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NCCN乳腺癌指南V1.2023更新①

2023年01月31日
来源:SIBCS


  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)

DCIS-1
  • 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-2
  • 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.


BINV-2
  • 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
  • 腋窝淋巴结阴性:
  • Negative axillary nodes:
  • 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.


BINV-3
  • 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.


BINV-5
  • 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.


BINV-9
  • 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.


BINV-12
  • 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.


BINV-14
  • 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.


BINV-15
  • 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.


BINV-16
  • 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)
  • (1 类)± 帕妥珠单抗 HER2 靶向治疗
  • 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.







               
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