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NCCN乳腺癌指南V1.2022更新(上)

  2021年11月24日,正值感恩节前夜,美国国家综合癌症网络(NCCN)悄然将乳腺癌临床实践指南2021年第8版更新至2022年第1版,全文由248页减少至244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31个

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  NCCN乳腺癌临床实践指南2022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。本版更新内容较多,更新如下(中划线为删除,下划线为新增)

整体修改

  • “乳房肿块切除术”改为“乳房保留手术”(保乳手术)

  • 'Lumpectomy' changed to 'breast-conserving surgery.'

DCIS-1

  • 脚注j修改:乳腺导管原位癌保乳手术后全乳放疗可减少同侧乳腺肿瘤复发率大约50%~70%

  • Footnote j, modified: WBRT following BCS reduces ipsilateral breast tumor recurrence rates in DCIS by about 50%-70%.

DCIS-2

  • 乳腺导管原位癌手术后治疗,第一项修改:对于雌激素受体阳性乳腺导管原位癌患者,考虑内分泌治疗5年

  • DCIS Postsurgical Treatment, first bullet modified: Consider endocrine therapy for 5 years for patients with ER-positive DCIS

BINV-1

  • 病理检查,新增项:如果考虑术后阿贝西利辅助治疗,进行Ki-67检测(参见BINV-K)

  • Pathology review, sub-bullet added: Ki-67 test if considering adjuvant abemaciclib (see BINV-K)

  • 第五项修改:如果患者存在遗传性乳腺癌风险、三阴性乳腺癌(任何年龄)或术后奥拉帕利辅助治疗指征,提供遗传咨询和检测

  • Fifth bullet modified: Genetic counseling and testing if patient is at risk for hereditary breast cancer, has triple-negative breast cancer (TNBC) (at any age), or is a candidate for adjuvant olaparib.

BINV-2

  • 新增标题:保乳手术和腋窝分期完成后的放疗

  • Heading added: 'RT after Completion of BCS and Axillary Staging'

  • 腋窝淋巴结阴性,第一项修改:全乳放疗±瘤床推量,并考虑对肿瘤位于中央/内侧象限或肿瘤>2厘米伴其他高风险特征(年轻或病理T3期肿瘤或病理T2期肿瘤伴以下高风险特征:3级、广泛淋巴血管浸润或雌激素受体阴性患者进行全部区域淋巴结放疗

  • Negative axillary nodes, first option modified: WBRT ± boost to tumor bed, and consider comprehensive regional nodal irradiation (RNI) in patients with central/medial tumors, or tumors >2 cm with other high-risk features (young age or pT3 tumors, orpT2 tumors with one of the following high-risk features: grade 3, extensive lymphovascular invasion [LVI], or ER-negative

  • 1~3枚腋窝淋巴结阳性,为了与BINV-D一致,对于不符合全部标准的患者,放疗修改为:全乳放疗包括存在风险的未清扫腋窝任何部位±瘤床推量(1类证据)。强烈推荐考虑全部区域淋巴结放疗对锁骨上区/锁骨下区、内乳淋巴结以及腋窝床任何存在风险的部位行放疗

  • 1-3 positive axillary nodes: Criteria modified for consistency with BINV-D. No after criteria, RT modified: WBRT with inclusion of any portion of the undissected axilla at risk ± boost to tumor bed (category 1). Strongly consider comprehensive RNI. RT to supraclavicular/infraclavicular regions, internal mammary nodes, and any part of the axillary bed at risk

  • ≥4枚腋窝淋巴结阳性,放疗修改为:全乳放疗±瘤床推量(1类证据)+全部区域淋巴结放疗+存在风险的未清扫腋窝任何部位(1类证据)锁骨上区/锁骨下区、内乳淋巴结以及腋窝床任何存在风险的部位(1类证据)

  • ≥4 positive axillary nodes, option modified: WBRT ± boost n to tumor bed (category 1) comprehensive RNI any portion of the undissected axilla at risk (category 1) supraclavicular/infraclavicular regions, internal mammary nodes, and any part of the axillary bed at risk (category 1).

