2023年1月27日,，時(shí)隔220天,，美國國家綜合癌癥網(wǎng)絡(luò)（NCCN）悄然將乳腺癌臨床實(shí)踐指南由2022年第4版更新至2023年第1版,，全文由232頁增加至255頁,，免費(fèi)注冊登錄后仍可免費(fèi)下載,。NCCN為非國立,、全國綜合癌癥中心聯(lián)盟組織,，1993年11月成立，1995年1月31日正式宣布成為全國聯(lián)盟，最初由13個(gè)美國知名綜合癌癥中心組成，目前已經(jīng)增至32個(gè)： NCCN乳腺癌臨床實(shí)踐指南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版架構(gòu)仍為臨床路徑＋循證解讀＋參考文獻(xiàn)，其依據(jù)主要來自權(quán)威學(xué)術(shù)期刊或?qū)W術(shù)會議最新發(fā)表的大樣本多中心隨機(jī)對照三期臨床研究結(jié)果。此次更新內(nèi)容較多，具體如下（中劃線為刪除,，下劃線為新增）- 主要治療，修改：乳房局部快速放療/乳房局部放療（APBI/PBI）
- Primary treatment, modified: Accelerated partial breast irradiation/partial breast radiation (APBI/PBI)
- 腳注j,，修改：乳腺導(dǎo)管原位癌（DCIS）低風(fēng)險(xiǎn)患者如果符合RTOG 9804試驗(yàn)關(guān)于DCIS低風(fēng)險(xiǎn)定義全部條件（包括篩查發(fā)現(xiàn)的DCIS,、核分級低或中、腫瘤大小≤2.5厘米,、手術(shù)切緣陰性且距離腫瘤的邊距>3mm）可以考慮接受APBI/PBI,。
- Footnote j, modified: Select patients with low-risk DCIS may be considered suitable for APBI/PBI if they meet all aspects of the definition of low-risk DCIS from the RTOG 9804 trial, including screen-detected DCIS, low to intermediate nuclear grade, tumor size ≤2.5 cm, and surgical resection with margins negative at >3 mm.
 - DCIS手術(shù)后治療，第1點(diǎn)第1小點(diǎn)修改：接受保乳手術(shù)和放療（1類）,，尤其對于雌激素受體（ER）陽性DCIS患者,。
- DCIS postsurgical treatment, 1st bullet, 1st sub-bullet modified: Treated with BCS and RT (category 1), especially for patients with ER-positive DCIS.
- 新增腳注n：對于接受芳香化酶抑制劑輔助治療的絕經(jīng)后（自然或誘發(fā)）患者，雙膦酸鹽（口服或靜脈注射）或地舒單抗可以維持或改善骨礦密度并降低骨折風(fēng)險(xiǎn),。兩種療法的最佳持續(xù)時(shí)間尚未確定,。持續(xù)時(shí)間超過3年的獲益或超過3年的最佳持續(xù)時(shí)間未知?？构琴|(zhì)疏松治療持續(xù)時(shí)間考慮因素包括骨礦密度,、治療效果、持續(xù)骨質(zhì)流失或骨折的風(fēng)險(xiǎn)因素,。停用地舒單抗后有自發(fā)骨折的病例報(bào)告,。對于接受雙膦酸鹽或地舒單抗治療的患者，開始治療前應(yīng)接受預(yù)防性牙科檢查,，并應(yīng)補(bǔ)充鈣和維生素D,。
- Footnote n added: The use of a bisphosphonate (PO/IV) or denosumab is acceptable to maintain or improve bone mineral density and reduce risk of fractures in postmenopausal (natural or induced) patients receiving adjuvant aromatase inhibitor therapy. Optimal duration of either therapy has not been established. Benefits from duration beyond 3 years or optimal duration beyond 3 years is not known. Factors to consider for duration of antiosteoporosis therapy include bone mineral density, response to therapy, and risk factors for continued bone loss or fracture. There are case reports of spontaneous fractures after denosumab discontinuation. Patients treated with a bisphosphonate or denosumab should undergo a dental examination with preventive dentistry prior to the initiation of therapy, and should take supplemental calcium and vitamin D.
 - cT1-3、cN0或cN+,、M0乳腺癌的局部區(qū)域治療,，修改：保乳手術(shù)＋腋窩手術(shù)分期（1類）± 腫瘤整形重建
- Locoregional treatment of cT1-3, cN0 or cN+, M0 Disease, modified: BCS with surgical axillary staging (category 1) ± oncoplastic reconstruction
- 修改：對于乳房中心或內(nèi)側(cè)腫瘤、病理T3期腫瘤,、病理T2期腫瘤且<10枚腋窩淋巴結(jié)切除并有以下高風(fēng)險(xiǎn)特征之一的患者：3級,、廣泛淋巴血管浸潤（LVI）或ER陰性，給予全乳放療（WBRT）± 瘤床加量o,，并考慮全身區(qū)域淋巴結(jié)放療（RNI）,。
- Modified: WBRT ± boosto to tumor bed, and consider comprehensive regional nodal irradiation (RNI) in patients with central/medial tumors, pT3 tumors, or pT2 tumors with <10 axillary nodes removed and one of the following high-risk features: grade 3, extensive lymphovascular invasion (LVI), or ER-negative.
