|
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由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： 
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）
BINV-L (8 of 9) 奈拉替尼 第1周：每天口服120mg（3片） 第2周：每天口服160mg（4片） 第3～48周：每天口服240mg（6片）
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 15-28 - Cycled every 28 days x 1 cycle - Followed by: 240 mg PO daily on days 1-28 - Cycled every 28 days x 12 cycles beginning with cycle 2
紫杉醇＋曲妥珠单抗＋帕妥珠单抗 Paclitaxel trastuzumab pertuzumab Paclitaxel 80 mg/m² IV day 1 - Cycled every 7 days x 12 cycles Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV - Cycled every 21 days x 4 cycles Pertuzumab 840 mg IV day 1 followed by 420 mg IV - Cycled every 21 days x 4 cycles
恩美曲妥珠单抗（T-DM1） Ado-trastuzumab emtansine (T-DM1) 
BINV-L (9 of 9)
BINV-M (1 of 2)
术前全身治疗适应证，新增：术前全身治疗可考虑用于临床肿瘤大小≤2厘米、淋巴结阴性、HER2阳性乳腺癌和三阴性乳腺癌 Candidates for Preoperative Systemic Therapy Added: Preoperative systemic therapy can be considered for cT1,N0 HER2-positive disease and TNBC
BINV-N (3 of 5)
70基因（MammaPrint）治疗意义（对于病理淋巴结阴性和1～3枚淋巴结阳性）更新：根据MINDACT研究将近9年长期随访结果，并按年龄和淋巴结状态对激素受体阳性HER2阴性乳腺癌患者的探索性分析（参见：七十基因能否指导年轻乳腺癌化疗） Treatment Implications updated for 70-gene (MammaPrint) (for pN0 and 1-3 positive nodes).
BINV-O
BINV-P HER2阴性和绝经后或绝经前接受卵巢切除或抑制：“首选方案”全部单药移至“其他推荐方案：一线和后线治疗”，一线和后线治疗其他推荐方案：氟维司群由1类改为2A类，删除：托瑞米芬 HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression: All single agents that were previously listed under 'Preferred Regimens' have been changed to 'Other Recommended regimens: First- and Subsequent-Line Therapy.' Other recommended regimens for first- and subsequent-line therapy: Fulvestrant was changed from a category 1 to a category 2A option. Option removed: Toremifene 新增脚注b：根据3期随机对照研究（MONALEESA-3）氟维司群±瑞博西利相比，一线治疗患者总生存显著获益（参见：晚期乳腺癌氟维司群＋蒙娜利莎总生存） Footnote b added: In phase 3 randomized controlled trials, ribociclib endocrine therapy has shown overall survival benefit in the first-line setting.
新增脚注d：根据3期随机对照研究（PALOMA-3、MONARCH-2、MONALEESA-3）氟维司群±CDK4/6抑制剂（哌柏西利、阿贝西利、瑞博西利）相比，二线治疗患者总生存显著获益（参见：哌柏西利＋氟维司群二线治疗晚期激素受体阳性乳腺癌总生存结局、阿贝西利＋氟维司群改善乳腺癌总生存、晚期乳腺癌氟维司群＋蒙娜利莎总生存） Footnote d added: In phase 3 randomized controlled trials, fulvestrant in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, and ribociclib) has shown overall survival benefit in the second-line setting.
BINV-Q (1 of 8) HER2阴性乳腺癌，特殊情况有用，删除选项：紫杉醇/贝伐珠单抗 HER2-negative disease Useful in certain circumstances, option removed: paclitaxel/bevacizumab 删除脚注h：晚期乳腺癌随机临床研究表明，某些一线或二线化疗药物＋贝伐珠单抗可略改善至疾病进展时间和缓解率，但是并未改善总生存。不同细胞毒药物对至疾病进展时间的影响可能有所不同，贝伐珠单抗＋每周紫杉醇的影响最大。 Footnotes removed: Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel. 删除脚注i：FDA批准的生物仿制药是贝伐珠单抗的合适替代品 Footnotes removed: An FDA-approved biosimilar is an appropriate substitute for bevacizumab.
BINV-Q (2 of 8) 复发无法切除（局部或区域）或IV期（M1）乳腺癌全身治疗方案 Systemic therapy regimens for HER2-positive, recurrent unresectable (local or regional) or stage IV (M1) disease 新增二线治疗选项：德喜曲妥珠单抗（T-DXd）为首选方案、1类（参见：这类乳腺癌新药究竟是CP还是海王） Second-line option added: Fam-trastuzumab deruxtecan-nxki; this is a category 1, preferred regimen.
