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21基因（Oncotype DX）复发评分问世之前，美国国家综合癌症网络（NCCN）指南推荐对于肿瘤大小≤1厘米（T1b）、淋巴结阴性、激素受体阳性、HER2阴性乳腺癌患者可以免去术后辅助化疗。不过，这些患者大约30%可能接受21基因复发评分，有必要考虑术后辅助化疗。 2019年11月4日，美国乳腺外科医师学会和美国肿瘤外科学会《肿瘤外科学报》在线发表宾夕法尼亚大学佩雷尔曼医学院的研究报告，根据是否进行21基因复发评分，比较了肿瘤大小≤5毫米（T1a）或1厘米（T1b）、淋巴结阴性、激素受体阳性、HER2阴性乳腺癌女性的临床结局。 该单中心回顾研究获得伦理审查委员会批准后，通过数据库查询到2009～2018年肿瘤大小≤1厘米、淋巴结阴性、激素受体阳性、HER2阴性乳腺癌患者2307例，其中肿瘤大小1～5毫米（T1a）727例、5～10毫米（T1b）1580例。根据21基因复发评分低、中、高（<18、18～30、>30）进一步对患者进行分层。通过对数秩检验、生存曲线、治疗权重逆向概率分析，比较各组患者的无病生存和总体生存。 结果，进行21基因复发评分患者1149例（49.8%）与未进行21基因复发评分患者1158例（50.2%）相比，肿瘤较大、年轻、白人的比例较高。 根据单因素分析，进行与未进行21基因复发评分的患者相比：
根据多因素治疗权重逆向概率分析，排除治疗因素影响，进行与未进行21基因复发评分的患者相比：
因此，该研究结果表明，总体而言，无论是否进行21基因复发评分，结局都非常好。对于肿瘤大小≥5毫米的患者，进行与未进行21基因复发评分相比，无病生存较好。建议对于肿瘤大小≥5毫米的患者，常规进行21基因复发评分。 Ann Surg Oncol. 2019 Nov 4. [Epub ahead of print] Impact of 21-Gene Expression Assay on Clinical Outcomes in Node-Negative ≤ T1b Breast Cancer. Maria Pomponio, Luke Keele, Elizabeth Hilt, Laura Burkbauer, Macy Goldbach, Susanna Nazarian, Kevin Fox, Julia Tchou. Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. BACKGROUND: Prior to the advent of Oncotype DX 21-gene recurrence score (oDX) assay, the National Comprehensive Cancer Network (NCCN) guideline supported omission of adjuvant chemotherapy in patients with ≤ 1 cm (T1b) hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2-) node tumors. However, around 30% of these patients would have an oDX recurrence score that warrants consideration of adjuvant chemotherapy. To clarify the potential benefit of oDX in these patients, we performed a retrospective analysis comparing clinical outcomes of women with T1a or T1b, N0 HR+ HER2- according to performance of oDX. PATIENTS AND METHODS: After receiving institutional review board (IRB) approval, an institutional database was queried to identify patients with HR+ HER2- ≤ T1bN0 tumors (n = 2307) diagnosed between 2009 and 2018. Patients were further stratified by recurrence score (RS) defined as low (< 18), intermediate (18-30), or high (> 30). Log-rank, Kaplan-Meier, and inverse probability of treatment weighting (IPW) analyses were used to compare disease-free survival (DFS) and overall survival (OS) across groups. RESULTS: Performance of oDX (n = 1149, 49.8%) was associated with larger tumors, younger age, and White race. On univariate analysis, performance of oDX was associated with improved OS (P < 0.01). On multivariate IPW analysis, performance of oDX lengthened DFS by an average of 16.5 months, while OS was similar between groups (P < 0.01 and P = 0.73). The improved DFS was mainly driven by those with tumors ≥ T1b. CONCLUSIONS: Overall, outcomes were excellent regardless of oDX testing. Performance of oDX testing was associated with improved DFS in patients with tumors ≥ T1b. Our results support routine use of oDX testing in patients with tumors ≥ T1b. DOI: 10.1245/s10434-019-08028-w
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