2023年1月27日，时隔220天，美国国家综合癌症网络（NCCN）悄然将乳腺癌临床实践指南由2022年第4版更新至2023年第1版，全文由232页增加至255页，免费注册登录后仍可免费下载。
NCCN为非国立、全国综合癌症中心联盟组织，1993年11月成立，1995年1月31日正式宣布成为全国联盟，最初由13个美国知名综合癌症中心组成，目前已经增至32个：
NCCN乳腺癌临床实践指南2020年更新了6版、2021年更新了8版、2022年只更新了4版。2023年第1版架构仍为临床路径＋循证解读＋参考文献，其依据主要来自权威学术期刊或学术会议最新发表的大样本多中心随机对照三期临床研究结果。此次更新内容较多，具体如下（中划线为删除，下划线为新增）
BINV-17
影像学检查，新增第3点：对于有种系突变或乳腺癌家族史的患者，参见NCCN遗传性/家族性高风险评定指南：乳腺癌、卵巢癌和胰腺癌
Imaging, 3rd bullet added: For patients with germline mutations or family history of breast cancer, please refer to See NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic
新增：治疗后监测
Added: Post treatment monitoring
新增第1点：对于接受左侧放疗、蒽环类或HER2靶向治疗的患者，监测心脏毒性。参见NCCN生存指南
1st bullet added: Cardiotoxicity monitoring for patients who received left-sided radiation therapy, anthracyclines, or HER2-targeted therapy. See NCCN Guidelines for Survivorship
新增第2点：提供合并症风险指导
2nd bullet added: Provide guidance on risk of comorbidities
脚注eee修改：持续时间超过3年的获益或超过3年的最佳持续时间尚不明确…
Footnote eee modified: Benefits of duration beyond 3 years or optimal duration beyond 3 years is not known...
BINV-18
检查，第5点，新增第6小点：在某些情况下有用
Workup, 5th bullet, 6th sub-bullet added: Useful in certain circumstances
第6小点新增：FDG PET/CT（对于ER阳性病变，考虑氟雌二醇PET）
Sub-bullet added: FDG PET/CT (consider FES/PET for ER-positive disease)
新增脚注iii：可以采用组织或血浆测定。组织测定的灵敏度较高，但是循环肿瘤DNA（ctDNA）可能较准确地反映肿瘤异质性。
Footnote iii added: Tissue or plasma-based assays may be used. Tissue-based assays have greater sensitivity, but circulating tumor DNA (ctDNA) may reflect tumor heterogeneity more accurately.
BINV-19
新增脚注mmm：对于拒绝乳房切除术以及符合免除放疗或乳房局部放疗（APBI/PBI）共识标准的某些患者，可以考虑再次保乳手术 ± 辅助APBI/PBI。此类患者再次BCS的数据有限。
Footnote mmm added: In selected patients who decline mastectomy and otherwise meet consensus criteria for radiotherapy omission or partial breast irradiation (APBI/PBI), repeat BCS +/- adjuvant APBI/PBI may be considered. There are limited data for a repeat BCS in this setting.
BINV-20
脚注rrr修改：如果存在骨转移、预计生存≥3个月且肾功能正常，化疗全身治疗或内分泌治疗应该加用地舒单抗、唑来膦酸或帕米膦酸二钠（同时补充钙和维生素D）（1 类）。
Footnote rrr modified: Denosumab, zoledronic acid, or pamidronate (all with calcium and vitamin D supplementation) should be given (category 1) in addition to chemotherapy systemic therapy or endocrine therapy if bone metastasis is present, expected survival is ≥3 months, and renal function is adequate.
BINV-21
新增脚注ttt：根据第5版ESO-ESMO国际共识指南，晚期乳腺癌内脏危象定义为：“根据体征和症状、实验室检查和疾病快速进展评定的严重器官功能障碍。内脏危象不仅仅是内脏转移的存在，还意味着重要器官受损，导致的临床适应证需要最快速有效治疗。”
Footnote ttt added: According to the 5th ESO-ESMO international consensus guidelines for advanced breast cancer visceral crisis is defined as: “severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important organ compromise leading to a clinical indication for the most rapidly efficacious therapy.”
新增脚注yyy：疾病稳定或观察到疗效后转为内分泌治疗是可以接受的（参见BINV-P）
Footnote yyy added: It is acceptable to switch to endocrine-based therapy after disease stabilizes or response is observed. (See BINV-P).
