2024年10月15日，时隔104天，美国国家综合癌症网络（NCCN）乳腺癌临床实践指南悄然由2024年第4版更新至2024年第5版，全文由257页增加至259页。
NCCN为全国综合癌症中心非国立联盟组织，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33个：
　　NCCN乳腺癌临床实践指南2024年第5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。此次更新依据主要来自早期乳腺癌术后两大CDK4/6抑制剂阿贝西利的monarchE研究以及瑞波西利的NATALEE研究，更新内容具体如下（中划线为删除，下划线为新增）
BINV-5
  • 修改脚注dd：参见术后内分泌±CDK4/6抑制剂治疗和术后内分泌治疗原则。（适用于后续页面）
  • Footnote dd revised: See Adjuvant Endocrine ± CDK4/6 Inhibitor Therapy and Principles of Adjuvant Endocrine Therapy. (Also for subsequent pages)
BINV-6
  • 中间临床路径全部选项新增：对于符合指征的患者，可以考虑术后阿贝西利或瑞波西利治疗。符合指征的标准参见BINV-K 2/3。
  • Middle pathway, option added to all nodes: Consider adjuvant abemaciclib or ribociclib for eligible patients. See BINV-K 2 of 3 for eligibility criteria.
  • 下方临床路径新增选项：对于符合指征的患者，可以选择术后阿贝西利或瑞波西利和/或奥拉帕利（如果检出种系BRCA1/2突变）治疗。符合指征的标准参见BINV-K 2/3。
  • Bottom pathway, options added: Select patients may be eligible for treatment with adjuvant abemaciclib or ribociclib and/or adjuvant olaparib if germline BRCA1/2 mutation. See BINV-K 2 of 3 and BINV-L for eligibility criteria.
  • 删除脚注kk：对于HR阳性HER2阴性、高风险乳腺癌患者，可以考虑术后阿贝西利两年联合内分泌治疗（参见BINV-K列所符合指征的标准）。对于符合术后奥拉帕利和阿贝西利治疗指征的患者，用药最佳顺序尚不明确。
  • Footnote kk removed: Two years of adjuvant abemaciclib in combination with endocrine therapy can be considered in patients with HR+/HER2-negative, high-risk breast cancer (see eligibility criteria listed on (BINV-K). In patients eligible for adjuvant olaparib and abemaciclib, the optimal sequence is not known.
  • 修改脚注oo：对于完成术后化疗的种系BRCA1/2突变患者，可选择术后奥拉帕利治疗1年。参见BINV-L。对于符合术后奥拉帕利和阿贝西利或瑞波西利治疗指征的患者，用药最佳顺序尚不明确。（适用于后续页面）
  • Footnote oo revised: 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. In patients eligible for adjuvant olaparib and abemaciclib or ribociclib the optimal sequence is not known. (Also for subsequent pages)
BINV-7
  • 对于肿瘤大于0.5厘米和病理淋巴结阴性患者，新增：对于符合指征的患者，可以考虑术后瑞波西利治疗。符合指征的标准参见BINV-K 2/3。
  • Added to Tumor > 0.5 cm and pN0: Consider adjuvant ribociclib for eligible patients. See BINV-K 2 of 3 for eligibility criteria.
BINV-8
  • 第5列全部临床路径新增选项：对于符合指征的患者，可以考虑术后阿贝西利或瑞波西利治疗。符合指征的标准参见BINV-K 2/3。
  • Added as an option to all pathways in column 5: Consider adjuvant abemaciclib or ribociclib for eligible patients. See BINV-K 2 of 3 for eligibility criteria.
BINV-16
  • 对于HR阳性HER2阴性、ypT1-4N0或ypN≥1的患者，修改临床路径：术后内分泌治疗（1类推荐意见）＋术后奥拉帕利（如果检出种系BRCA1/2突变CPS＋EG评分≥3且有残癌，1类推荐意见）。符合指征的标准参见BINV-L 1/9。部分患者可能符合术后阿贝西利治疗指征。对于符合指征的患者，可以考虑术后阿贝西利或瑞波西利治疗。符合指征的标准参见BINV-K 2/3。
  • HR-positive/HER2-negative, ypT1-4,N0 or ypN≥1 pathway revised: Adjuvant endocrine therapy (category 1)+ adjuvant olaparib if germline BRCA1/2 mutation CPS+EG score ≥3, and residual disease (category 1). See BINV-L 1 of 9 for eligibility criteria. Select patients may be eligible for adjuvant abemaciclib. Consider adjuvant abemaciclib or ribociclib for eligible patients. See BINV-K 2 of 3 for eligibility criteria.
BINV-I (2 of 3)
  • 放疗＋术前或术后全身治疗，修改第2点第2项：阿贝西利或瑞波西利应于手术、放疗、化疗完成后开始用药，同时进行内分泌治疗。
  • RT with Preoperative or Adjuvant Systemic Therapy, Bullet 2, sub-bullet 1 revised: Abemaciclib or ribociclib should be initiated after completion of surgery/RT/chemotherapy, concurrently with endocrine therapy.
BINV-K

  • 修改临床路径，加入对符合指征的患者给予术后阿贝西利或瑞波西利。

  • Pathway revised to include adjuvant abemaciclib or ribociclib in eligible patients.

  • 修改脚注i：对于HR阳性HER2阴性乳腺癌患者：1）对于高风险乳腺癌患者（即术前和/或手术时确认≥4枚阳性淋巴结，或术前影像学和/或手术时1～3枚阳性淋巴结且组织学3级或肿瘤≥5厘米）可考虑术后阿贝西利2年联合内分泌治疗（1类推荐意见，首选）。阿贝西利＋他莫昔芬的静脉血栓栓塞发生率（4.3%）高于阿贝西利＋芳香化酶抑制剂（1.8%）。2）对于任何淋巴结转移（不包括淋巴结微转移）患者，或者淋巴结阴性且肿瘤>5厘米，或者肿瘤大小2～5厘米且组织学2级（且基因组风险高或Ki-67≥20%）或组织学3级，可以考虑术后瑞波西利3年联合芳香化酶抑制剂治疗（1类推荐意见，首选）。值得注意的是，术后CDK4/6抑制剂已对大多接受术后/术前化疗的高风险患者进行研究；未接受化疗的患者数据有限。对于符合术后奥拉帕利（参见BINV-L）和阿贝西利或瑞波西利治疗指征的患者，用药最佳顺序及其获益尚不明确。

  • In patients with HR-positive/HER2-negative breast cancer, 1) for those with high-risk breast cancer (ie, those with ≥4 positive lymph nodes (confirmed preoperatively and/or at surgery), or 1-3 positive lymph nodes with either grade 3 disease or tumor size ≥5 cm (on pre-operative imaging and/or at surgery), 2 years of adjuvant abemaciclib can be considered in combination with endocrine therapy (category 1, preferred). VTE risk should be considered when combining abemaciclib with tamoxifen. 2) For those with any lymph node involvement (excluding microscopic nodal involvement), or if no nodal involvement either tumor size >5 cm, or if tumor size 2-5 cm, either Grade 2 (and high genomic risk or Ki-67 ≥20%), or Grade 3, three years of ribociclib with aromatase inhibitor may be considered (Category 1, preferred). Notably adjuvant CDK4/6 inhibitors have been studied in high-risk patients who mostly received adjuvant/neoadjuvant chemotherapy; there are limited data in those who did not receive chemotherapy. In patients eligible for adjuvant olaparib (see BINV-L) and abemaciclib or ribociclib, the benefit and optimal sequence is not known.


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