy.
乳腺浸润癌：复发或IV期（M1）病变的全身治疗（BINV-24、BINV-25、BINV-26）
修改：ECOG体力状态评分≥3分或连续三线化疗后无临床获益 → 大多数患者有指征进行多线全身治疗以缓解晚期乳腺癌。每次重新评定时，临床医师应该通过医患共同决策流程，评定现行治疗的意义、更换化疗方案的风险和获益、患者体力状态、患者个人偏好。
Replaced No clinical benefit after 3 sequential lines of targeted therapy or ECOG performance status ≥3 with Most patients will be candidates for multiple lines of systemic therapy to palliate advanced breast cancer. At each reassessment clinicians should assess value of ongoing treatment, the risks and benefits of an additional line of chemotherapy, patient performance status, and patient preferences through a shared decision-making process.
修改脚注：更换HER2治疗方案的潜在副作用可能超过体力状态不佳患者的任何临床获益，新增：必须考虑患者个人偏好。
Modified footnote: The potential side effects of additional HER2-targeted therapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account.
修改：不考虑进一步细胞毒性HER2靶向治疗并且继续支持治疗
Modified: Consider no further cytotoxic HER2-targeted therapy and continue supportive care.
乳腺浸润癌：HER2检测原则（BINV-A）
该页根据美国临床肿瘤学会（ASCO）美国病理学会（CAP）HER2检测指南进行了大幅修订
This page has been extensively revised based on the ASCO/CAP HER2 testing guideline. Principles of HER2 Testing, modified with permission from Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol 2018;36:2105-2122.
相关阅读
乳腺浸润癌：生育与节育（BINV-C）
修改：随机对照研究表明，对于雌激素受体阴性肿瘤乳腺肿瘤（无论激素受体状态如何）绝经前女性，辅助化疗期间给予促性腺激素释放激素（GnRH）激动剂治疗进行卵巢抑制，可以保护卵巢功能，并且减少化疗所致闭经的可能性。
Modified bullet: Randomized trials have shown that ovarian suppression with GnRH agonist therapy administered during adjuvant chemotherapy in premenopausal women with breast tumors (regardless of hormone receptor status), ER-negative tumors may preserve ovarian function and diminish the likelihood of chemotherapy-induced amenorrhea.
乳腺浸润癌：手术腋窝分期（BINV-D）
修改标题：T0 N1 M0、T1-3 N0-1 M0
Modified page title: Surgical axillary staging - T0,N1,M0; T1-3, N0-1, M0 disease.
修改脚注a：对于临床触诊阳性淋巴结，考虑通过超声引导细针穿刺或粗针活检进行病理检查确认恶性肿瘤，确定患者是否需要腋窝淋巴结清扫。
Modified footnote: Consider pathologic confirmation of malignancy in clinically positive nodes using ultrasound-guided FNA or core biopsy in determining if a patient needs axillary lymph node dissection.
对于诊断时临床触诊阳性淋巴结，进行I/II级腋窝淋巴结清扫，新增：或者符合ACOSOG Z0011研究所有下列标准并且肿瘤负荷低，可以考虑前哨淋巴结活检
Clinically node positive at time of diagnosis, axillary dissection level I/II, added or if meets ALL the ACOSOG Z0011 trial criteria listed below and low tumor burden, may consider sentinel lymph node biopsy.
新增脚注e：腋窝肿瘤负荷低指淋巴结病变（1）通过影像学检出而临床触诊不明显（2）可能仅限于一或两个腋窝淋巴结。
Added a new footnote: Low tumor burden in the axilla means nodal disease that 1) is image-detected disease not apparent on clinical exam and 2) appears to be limited to one or two axillary nodes.
对于诊断时临床触诊阴性淋巴结，符合所有下列标准，新增：来自ACOSOG Z0011研究
Clinically node negative at time of diagnosis, meets ALL of the following criteria, added from the ACOSOG Z0011 trial.
乳腺浸润癌：需要放疗的保乳治疗特殊事项（BINV-G）
需要放疗的保乳治疗相对禁忌证：
Under relative contraindications for breast-conserving therapy requiring therapy:
删除“肿瘤＞5厘米（2B类证据）”
Removed "Tumors >5cm (category 2B)."
修改：李-佛美尼综合征（利-弗劳梅尼综合征）可能→已知或可疑（2B类证据）
Modified: May have Known or suspected Li-Fraumeni syndrome (category 2B).
乳腺浸润癌：放疗原则（BINV-I）
个体化治疗的优化，新增：乳房、胸壁和淋巴结引流区域的放疗通常结合光子束＋电子束。
Optimizing Delivery of Individual Therapy, added a new bullet: Radiation to the breast/chest wall and nodal regions is generally delivered with photons ± electrons.
放疗剂量，修改：淋巴结引流区域剂量46～50戈瑞分割为23～25次 → 45-50.4戈瑞分割为25～28次
Regional nodal radiation, modified RT dosing: Dose is 45-50.4 Gy in 25-28 fractions to the regional nodal fields.
