|
前情提要 時(shí)隔106天，正值大年初五全球華人迎接財(cái)神之際，美國國家綜合癌癥網(wǎng)絡(luò)（NCCN）于美國東部時(shí)間2019年2月8日悄然將《乳腺癌臨床實(shí)踐指南》更新至2018年第4版，全文由212頁增加至215頁，免費(fèi)注冊后可免費(fèi)下載：
NCCN為非國立、非營利、全國綜合癌癥中心聯(lián)盟組織，1993年11月正式成立，1995年1月31日宣布成為全國聯(lián)盟，其總部于2018年9月28日由賓夕法尼亞州華盛頓堡遷至普利茅斯米庭，由最初13個(gè)至目前28個(gè)美國知名綜合癌癥中心組成：
關(guān)于前版（2018年第3版）NCCN乳腺癌臨床實(shí)踐指南，具體請參閱我國非NCCN官方微信公眾號（NCCN指南、NCCN指南者）于2018年11月11日推出的非官方中文版： 關(guān)于本版（2018年第4版）NCCN乳腺癌臨床實(shí)踐指南，其架構(gòu)仍為臨床路徑＋循證解讀＋參考文獻(xiàn)，其依據(jù)仍來自權(quán)威期刊最新發(fā)表的III期大樣本多中心隨機(jī)對照研究結(jié)果，更新不多，主要調(diào)整了一些標(biāo)題的措辭、加入了最新公布的KATHERINE、CREATE-X研究證據(jù)，具體如下： 
BINV-11：標(biāo)題修改 可手術(shù)病變的術(shù)前系統(tǒng)（全身）治療：檢查－臨床分期 → 可手術(shù)病變：術(shù)前系統(tǒng)（全身）治療前檢查－臨床分期 Preoperative systemic therapy for operable disease: workup - clinical stage → Operable disease: workup prior to preoperative systemic therapy - clinical stage
BINV-12：標(biāo)題修改
術(shù)前系統(tǒng)（全身）治療：乳房和腋窩評估 → 可手術(shù)病變：術(shù)前系統(tǒng)（全身）治療前乳房和腋窩評估 Preoperative Systemic Therapy: Breast and Axillary Evaluation → Operable Disease: Breast And Axillary Evaluation Prior To Preoperative Systemic Therapy
BINV-13：標(biāo)題修改 
BINV-14：標(biāo)題修改 BINV-14：輔助治療，HER2陽性病變，新增如下選擇 若無殘余病變：完成至多一年的曲妥珠單抗（1類證據(jù)）±帕妥珠單抗（APHINITY）HER2靶向治療。若有指征，HER2靶向治療可與放療和內(nèi)分泌治療同時(shí)進(jìn)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 若有殘余病變：曲妥珠單抗-恩坦辛（T-DM1）單用14個(gè)周期（1類證據(jù)：KATHERINE）。若T-DM1由于毒性反應(yīng)停藥，則曲妥珠單抗（1類證據(jù)）±帕妥珠單抗完成一年HER2靶向治療。若有指征，HER2靶向治療可與放療和內(nèi)分泌治療同時(shí)進(jìn)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. 編者按：根據(jù)美國食品藥品管理局（FDA）要求，為避免與曲妥珠單抗混淆，曲妥珠單抗-恩坦辛增加前綴“ado-”（antibody-drug of）以減少配藥出錯(cuò)。 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：原腳注“ff”改為“tt”，加入T-DM1 對于激素受體陽性、HER2陽性病變、預(yù)估高復(fù)發(fā)風(fēng)險(xiǎn)患者，曲妥珠單抗輔助治療后，考慮奈拉替尼（來那替尼）延長輔助治療。對于接受帕妥珠單抗或T-DM1輔助治療的患者，奈拉替尼（來那替尼）延長輔助治療的利弊（獲益或毒性）尚不明確。 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：標(biāo)題修改 不可手術(shù)或局部晚期乳腺癌（非炎性）術(shù)前系統(tǒng)（全身）治療：臨床分期和檢查 → 不可手術(shù)或局部晚期乳腺癌（非炎性）：術(shù)前系統(tǒng)（全身）治療前檢查 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：標(biāo)題修改 不可手術(shù)或局部晚期乳腺癌（非炎性）術(shù)前系統(tǒng)（全身）治療：局部區(qū)域治療和輔助治療 → 不可手術(shù)或局部晚期乳腺癌（非炎性）：術(shù)前系統(tǒng)（全身）治療 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：新增章節(jié)（原 BINV-17～BINV-28 相應(yīng)調(diào)整為 BINV-18～BINV-28） 
BINV-K1：將BINV-K1拆分為BINV-K1和BINV-K2 對于HER2陰性乳腺癌新輔助或輔助治療推薦方案，新增：對于紫杉類、烷化類、蒽環(huán)類術(shù)前化療后的三陰性乳腺癌和殘余病變，推薦卡培他濱。 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. 新增腳注8：每21天的第1～14天每天2次口服卡培他濱每平方米體表面積1000～1250毫克，共6～8個(gè)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：對于HER2陽性乳腺癌新輔助或輔助治療推薦方案，新增如下選擇
若無術(shù)前治療或術(shù)前治療后有殘余病變：完成至多一年的曲妥珠單抗（1類證據(jù)）±帕妥珠單抗（APHINITY）HER2靶向治療。 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. 若術(shù)前治療后有殘余病變：曲妥珠單抗-恩坦辛（T-DM1）單用14個(gè)周期（1類證據(jù)：KATHERINE）。若T-DM1由于毒性反應(yīng)停藥，則曲妥珠單抗（1類證據(jù)）±帕妥珠單抗完成一年HER2靶向治療。 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. 新增腳注11：對于激素受體陽性、HER2陽性病變、預(yù)估高復(fù)發(fā)風(fēng)險(xiǎn)患者，曲妥珠單抗輔助治療后，考慮奈拉替尼（來那替尼）延長輔助治療。對于接受帕妥珠單抗或T-DM1輔助治療的患者，奈拉替尼（來那替尼）延長輔助治療的利弊（獲益或毒性）尚不明確。 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. 新增腳注12：每21天T-DM1每公斤體重3.6毫克，共14個(gè)周期。參考文獻(xiàn)：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
|