- 修改：對于某些低風(fēng)險(xiǎn)患者，考慮行APBI/PBI（1類）
- Modified: Consideration of APBI/PBI in selected low-risk patients (category 1)
- 新增腳注m：局部組織重排,、局部皮瓣,、區(qū)域皮瓣、乳房縮小和乳房固定術(shù)等技術(shù)可以實(shí)現(xiàn)更大體積的切除,，同時(shí)優(yōu)化保乳手術(shù)患者的美觀結(jié)局,。
- Footnote m added: Includes techniques such as local tissue rearrangement, local flaps, regional flaps, breast reduction and mastopexy to allow for greater volumes of resection while optimizing aesthetic outcomes in patients undergoing BCS.
 - 腳注t，修改：對于伴有多個(gè)高風(fēng)險(xiǎn)復(fù)發(fā)因素的患者,，包括乳房中心或內(nèi)側(cè)腫瘤或腫瘤≥2厘米且<10枚腋窩淋巴結(jié)切除并至少符合以下一項(xiàng)：3級,、ER陰性或LVI，可以考慮乳房切除術(shù)后放療,。
- Footnote t modified: Postmastectomy RT may be considered for patients with multiple high-risk recurrence factors, including central/medial tumors or tumors ≥2 cm with <10 axillary nodes removed and at least one of the following: grade 3, ER-negative, or LVI.
- 病理淋巴結(jié)陽性（≥1個(gè)同側(cè)轉(zhuǎn)移灶>2毫米）,，修改：輔助化療＋曲妥珠單抗＋帕妥珠單抗（1類，首選）和內(nèi)分泌治療
- pN+ ((≥1 ipsilateral metastases >2 mm), modified: Adjuvant chemotherapy with trastuzumab + pertuzumab (category 1, preferred) and endocrine therapy.
- 新增腳注hh：HER2陽性早期乳腺癌輔助治療APHINITY試驗(yàn)結(jié)果更新,，中位隨訪8.4年,，證實(shí)帕妥珠單抗加入曲妥珠單抗＋化療預(yù)防浸潤病變復(fù)發(fā)獲益。
- Footnote hh added: Updated results from the adjuvant APHINITY trial in HER2-positive early breast cancer, with a median follow-up of 8.4 years, have confirmed the benefit of adding pertuzumab to trastuzumab plus chemotherapy in preventing invasive disease recurrences.
- 病理淋巴結(jié)陽性（≥1個(gè)同側(cè)轉(zhuǎn)移灶>2毫米）,，修改：輔助化療＋曲妥珠單抗＋帕妥珠單抗（1類）
- pN+ (≥1 ipsilateral metastases >2 mm), modified: Adjuvant chemotherapy with trastuzumab + pertuzumab (category 1)
- 新增腳注hh：HER2陽性早期乳腺癌輔助治療APHINITY試驗(yàn)結(jié)果更新,，中位隨訪8.4年，證實(shí)帕妥珠單抗加入曲妥珠單抗＋化療預(yù)防浸潤病變復(fù)發(fā)獲益,。
- Footnote hh added: Updated results from the adjuvant APHINITY trial in HER2-positive early breast cancer, with a median follow-up of 8.4 years, have confirmed the benefit of adding pertuzumab to trastuzumab plus chemotherapy in preventing invasive disease recurrences.
- 附加檢查,，考慮附加檢測,，第4點(diǎn)修改：FDG PET/CT（可選）（在某些情況下有用）
- Additional workup, additional tests to consider, 4th bullet modified: FDG PET/CT (optional)(useful in certain circumstances)
- 刪除腳注：如果已行FDG PET/CT且PET和CT部分均明確提示骨轉(zhuǎn)移，那么可能不必骨掃描或氟化鈉PET/CT,。
- Footnote removed: Bone scan or sodium fluoride PET/CT may not be needed if FDG PET/CT is performed and clearly indicates bone metastasis, on both the PET and CT component.
- 刪除腳注：FDG PET/CT可以與診斷性CT同時(shí)進(jìn)行,，在標(biāo)準(zhǔn)分期檢查結(jié)果不明或可疑的情況下可能有幫助。FDG PET/CT還可能有助于常規(guī)分期方法發(fā)現(xiàn)未被懷疑的區(qū)域淋巴結(jié)病變和/或遠(yuǎn)處轉(zhuǎn)移,。
- Footnote removed: FDG PET/CT may be performed at the same time as diagnostic CT, and may be helpful in situations where standard staging studies are equivocal or suspicious. FDG PET/CT may also be helpful in identifying unsuspected regional nodal disease and/or distant metastases when used in addition to standard staging studies.
- 新增腳注uu：FDG PET/CT對晚期病變（III期）和導(dǎo)管浸潤癌（與小葉相比）組織檢查最有用和準(zhǔn)確,，但是可能對早期病變（IIA期病變：T1N1、T2N0）特定情況有用,，例如：CT＋骨掃描結(jié)果模棱兩可,；懷疑未檢測到的淋巴結(jié)和/或遠(yuǎn)處病變；治療效果評定,。FDG PET/CT可以用于初始標(biāo)準(zhǔn)分期的輔助或替代,，并且可以與診斷性CT同時(shí)進(jìn)行。相反,，如果前期FDG PET/CT明確表明PET和CT部分的結(jié)果一致,，那么可能不必骨掃描或氟化鈉PET/CT。
- Footnote added: FDG PET/CT is most beneficial and accurate for advanced disease (stage III) and invasive ductal (compared to lobular) histology, but may be useful in selected circumstances of earlier stage disease (stage IIA disease: T1N1, T2N0) such as: equivocal CT+ bone scan results; suspicion of undetected nodal and/or distant disease; and treatment response assessment. An FDG PET/CT may be utilized as an adjunct to, or in lieu of, initial standard staging and may be performed simultaneously with diagnostic CT. Conversely, a bone scan or sodium fluoride PET/CT may not be needed if an upfront FDG PET/CT clearly indicates consistent findings on both PET and CT components.
