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）- 主要治疗，修改：乳房局部快速放疗/乳房局部放疗（APBI/PBI）
- Primary treatment, modified: Accelerated partial breast irradiation/partial breast radiation (APBI/PBI)
- 脚注j，修改：乳腺导管原位癌（DCIS）低风险患者如果符合RTOG 9804试验关于DCIS低风险定义全部条件（包括筛查发现的DCIS、核分级低或中、肿瘤大小≤2.5厘米、手术切缘阴性且距离肿瘤的边距>3mm）可以考虑接受APBI/PBI。
- Footnote j, modified: Select patients with low-risk DCIS may be considered suitable for APBI/PBI 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.
 - DCIS手术后治疗，第1点第1小点修改：接受保乳手术和放疗（1类），尤其对于雌激素受体（ER）阳性DCIS患者。
- DCIS postsurgical treatment, 1st bullet, 1st sub-bullet modified: Treated with BCS and RT (category 1), especially for patients with ER-positive DCIS.
- 新增脚注n：对于接受芳香化酶抑制剂辅助治疗的绝经后（自然或诱发）患者，双膦酸盐（口服或静脉注射）或地舒单抗可以维持或改善骨矿密度并降低骨折风险。两种疗法的最佳持续时间尚未确定。持续时间超过3年的获益或超过3年的最佳持续时间未知。抗骨质疏松治疗持续时间考虑因素包括骨矿密度、治疗效果、持续骨质流失或骨折的风险因素。停用地舒单抗后有自发骨折的病例报告。对于接受双膦酸盐或地舒单抗治疗的患者，开始治疗前应接受预防性牙科检查，并应补充钙和维生素D。
- Footnote n added: The use of a bisphosphonate (PO/IV) or denosumab is acceptable to maintain or improve bone mineral density and reduce risk of fractures in postmenopausal (natural or induced) patients receiving adjuvant aromatase inhibitor therapy. Optimal duration of either therapy has not been established. Benefits from duration beyond 3 years or optimal duration beyond 3 years is not known. Factors to consider for duration of antiosteoporosis therapy include bone mineral density, response to therapy, and risk factors for continued bone loss or fracture. There are case reports of spontaneous fractures after denosumab discontinuation. Patients treated with a bisphosphonate or denosumab should undergo a dental examination with preventive dentistry prior to the initiation of therapy, and should take supplemental calcium and vitamin D.
 - cT1-3、cN0或cN+、M0乳腺癌的局部区域治疗，修改：保乳手术＋腋窝手术分期（1类）± 肿瘤整形重建
- Locoregional treatment of cT1-3, cN0 or cN+, M0 Disease, modified: BCS with surgical axillary staging (category 1) ± oncoplastic reconstruction
- 修改：对于乳房中心或内侧肿瘤、病理T3期肿瘤、病理T2期肿瘤且<10枚腋窝淋巴结切除并有以下高风险特征之一的患者：3级、广泛淋巴血管浸润（LVI）或ER阴性，给予全乳放疗（WBRT）± 瘤床加量o，并考虑全身区域淋巴结放疗（RNI）。
- Modified: WBRT ± boosto to tumor bed, and consider comprehensive regional nodal irradiation (RNI) in patients with central/medial tumors, pT3 tumors, or pT2 tumors with <10 axillary nodes removed and one of the following high-risk features: grade 3, extensive lymphovascular invasion (LVI), or ER-negative.
- 修改：对于某些低风险患者，考虑行APBI/PBI（1类）
- Modified: Consideration of APBI/PBI in selected low-risk patients (category 1)
- 新增脚注m：局部组织重排、局部皮瓣、区域皮瓣、乳房缩小和乳房固定术等技术可以实现更大体积的切除，同时优化保乳手术患者的美观结局。
- Footnote m added: Includes techniques such as local tissue rearrangement, local flaps, regional flaps, breast reduction and mastopexy to allow for greater volumes of resection while optimizing aesthetic outcomes in patients undergoing BCS.
 - 脚注t，修改：对于伴有多个高风险复发因素的患者，包括乳房中心或内侧肿瘤或肿瘤≥2厘米且<10枚腋窝淋巴结切除并至少符合以下一项：3级、ER阴性或LVI，可以考虑乳房切除术后放疗。
- Footnote t modified: Postmastectomy RT may be considered for patients with multiple high-risk recurrence factors, including central/medial tumors or tumors ≥2 cm with <10 axillary nodes removed and at least one of the following: grade 3, ER-negative, or LVI.