BINV-3

  • 新增标题:乳房切除术和腋窝分期完成后的放疗

  • Heading added: 'RT after Completion of Mastectomy and Axillary Staging'

  • 对锁骨上区/锁骨下区、内乳淋巴结以及腋窝床任何存在风险的部位行放疗改为全部区域淋巴结放疗(包括存在风险的未清扫腋窝任何部位)(同样修改BINV-14/15和IBC-2)

  • Where recommended, 'RT to supraclavicular/infraclavicular regions, internal mammary nodes, and any part of the axillary bed at risk' has been changed to: 'and comprehensive RNI (including any portion of the undissected axilla at risk.' (Also on BINV-14/15, and IBC-2)

BINV-4

  • 绝经前患者进一步分为pT1-3且pN0pT1-3且pN ,分别链接至BINV-7、BINV-8

  • Separate links added to BINV-7 and BINV-8.

BINV-5

  • 脚注aa移至BINV-K:证据表明激素受体阳性乳腺癌绝经前患者卵巢手术或放疗去势获益程度与单用环磷酰胺+甲氨蝶呤+氟尿嘧啶相似(同样修改BINV-7、BINV-8和BINV-11)

  • Footnote moved from this page to BINV-K: Evidence suggests that the magnitude of benefit from surgical or radiation ovarian ablation in premenopausal patients with HR-positive breast cancer is similar to that achieved with CMF alone. (Also on BINV-7, BINV-8, and BINV-11)

  • 脚注bb分别移至BINV-L和BINV-I:化疗+内分泌治疗用于术后辅助治疗时应先化疗后内分泌治疗,现有数据表明内分泌治疗序贯或同步放疗可接受(同样修改BINV-6至BINV-11)

  • Footnote text was moved: (Also on BINV-6 through BINV-11) Moved to BINV-L, 3 of 10: Chemotherapy and endocrine therapy used as adjuvant therapy should be given sequentially with endocrine therapy following chemotherapy. Moved to BINV-I (2 of 3): Available data suggest that sequential or concurrent endocrine therapy with RT is acceptable.

  • 脚注删除:年龄≥70岁者化疗推荐意见证据有限,参见NCCN老年肿瘤患者指南(同样修改BINV-6至BINV-11)

  • Footnote removed: There are limited data to make chemotherapy recommendations for those ≥70 y of age. See NCCN Guidelines for Older Adult Oncology. (Also on BINV-6 through BINV-11)

  • 脚注ee修改:对于肿瘤淋巴结阳性或高风险淋巴结阴性绝经(自然或诱发)绝经后患者,为了减少3~5年远处转移风险,考虑术后双膦酸盐辅助治疗(同样修改BINV-6至BINV-11和BINV-16)

  • Footnote ee modified: Consider adjuvant bisphosphonate therapy for risk reduction of distant metastasis for 3-5 years in postmenopausal patients with (natural or induced) menopause with high-risk node-negative or node-positive tumors. (Also on BINV-6 through BINV-11 and BINV-16)

BINV-6

  • 新增脚注jj:对于完成术后辅助化疗的种系BRCA1/2突变患者,可选择加用1年奥拉帕利辅助治疗,参见BINV-L(同样修改BINV-8和BINV-10)

  • Footnote jj added: Addition of 1 year of adjuvant olaparib is an option for select patients with germline BRCA1/2 mutation after completion of adjuvant chemotherapy. See BINV-L (1 of 8). (Also on BINV-8 and BINV-10)

BINV-12

  • 临床分期标准修改:c≥T2或cN 且M0或cT1,N0的HER2阳性乳腺癌,或cT1,N0的三阴性乳腺癌并考虑术前全身治疗关于术前全身治疗标准,参见BINV-M)

