美国乳腺癌临床实践指南迎接财神

前情提要

　　时隔106天，正值大年初五全球华人迎接财神之际，美国国家综合癌症网络（NCCN）于美国东部时间2019年2月8日悄然将《乳腺癌临床实践指南》更新至2018年第4版，全文由212页增加至215页，免费注册后可免费下载：

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：

　　关于前版（2018年第3版）NCCN乳腺癌临床实践指南，具体请参阅我国非NCCN官方微信公众号（NCCN指南、NCCN指南者）于2018年11月11日推出的非官方中文版：

　　关于本版（2018年第4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，其依据仍来自权威期刊最新发表的III期大样本多中心随机对照研究结果，更新不多，主要调整了一些标题的措辞、加入了最新公布的KATHERINE、CREATE-X研究证据，具体如下：

BINV-11：标题修改

• 可手术病变的术前系统（全身）治疗：检查－临床分期 → 可手术病变：术前系统（全身）治疗前检查－临床分期

• Preoperative systemic therapy for operable disease: workup - clinical stage → Operable disease: workup prior to preoperative systemic therapy - clinical stage

BINV-12：标题修改

• 术前系统（全身）治疗：乳房和腋窝评估 → 可手术病变：术前系统（全身）治疗前乳房和腋窝评估

• Preoperative Systemic Therapy: Breast and Axillary Evaluation → Operable Disease: Breast And Axillary Evaluation Prior To Preoperative Systemic Therapy

BINV-13：标题修改

• 术前系统（全身）治疗：手术治疗 → 可手术病变：术前系统（全身）治疗和手术治疗

• Preoperative systemic therapy: surgical treatment → Operable disease: preoperative systemic therapy and surgical treatment

BINV-14：标题修改

• 术前系统（全身）治疗：辅助治疗 → 可手术病变：辅助治疗

• Preoperative systemic therapy: adjuvant therapy → Operable disease: adjuvant therapy

BINV-14：辅助治疗，HER2阳性病变，新增如下选择

• 若无残余病变：完成至多一年的曲妥珠单抗（1类证据）±帕妥珠单抗（APHINITY）HER2靶向治疗。若有指征，HER2靶向治疗可与放疗和内分泌治疗同时进行。

• If no residual disease: Complete up to one year of HER-2 targeted therapy with trastuzumab (category 1) ± pertuzumab. HER-2 targeted therapy may be administered concurrently with radiation and with endocrine therapy if indicated. tt

• 若有残余病变：曲妥珠单抗-恩坦辛（T-DM1）单用14个周期（1类证据：KATHERINE）。若T-DM1由于毒性反应停药，则曲妥珠单抗（1类证据）±帕妥珠单抗完成一年HER2靶向治疗。若有指征，HER2靶向治疗可与放疗和内分泌治疗同时进行。

• If residual disease: Ado-trastuzumab emtansine (category 1) alone for 14 cycles. If ado-trastuzumab emtansine discontinued for toxicity, then trastuzumab (category 1) ± pertuzumab to complete one year of therapy. HER-2 targeted therapy may be administered concurrently with radiation and with endocrine therapy if indicated. 

• 编者按：根据美国食品药品管理局（FDA）要求，为避免与曲妥珠单抗混淆，曲妥珠单抗-恩坦辛增加前缀“ado-”（antibody-drug of）以减少配药出错。

• In the United States, Kadcyla was approved with the generic name "ado-trastuzumab emtansine", rather than the original United States Adopted Name (USAN) issued in 2009, "trastuzumab emtansine". Trastuzumab is the anti-HER2 antibody; emtansine refers to the linker-drug (SMCC-DM1). The "ado-" prefix was added at the request of the FDA to help prevent dispensing errors. USAN name: The original USAN name of trastuzumab emtansine was revised to ado-trastuzumab emtansine to eliminate potential confusion with trastuzumab.

BINV-14：原脚注“ff”改为“tt”，加入T-DM1

• 对于激素受体阳性、HER2阳性病变、预估高复发风险患者，曲妥珠单抗辅助治疗后，考虑奈拉替尼（来那替尼）延长辅助治疗。对于接受帕妥珠单抗或T-DM1辅助治疗的患者，奈拉替尼（来那替尼）延长辅助治疗的利弊（获益或毒性）尚不明确。

• Consider extended adjuvant neratinib following adjuvant trastuzumab-containing therapy for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence. The benefit or toxicities associated with extended neratinib in patients who have received pertuzumab is unknown. → Consider extended adjuvant neratinib following adjuvant trastuzumab-containing therapy for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence. The benefit or toxicities associated with extended neratinib in patients who have received pertuzumab or ado-trastuzumab emtansine is unknown.