- 病理淋巴结阳性（≥1个同侧转移灶>2毫米），修改：辅助化疗＋曲妥珠单抗＋帕妥珠单抗（1类，首选）和内分泌治疗
- pN+ ((≥1 ipsilateral metastases >2 mm), modified: Adjuvant chemotherapy with trastuzumab + pertuzumab (category 1, preferred) and endocrine therapy.
- 新增脚注hh：HER2阳性早期乳腺癌辅助治疗APHINITY试验结果更新，中位随访8.4年，证实帕妥珠单抗加入曲妥珠单抗＋化疗预防浸润病变复发获益。
- Footnote hh added: Updated results from the adjuvant APHINITY trial in HER2-positive early breast cancer, with a median follow-up of 8.4 years, have confirmed the benefit of adding pertuzumab to trastuzumab plus chemotherapy in preventing invasive disease recurrences.
- 病理淋巴结阳性（≥1个同侧转移灶>2毫米），修改：辅助化疗＋曲妥珠单抗＋帕妥珠单抗（1类）
- pN+ (≥1 ipsilateral metastases >2 mm), modified: Adjuvant chemotherapy with trastuzumab + pertuzumab (category 1)
- 新增脚注hh：HER2阳性早期乳腺癌辅助治疗APHINITY试验结果更新，中位随访8.4年，证实帕妥珠单抗加入曲妥珠单抗＋化疗预防浸润病变复发获益。
- Footnote hh added: Updated results from the adjuvant APHINITY trial in HER2-positive early breast cancer, with a median follow-up of 8.4 years, have confirmed the benefit of adding pertuzumab to trastuzumab plus chemotherapy in preventing invasive disease recurrences.
- 附加检查，考虑附加检测，第4点修改：FDG PET/CT（可选）（在某些情况下有用）
- Additional workup, additional tests to consider, 4th bullet modified: FDG PET/CT (optional)(useful in certain circumstances)
- 删除脚注：如果已行FDG PET/CT且PET和CT部分均明确提示骨转移，那么可能不必骨扫描或氟化钠PET/CT。
- Footnote removed: Bone scan or sodium fluoride PET/CT may not be needed if FDG PET/CT is performed and clearly indicates bone metastasis, on both the PET and CT component.
- 删除脚注：FDG PET/CT可以与诊断性CT同时进行，在标准分期检查结果不明或可疑的情况下可能有帮助。FDG PET/CT还可能有助于常规分期方法发现未被怀疑的区域淋巴结病变和/或远处转移。
- Footnote removed: FDG PET/CT may be performed at the same time as diagnostic CT, and may be helpful in situations where standard staging studies are equivocal or suspicious. FDG PET/CT may also be helpful in identifying unsuspected regional nodal disease and/or distant metastases when used in addition to standard staging studies.
- 新增脚注uu：FDG PET/CT对晚期病变（III期）和导管浸润癌（与小叶相比）组织检查最有用和准确，但是可能对早期病变（IIA期病变：T1N1、T2N0）特定情况有用，例如：CT＋骨扫描结果模棱两可；怀疑未检测到的淋巴结和/或远处病变；治疗效果评定。FDG PET/CT可以用于初始标准分期的辅助或替代，并且可以与诊断性CT同时进行。相反，如果前期FDG PET/CT明确表明PET和CT部分的结果一致，那么可能不必骨扫描或氟化钠PET/CT。
- Footnote added: FDG PET/CT is most beneficial and accurate for advanced disease (stage III) and invasive ductal (compared to lobular) histology, but may be useful in selected circumstances of earlier stage disease (stage IIA disease: T1N1, T2N0) such as: equivocal CT+ bone scan results; suspicion of undetected nodal and/or distant disease; and treatment response assessment. An FDG PET/CT may be utilized as an adjunct to, or in lieu of, initial standard staging and may be performed simultaneously with diagnostic CT. Conversely, a bone scan or sodium fluoride PET/CT may not be needed if an upfront FDG PET/CT clearly indicates consistent findings on both PET and CT components.
- 保乳手术可行，修改：保乳手术＋腋窝手术分期 ± 肿瘤整形重建
- BCS possible, modified: BCS with surgical axillary staging ± oncoplastic reconstruction
- 新增脚注m：局部组织重排、局部皮瓣、区域皮瓣、乳房缩小和乳房固定术等技术可以实现更大体积的切除，同时优化保乳手术患者的美观结局。
- Footnote m added: Includes techniques such as local tissue rearrangement, local flaps, regional flaps, breast reduction and mastopexy to allow for greater volumes of resection while optimizing aesthetic outcomes in patients undergoing BCS.
