中等复发风险乳腺癌是否需要化疗

　　编者按：根据乳腺癌21基因表达检测结果，可以对乳腺癌的复发风险进行评分。如果复发评分高于25分，那么预测化疗获益大，有必要接受化疗；如果复发评分低于11分，那么不化疗的复发风险低，无必要接受化疗；不过，对于复发评分不高不低（11～25分）的大多数患者，化疗获益尚不明确。

　　2018年6月3日，美国麻省医学会《新英格兰医学杂志》在线发表爱因斯坦医学院、达纳法伯癌症研究所、洛约拉大学、西北大学、密歇根大学、弗吉尼亚联邦大学、北卡罗来纳大学、杜克大学、梅奥医学中心、国家癌症研究所、印第安纳大学、文斯隆巴肿瘤医院、福克斯河谷肿瘤医院、华盛顿大学、匹兹堡大学、NSABP、埃默里大学、德克萨斯大学、堪萨斯癌症中心、范德比大学、罗格斯大学新泽西癌症研究所、夏威夷大学、加拿大多伦多大学、麦克马斯特大学、爱尔兰癌症研究组织、秘鲁国家肿瘤疾病研究所的随机对照临床研究（TAILORx）报告，对乳腺癌21基因表达检测复发评分处于中等范围（11～25分）患者的化疗获益进行了探讨。

　　该随机对照临床研究研究（TAILORx）于2006年4月7日～2010年10月6日入组激素受体阳性、HER2阴性、腋窝淋巴结阴性乳腺癌女性1万273例。最后，9719例患者的随访资料符合要求，其中6711例（69%）复发评分处于中等范围（11～25分），术后随机分配接受辅助化疗＋内分泌治疗或单用内分泌治疗。主要研究终点为单用内分泌治疗与化疗＋内分泌治疗相比，无浸润病变生存（定义为无浸润病变复发、第二原发癌或死亡）的非劣效性。

　　结果发现，单用内分泌治疗与化疗＋内分泌治疗相比，无浸润病变生存相似（浸润病变复发、第二原发癌或死亡的风险比：1.08，95%置信区间：0.94～1.24，P=0.26）。

　　随访9年时，两个治疗组的无浸润病变生存率（83.3%比84.3%）、无远处病变复发率（94.5%比95.0%）、无远处或局部区域病变复发率（92.2%比92.9%）、总生存率（93.9%比93.8%）相似。

　　化疗的无浸润病变生存获益，随着复发评分和年龄的不同组合而变化（P=0.004），复发评分为16～25且年龄≤50岁女性可见某些化疗获益。

　　因此，该研究结果表明，对于21基因复发评分处于中等范围的激素受体阳性、HER2阴性、腋窝淋巴结阴性乳腺癌女性，术后辅助化疗＋内分泌治疗与单用内分泌治疗相比，效果相似，虽然某些化疗获益可见于年龄≤50岁女性。

相关阅读

N Engl J Med. 2018 Jun 3. [Epub ahead of print]

Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.

Joseph A. Sparano, Robert J. Gray, Della F. Makower, Kathleen I. Pritchard, Kathy S. Albain, Daniel F. Hayes, Charles E. Geyer, Jr., Elizabeth C. Dees, Matthew P. Goetz, John A. Olson, Jr., Tracy Lively, Sunil S. Badve, Thomas J. Saphner, Lynne I. Wagner, Timothy J. Whelan, Matthew J. Ellis, Soonmyung Paik, William C. Wood, Peter M. Ravdin, Maccon M. Keane, Henry L. Gomez Moreno, Pavan S. Reddy, Timothy F. Goggins, Ingrid A. Mayer, Adam M. Brufsky, Deborah L. Toppmeyer, Virginia G. Kaklamani, Jeffrey L. Berenberg, Jeffrey Abrams, George W. Sledge, Jr.

Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Dana-Farber Cancer Institute, Boston; Sunnybrook Research Institute, Toronto; McMaster University, Hamilton, ON, Canada; Loyola University Chicago Stritch School of Medicine, Maywood; Northwestern University, Chicago, Illinois; University of Michigan, Ann Arbor; Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond; University of North Carolina, Chapel Hill; Duke University Medical Center, Durham, North Carolina; Mayo Clinic, Jacksonville, FL; National Institutes of Health, National Cancer Institute, Bethesda, MD; Indiana University School of Medicine, Indiana University Hospital, Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers; Fox Valley Hematology and Oncology, Appleton, Wisconsin; Washington University, St. Louis; National Surgical Adjuvant Breast and Bowel Project Pathology Office, University of Pittsburgh, Pittsburgh; Emory University, Atlanta; University of Texas, San Antonio; Cancer Trials Ireland, Dublin; Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru; Cancer Center of Kansas, Wichita; Vanderbilt University, Nashville; Rutgers Cancer Institute of New Jersey, New Brunswick; University of Hawaii Cancer Center, Honolulu.

BACKGROUND: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score.

METHODS: We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death).

RESULTS: Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25.

CONCLUSIONS: Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger.

Funded by the National Cancer Institute, Eastern Cooperative Oncology Group (ECOG), American College of Radiology Imaging Network (ACRIN) Cancer Research Group, Southwest Oncology Group, Alliance for Clinical Trials in Oncology, NRG Oncology, Canadian Cancer Trials Group, Genomic Health

TAILORx ClinicalTrials.gov number, NCT00310180.

DOI: 10.1056/NEJMoa1804710

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