乳腺浸润癌：男性乳腺癌特殊事项（BINV-J）
新增章节
Special Considerations for Breast Cancer in Men is a new section to the guidelines.
相关阅读
乳腺浸润癌：内分泌辅助治疗（BINV-K）
修改脚注b：权衡卵巢抑制治疗相关风险和获益的讨论至关重要。根据SOFT和TEXT临床研究结局，对于复发风险较高（即年轻、肿瘤分级高、淋巴结受累）的绝经前女性，应该考虑芳香酶抑制剂或他莫昔芬5年＋卵巢抑制。删除：2014年《新英格兰医学杂志》参考文献，因为2018年《新英格兰医学杂志》已经发表SOFT和TEXT两项研究中位随访8年的生存结局。
Modified footnote: A balanced discussion of the risks and benefits associated with ovarian suppression therapy is critical. Aromatase inhibitor or tamoxifen for 5 y plus ovarian suppression should be considered, based on SOFT and TEXT clinical trial outcomes, for premenopausal women at higher risk of recurrence (ie, young age, high-grade tumor, lymph node involvement). Pagani, NEJM 2014, Prudence, NEJM 2014). Survival data are still pending.
修改脚注c：专家组认为三种选择性芳香酶抑制剂（即阿那曲唑、来曲唑、依西美坦）术后辅助和术前新辅助随机对照研究表明，抗肿瘤效果和毒性反应特征相似。芳香酶抑制剂辅助治疗的最佳持续时间尚不确定。
Modified footnote: The panel believes The three selective aromatase inhibitors (ie, anastrozole, letrozole, exemestane) have shown similar anti-tumor efficacy and toxicity profiles in randomized studies in the adjuvant and preoperative settings. The optimal duration of aromatase inhibitors in adjuvant therapy is uncertain.
相关阅读
乳腺浸润癌：术前、辅助治疗方案（BINV-L）
新增脚注f：考虑头皮冷却以减少化疗患者化疗所致脱发的发生率，蒽环类化疗方案可能效果不大（亦适用于BINV-Q）
Added a new footnote: Consider scalp cooling to reduce incidence of chemotherapy-induced alopecia for patients receiving chemotherapy. Results may be less effective with anthracycline-containing regimens. (also applies to BINV-Q)
新增脚注j：皮下注射曲妥珠单抗透明质酸酶制剂可以替代静脉注射曲妥珠单抗，与静脉注射曲妥珠单抗相比，剂量和给药须知不同。曲妥珠单抗透明质酸酶制剂不能替代曲妥珠单抗恩坦辛（又称恩特曲妥珠单抗、恩星曲妥珠单抗、T-DM1）
Added a new footnote: Trastuzumab and hyaluronidase-oysk injection for subcutaneous use may be substituted for trastuzumab. It has different dosage and administration instructions compared to intravenous trastuzumab. Do not substitute trastuzumab and hyaluronidase-oysk for or with ado-trastuzumab emtansine. (also applies to BINV-P and BINV-Q).
删除：2012年《柳叶刀肿瘤学分册》帕妥珠单抗＋曲妥珠单抗新辅助治疗局部晚期、炎性或早期HER2阳性乳腺癌的多中心非盲II期随机对照研究（NeoSphere）参考文献，因为2016年《柳叶刀肿瘤学分册》已经发表NeoSphere研究5年分析结果。
Removed the following reference from BINV-L page 6: Gianni L, Pienkowski T, Im YH, et al. Lancet Oncol 2012;13:25-32.
新增：2006年《新英格兰医学杂志》多西他赛或长春瑞滨±曲妥珠单抗辅助治疗早期HER2阳性乳腺癌的随机对照研究（FinHer）
Added: Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354:809-20.
相关阅读
乳腺浸润癌：术前全身治疗原则（BINV-M）
修改：一些研究表明，接受术前全身治疗的患者与接受术后辅助全身治疗的患者相比，术前化疗后局部和淋巴引流区域复发的风险增加，该局部和淋巴引流区域复发风险增加的原因在于术前治疗患者的最终局部治疗方法不合理。这些被纳入分析的研究所用化疗方案并不标准、未包括靶向治疗、并未采用现代影像学技术、有些使用了不标准的局部和淋巴引流区域管理方法。应该注意遵循BINV-12和BINV-15概述的方法，以确保合理的局部和淋巴引流区域管理。
Modified bullet: Some studies suggest have reported an increased risk of locoregional recurrence in patients receiving preoperative systemic therapy compared with those receiving postoperative adjuvant systemic therapy. This increased risk of locoregional relapse has been attributed to suboptimal delivery of definitive local therapy in patients treated in the preoperative setting. following use of preoperative chemotherapy. The trials analyzed used chemotherapy regimens that are no longer standard, did not include targeted therapies, and did not use modern imaging techniques, and some used non-standard locoregional management. Care should be taken to follow the procedures outlined in BINV-12 and BINV-15 to assure appropriate locoregional management.