- 保乳手術(shù)可行,，修改：保乳手術(shù)＋腋窩手術(shù)分期 ± 腫瘤整形重建
- BCS possible, modified: BCS with surgical axillary staging ± oncoplastic reconstruction
- 新增腳注m：局部組織重排,、局部皮瓣、區(qū)域皮瓣,、乳房縮小和乳房固定術(shù)等技術(shù)可以實(shí)現(xiàn)更大體積的切除,，同時(shí)優(yōu)化保乳手術(shù)患者的美觀結(jié)局。
- Footnote m added: Includes techniques such as local tissue rearrangement, local flaps, regional flaps, breast reduction and mastopexy to allow for greater volumes of resection while optimizing aesthetic outcomes in patients undergoing BCS.
- 腳注vv修改：準(zhǔn)確評定乳腺腫瘤內(nèi)或區(qū)域淋巴結(jié)術(shù)前全身治療效果很難,，應(yīng)該包括初始腫瘤分期時(shí)體格檢查和影像學(xué)檢查（乳腺X線攝片和/或乳腺超聲和/或乳腺磁共振成像）異常表現(xiàn),。術(shù)前影像學(xué)檢查方法的選擇應(yīng)由多學(xué)科團(tuán)隊(duì)決定。對于評定腫瘤輔助治療效果,，磁共振成像比乳腺X線攝片更準(zhǔn)確,。
- Footnote vv modified: 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 ultrasound 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. MRI is more accurate than mammography for assessing tumor response to adjuvant therapy.
- 局部區(qū)域治療，修改：考慮附加全身化學(xué)治療和/或術(shù)前放療
- Locoregional treatment, modified: Consider additional systemic chemotherapy and/or preoperative radiation
- 腳注vv修改：準(zhǔn)確評定乳腺腫瘤內(nèi)或區(qū)域淋巴結(jié)術(shù)前全身治療效果很難,，應(yīng)該包括初始腫瘤分期時(shí)體格檢查和影像學(xué)檢查（乳腺X線攝片和/或乳腺超聲和/或乳腺磁共振成像）異常表現(xiàn),。術(shù)前影像學(xué)檢查方法的選擇應(yīng)由多學(xué)科團(tuán)隊(duì)決定。對于評定腫瘤輔助治療效果,，磁共振成像比乳腺X線攝片更準(zhǔn)確,。
- Footnote vv modified: 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 ultrasound 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. MRI is more accurate than mammography for assessing tumor response to adjuvant therapy.
- 腳注xx修改：完成已計(jì)劃的化療全身治療方案療程，如果術(shù)前未完成,。
- Footnote xx modified: Complete planned chemotherapy systemic therapy regimen course, if not completed preoperatively.
- HR陰性且HER2陽性,，ypT1-4、N0或ypN≥1,，修改：如果由于毒性停用恩美曲妥珠單抗,，那么曲妥珠單抗（1類）± 帕妥珠單抗完成1年治療用曲妥珠單抗 ± 帕妥珠單抗完成（最多）1年HER2靶向治療,。如果初始分期時(shí)淋巴結(jié)陽性，曲妥珠單抗＋帕妥珠單抗（1類）
- HR-negative/HER2-positive, ypT1-4,N0 or ypN≥1, modified: If ado-trastuzumab emtansine discontinued for toxicity, then trastuzumab (category 1) ± pertuzumab to complete 1 year of therapy complete (up to) 1 year of HER2-directed therapy with trastuzumab +/- pertuzumab. If node positive at initial staging, trastuzumab + pertuzumab (category 1)
- HR陽性且HER2陽性,，ypT0N0或病理完全緩解,，修改：內(nèi)分泌治療bb,cc（1 類）＋曲妥珠單抗 ± 帕妥珠單抗完成最多1年HER2靶向治療用曲妥珠單抗 ± 帕妥珠單抗完成（最多）1年HER2靶向治療。如果初始分期時(shí)淋巴結(jié)陽性,，曲妥珠單抗＋帕妥珠單抗（1類）
- HR-positive/HER2-positive, ypT0N0 or pCR, modified: Endocrine therapybb,cc (category 1) + complete up to one year of HER2-targeted therapy with trastuzumab (category 1) ± pertuzumab complete (up to) 1 year of HER2-directed therapy with trastuzumab +/- pertuzumab. If node positive at initial staging, trastuzumab + pertuzumab (category 1)
- 腳注ccc修改：沒有關(guān)于序貫治療或指導(dǎo)選擇輔助治療的數(shù)據(jù)。對于符合卡培他濱,、帕博利珠單抗和/或奧拉帕利單藥或多藥治療標(biāo)準(zhǔn)的患者,，沒有關(guān)于這些藥物序貫或聯(lián)合輔助治療的數(shù)據(jù)。不過,，對于某些復(fù)發(fā)風(fēng)險(xiǎn)較高的患者,，可以考慮序貫或聯(lián)合用藥。
- Footnote ccc modified: There are no data on sequencing or to guide selection of an adjuvant therapy. There are no data on sequencing or combining adjuvant capecitabine, pembrolizumab and/or olaparib in patients who meet criteria for treatment with one or more of these agents. However, their sequential/combined use may be considered in certain patients with high-risk of recurrence.
