早期乳腺癌术后化疗决策指南更新
2015年《新英格兰医学杂志》发表的美国国家癌症研究所TAILORx研究结果证实，根据21基因（Oncotype DX）检测结果，进行复发风险评分，可以预测早期乳腺浸润癌术后复发风险以及术后辅助化疗能否获益：复发风险评分较低（0～10分）患者可以避免术后辅助化疗，复发风险评分较高（≥26分）患者推荐接受术后辅助化疗。根据该研究结果，2016年《临床肿瘤学杂志》发表美国临床肿瘤学会临床实践指南：利用生物标志指导早期乳腺浸润癌女性术后全身辅助治疗决策。2018年《新英格兰医学杂志》发表了TAILORx研究复发风险评分中等（11～25分）患者的术后辅助化疗结果。
2019年5月31日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表法国巴黎第十一大学古斯塔夫鲁西研究所、美国临床肿瘤学会、犹他大学亨斯迈癌症研究所、德克萨斯大学MD安德森癌症中心、西雅图癌症研究生物统计学研究所、犹他大学山际医疗中心、华盛顿大学晚期癌症研究组织、梅奥医学中心、密歇根大学、霍普金斯大学综合癌症中心起草的利用生物标志指导早期乳腺浸润癌女性术后全身辅助治疗决策，结合TAILORx研究最新结果，对美国临床肿瘤学会临床实践指南进行了更新。
该指南更新主要针对利用21基因检测结果指导全身辅助治疗决策，主要依据来自个体化治疗方案分配研究（TAILORx），该研究根据21基因复发风险评分对内分泌治疗±化疗的无浸润病变生存进行了随机对照。指南更新专家组审核了TAILORx研究结果以及其他已经发表的21基因复发风险评分研究文献，对其临床效果的证据进行评定。最后，指南对于激素受体阳性腋窝淋巴结阴性乳腺癌患者的推荐意见更新如下：
如果21基因复发风险评分小于26分：化疗获益微乎其微，尤其对于年龄>50岁的患者；对于年龄>50岁患者，临床医师可以建议单用内分泌治疗；对于年龄≤50岁患者，如果21基因复发风险评分16～25分，临床医师可以提供化疗＋内分泌治疗。
如果21基因复发风险评分大于30分：应该考虑化疗＋内分泌治疗。
如果21基因复发风险评分26～30分：根据非正式共识，指南更新专家组推荐肿瘤内科医师可以提供化疗＋内分泌治疗。
相关阅读
J Clin Oncol. 2019 May 31. [Epub ahead of print]
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx.
Andre F, Ismaila N, Henry NL, Somerfield MR, Bast RC, Barlow W, Collyar DE, Hammond ME, Kuderer NM, Liu MC, Van Poznak C, Wolff AC, Stearns V.
Institute Gustave Roussy, Paris Sud University, Paris, France; American Society of Clinical Oncology, Alexandria, VA; University of Utah Huntsman Cancer Institute, Salt Lake City, UT; The University of Texas MD Anderson Cancer Center, Houston, TX; Cancer Research and Biostatistics, Seattle, WA; Patient Advocates in Research, Danville, CA; University of Utah and Intermountain Health Care, Salt Lake City, UT; Advanced Cancer Research Group and University of Washington, Seattle, WA; Mayo Clinic College of Medicine, Rochester, MN; University of Michigan, Ann Arbor, MI; Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
PURPOSE: This focused update addresses the use of Oncotype DX in guiding decisions on the use of adjuvant systemic therapy.
METHODS: ASCO uses a signals approach to facilitate guideline updating. For this focused update, the publication of the Trial Assigning Individualized Options for Treatment (TAILORx) evaluating noninferiority of endocrine therapy alone versus chemoendocrine therapy for invasive disease-free survival in women with Oncotype DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Oncotype DX assay to assess for evidence of clinical utility.
UPDATED RECOMMENDATIONS: For patients with hormone receptor-positive, axillary node-negative breast cancer whose tumors have Oncotype DX recurrence scores of less than 26, there is little to no benefit from chemotherapy, especially for patients older than age 50 years. Clinicians may recommend endocrine therapy alone for women older than age 50 years. For patients 50 years of age 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 these patients with recurrence scores of 26 to 30.
PMID: 31150316
DOI: 10.1200/JCO.19.00945