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）- 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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