术前全身治疗已知获益，新增：允许残留病变的HER2阳性和三阴性乳腺癌患者调整或加入辅助治疗方案。
Added a new bullet under Known benefits: Allows the modification or addition of adjuvant regimens among patients with HER2 positive and triple-negative breast cancer with residual disease.
乳腺浸润癌：复发或IV期（M1）激素受体阳性病变的全身治疗（BINV-P）
修改：HER2阴性和绝经后，新增：或绝经前接受卵巢切除或抑制
Changed heading: HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression.
修改脚注c：CDK4/6抑制剂（阿本西利、哌柏西利、瑞波西利）联合芳香酶抑制剂（阿那曲唑、来曲唑、依西美坦）或氟维司群，可以作为激素受体阳性HER2阴性转移性乳腺癌绝经后或绝经前（接受LHRH激动剂进行卵巢抑制或切除）女性一线疗法的治疗选择。两项随机对照研究将氟维司群＋CDK4/6抑制剂（哌柏西利、瑞波西利）用于一线治疗。
Modified footnote: 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.
新增脚注：如果治疗以化疗＋曲妥珠单抗＋帕妥珠单抗开始，并且化疗停止，内分泌治疗可以加入曲妥珠单抗＋帕妥珠单抗。
Added a footnote: If treatment was initiated with chemotherapy and trastuzumab + pertuzumab, and the chemotherapy was stopped, endocrine therapy may be added to the trastuzumab + pertuzumab.
乳腺浸润癌：复发或IV期（M1）病变的化疗方案（BINV-Q）
HER2阴性推荐方案，新增：铂类（适用于三阴性乳腺癌和生殖细胞BRCA1/2突变患者）卡铂和顺铂由其他方案移至推荐方案
HER2-Negative, preferred regimens, added: Platinum (option for patients with triple-negative tumors and germline BRCA1/2 mutation): Moved carboplatin and cisplatin from 'Other" to "Preferred."
新增：阿特利珠单抗＋白蛋白结合型紫杉醇（适用于PD-L1阳性三阴性乳腺癌）以及脚注e
Added Atezolizumab + albumin-bound paclitaxel (option for patients with PD-L1-positive TNBC) with new footnote e.
修改脚注d：对于适合单药治疗的HER2阴性乳腺癌患者，强烈推荐生殖细胞BRCA1/2检测
Modified footnote: Patients with HER2-negative disease eligible for single-agent therapy, strongly consider for germline BRCA1/2 testing.
妊娠期乳腺癌（PREG-1）
修改：通过细针穿刺或粗针活检确诊的乳腺癌妊娠患者；分期时无远处转移。
Modified: Pregnant patient with confirmed breast cancer diagnosis by FNA or core biopsy; No distant metastases on staging.
修改脚注：无足够的安全数据推荐紫杉类常规用于妊娠期间。不过，如果根据疾病状态，如有临床指征，妊娠前三个月后紫杉醇每周给药可被接受。妊娠期间禁用抗HER2疗法。
Modified footnote: There are insufficient safety data to recommend general use of taxanes during pregnancy. However, the use of paclitaxel weekly administration after the first trimester is acceptable if clinically indicated by disease status. The use of anti- HER2 therapy is contraindicated during pregnancy.
新增脚注：如果妊娠前三个月后，可以考虑妊娠中期进行术前化疗。
New footnote: If late 1st trimester, may consider preoperative chemotherapy in the 2nd trimester.
相关警示
根据《中华人民共和国刑法》第一百四十一条，生产、销售假药，足以严重危害人体健康的，处三年以下有期徒刑或者拘役，并处或者单处销售金额百分之五十以上二倍以下罚金；对人体健康造成严重危害的，处三年以上十年以下有期徒刑，并处销售金额百分之五十以上二倍以下罚金；致人死亡或者对人体健康造成特别严重危害的，处十年以上有期徒刑、无期徒刑或者死刑，并处销售金额百分之五十以上二倍以下罚金或者没收财产。本条所称假药，是指依照《中华人民共和国药品管理法》的规定属于假药和按假药处理的药品、非药品。
根据《中华人民共和国药品管理法》第四十八条，有下列情形之一的药品，按假药论处：国务院药品监督管理部门规定禁止使用的；依照本法必须批准而未经批准生产、进口，或者依照本法必须检验而未经检验即销售的；变质的；被污染的；使用依照本法必须取得批准文号而未取得批准文号的原料药生产的；所标明的适应症或者功能主治超出规定范围的。
根据最高人民法院和最高人民检察院《关于办理生产、销售假药、劣药刑事案件具体问题的解释》第四条，医疗机构知道或者应当知道是假药而使用或者销售，符合本解释第一条或者第二条规定标准的，以销售假药罪追究刑事责任。
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