  • Clinical stage, criteria modified: c≥T2 or cN and M0 or cT1,N0 HER2-positive disease or cT1,N0 TNBC and Considering preoperative systemic therapy (For preoperative systemic therapy criteria, see BINV-M, 1 of 2)

  • 其他检查,第四项修改:胸部诊断性CT±造影剂

  • Additional workup, fourth bullet modified: Chest diagnostic CT with ± contrast

BINV-13

  • 第一列第三项修改:对可疑和/或临床阳性腋窝淋巴结推荐活检±标记夹放置(如果之前未做)

  • First column, third bullet, changed 'Biopsy ± clip placement...' to 'Biopsy clip placement recommended of suspicious and/or clinically positive axillary lymph nodes, if not previously done.'

BINV-14

  • 第一列第一项修改:完全缓解或部分缓解如果保乳手术可能

  • First column, options modified: Complete response or Partial response If BCS possible

  • 第一列第二项修改:部分缓解或任何时候确认疾病进展如果保乳手术不可能

  • Partial response, lumpectomy not possible or Confirmed progressive disease at any time If BCS not possible

  • 保乳手术后辅助治疗,新增最后一项:对于任何cN0, ypN0,术后全乳放疗±瘤床推量

  • Adjuvant therapy after breast-conserving surgery, last bullet added: Any cN0, ypN0: Adjuvant RT to whole breast ± boost to tumor bed

  • 乳房切除术后辅助治疗,新增最后一项:如果经过前哨淋巴结活检或腋窝淋巴结清扫,对于任何cN0, ypN0,也可进行术后全身治疗(参见BINV-16)

  • Adjuvant therapy after mastectomy, last option added: or Adjuvant systemic therapy (see BINV-16) without adjuvant RT for any cN0, ypN0 if axilla was assessed by SLNB or axillary node dissection.

BINV-16

  • 激素受体阳性HER2阴性乳腺癌,ypT0N0或病理完全缓解或ypT1-4,N0或ypN≥1,术后全身治疗修改:术后内分泌治疗(1类证据)+奥拉帕利(如果种系BRCA1/2突变、CPS EG评分≥3且残留病变)

  • HR-positive/HER2-Negative disease ypT0N0 or pCR or ypT1-4,N0 or ypN≥1, adjuvant systemic therapy modified: Adjuvant endocrine therapy (category 1) adjuvant olaparib if germline BRCA1/2 mutation CPS EG score ≥3, and residual disease

  • 三阴性乳腺癌,ypT0N0或病理完全缓解,术后全身治疗新增:对于高风险患者,术后帕博利珠单抗(如果术前用过帕博利珠单抗)

  • HR-Negative/HER2-Negative disease ypT0N0 or pCR, adjuvant systemic therapy added: For high-risk: Adjuvant pembrolizumab (if pembrolizumab-containing regimen was given preoperatively)

  • 三阴性乳腺癌,ypT1-4,N0或ypN≥1,术后全身治疗修改:考虑术后卡培他滨(6~8个周期)或奥拉帕利1年(如果种系BRCA1/2突变)或帕博利珠单抗(如果术前用过帕博利珠单抗)

  • HR-Negative/HER2-Negative disease ypT1-4,N0 or ypN≥1, adjuvant systemic therapy options modified: Consider Adjuvant capecitabine (6-8 cycles) or Adjuvant olaparib for 1 year if germline BRCA1/2 mutation or Adjuvant pembrolizumab (if pembrolizumab-containing regimen was given preoperatively)

  • 原脚注zz移至BINV-I并修改:术后HER2靶向治疗和/或内分泌治疗可与放疗同时进行,而卡培他滨应用于放疗完成后

  • Footnote moved to BINV-I (2 of 3), and modified: Adjuvant HER2- targeted therapy and/or endocrine therapy may be delivered concurrently with RT. , while capecitabine should follow completion of RT.

