早期乳腺癌术后全身治疗指南更新
70基因（MammaPrint）、21基因（Oncotype DX）是指导早期乳腺癌术后全身辅助治疗决策的两大多基因检测方法，如同空客、波音两大欧美民航飞机制造公司，多年来竞争激烈。2016年，美国临床肿瘤学会参考安大略省癌症医疗中心指南，首次发表患者和疾病因素对早期可手术乳腺癌全身辅助治疗决策的作用推荐意见（安大略是加拿大人口最多、经济教育科技文化卫生最发达的省份，也是加拿大首都渥太华所在地，与美国明尼苏达、密歇根、俄亥俄、宾夕法尼亚、纽约等州接壤、交流密切，安大略省癌症医疗中心是安大略省政府根据《癌症法案》成立的癌症医疗咨询、管理、指导机构）。
2019年6月17日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表美国临床肿瘤学会、犹他大学、范德堡大学、斯坦福大学、北卡罗来纳大学、洛杉矶患者研究宣传组织、北极光癌症研究所、爱荷华大学、霍普金斯大学、加拿大多伦多大学、安大略省癌症医疗中心、巴西圣保罗肿瘤学临床协作组起草的美国临床肿瘤学会参考安大略省癌症医疗中心指南更新：患者和疾病因素对早期可手术乳腺癌全身辅助治疗决策的作用。
此次更新主要证据为美国、欧洲的两大随机对照三期临床研究结果：
美国国家癌症研究所资助的21基因指导早期乳腺癌术后辅助化疗研究：TAILORx (Trial Assigning Individualized Options for Treatment): Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (NCT00310180)
欧洲癌症研究与治疗组织的70基因指导早期乳腺癌术后辅助化疗研究：MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes (NCT00433589)
此次对于激素受体阳性HER2阴性早期乳腺癌术后全身辅助治疗临床医师与患者共同决策的推荐意见，主要更新如下：
对于年龄＞50岁且21基因复发评分＜26的患者：化疗获益极少，临床医师可以仅仅提供内分泌治疗。
对于年龄≤50岁且21基因复发评分＜16的患者：化疗获益极少，临床医师可以仅仅提供内分泌治疗。
对于年龄≤50岁且21基因复发评分16～25的患者：临床医师可以提供化疗＋内分泌治疗。
对于21基因复发评分＞30的患者：应该考虑化疗＋内分泌治疗。
对于21基因复发评分26～30的患者：根据非正式共识，专家组推荐肿瘤内科医师可以提供化疗＋内分泌治疗。
70基因分析可以用于指导激素受体阳性且淋巴结阴性乳腺癌患者和部分淋巴结阳性乳腺癌患者放弃术后全身辅助化疗的决策。
对于淋巴结阳性和淋巴结阴性乳腺癌患者，70基因检测的临床有效证据仅对确定为临床风险较高患者明显；因此，专家组不推荐对确定为临床风险较低患者使用70基因检测。
2016年指南其余推荐意见不变。
相关阅读
J Clin Oncol. 2019 Jun 17. [Epub ahead of print]
Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline.
Henry NL, Somerfield MR, Abramson VG, Ismaila N, Allison KH, Anders CK, Chingos DT, Eisen A, Ferrari BL, Openshaw TH, Spears PA, Vikas P, Stearns V.
University of Utah Huntsman Cancer Institute, Salt Lake City, UT; American Society of Clinical Oncology, Alexandria, VA; Vanderbilt-Ingram Cancer Center, Nashville, TN; Stanford University Medical Center, Stanford, CA; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Patient Advocate in Research, Los Angeles, CA; Sunnybrook Odette Cancer Centre, Cancer Care Ontario, Toronto, Canada; Oncoclinicas Group, Sao Paulo, Brazil; Northern Light Cancer Institute, Brewer, ME; University of Iowa Holden Comprehensive Cancer Center, Iowa City, IA; Kimmel Cancer Center at Johns Hopkins, Baltimore, MD.
PURPOSE: To update the American Society of Clinical Oncology endorsement of the Cancer Care Ontario recommendations on the Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer.
METHODS: Two phase III trials—the Trial Assigning Individualized Options for Treatment (TAILORx) in women with hormone receptor-positive, node-negative tumors and the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) trial—provided the evidence for this update.
UPDATED RECOMMENDATIONS: Shared decision making between clinicians and patients is appropriate for adjuvant systemic therapy for breast cancer. For patients older than age 50 years and whose tumors have Oncotype DX recurrence scores less than 26, and for patients age 50 years or younger whose tumors have Oncotype DX recurrence scores less than 16, there is little to no benefit from chemotherapy. Clinicians may offer endocrine therapy alone for these patients. For patients age 50 years or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the Panel recommends that oncologists may offer chemoendocrine therapy to patients with Oncotype DX scores of 26 to 30.
The MammaPrint assay could be used to guide decisions on withholding adjuvant systemic chemotherapy in patients with hormone receptor-positive lymph node-negative breast cancer and in select patients with lymph node-positive cancers. In both patients with node-positive and node-negative disease, evidence of clinical utility of the MammaPrint assay was only apparent in those determined to be at high clinical risk; the Panel thus did not recommend use of MammaPrint assay in patients determined to be at low clinical risk. Remaining recommendations from the 2016 ASCO guideline endorsement are unchanged.
PMID: 31206315
DOI: 10.1200/JCO.19.00948