- 影像學(xué)檢查,，新增第3點(diǎn)：對于有種系突變或乳腺癌家族史的患者,，參見NCCN遺傳性/家族性高風(fēng)險(xiǎn)評定指南：乳腺癌、卵巢癌和胰腺癌
- Imaging, 3rd bullet added: For patients with germline mutations or family history of breast cancer, please refer to See NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic
- Added: Post treatment monitoring
- 新增第1點(diǎn)：對于接受左側(cè)放療,、蒽環(huán)類或HER2靶向治療的患者,，監(jiān)測心臟毒性。參見NCCN生存指南
- 1st bullet added: Cardiotoxicity monitoring for patients who received left-sided radiation therapy, anthracyclines, or HER2-targeted therapy. See NCCN Guidelines for Survivorship
- 新增第2點(diǎn)：提供合并癥風(fēng)險(xiǎn)指導(dǎo)
- 2nd bullet added: Provide guidance on risk of comorbidities
- 腳注eee修改：持續(xù)時(shí)間超過3年的獲益或超過3年的最佳持續(xù)時(shí)間尚不明確…
- Footnote eee modified: Benefits of duration beyond 3 years or optimal duration beyond 3 years is not known...
- 檢查,，第5點(diǎn),，新增第6小點(diǎn)：在某些情況下有用
- Workup, 5th bullet, 6th sub-bullet added: Useful in certain circumstances
- 第6小點(diǎn)新增：FDG PET/CT（對于ER陽性病變，考慮氟雌二醇PET）
- Sub-bullet added: FDG PET/CT (consider FES/PET for ER-positive disease)
- 新增腳注iii：可以采用組織或血漿測定,。組織測定的靈敏度較高,，但是循環(huán)腫瘤DNA（ctDNA）可能較準(zhǔn)確地反映腫瘤異質(zhì)性。
- Footnote iii added: Tissue or plasma-based assays may be used. Tissue-based assays have greater sensitivity, but circulating tumor DNA (ctDNA) may reflect tumor heterogeneity more accurately.
- 新增腳注mmm：對于拒絕乳房切除術(shù)以及符合免除放療或乳房局部放療（APBI/PBI）共識標(biāo)準(zhǔn)的某些患者,，可以考慮再次保乳手術(shù) ± 輔助APBI/PBI,。此類患者再次BCS的數(shù)據(jù)有限。
- Footnote mmm added: In selected patients who decline mastectomy and otherwise meet consensus criteria for radiotherapy omission or partial breast irradiation (APBI/PBI), repeat BCS +/- adjuvant APBI/PBI may be considered. There are limited data for a repeat BCS in this setting.
- 腳注rrr修改：如果存在骨轉(zhuǎn)移,、預(yù)計(jì)生存≥3個(gè)月且腎功能正常,，化療全身治療或內(nèi)分泌治療應(yīng)該加用地舒單抗、唑來膦酸或帕米膦酸二鈉（同時(shí)補(bǔ)充鈣和維生素D）（1 類）,。
- Footnote rrr modified: Denosumab, zoledronic acid, or pamidronate (all with calcium and vitamin D supplementation) should be given (category 1) in addition to chemotherapy systemic therapy or endocrine therapy if bone metastasis is present, expected survival is ≥3 months, and renal function is adequate.
- 新增腳注ttt：根據(jù)第5版ESO-ESMO國際共識指南,，晚期乳腺癌內(nèi)臟危象定義為：“根據(jù)體征和癥狀、實(shí)驗(yàn)室檢查和疾病快速進(jìn)展評定的嚴(yán)重器官功能障礙,。內(nèi)臟危象不僅僅是內(nèi)臟轉(zhuǎn)移的存在,，還意味著重要器官受損，導(dǎo)致的臨床適應(yīng)證需要最快速有效治療,?！?/span>
- Footnote ttt added: According to the 5th ESO-ESMO international consensus guidelines for advanced breast cancer visceral crisis is defined as: “severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important organ compromise leading to a clinical indication for the most rapidly efficacious therapy.”
- 新增腳注yyy：疾病穩(wěn)定或觀察到療效后轉(zhuǎn)為內(nèi)分泌治療是可以接受的（參見BINV-P）
- Footnote yyy added: It is acceptable to switch to endocrine-based therapy after disease stabilizes or response is observed. (See BINV-P).
- 腳注zzz修改：對于體力狀態(tài)低下的患者,，額外化療全身治療的潛在副作用可能超過任何臨床獲益。必須考慮患者意愿,。
- Footnote zzz modified: The potential side effects of additional chemotherapy systemic therapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account.
- 腳注zzz修改：對于體力狀態(tài)低下的患者,，額外化療全身治療的潛在副作用可能超過任何臨床獲益。必須考慮患者意愿,。
- Footnote zzz modified: The potential side effects of additional chemotherapy systemic therapy may outweigh any clinical benefit in a patient who has a compromised performance status. Patient preference must be taken into account.