  • 新增脚注zz:高风险标准包括II~III期三阴性乳腺癌。术后帕博利珠单抗用药(2A类证据)应个体化

  • Footnote zz added: High-risk criteria include stage II-III TNBC. The use of adjuvant pembrolizumab (category 2A) may be individualized.

  • 新增脚注aaa:OlympiA研究入组患者未用卡培他滨;因此,指导术后辅助治疗选择或顺序的数据缺乏

  • Footnote aaa added: Patients in the OlympiA trial did not receive capecitabine; thus, there are no data on sequencing or to guide selection of an adjuvant therapy.

BINV-17

  • 内分泌治疗第二项第一点修改:与年龄相符的妇科筛查每12个月进行每年妇科评定(如果子宫存在)

  • Endocrine therapy Second bullet, first sub-bullet modified: Age-appropriate gynecologic screening Annual gynecologic assessment every 12 mo if uterus present

BINV-18

  • 全身分期影像检查,第一项修改:胸部诊断性CT±造影剂(同样修改IBC-1)

  • Imaging for systemic staging, first bullet modified: Chest diagnostic CT with ± contrast (Also on IBC-1)

  • 生物标志检测第一项修改:至少首次复发时活检(如果进展,考虑再次活检)

  • Biomarker testing First bullet modified: Biopsy of at least first recurrence of disease (consider re-biopsy if progression)

  • 生物标志检测第二项修改:评估雌激素受体、孕激素受体和HER2状态以区分复发病变与新的原发病变

  • Biomarker testing Second bullet modified: Evaluation of ER/PR and HER2 status to differentiate recurrent disease from new primary

  • 脚注eee最后新增:由于雌激素受体、孕激素受体和HER2状态可随治疗和转移进展而变化,如果治疗将改变,那么考虑对新标本进行再次检测可能是合理的

  • Footnote eee, last line added: Since ER/PR and HER2 status can change with treatment and metastatic progression, it may be appropriate to consider repeat testing on new samples in these scenarios if management will change.

BINV-19

  • 脚注iii修改:对于已经前哨淋巴结活检的保乳手术后乳房局部复发患者,虽然重复前哨淋巴结活检的准确性尚未证实,但是可以考虑重复前哨淋巴结活检。另一方面,乳房切除术后重复前哨淋巴结活检的预后意义尚不明确,并不鼓励。乳房切除术后,可以考虑重复前哨淋巴结活检,尽管数据有限。

  • Footnote iii modified: In patients with a local breast recurrence after BCS who had a prior SLNB, a repeat SLNB may be considered although the accuracy of repeat SLNB is unproven. On the other hand, the prognostic significance of repeat SNB after mastectomy is unknown and its use is discouraged. After mastectomy, repeat SLNB may be considered although there are limited data in this setting.

BINV-22

  • 脚注uuu删除(保留于BINV-P):如果CDK4/6抑制剂治疗期间疾病进展,支持其他CDK4/6抑制剂方案下一线治疗的数据有限。同样,如果依维莫司方案治疗期间疾病进展,支持其他依维莫司方案下一线治疗的数据也缺乏

  • Footnote removed from this page (it remains on BINV-P): If there is disease progression while on CDK4/6 inhibitor therapy, there are limited data to support an additional line of therapy with another CDK4/6-containing regimen. Likewise, if there is disease progression while on a everolimus-containing regimen, there are no data to support an additional line of therapy with another everolimus regimen.

BINV-23

  • 由于重复而删除选项:其他HER2靶向治疗

  • Option removed due to redundancy: Other HER2-targeted therapies

  • 脚注vvv修改:对于绝经前患者,选择性雌激素调节剂他莫昔芬单药(不切除或抑制卵巢)+HER2靶向治疗也是一种选择

  • Footnote vvv modified: For premenopausal patients, selective ER modulators tamoxifen alone (without ovarian ablation/suppression) HER2-targeted therapy is also an option.


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2021版CBCS指南与规范完整版

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