BINV-15：标题修改

• 不可手术或局部晚期乳腺癌（非炎性）术前系统（全身）治疗：临床分期和检查 → 不可手术或局部晚期乳腺癌（非炎性）：术前系统（全身）治疗前检查

• Preoperative systemic therapy for inoperable or locally advanced breast cancer (non-inflammatory) → Inoperable or locally advanced breast cancer (non-inflammatory): workup prior to preoperative systemic therapy

BINV-16：标题修改

• 不可手术或局部晚期乳腺癌（非炎性）术前系统（全身）治疗：局部区域治疗和辅助治疗 → 不可手术或局部晚期乳腺癌（非炎性）：术前系统（全身）治疗

• Preoperative systemic therapy for inoperable or locally advanced breast cancer (non-inflammatory) → Inoperable or locally advanced breast cancer (non-inflammatory): preoperative systemic therapy

BINV-17：新增章节（原 BINV-17～BINV-28 相应调整为 BINV-18～BINV-28）

• 不可手术或局部晚期乳腺癌（非炎性）：辅助治疗（具体内容与BINV-14相同）

• Inoperable or locally advanced breast cancer (non-inflammatory): adjuvant therapy

BINV-K1：将BINV-K1拆分为BINV-K1和BINV-K2

• 对于HER2阴性乳腺癌新辅助或辅助治疗推荐方案，新增：对于紫杉类、烷化类、蒽环类术前化疗后的三阴性乳腺癌和残余病变，推荐卡培他滨。

• Added the following options under HER2-negative, preferred regimens: If triple-negative breast cancer and residual disease after preoperative therapy with taxane-, alkylator-, and anthracycline-based chemotherapy: capecitabine. 

• 新增脚注8：每21天的第1～14天每天2次口服卡培他滨每平方米体表面积1000～1250毫克，共6～8个周期。

• Footnote 8 is new: Capecitabine 1,000-1,250 mg/m² PO twice daily on Days 1-14. Cycled every 21 days for 6-8 cycles. Masuda N, Lee SJ, Ohtani S, et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N Engl J Med 2017;376:2147-2159.

BINV-K2：对于HER2阳性乳腺癌新辅助或辅助治疗推荐方案，新增如下选择

• 若无术前治疗或术前治疗后有残余病变：完成至多一年的曲妥珠单抗（1类证据）±帕妥珠单抗（APHINITY）HER2靶向治疗。

• If no residual disease after preoperative therapy or if no preoperative therapy: Complete up to one year of HER-2 targeted therapy with trastuzumab (category 1) ± pertuzumab.

• 若术前治疗后有残余病变：曲妥珠单抗-恩坦辛（T-DM1）单用14个周期（1类证据：KATHERINE）。若T-DM1由于毒性反应停药，则曲妥珠单抗（1类证据）±帕妥珠单抗完成一年HER2靶向治疗。

• If residual disease after preoperative therapy: Ado-trastuzumab emtansine (category 1) alone for 14 cycles. If ado-trastuzumab emtansine discontinued for toxicity, then trastuzumab (category 1) ± pertuzumab to complete one year of therapy.

• 新增脚注11：对于激素受体阳性、HER2阳性病变、预估高复发风险患者，曲妥珠单抗辅助治疗后，考虑奈拉替尼（来那替尼）延长辅助治疗。对于接受帕妥珠单抗或T-DM1辅助治疗的患者，奈拉替尼（来那替尼）延长辅助治疗的利弊（获益或毒性）尚不明确。

• Footnote 11 is new to the page: Consider extended adjuvant neratinib following adjuvant trastuzumab-containing therapy for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence. The benefit or toxicities associated with extended neratinib in patients who have received pertuzumab or ado-trastuzumab emtansine is unknown.

• 新增脚注12：每21天T-DM1每公斤体重3.6毫克，共14个周期。参考文献：von Minckwitz G, Huang C, Mano M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med 2018; DOI: 10.1056/NEJMoa1814017

• Footnote 12 is new: Ado-trastuzumab emtansine 3.6 mg/kg cycled every 21 days for 14 cycles. von Minckwitz G, Huang C, Mano M, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med 2018; DOI: 10.1056/NEJMoa1814017

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