- 新增腳注d：HER2免疫組化0和1+的區(qū)別目前對于晚期乳腺癌具有臨床意義,，因?yàn)镠ER2免疫組化1+或2+且原位雜交陰性結(jié)果（原發(fā)或轉(zhuǎn)移標(biāo)本）晚期乳腺癌患者可能有指征針對HER2低表達(dá)進(jìn)行治療。
- Footnote d added: The distinction between HER2 IHC 0 and 1+ is currently clinically relevant in in the metastatic setting since metastatic patients with HER2 1+ or 2+/ISH negative results (on primary or metastatic samples) may be eligible for for treatment targeting non-amplified levels of HER2 expression.
- 臨床適應(yīng)證和應(yīng)用,，第5點(diǎn)修改并新增第1,、2小點(diǎn)：磁共振成像對于既往乳腺癌患者隨訪篩查的作用尚不明確。通常應(yīng)該考慮用于以下情況：1）乳腺致密患者保乳手術(shù)＋放療,，2）50歲之前確診患者
- Clinical indications and applications, 5th bullet modified and subsequent bullets added: The utility of MRI in follow-up screening of patients with prior breast cancer is undefined. It should generally be considered for: 1) Patients with dense breasts in the BCS + RT 2) Those diagnosed before the age of 50
- 新增參考文獻(xiàn)：Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: Recommendations from the ACR. J Am Coll Radiol. 2018;15:408-414.
- References have been updated.
- 第2點(diǎn)修改：這些切緣推薦意見不可直接用于進(jìn)行APBI/PBI的患者,，關(guān)于此類患者局部復(fù)發(fā)的數(shù)據(jù)較少。
- 2nd bullet modified: These margin recommendations cannot be applied directly to patients undergoing APBI/PBI, where data regarding local recurrence are more limited...
- 修改第1小點(diǎn)：以往,，為了治療癌癥,，進(jìn)行保留皮膚的乳房切除術(shù)時(shí)會犧牲NAC。不過,，對于有經(jīng)驗(yàn)多學(xué)科團(tuán)隊(duì)嚴(yán)格篩選的癌癥患者,，可以選擇保留NAC的術(shù)式。
- 1st sub-bullet modified: Historically, the NAC has been sacrificed with skin-sparing mastectomy for cancer therapy. However, NAC-sparing procedures may be an option in cancer patients who are carefully selected by experienced multidisciplinary teams.
- 新增第1小點(diǎn)：隨機(jī)對照試驗(yàn)證實(shí),，預(yù)防性外用2%硝酸甘油（總劑量45毫克）可減少保留皮膚或乳頭的乳房切除術(shù)皮瓣壞死,。
- 3rd sub-bullet added: Topical 2% nitroglycerine (45 mg total dose) used prophylactically has been shown to reduce mastectomy skin flap necrosis in both skinsparing mastectomy and nipple sparing mastectomy in one randomized control trial.
- 優(yōu)化個(gè)體化治療的實(shí)施，第1點(diǎn)修改：
- Optimizing delivery of individual therapy, 1st bullet:
- 第1小點(diǎn)修改：應(yīng)該常規(guī)根據(jù)三維CT制定治療計(jì)劃勾畫靶區(qū)和鄰近有風(fēng)險(xiǎn)器官,。應(yīng)該常規(guī)根據(jù)三維CT制定治療計(jì)劃,，勾畫靶區(qū)和有風(fēng)險(xiǎn)器官，并評定整個(gè)治療區(qū)的劑量分布,。
- 1st sub-bullet modified: 3-D CT-based treatment planning should be routinely utilized to delineate target volumes and adjacent organs at risk. CT-based treatment planning should routinely be utilized to delineate target volumes & organs at risk, and assess dose distribution across the entire treatment volume.
- 第3小點(diǎn)修改：采用楔形填充材料,、分段正向規(guī)劃和調(diào)強(qiáng)放療（IMRT）可以實(shí)現(xiàn)較好的靶區(qū)劑量均勻性并保護(hù)正常組織。應(yīng)該優(yōu)化治療計(jì)劃,，最大程度提高整個(gè)靶區(qū)的均勻性,，同時(shí)最大程度減少有風(fēng)險(xiǎn)器官的劑量。
- 3rd sub-bullet modified: Improved homogeneity of the target dose and sparing of normal tissues can be accomplished using compensators such as wedges, forward planning using segments, and intensity-modulated RT (IMRT). Treatment planning should be optimized to maximally improve homogeneity across the target volume while minimizing dose to organs at risk
- 第5小點(diǎn)修改：每周進(jìn)行影像學(xué)檢查驗(yàn)證治療擺位一致性,。當(dāng)采用某些技術(shù)（即俯臥位乳房）時(shí),，更頻繁的影像學(xué)檢查可能是合適的。不推薦標(biāo)準(zhǔn)化采用每天影像學(xué)檢查,。至少應(yīng)該每周進(jìn)行影像學(xué)檢查驗(yàn)證治療擺位,。對于可重復(fù)性不一致的某些病例，可能需要更頻繁的影像學(xué)檢查。影像引導(dǎo)放療（IGRT）可與深吸氣屏氣（DIBH）技術(shù)一起應(yīng)用,，以減少心,、肺或肝的正常組織暴露。
- 5th sub-bullet modified: Verification of treatment setup consistency is done with weekly imaging. When using certain techniques (ie, prone breast), more frequent imaging may be appropriate. Standard utilization of daily imaging is not recommended. At a minimum, weekly imaging to verify treatment setup should be utilized. More frequent imaging may be needed for selected cases with inconsistent reproducibility. IGRT may be utilized with DIBH to reduce normal tissue exposure of the heart, lung or liver.