BINV-22
脚注zzz修改：对于体力状态低下的患者，额外化疗全身治疗的潜在副作用可能超过任何临床获益。必须考虑患者意愿。
Footnote zzz modified: The potential side effects of additional chemotherapy systemic therapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account.
BINV-26
脚注zzz修改：对于体力状态低下的患者，额外化疗全身治疗的潜在副作用可能超过任何临床获益。必须考虑患者意愿。
Footnote zzz modified: The potential side effects of additional chemotherapy systemic therapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account.
BINV-A (1 of 2)
新增脚注d：HER2免疫组化0和1+的区别目前对于晚期乳腺癌具有临床意义，因为HER2免疫组化1+或2+且原位杂交阴性结果（原发或转移标本）晚期乳腺癌患者可能有指征针对HER2低表达进行治疗。
Footnote d added: The distinction between HER2 IHC 0 and 1+ is currently clinically relevant in in the metastatic setting since metastatic patients with HER2 1+ or 2+/ISH negative results (on primary or metastatic samples) may be eligible for for treatment targeting non-amplified levels of HER2 expression.
BINV-B
临床适应证和应用，第5点修改并新增第1、2小点：磁共振成像对于既往乳腺癌患者随访筛查的作用尚不明确。通常应该考虑用于以下情况：1）乳腺致密患者保乳手术＋放疗，2）50岁之前确诊患者
Clinical indications and applications, 5th bullet modified and subsequent bullets added: The utility of MRI in follow-up screening of patients with prior breast cancer is undefined. It should generally be considered for: 1) Patients with dense breasts in the BCS + RT 2) Those diagnosed before the age of 50
新增参考文献：Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: Recommendations from the ACR. J Am Coll Radiol. 2018;15:408-414.
References have been updated.
BINV-F (2 of 2)
第2点修改：这些切缘推荐意见不可直接用于进行APBI/PBI的患者，关于此类患者局部复发的数据较少。
2nd bullet modified: These margin recommendations cannot be applied directly to patients undergoing APBI/PBI, where data regarding local recurrence are more limited...
BINV-H (7 of 7)
保留乳头的乳房切除术（NAC）
Nipple-sparing masectomy
修改第1小点：以往，为了治疗癌症，进行保留皮肤的乳房切除术时会牺牲NAC。不过，对于有经验多学科团队严格筛选的癌症患者，可以选择保留NAC的术式。
1st sub-bullet modified: Historically, the NAC has been sacrificed with skin-sparing mastectomy for cancer therapy. However, NAC-sparing procedures may be an option in cancer patients who are carefully selected by experienced multidisciplinary teams.
新增第1小点：随机对照试验证实，预防性外用2%硝酸甘油（总剂量45毫克）可减少保留皮肤或乳头的乳房切除术皮瓣坏死。
3rd sub-bullet added: Topical 2% nitroglycerine (45 mg total dose) used prophylactically has been shown to reduce mastectomy skin flap necrosis in both skinsparing mastectomy and nipple sparing mastectomy in one randomized control trial.
BINV-I (1 of 3)
优化个体化治疗的实施，第1点修改：
Optimizing delivery of individual therapy, 1st bullet:
第1小点修改：应该常规根据三维CT制定治疗计划勾画靶区和邻近有风险器官。应该常规根据三维CT制定治疗计划，勾画靶区和有风险器官，并评定整个治疗区的剂量分布。
1st sub-bullet modified: 3-D CT-based treatment planning should be routinely utilized to delineate target volumes and adjacent organs at risk. CT-based treatment planning should routinely be utilized to delineate target volumes & organs at risk, and assess dose distribution across the entire treatment volume.
第3小点修改：采用楔形填充材料、分段正向规划和调强放疗（IMRT）可以实现较好的靶区剂量均匀性并保护正常组织。应该优化治疗计划，最大程度提高整个靶区的均匀性，同时最大程度减少有风险器官的剂量。
3rd sub-bullet modified: Improved homogeneity of the target dose and sparing of normal tissues can be accomplished using compensators such as wedges, forward planning using segments, and intensity-modulated RT (IMRT). Treatment planning should be optimized to maximally improve homogeneity across the target volume while minimizing dose to organs at risk
第5小点修改：每周进行影像学检查验证治疗摆位一致性。当采用某些技术（即俯卧位乳房）时，更频繁的影像学检查可能是合适的。不推荐标准化采用每天影像学检查。至少应该每周进行影像学检查验证治疗摆位。对于可重复性不一致的某些病例，可能需要更频繁的影像学检查。影像引导放疗（IGRT）可与深吸气屏气（DIBH）技术一起应用，以减少心、肺或肝的正常组织暴露。
5th sub-bullet modified: Verification of treatment setup consistency is done with weekly imaging. When using certain techniques (ie, prone breast), more frequent imaging may be appropriate. Standard utilization of daily imaging is not recommended. At a minimum, weekly imaging to verify treatment setup should be utilized. More frequent imaging may be needed for selected cases with inconsistent reproducibility. IGRT may be utilized with DIBH to reduce normal tissue exposure of the heart, lung or liver.
