對于早期乳腺癌，術(shù)后全身治療（化療、內(nèi)分泌治療和靶向治療）又稱輔助治療，可減少術(shù)后復(fù)發(fā)轉(zhuǎn)移風(fēng)險，目前已經(jīng)成為治療常規(guī)；術(shù)前全身治療又稱新輔助治療，可提高手術(shù)的可行性和成功率，目前仍然存在五大臨床問題：哪些乳腺癌患者適合進行新輔助全身治療？新輔助化療患者應(yīng)如何衡量療效？對于三陰性乳腺癌患者推薦什么新輔助全身治療方案？對于HER2陰性激素受體陽性乳腺癌患者推薦什么新輔助治療？對于HER2陽性乳腺癌患者推薦什么新輔助治療方法？

　　2021年1月28日，美國臨床腫瘤學(xué)會《臨床腫瘤學(xué)雜志》在線發(fā)表美國國家癌癥研究所、美國臨床腫瘤學(xué)會、北卡羅來納大學(xué)萊恩伯格綜合癌癥中心、西雅圖抗癌聯(lián)盟、弗吉尼亞癌癥中心、杜克大學(xué)、西北大學(xué)、紐約紀(jì)念醫(yī)院斯隆凱特林癌癥中心、邁阿密大學(xué)米勒醫(yī)學(xué)院西爾維斯特綜合癌癥中心、哈佛大學(xué)達納法伯癌癥研究所、羅文大學(xué)庫珀醫(yī)學(xué)院MD安德森癌癥中心、德克薩斯大學(xué)MD安德森癌癥中心、哥倫比亞大學(xué)赫伯特歐文綜合癌癥中心、德國乳腺癌協(xié)作組聯(lián)合起草的美國臨床腫瘤學(xué)會指南：乳腺癌新輔助化療、內(nèi)分泌治療和靶向治療，對五大臨床問題提供了推薦意見，全文共計23頁。

　　美國臨床腫瘤學(xué)會指南專家組首先對2000年1月1日～2020年8月31日發(fā)表的乳腺癌新輔助治療文獻進行系統(tǒng)檢索評審，并提供治療方案推薦意見。結(jié)果，共計41篇論文符合入選標(biāo)準(zhǔn)，并為指南推薦意見提供了證據(jù)基礎(chǔ)。指南草案于2020年8月28日～2020年9月8日公開征求意見，并于2020年12月4日正式提交。該指南主要推薦意見如下：

• 進行新輔助治療的患者應(yīng)由多學(xué)科醫(yī)療團隊管理。

• 新輔助治療合適候選者包括炎性乳腺癌患者、不可切除或局部晚期病灶可能轉(zhuǎn)為可切除者、高風(fēng)險HER2陽性或三陰性乳腺癌殘留病灶可能指導(dǎo)治療改變者。

• 新輔助治療也可用于減少局部治療（保乳手術(shù)、腋窩淋巴結(jié)清掃）范圍或縮短手術(shù)延遲時間（例如術(shù)前需要基因檢測指導(dǎo)治療決策或考慮乳房重建方案）。

• 雖然應(yīng)常規(guī)采用腫瘤組織學(xué)、分級、分期、雌孕激素受體和HER2表達指導(dǎo)臨床決策，但是尚無充分證據(jù)支持采用其他免疫化學(xué)或形態(tài)學(xué)標(biāo)志物（例如腫瘤浸潤淋巴細胞）或基因組檢測。

• 臨床淋巴結(jié)陽性和（或）腫瘤大于1厘米（≥T1c）三陰性乳腺癌患者應(yīng)予蒽環(huán)類和紫杉類化療方案；臨床腫瘤大小0.1～0.5厘米或0.5～1厘米且淋巴結(jié)陰性（cT1a或cT1bN0）三陰性乳腺癌患者不應(yīng)常規(guī)進行新輔助治療。