- 第6小點(diǎn)修改：內(nèi)乳淋巴結(jié)放療時(shí),，應(yīng)該采用劑量體積直方圖（DVH）評估劑量限制,、正常組織（即心、肺）劑量和限制以及計(jì)劃靶區(qū)（PTV）,。
- 6th sub-bullet modified: When treating the internal mammary nodes, Dose-volume histograms (DVHs) should be used to evaluate dose constraints, dose and constraints to normal tissues (ie, heart, lung), and planning target volumes (PTVs).
- 第3點(diǎn)第1小點(diǎn)修改：對于年齡>50歲保乳手術(shù)后pTis,、T1、T2,、N0的患者,，可以考慮采用28.5戈瑞分割為5次（每周一次）超大分割全乳放療，雖然該方案的加強(qiáng)放療最佳分割尚不明確,。對于50歲以上淋巴結(jié)陰性早期乳腺癌保乳手術(shù)后患者，尤其不打算加強(qiáng)放療者,，可以考慮28.5戈瑞分割為5次（每周一次）超大分割全乳放療,。
- 3rd bullet, 1st sub-bullet modified: Ultra-hypofractionated WBRT of 28.5 Gy delivered as 5 (once-a-week) fractions may be considered in select patients aged >50 years following BCS with pTis/T1/T2/N0, though the optimal fractionation for the boost delivery is unknown for this regimen. Ultra-hypofractionated WBRT of 28.5 Gy in 5 (once-a-week) fractions may be considered for selected pts over 50 yrs following BCS with early-stage, node-negative disease, particularly those in whom a boost is not intended.
- 第4小點(diǎn)修改：采用該方案時(shí)必須進(jìn)行三維計(jì)劃以盡量減少不均勻性和心肺暴露。三維治療計(jì)劃應(yīng)該根據(jù)上述進(jìn)行優(yōu)化,。
- 4th bullet modified: 3-D planning to minimize inhomogeneity and exposure to heart and lung is essential when using this regimen. 3D treatment planning should be optimized as described in the section above.
- Chest wall radiation (including breast reconstruction), RT dosing:
- 新增第1點(diǎn)：胸壁放療劑量為45～50.4戈瑞,，每次1.8～2戈瑞，分割為25～28次,；對于未行乳房重建的患者可以選擇40戈瑞（2.67戈瑞×15次）或42.5戈瑞（2.66戈瑞×16次）,。加強(qiáng)放療：10～16戈瑞，每次1.8～2.0戈瑞,，共5～8次,。
- 1st bullet and subsequent bullets added: Chest wall RT dose is 45-50.4 Gy at 1.8-2 Gy/fx; in 25-28 fractions patients not undergoing breast reconstruction may alternatively receive 40 Gy at 2.67 Gy/fx or 42.5 Gy at 2.66 Gy/fx. 45-50.4 Gy at 1.8-2.0 Gy/fx total 25-28 fractions. 40 Gy at 2.67 Gy/fx or 42.5 Gy at 266 Gy/fx total 15-16 fractions. Boost: 10-16 Gy at 1.8 to 2.0 Gy/fx total 5-8 fractions.
- 新增第2點(diǎn)：胸壁瘢痕加強(qiáng)放療每次10～16戈瑞，可以采用電子或光子±組織填充材料,。
- 2nd bullet added: Chest wall scar boost of 10-16 Gy/fx may be delivered with or without bolus using electrons or photons. Chest wall scar boost may be delivered with or without bolus using electrons or photons.
- 刪除：劑量為胸壁45～50.4戈瑞分25～28次±瘢痕加強(qiáng)放療每次1.8～2戈瑞,，至總劑量大約60～66戈瑞?？梢圆捎秒娮踊蚬庾印澜M織填充材料進(jìn)行胸壁瘢痕加強(qiáng)放療,。
- Sub-bullet removed: Dose is 45-50.4 Gy in 25-28 fractions to the chest wall ± scar boost, at 1.8-2 Gy per fraction, to a total dose of approximately 60-66 Gy.
- Regional Nodal Radiation, RT dosing:
- 刪除：區(qū)域淋巴結(jié)照射野劑量為45～50.4戈瑞分割為25～28次。
- Bullet removed: Dose is 45-50.4 Gy in 25-28 fractions to the regional nodal fields.
- 新增第1點(diǎn)：區(qū)域淋巴結(jié)劑量為45～50.4戈瑞,，每次1.8～2格戈瑞,；對于未行乳房重建的患者可以選擇40戈瑞（2.67戈瑞×15次）或42.5戈瑞（2.66戈瑞×16次）
- 1st bullet added: Regional node dose is 45-50.4 Gy at 1.8-2 Gy/fx; patients not undergoing breast reconstruction may alternatively receive 40 Gy at 2.67 Gy/fx or 42.5 Gy at 2.66 Gy/fx
- 新增第2點(diǎn)：可以對未經(jīng)手術(shù)處理的嚴(yán)重受累或腫大淋巴結(jié)（即內(nèi)乳或鎖骨上）補(bǔ)充加強(qiáng)放療。
- 2nd bullet added: A supplemental boost of RT can be delivered to grossly involved or enlarged lymph nodes (i.e. internal mammary or supraclavicular) that have not been surgically addressed.
- RT with preoperative or adjuvant systemic therapy
- Sequencing of RT with systemic therapy:
- 第1點(diǎn)第2小點(diǎn)修改：卡培他濱應(yīng)該通常在放療完成后給予,。
- 1st bullet, 2nd sub-bullet modified: Capecitabine should be is typically given after completion of RT.