第6小点修改：内乳淋巴结放疗时，应该采用剂量体积直方图（DVH）评估剂量限制、正常组织（即心、肺）剂量和限制以及计划靶区（PTV）。
6th sub-bullet modified: When treating the internal mammary nodes, Dose-volume histograms (DVHs) should be used to evaluate dose constraints, dose and constraints to normal tissues (ie, heart, lung), and planning target volumes (PTVs).
全乳放疗修改
Whole Breast Radiation
第3点第1小点修改：对于年龄>50岁保乳手术后pTis、T1、T2、N0的患者，可以考虑采用28.5戈瑞分割为5次（每周一次）超大分割全乳放疗，虽然该方案的加强放疗最佳分割尚不明确。对于50岁以上淋巴结阴性早期乳腺癌保乳手术后患者，尤其不打算加强放疗者，可以考虑28.5戈瑞分割为5次（每周一次）超大分割全乳放疗。
3rd bullet, 1st sub-bullet modified: Ultra-hypofractionated WBRT of 28.5 Gy delivered as 5 (once-a-week) fractions may be considered in select patients aged >50 years following BCS with pTis/T1/T2/N0, though the optimal fractionation for the boost delivery is unknown for this regimen. Ultra-hypofractionated WBRT of 28.5 Gy in 5 (once-a-week) fractions may be considered for selected pts over 50 yrs following BCS with early-stage, node-negative disease, particularly those in whom a boost is not intended.
第4小点修改：采用该方案时必须进行三维计划以尽量减少不均匀性和心肺暴露。三维治疗计划应该根据上述进行优化。
4th bullet modified: 3-D planning to minimize inhomogeneity and exposure to heart and lung is essential when using this regimen. 3D treatment planning should be optimized as described in the section above.
BINV-I (2 of 3)
胸壁放疗（包括乳房重建）放疗剂量：
Chest wall radiation (including breast reconstruction), RT dosing:
新增第1点：胸壁放疗剂量为45～50.4戈瑞，每次1.8～2戈瑞，分割为25～28次；对于未行乳房重建的患者可以选择40戈瑞（2.67戈瑞×15次）或42.5戈瑞（2.66戈瑞×16次）。加强放疗：10～16戈瑞，每次1.8～2.0戈瑞，共5～8次。
1st bullet and subsequent bullets added: Chest wall RT dose is 45-50.4 Gy at 1.8-2 Gy/fx; in 25-28 fractions patients not undergoing breast reconstruction may alternatively receive 40 Gy at 2.67 Gy/fx or 42.5 Gy at 2.66 Gy/fx. 45-50.4 Gy at 1.8-2.0 Gy/fx total 25-28 fractions. 40 Gy at 2.67 Gy/fx or 42.5 Gy at 266 Gy/fx total 15-16 fractions. Boost: 10-16 Gy at 1.8 to 2.0 Gy/fx total 5-8 fractions.
新增第2点：胸壁瘢痕加强放疗每次10～16戈瑞，可以采用电子或光子±组织填充材料。
2nd bullet added: Chest wall scar boost of 10-16 Gy/fx may be delivered with or without bolus using electrons or photons. Chest wall scar boost may be delivered with or without bolus using electrons or photons.
删除：剂量为胸壁45～50.4戈瑞分25～28次±瘢痕加强放疗每次1.8～2戈瑞，至总剂量大约60～66戈瑞。可以采用电子或光子±组织填充材料进行胸壁瘢痕加强放疗。
Sub-bullet removed: Dose is 45-50.4 Gy in 25-28 fractions to the chest wall ± scar boost, at 1.8-2 Gy per fraction, to a total dose of approximately 60-66 Gy.
区域淋巴结放疗：
Regional Nodal Radiation, RT dosing:
删除：区域淋巴结照射野剂量为45～50.4戈瑞分割为25～28次。
Bullet removed: Dose is 45-50.4 Gy in 25-28 fractions to the regional nodal fields.