修改二线治疗选项：恩美曲妥珠单抗（T-DM1）由首选方案、1类推荐改为其他推荐方案、2A类 Second-line option modified: Ado-trastuzumab emtansine (T-DM1) has been changed from a category 1, preferred regimen to a category 2A, other recommended regimen. 修改行首：三线及以上（最佳顺序尚不明确） Heading modified: Third line and beyond (optimal sequence is not known.) 修改脚注j：方案也可用于三线及以上选项或四线选项；三线及以上治疗的最佳顺序尚不明确。 Footnote j modified: Regimens may also be used as an option for third line and beyond or fourth-line option; the optimal sequence for third-line therapy and beyond is not known. 新增脚注l：德喜曲妥珠单抗（T-DXd）可被考虑用于特定患者（即新辅助或12个月含帕妥珠单抗方案辅助治疗6个月内迅速进展）一线治疗选项之一。 Footnote l added: Fam-trastuzumab deruxtecan-nxki may be considered in the first-line setting as an option for select patients (ie, those with rapid progression within 6 months of neoadjuvant or adjuvant therapy [12 months for pertuzumab-containing regimens]). 修改脚注n：妥卡替尼＋曲妥珠单抗＋卡培他滨对于恩美曲妥珠单抗治疗期间全身或中枢神经系统进展患者三线及以上治疗为首选。不过，妥卡替尼＋曲妥珠单抗＋卡培他滨并可用于二线治疗。 Footnote n modified: Tucatinib trastuzumab capecitabine is preferred in patients with both systemic and CNS progression in the third line setting and beyond; on ado-trastuzumab emtansine. However, tucatinib trastuzumab capecitabine and it may be given in the second-line setting. 删除脚注：德喜曲妥珠单抗（T-DXd）对于恩美曲妥珠单抗治疗期间进展的内脏转移患者为首选 Footnote removed: Fam-trastuzumab deruxtecan-nxki is preferred in patients with visceral metastases if progression on ado-trastuzumab emtansine.
BINV-Q (5 of 8) 曲妥珠单抗＋多西他赛，第二项修改为：每28天第1、8、15天静脉注射多西他赛35mg/m² Trastuzumab docetaxel, second bullet modified: Docetaxel 35 mg/m² IV days 1, 8, and 15 weekly cycled every 28 days
BINV-Q (6 of 8) 曲妥珠单抗＋拉帕替尼，第一项修改为：每天口服拉帕替尼1250mg1000mg Trastuzumab lapatinib, first bullet modified: Lapatinib 1000 mg PO daily for 21 days
BINV-R (1 of 3)
BINV-S (3 of 3) 骨扫描，接受内分泌治疗者：由每4～6个月改为每2～6个月 Bone scan, frequency modified for those receiving endocrine therapy to: Every 2-6 months.
PHYLL-1 切除活检后，良性分叶状肿瘤由观察改为推荐临床随访3年 After excisional biopsy, moved benign phyllodes tumor to separate pathway, recommending clinical follow-up for 3 y.
IBC-1 删除脚注j：精准评定术前全身治疗对乳房内肿瘤或区域淋巴结的效果较难，应包括初始肿瘤分期时体检和影像检查（乳腺钼靶和/或乳腺磁共振）异常表现。术前影像检查方法选择应由多学科团队决定。 Footnote removed: 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 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.
IBC-2 新增列首：术前治疗效果 Heading added for clarification: Response to Preoperative Therapy 未缓解→考虑追加全身化疗和/ 或术前放疗→新增：患者可能适合多线全身治疗以缓解晚期乳腺癌。每次再次评定时，临床医师应通过医患共同决策过程评定继续治疗的价值、多线全身治疗的风险和获益、患者体力状态和患者意愿。 Added to 'no response' pathway: Patients may be candidates for multiple lines of systemic therapy to palliate advanced breast cancer. At each reassessment clinicians should assess value of ongoing treatment, the risks and benefits of an additional line of systemic therapy, patient performance status, and patient preferences through a shared decision making process.
ST-5 组织学类型（原列于ST-4）替换为：组织病理学类型——世界卫生组织（WHO）分类第5版（2019） Replaced Histologic Types (previously listed on ST-4) with the following: Histopathologic Type- WHO Classification 5th Edition (2019) WHO肿瘤分类编委会.WHO肿瘤分类第5版：乳腺肿瘤. 里昂：国际癌症研究机构（2019） WHO Classification of Tumors Editorial Board, ed. WHO classification of tumors, 5th edition - Breast tumors. Lyon: International Agency for Research on Cancer 2019.
|