- 第2點(diǎn)修改：現(xiàn)有數(shù)據(jù)表明,，內(nèi)分泌治療序貫或同步放療都可接受。由于聯(lián)合治療的副作用，可能首選放療完成時(shí)開始內(nèi)分泌治療,。內(nèi)分泌治療可以與放療同時(shí)進(jìn)行或在放療完成后開始,。新數(shù)據(jù)表明，CDK4/6抑制劑可能增強(qiáng)放療對腫瘤組織和正常組織的毒性,。
- 2nd bullet modified: Available data suggest that sequential or concurrent endocrine therapy with RT is acceptable. Due to compounding side effects, initiating endocrine therapy at the completion of RT may be preferred. Endocrine therapy may be delivered concurrently with RT or started after the completion of RT. Emerging data on toxicities of RT when given currently with CDK 4/6 inhibitors.
- 乳房局部快速放療（APBI）/乳房局部放療（PBI）
- Accelerated Partial Breast Irradiation (APBI) modified: Accelerated Partial Breast Irradiation/Partial Breast Irradiation (APBI/PBI)
- 刪除：APBI研究表明,，對于某些早期乳腺癌低風(fēng)險(xiǎn)患者，APBI與標(biāo)準(zhǔn)全乳放療相比,，局部控制率相似,。但是，若干研究表明,，采用外照射的APBI與標(biāo)準(zhǔn)全乳放療相比,，美觀結(jié)局較差。隨訪有限,，研究仍在進(jìn)行,。
- Bullet removed: Studies of APBI suggest that rates of local control in selected low-risk patients with early-stage breast cancer are comparable to those treated with standard WBRT. However, compared to standard WBRT, several studies document an inferior cosmetic outcome with external beam delivery methods of APBI. Follow-up is limited and studies are ongoing.
- 新增：對于某些早期乳腺癌低風(fēng)險(xiǎn)患者，ABPI/PBI與全乳放療相比,，局部控制相似,。不過，減少長期美觀副作用的最佳外照射APBI/PBI技術(shù)及其分割方案尚未確定,。
- Bullet added: ABPI/PBI offers comparable local control to WBRT in selected low-risk patients with early-stage breast cancer. However, the optimal external beam-APBI/PBI technique/fractionation for minimizing long-term cosmesis effects has not been determined.
- 新增腳注g：安全數(shù)據(jù)支持化療前或化療時(shí)給予促性腺激素釋放激素（GnRH）激動劑,，尤其如果為了加強(qiáng)生育能力保護(hù)作用。對于仍未絕經(jīng)患者,，也可以在化療后開始,。
- Footnote g added: Safety data support administration of GnRH agonists before or with chemotherapy, especially if there is a goal to enhance fertility preservation. They can also be initiated after chemotherapy in patients who remain premenopausal.
- 修改腳注i：對卵巢抑制治療權(quán)衡利弊進(jìn)行討論至關(guān)重要，包括提前絕經(jīng)的潛在副作用,。根據(jù)SOFT和TEXT臨床試驗(yàn)的結(jié)果,，對于復(fù)發(fā)風(fēng)險(xiǎn)較高（例如發(fā)病年齡較輕、腫瘤分級較高,、淋巴結(jié)受累）絕經(jīng)前患者,，應(yīng)該考慮芳香化酶抑制劑或他莫昔芬5年＋卵巢抑制。應(yīng)該慎與CYP2D6強(qiáng)抑制劑合用,。
- Footnote i modified: A balanced discussion of the risks and benefits associated with ovarian suppression therapy is critical, including the potential side effects of premature menopause. Aromatase inhibitor or tamoxifen for 5 y plus ovarian suppression should be considered, based on SOFT and TEXT clinical trial outcomes, for premenopausal patients at higher risk of recurrence (ie, young age, high-grade tumor, lymph node involvement). Coadministration of strong inhibitors of CYP2D6 should be used with caution.
- 術(shù)前/輔助治療方案,，HER2陰性首選方案：
- Preoperative/adjuvant therapy regimens, HER2-Negative: Preferred regimens:
- 第1方案修改：劑量密集AC（多柔比星＋環(huán)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：劑量密集AC（多柔比星＋環(huán)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
- 腳注g修改：不推薦鉑類藥物用于輔助治療。如果鉑類藥物加入蒽環(huán)類方案,，那么化療最佳順序和紫杉類藥物選擇尚未確定,。卡鉑可以作為帕博利珠單抗方案的一部分。
- 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.
- 術(shù)前/輔助治療方案,，HER2陰性首選方案：術(shù)前帕博利珠單抗＋化療→術(shù)后帕博利珠單抗
- Preoperative/adjuvant therapy regimens, HER2- Preferred Regimens: Preoperative pembrolizumab + chemotherapy followed by adjuvant pembrolizumab
- 術(shù)前,，修改：第1天靜脈注射卡鉑AUC5或第1,、8、15天靜脈注射卡鉑AUC1.5
- Preoperative - Modified: Carboplatin AUC 5 IV Day 1 Or Carboplatin AUC 1.5 IV Days 1, 8, 15
- 刪除腳注：還有膠囊制劑可選,。不過,，由于劑量和生物利用度存在差異，不可以按相同毫克用膠囊代替片劑,。
- 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.