- 脚注vv修改：准确评定乳腺肿瘤内或区域淋巴结术前全身治疗效果很难，应该包括初始肿瘤分期时体格检查和影像学检查（乳腺X线摄片和/或乳腺超声和/或乳腺磁共振成像）异常表现。术前影像学检查方法的选择应由多学科团队决定。对于评定肿瘤辅助治疗效果，磁共振成像比乳腺X线摄片更准确。
- Footnote vv 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 at the time of initial tumor staging. Selection of imaging methods prior to surgery should be determined by the multidisciplinary team. MRI is more accurate than mammography for assessing tumor response to adjuvant therapy.
- 局部区域治疗，修改：考虑附加全身化学治疗和/或术前放疗
- Locoregional treatment, modified: Consider additional systemic chemotherapy and/or preoperative radiation
- 脚注vv修改：准确评定乳腺肿瘤内或区域淋巴结术前全身治疗效果很难，应该包括初始肿瘤分期时体格检查和影像学检查（乳腺X线摄片和/或乳腺超声和/或乳腺磁共振成像）异常表现。术前影像学检查方法的选择应由多学科团队决定。对于评定肿瘤辅助治疗效果，磁共振成像比乳腺X线摄片更准确。
- Footnote vv 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 at the time of initial tumor staging. Selection of imaging methods prior to surgery should be determined by the multidisciplinary team. MRI is more accurate than mammography for assessing tumor response to adjuvant therapy.
- 脚注xx修改：完成已计划的化疗全身治疗方案疗程，如果术前未完成。
- Footnote xx modified: Complete planned chemotherapy systemic therapy regimen course, if not completed preoperatively.
- HR阴性且HER2阳性，ypT1-4、N0或ypN≥1，修改：如果由于毒性停用恩美曲妥珠单抗，那么曲妥珠单抗（1类）± 帕妥珠单抗完成1年治疗用曲妥珠单抗 ± 帕妥珠单抗完成（最多）1年HER2靶向治疗。如果初始分期时淋巴结阳性，曲妥珠单抗＋帕妥珠单抗（1类）
- HR-negative/HER2-positive, ypT1-4,N0 or ypN≥1, modified: If ado-trastuzumab emtansine discontinued for toxicity, then trastuzumab (category 1) ± pertuzumab to complete 1 year of therapy complete (up to) 1 year of HER2-directed therapy with trastuzumab +/- pertuzumab. If node positive at initial staging, trastuzumab + pertuzumab (category 1)
- HR阳性且HER2阳性，ypT0N0或病理完全缓解，修改：内分泌治疗bb,cc（1 类）＋曲妥珠单抗 ± 帕妥珠单抗完成最多1年HER2靶向治疗用曲妥珠单抗 ± 帕妥珠单抗完成（最多）1年HER2靶向治疗。如果初始分期时淋巴结阳性，曲妥珠单抗＋帕妥珠单抗（1类）
- HR-positive/HER2-positive, ypT0N0 or pCR, modified: Endocrine therapybb,cc (category 1) + complete up to one year of HER2-targeted therapy with trastuzumab (category 1) ± pertuzumab complete (up to) 1 year of HER2-directed therapy with trastuzumab +/- pertuzumab. If node positive at initial staging, trastuzumab + pertuzumab (category 1)
- 脚注ccc修改：没有关于序贯治疗或指导选择辅助治疗的数据。对于符合卡培他滨、帕博利珠单抗和/或奥拉帕利单药或多药治疗标准的患者，没有关于这些药物序贯或联合辅助治疗的数据。不过，对于某些复发风险较高的患者，可以考虑序贯或联合用药。
- Footnote ccc modified: There are no data on sequencing or to guide selection of an adjuvant therapy. There are no data on sequencing or combining adjuvant capecitabine, pembrolizumab and/or olaparib in patients who meet criteria for treatment with one or more of these agents. However, their sequential/combined use may be considered in certain patients with high-risk of recurrence.
- 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
- 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
- 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...
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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...
- 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.
- 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).
- 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.
- 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.
- 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.
- RT with preoperative or adjuvant systemic therapy
- 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.
- 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.
- 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.