新增第1点：区域淋巴结剂量为45～50.4戈瑞，每次1.8～2格戈瑞；对于未行乳房重建的患者可以选择40戈瑞（2.67戈瑞×15次）或42.5戈瑞（2.66戈瑞×16次）
1st bullet added: Regional node dose is 45-50.4 Gy at 1.8-2 Gy/fx; patients not undergoing breast reconstruction may alternatively receive 40 Gy at 2.67 Gy/fx or 42.5 Gy at 2.66 Gy/fx
新增第2点：可以对未经手术处理的严重受累或肿大淋巴结（即内乳或锁骨上）补充加强放疗。
2nd bullet added: A supplemental boost of RT can be delivered to grossly involved or enlarged lymph nodes (i.e. internal mammary or supraclavicular) that have not been surgically addressed.
放疗与术前或术后全身治疗
RT with preoperative or adjuvant systemic therapy
放疗与全身治疗的顺序：
Sequencing of RT with systemic therapy:
第1点第2小点修改：卡培他滨应该通常在放疗完成后给予。
1st bullet, 2nd sub-bullet modified: Capecitabine should be is typically given after completion of RT.
第2点修改：现有数据表明，内分泌治疗序贯或同步放疗都可接受。由于联合治疗的副作用，可能首选放疗完成时开始内分泌治疗。内分泌治疗可以与放疗同时进行或在放疗完成后开始。新数据表明，CDK4/6抑制剂可能增强放疗对肿瘤组织和正常组织的毒性。
2nd bullet modified: Available data suggest that sequential or concurrent endocrine therapy with RT is acceptable. Due to compounding side effects, initiating endocrine therapy at the completion of RT may be preferred. Endocrine therapy may be delivered concurrently with RT or started after the completion of RT. Emerging data on toxicities of RT when given currently with CDK 4/6 inhibitors.
BINV-I (3 of 3)
乳房局部快速放疗（APBI）/乳房局部放疗（PBI）
Accelerated Partial Breast Irradiation (APBI) modified: Accelerated Partial Breast Irradiation/Partial Breast Irradiation (APBI/PBI)
删除：APBI研究表明，对于某些早期乳腺癌低风险患者，APBI与标准全乳放疗相比，局部控制率相似。但是，若干研究表明，采用外照射的APBI与标准全乳放疗相比，美观结局较差。随访有限，研究仍在进行。
Bullet removed: Studies of APBI suggest that rates of local control in selected low-risk patients with early-stage breast cancer are comparable to those treated with standard WBRT. However, compared to standard WBRT, several studies document an inferior cosmetic outcome with external beam delivery methods of APBI. Follow-up is limited and studies are ongoing.
新增：对于某些早期乳腺癌低风险患者，ABPI/PBI与全乳放疗相比，局部控制相似。不过，减少长期美观副作用的最佳外照射APBI/PBI技术及其分割方案尚未确定。
Bullet added: ABPI/PBI offers comparable local control to WBRT in selected low-risk patients with early-stage breast cancer. However, the optimal external beam-APBI/PBI technique/fractionation for minimizing long-term cosmesis effects has not been determined.
BINV-K
新增脚注g：安全数据支持化疗前或化疗时给予促性腺激素释放激素（GnRH）激动剂，尤其如果为了加强生育能力保护作用。对于仍未绝经患者，也可以在化疗后开始。
Footnote g added: Safety data support administration of GnRH agonists before or with chemotherapy, especially if there is a goal to enhance fertility preservation. They can also be initiated after chemotherapy in patients who remain premenopausal.
修改脚注i：对卵巢抑制治疗权衡利弊进行讨论至关重要，包括提前绝经的潜在副作用。根据SOFT和TEXT临床试验的结果，对于复发风险较高（例如发病年龄较轻、肿瘤分级较高、淋巴结受累）绝经前患者，应该考虑芳香化酶抑制剂或他莫昔芬5年＋卵巢抑制。应该慎与CYP2D6强抑制剂合用。
Footnote i modified: A balanced discussion of the risks and benefits associated with ovarian suppression therapy is critical, including the potential side effects of premature menopause. Aromatase inhibitor or tamoxifen for 5 y plus ovarian suppression should be considered, based on SOFT and TEXT clinical trial outcomes, for premenopausal patients at higher risk of recurrence (ie, young age, high-grade tumor, lymph node involvement). Coadministration of strong inhibitors of CYP2D6 should be used with caution.
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