- 術(shù)前/輔助治療方案,，HER2陰性方案：在某些情況下有用，CMF化療方案：
- Preoperative/adjuvant therapy regimens, HER2- Negative Regimens: Useful in certain circumstances, CMF chemotherapy:
- 第1點(diǎn)修改：第1～天口服環(huán)磷酰胺100mg/m2（靜脈注射可接受）
- 1st bullet modified: Cyclophosphamide 100 mg/m2 PO days 1-14 (IV acceptable)
- 新增：或8個(gè)周期每21天第1天靜脈注射環(huán)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
- 術(shù)前/輔助治療方案,，HER2陽性,，在某些情況下有用：紫杉醇＋曲妥珠單抗＋帕妥珠單抗
- Preoperative/adjuvant therapy regimens, HER2-Positive, Useful in certain circumstances: Paclitaxel + trastuzumab + pertuzumab
- 新增：隨后每21天第1天靜脈注射曲妥珠單抗6mg/kg＋帕妥珠單抗420mg，完成1年治療
- 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).
- 標(biāo)題修改：根據(jù)基因表達(dá)分析考慮延長術(shù)后全身治療
- Title of page modified: Gene expression assays for consideration of extended adjuvant systemic therapy.
- 復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）ER和/或PR陽性乳腺癌全身治療：該頁已被大幅修改,。
- 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:
- 芳香化酶抑制劑＋CDK4/6抑制劑b：瑞波西利（1類）c、阿貝西利,、哌柏西利
- Aromatase inhibitor + CDK4/6 inhibitorb: Aromatase inhibitor + ribociclib (category 1)c, Aromatase inhibitor + abemaciclib, Aromatase inhibitor + palbociclib
- 氟維司群d＋CDK4/6抑制劑b：瑞波西利（1類）e,、阿貝西利（1類）e、哌柏西利
- Fulvestrantd + CDK4/6 inhibitorb: Fulvestrant + ribociclib (category 1)e, Fulvestrant + abemaciclib (category 1)e, Fulvestrant + palbociclib
- 由一線治療首選方案移至其他推薦方案：選擇性ER下調(diào)劑（氟維司群,，1 類）＋非甾體芳香化酶抑制劑（阿那曲唑、來曲唑）（1類）
- Other Recommended Regimens: Selective ER down-regulator (fulvestrant, category 1) + non-steroidal aromatase inhibitor (anastrozole, letrozole) (category 1)
- 在某些情況下有用,，后線治療,，新增：其他靶向治療選擇，參見BINV-Q（6 of 14）
- Useful in Certain Circumstances, Subsequent-Line Therapy: Addtional targeted therapy options, see BINV-Q (6 of 14)
- 新增腳注b：對于CDK4/6抑制劑的選擇存在爭議,，因?yàn)檫@些藥物缺乏頭對頭比較,，并且3期隨機(jī)研究人群存在一些差異
- 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.
- 新增腳注d：考慮用于術(shù)后內(nèi)分泌治療期間疾病進(jìn)展或術(shù)后內(nèi)分泌治療完成后12個(gè)月內(nèi)早期疾病復(fù)發(fā)
- d Consider for disease progression on adjuvant ET or with early disease relapse within 12 months of adjuvant ET completion
- 新增腳注e：根據(jù)3期隨機(jī)對照試驗(yàn)，氟維司群＋瑞波西利或阿貝西利一線治療患者總生存可獲益
- e In phase 3 randomized controlled trials, fulvestrant + ribociclib or abemaciclib has shown OS benefit in the first-line setting
- 修改腳注g：如果CDK4/6抑制劑治療期間疾病進(jìn)展,，有限的數(shù)據(jù)支持改用其他CKD4/6抑制劑,。如果哌柏西利治療期間疾病進(jìn)展，有限的2期研究數(shù)據(jù)支持改用瑞波西利二線治療,。
- 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
- 復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）乳腺癌全身治療方案：該章節(jié)與BINV-R合并,，已被大幅修改，由8頁增加至14頁,。
- Systemic therapy regimens for Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: This section has been extensively revised.
- 標(biāo)題修改：復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）乳腺癌全身治療方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- 標(biāo)題修改：復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）乳腺癌全身治療方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- 標(biāo)題修改：復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）乳腺癌全身治療方案用法用量
- Title of page modified: Dosing: Systemic Therapy Regimens for recurrent unresectable (local or regional) or Stage IV (M1) Disease
- HER2陽性方案（續(xù)）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,，卡培他濱第1～14天每天2次口服750mg/m2,、第15～21天停用；隨后奈拉替尼每天口服240mg，卡培他濱每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
- 復(fù)發(fā)無法切除（局部或區(qū)域）或IV期（M1）乳腺癌其他靶向治療用法用量：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.
- 腳注d修改：妊娠期間紫杉類用藥數(shù)據(jù)有限,。最佳療程尚不明確,。如果用藥，NCCN專家組推薦如果疾病狀態(tài)有臨床指征,，那么妊娠早期后每周給予紫杉醇,。妊娠期間禁用抗HER2治療。
- 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.
- 刪除檢查：術(shù)前全身治療,，蒽環(huán)類＋紫杉類（首選）,。如果腫瘤HER2陽性，那么HER2靶向治療,。新增：參見術(shù)前/輔助治療方案（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)
- 刪除腳注：參見術(shù)前/輔助治療方案（BINV-L）
- Footnote removed: See Preoperative/Adjuvant Therapy Regimens (BINV-L)
- A new section has been added: Abbreviations
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