• 三陰性乳腺癌患者可予卡鉑，以提高病理完全緩解。

• 當(dāng)前將免疫檢查點抑制劑加入標(biāo)準(zhǔn)化療的證據(jù)不足。

• 對于激素受體陽性HER2陰性乳腺癌患者，若無需手術(shù)病理數(shù)據(jù)和（或）腫瘤基因組檢測即可決定化療方案，則新輔助化療可用于取代輔助化療。

• 對于激素受體陽性HER2陰性絕經(jīng)后患者，新輔助內(nèi)分泌治療＋芳香酶抑制劑可用于降低分期，以增加局部區(qū)域治療選擇；如無手術(shù)意向，內(nèi)分泌治療可用于控制病灶。

• 對于淋巴結(jié)陽性或高風(fēng)險淋巴結(jié)陰性、HER2陽性乳腺癌患者，應(yīng)予新輔助化療并聯(lián)合HER2靶向治療。

• 腫瘤大小0.1～1厘米且淋巴結(jié)陰性（T1aN0和T1bN0）HER2陽性乳腺癌患者不應(yīng)常規(guī)進行新輔助治療。

J Clin Oncol. 2021 Jan 28. Online ahead of print.

Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline.

Korde LA, Somerfield MR, Carey LA, Crews JR, Denduluri N, Hwang ES, Khan SA, Loibl S, Morris EA, Perez A, Regan MM, Spears PA, Sudheendra PK, Symmans WF, Yung RL, Harvey BE, Hershman DL.

National Cancer Institute, Bethesda, MD; American Society of Clinical Oncology, Alexandria, VA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Seattle Cancer Care Alliance, Seattle, WA; US Oncology Network, Virginia Cancer Specialists, Arlington, VA; Duke University, Durham, NC; Northwestern University, Chicago, IL; German Breast Group, Neu-Isenburg, Germany; Memorial Sloan Kettering Cancer Center, New York, NY; Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Plantation, FL; Dana Farber Cancer Institute, Boston, MA; MD Anderson Cooper University Health Care, Camden, NJ; MD Anderson Cancer Center, Houston, TX; Herbert Irving Comprehensive Cancer Center at Columbia University, New York, NY.

PURPOSE: To develop guideline recommendations concerning optimal neoadjuvant therapy for breast cancer.

METHODS: ASCO convened an Expert Panel to conduct a systematic review of the literature on neoadjuvant therapy for breast cancer and provide recommended care options.

RESULTS: A total of 41 articles met eligibility criteria and form the evidentiary basis for the guideline recommendations.

RECOMMENDATIONS: Patients undergoing neoadjuvant therapy should be managed by a multidisciplinary care team. Appropriate candidates for neoadjuvant therapy include patients with inflammatory breast cancer and those in whom residual disease may prompt a change in therapy. Neoadjuvant therapy can also be used to reduce the extent of local therapy or reduce delays in initiating therapy. Although tumor histology, grade, stage, and estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) expression should routinely be used to guide clinical decisions, there is insufficient evidence to support the use of other markers or genomic profiles. Patients with triple-negative breast cancer (TNBC) who have clinically node-positive and/or at least T1c disease should be offered an anthracycline- and taxane-containing regimen; those with cT1a or cT1bN0 TNBC should not routinely be offered neoadjuvant therapy. Carboplatin may be offered to patients with TNBC to increase pathologic complete response. There is currently insufficient evidence to support adding immune checkpoint inhibitors to standard chemotherapy. In patients with hormone receptor (HR)-positive (HR-positive), HER2-negative tumors, neoadjuvant chemotherapy can be used when a treatment decision can be made without surgical information. Among postmenopausal patients with HR-positive, HER2-negative disease, hormone therapy can be used to downstage disease. Patients with node-positive or high-risk node-negative, HER2-positive disease should be offered neoadjuvant therapy in combination with anti-HER2-positive therapy. Patients with T1aN0 and T1bN0, HER2-positive disease should not be routinely offered neoadjuvant therapy.

PMID: 33507815

DOI: 10.1200/JCO.20.03399