- Preoperative/adjuvant therapy regimens, HER2-Negative: Preferred regimens:
- 第1方案修改：剂量密集AC（多柔比星＋环磷酰胺）之后或之前每2周紫杉醇
- 1st regimen modified: Dose-dense AC (doxorubicin/cyclophosphamide) followed or preceded by paclitaxel every 2 weeks
- 第2方案修改：剂量密集AC（多柔比星＋环磷酰胺）之后或之前每周紫杉醇
- 2nd regimen modified: Dose-dense AC (doxorubicin/cyclophosphamide) followed or preceded by weekly paclitaxel
- 脚注g修改：不推荐铂类药物用于辅助治疗。如果铂类药物加入蒽环类方案，那么化疗最佳顺序和紫杉类药物选择尚未确定。卡铂可以作为帕博利珠单抗方案的一部分。
- Footnote g modified: The use of platinum agents in the adjuvant setting is not recommended. If platinum agents are included in an anthracyclinebased regimen, the optimal sequence of chemotherapy and choice of taxane agent is not established. Carboplatin may be used as part of the pembrolizumab regimen.
- 术前/辅助治疗方案，HER2阴性首选方案：术前帕博利珠单抗＋化疗→术后帕博利珠单抗
- Preoperative/adjuvant therapy regimens, HER2- Preferred Regimens: Preoperative pembrolizumab + chemotherapy followed by adjuvant pembrolizumab
- 术前，修改：第1天静脉注射卡铂AUC5或第1、8、15天静脉注射卡铂AUC1.5
- Preoperative - Modified: Carboplatin AUC 5 IV Day 1 Or Carboplatin AUC 1.5 IV Days 1, 8, 15
- 删除脚注：还有胶囊制剂可选。不过，由于剂量和生物利用度存在差异，不可以按相同毫克用胶囊代替片剂。
- Footnote removed: There is also a capsule formulation available. However, do not substitute the capsules for the tablets on a mg-per-mg basis due to differences in dosing and bioavailability.
- 术前/辅助治疗方案，HER2阴性方案：在某些情况下有用，CMF化疗方案：
- Preoperative/adjuvant therapy regimens, HER2- Negative Regimens: Useful in certain circumstances, CMF chemotherapy:
- 第1点修改：第1～天口服环磷酰胺100mg/m²（静脉注射可接受）
- 1st bullet modified: Cyclophosphamide 100 mg/m² PO days 1-14 (IV acceptable)
- 新增：或8个周期每21天第1天静脉注射环磷酰胺600mg/m²＋甲氨蝶呤40mg/m²＋氟尿嘧啶600mg/m²
- Added: Or Cyclophosphamide 600 mg/m² IV day 1, Methotrexate 40 mg/ m² IV day 1, 5-fluorouracil 600 mg/m² IV day 1, Cycled every 21 days for 8 cycles
- 术前/辅助治疗方案，HER2阳性，在某些情况下有用：紫杉醇＋曲妥珠单抗＋帕妥珠单抗
- Preoperative/adjuvant therapy regimens, HER2-Positive, Useful in certain circumstances: Paclitaxel + trastuzumab + pertuzumab
- 新增：随后每21天第1天静脉注射曲妥珠单抗6mg/kg＋帕妥珠单抗420mg，完成1年治疗
- Added: Followed by: Trastuzumab 6 mg/kg IV; Pertuzumab 420 mg IV day 1; Cycled every 21 days to complete 1 y of therapy
- Footnote c added: Postmenopausal patients with UltraLow risk in the Stockholm Tamoxifen trial had a 20-year breast cancer specific survival of 97% with 2-5 years of Tamoxifen (Esserman LJ, et al. JAMA Oncology 2017;3:1503-1510). Patients with an ultralow-risk in the MINDACT trial have shown 8-year breast cancer specific survival above 99%. (Lopes Cardozo JMN, et al. J Clin Oncol 2022;40:1335-1345).
- Title of page modified: Gene expression assays for consideration of extended adjuvant systemic therapy.
- 复发无法切除（局部或区域）或IV期（M1）ER和/或PR阳性乳腺癌全身治疗：该页已被大幅修改。
- Systemic therapy for ER- and/or PR-positive Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: This page has been extensively revised.
- Preferred Regimens, First-Line Therapy:
- 芳香化酶抑制剂＋CDK4/6抑制剂b：瑞波西利（1类）c、阿贝西利、哌柏西利
- Aromatase inhibitor + CDK4/6 inhibitorb: Aromatase inhibitor + ribociclib (category 1)c, Aromatase inhibitor + abemaciclib, Aromatase inhibitor + palbociclib
- 氟维司群d＋CDK4/6抑制剂b：瑞波西利（1类）e、阿贝西利（1类）e、哌柏西利
- Fulvestrantd + CDK4/6 inhibitorb: Fulvestrant + ribociclib (category 1)e, Fulvestrant + abemaciclib (category 1)e, Fulvestrant + palbociclib
- 由一线治疗首选方案移至其他推荐方案：选择性ER下调剂（氟维司群，1 类）＋非甾体芳香化酶抑制剂（阿那曲唑、来曲唑）（1类）
- Other Recommended Regimens: Selective ER down-regulator (fulvestrant, category 1) + non-steroidal aromatase inhibitor (anastrozole, letrozole) (category 1)
- 在某些情况下有用，后线治疗，新增：其他靶向治疗选择，参见BINV-Q（6 of 14）
- Useful in Certain Circumstances, Subsequent-Line Therapy: Addtional targeted therapy options, see BINV-Q (6 of 14)
- 新增脚注b：对于CDK4/6抑制剂的选择存在争议，因为这些药物缺乏头对头比较，并且3期随机研究人群存在一些差异
- b There is controversy on the choice of CDK4/6i as there are no head to head comparisons between the agents and there are some differences in the study populations in the phase 3 randomized studies.
