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NCCN乳腺癌临床实践指南(V2.2020)

美国综合癌症网络 SIBCS 2023-01-13


前情提要


  仅仅时隔21天,美国国家综合癌症网络(NCCN)于美国东部时间2020年2月5日悄然将《乳腺癌临床实践指南》更新至2020年第2版,全文由216页增至224页,免费注册后仍可免费下载:



NCCN为非国立、非营利、全国综合癌症中心联盟组织,1993年11月正式成立,1995年1月31日宣布成为全国联盟,其总部于2018年9月28日由宾夕法尼亚州华盛顿堡迁至普利茅斯米庭,由最初13个至目前28个美国知名综合癌症中心组成:



  关于本版(2020年第2版)NCCN乳腺癌临床实践指南,其架构仍为临床路径+循证解读+参考文献,其依据仍来自权威学术期刊最新发表的大样本多中心随机对照三期临床研究结果。本版指南更新不多,几乎完全为了第一三共阿斯利康联合开发的德卢曲妥珠单抗而度身定制,其依据为2019年12月11日《新英格兰医学杂志》和美国圣安东尼奥乳腺癌论坛同时发表的国际多中心非盲单组两部分二期临床研究,并于2019年12月20日被美国食品药品监督管理局(FDA)快速批准上市。本版指南更新具体如下:



  • 乳腺浸润癌:复发或IV期(M1)病变的全身治疗:激素受体阳性HER2阳性(BINV-22)

  • Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-Positive; HER2-Positive (BINV-22)

  • 新增德卢曲妥珠单抗,加入复发或IV期(M1)HER2阳性病变的全身治疗选择。

  • Fam-trastuzumab deruxtecan-nxki has been added to the systemic therapy options for recurrent or stage IV (M1) HER2-positive disease.

  • 新增脚注xxx:德卢曲妥珠单抗适用于既往HER2靶向治疗至少二线失败之后的乳腺癌转移患者,禁用于肺实质炎或间质性肺病患者。

  • Footnote xxx has been added: Fam-trastuzumab deruxtecan-nxki is indicated following two or more lines of prior HER2-targeted therapy in the metastatic setting. This agent is contraindicated for patients with pneumonitis or interstitial lung disease (ILD).



  • 乳腺浸润癌:复发或IV期(M1)病变的全身治疗:激素受体阳性HER2阳性(BINV-23)

  • Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-Positive; HER2-Positive (BINV-23)

  • 新增脚注xxx:德卢曲妥珠单抗适用于既往HER2靶向治疗至少二线失败之后的乳腺癌转移患者,禁用于肺实质炎或间质病患者。

  • Footnote xxx has been added: Fam-trastuzumab deruxtecan-nxki is indicated following two or more lines of prior HER2-targeted therapy in the metastatic setting. This agent is contraindicated for patients with pneumonitis or interstitial lung disease (ILD).



  • 乳腺浸润癌:复发或IV期(M1)病变的全身治疗:激素受体阴性HER2阳性(BINV-24)

  • Invasive Breast Cancer: Systemic Treatment of Recurrent or Stage IV (M1) Disease: ER- and/or PR-Negative; HER2-Positive (BINV-24)

  • 新增德卢曲妥珠单抗,加入复发或IV期(M1)HER2阳性病变的全身治疗选择。

  • Fam-trastuzumab deruxtecan-nxki has been added to the systemic therapy options for recurrent or stage IV (M1) HER2-positive disease.

  • 新增脚注xxx:德卢曲妥珠单抗适用于既往HER2靶向治疗至少二线失败之后的乳腺癌转移患者,禁用于肺实质炎或肺间质病患者。

  • Footnote xxx has been added: Fam-trastuzumab deruxtecan-nxki is indicated following two or more lines of prior HER2-targeted therapy in the metastatic setting. This agent is contraindicated for patients with pneumonitis or interstitial lung disease (ILD).



  • 乳腺浸润癌:复发或IV期(M1)激素受体阳性病变的全身治疗(BINV-P)

  • Invasive Breast Cancer: Systemic Therapy for ER- and/or PR-Positive Recurrent or Stage IV (M1) Disease (BINV-P)

  • 修改脚注g:不可用曲妥珠单抗-透明质酸酶(皮下注射制剂)代替恩美曲妥珠单抗(T-DM1)或德卢曲妥珠单抗

  • Footnote g modified: Do not substitute trastuzumab and hyaluronidase-oysk for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan-nxki.



  • 乳腺浸润癌:复发或IV期(M1)病变的全身治疗方案(BINV-Q)

  • Invasive Breast Cancer: Systemic Therapy Regimens for Recurrent or Stage IV (M1) Disease (BINV-Q)

  • 新增德卢曲妥珠单抗,加入复发或IV期(M1)HER2阳性病变的其他推荐方案。

  • Fam-trastuzumab deruxtecan-nxki has been added to the other recommended regimens for HER2-positive recurrent or stage IV (M1) disease.

  • 新增德卢曲妥珠单抗用法:每21天第1天,每公斤体重5.4毫克,静脉注射。

  • 5.4 mg/kg IV day 1, Cycled every 21 days

  • 新增脚注k:德卢曲妥珠单抗适用于既往HER2靶向治疗至少二线失败之后的乳腺癌转移患者,禁用于肺实质炎或肺间质病患者。

  • Footnote k added: Fam-trastuzumab deruxtecan-nxki is indicated following two or more lines of prior HER2-targeted therapy in the metastatic setting. This agent is contraindicated for patients with pneumonitis or interstitial lung disease (ILD).

  • 新增参考文献:德卢曲妥珠单抗用于既往治疗失败的HER2乳腺癌(新英格兰医学杂志)

  • Reference added: Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2019. DOI: 10.1056/NEJMoa1914510. [Epub ahead of print]

  • 修改脚注l:不可用曲妥珠单抗-透明质酸酶(皮下注射制剂)代替恩美曲妥珠单抗(T-DM1)或德卢曲妥珠单抗

  • Footnote l modified: Do not substitute trastuzumab and hyaluronidase-oysk for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan-nxki.





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