- 新增脚注d：考虑用于术后内分泌治疗期间疾病进展或术后内分泌治疗完成后12个月内早期疾病复发
- d Consider for disease progression on adjuvant ET or with early disease relapse within 12 months of adjuvant ET completion
- 新增脚注e：根据3期随机对照试验，氟维司群＋瑞波西利或阿贝西利一线治疗患者总生存可获益
- e In phase 3 randomized controlled trials, fulvestrant + ribociclib or abemaciclib has shown OS benefit in the first-line setting
- 修改脚注g：如果CDK4/6抑制剂治疗期间疾病进展，有限的数据支持改用其他CKD4/6抑制剂。如果哌柏西利治疗期间疾病进展，有限的2期研究数据支持改用瑞波西利二线治疗。
- g If there is disease progression while on a CDK4/6 inhibitor, there are limited data to support the use of another CKD4/6 inhibitor. If there is disease progression while on palbociclib, there are limited phase II data to support the use of ribociclib in the second line setting
- 复发无法切除（局部或区域）或IV期（M1）乳腺癌全身治疗方案：该章节与BINV-R合并，已被大幅修改，由8页增加至14页。
- Systemic therapy regimens for Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: This section has been extensively revised.
- 标题修改：复发无法切除（局部或区域）或IV期（M1）乳腺癌全身治疗方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- 标题修改：复发无法切除（局部或区域）或IV期（M1）乳腺癌全身治疗方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- 标题修改：复发无法切除（局部或区域）或IV期（M1）乳腺癌全身治疗方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- HER2阳性方案（续）新增：奈拉替尼第1～7天每天口服120mg、第8～14天每天口服160mg、第15～21天每天口服240mg，卡培他滨第1～14天每天2次口服750mg/m²、第15～21天停用；随后奈拉替尼每天口服240mg，卡培他滨每21天第1～14天每天2次口服750mg/m²
- HER2-Positive Regimens (continued), added: Neratinib 120 mg PO daily on days 1-7, followed by 160 mg PO daily on days 8-14, followed by 240 mg PO daily on days 15-21; Capecitabine 750 mg/m² PO twice daily on days 1-14, Cycled every 21 days x 1 cycle; Followed by Neratinib 240 mg PO daily on days 1-21 Capecitabine 750 mg/m² PO twice daily on days 1-14, Cycled every 21 days beginning with cycle 2
- 复发无法切除（局部或区域）或IV期（M1）乳腺癌其他靶向治疗用法用量：原BINV-R（2 of 3）
- Dosing: Additional targeted therapies and associated biomarker testing for recurrent unresectable (local or regional) or stage IV (M1) disease: This page has been extensively revised.
- 脚注d修改：妊娠期间紫杉类用药数据有限。最佳疗程尚不明确。如果用药，NCCN专家组推荐如果疾病状态有临床指征，那么妊娠早期后每周给予紫杉醇。妊娠期间禁用抗HER2治疗。
- Footnote d modified: There are limited data on the use of taxanes during pregnancy. The optimal schedule is unclear. If used, the NCCN Panel recommends weekly administration of paclitaxel after the first trimester if clinically indicated by disease status. The use of anti-HER2 therapy is contraindicated during pregnancy.
- 删除检查：术前全身治疗，蒽环类＋紫杉类（首选）。如果肿瘤HER2阳性，那么HER2靶向治疗。新增：参见术前/辅助治疗方案（BINV-L）
- Workup Removed: Preoperative systemic therapy, anthracycline + taxane (preferred). If tumor HER2-positive, HER2-targeted therapy. Added: See Preoperative/Adjuvant Therapy Regimens (BINV-L)
- Footnote removed: See Preoperative/Adjuvant Therapy Regimens (BINV-L)
- A new section has been added: Abbreviations
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