Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy A Secondary Analysis of the TAILORx Randomized Clinical Trial
Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy A Secondary Analysis of the TAILORx Randomized Clinical Trial
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DOI：
10.1001/jamaoncol.2019.4794
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发表时间：
2020-03-01
期刊：
影响因子：
28.4
通讯作者：
Sledge, George W., Jr.
中科院分区：
文献类型：
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作者：
Sparano, Joseph A.;Gray, Robert J.;Sledge, George W., Jr.
重要性 通过乳腺癌检测得出的高 21 基因复发评分 (RS) 可以预测局部治疗和单独内分泌治疗后早期乳腺癌的远处复发以及化疗获益。目的 描述在 TAILORx 试验中接受辅助化疗加内分泌治疗的高 RS 女性的临床结果，该人群预计单独使用内分泌治疗会有较高的远处复发率。设计、设置和参与者在这项对多中心随机临床试验数据的二次分析中，1389 名患有激素受体阳性、ERBB2 阴性、腋窝淋巴结阴性乳腺癌且 RS 为 26 至 100 的女性患者被前瞻性地分配接受除内分泌治疗外的辅助化疗。该分析于 2019 年 5 月 12 日进行。 干预 辅助化疗方案由治疗医生选择。主要成果和措施 避免乳腺癌远处复发，避免复发、第二原发癌和死亡（也称为无侵袭性疾病生存 [IDFS]）。结果 在 9719 名符合资格的女性中，平均年龄为 56 岁（范围为 23-75 岁），1389 名（14%）的复发评分为 26 至 100，其中 598 名（42%）的 RS 为 26 至 30，791 名（58%）的 RS 为 31 至 100。 最常见的化疗方案包括多西他赛/环磷酰胺589 例 (42%)、不含紫杉烷的蒽环类药物 334 例 (24%)、蒽环类和紫杉类药物 244 例 (18%)、环磷酰胺/甲氨蝶呤/5-氟尿嘧啶 52 例 (4%)、其他方案 81 例 (6%)、未化疗 89 例 (6%)。 5 年时，估计远处部位乳腺癌无复发率为 93.0%（标准误差 [SE]，0.8%），远处和/或局部部位乳腺癌无复发率为 91.0%（SE，0.8%），IDFS 87.6%（SE，1.0%），总生存率为 95.9%（SE，0.6%）。结论和相关性 在前瞻性 TAILORx 试验中，RS 为 26 至 100 的女性，主要采用含紫杉烷和/或蒽环类药物的辅助化疗方案加内分泌治疗，估计 5 年无远处乳腺癌复发率为 93%，这一结果优于该人群中单独内分泌治疗的预期结果。 问题 治疗时，与高 21 基因复发评分相关的早期乳腺癌的预后如何辅助化疗加内分泌治疗？结果 在这项随机临床试验的二次分析中，在 1389 名接受辅助化疗且 21 基因检测得分为 26 至 100 分的早期乳腺癌女性中，估计 5 年内无远处复发的比例为 93%。意义 在激素受体阳性、ERBB2 阴性、腋窝淋巴结阴性乳腺癌和 21 基因复发评分高的女性中，与单独内分泌治疗相比，接受化疗内分泌治疗时没有远处复发的比例更高。TAILORx 随机临床试验的这项二次分析描述了接受辅助化疗加内分泌治疗的 21 基因复发评分高的女性的临床结果，预计该人群的远处复发率很高单纯内分泌治疗。
Importance A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit. Objective To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. Design, Setting, and Participants In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019. Interventions The adjuvant chemotherapy regimen was selected by the treating physician. Main Outcomes and Measures Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]). Results Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%). Conclusions and Relevance The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population.Question What is the prognosis in early breast cancer associated with a high 21-gene recurrence score when treated with adjuvant chemotherapy plus endocrine therapy? Findings In this secondary analysis of a randomized clinical trial, among 1389 women with early breast cancer and a high score of 26 to 100 by 21-gene assay who received adjuvant chemotherapy, the estimated proportion free from distant recurrence at 5 years was 93%. Meaning In women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high 21-gene recurrence score, a higher proportion were free from distant recurrence when treated with chemoendocrine therapy than expected with endocrine therapy alone.This secondary anaysis of the TAILORx randomized clinical trial describes clinical outcomes for women with a high 21-gene recurrence score who received adjuvant chemotherapy plus endocrine therapy, a population expected to have a high distant recurrence rate with endocrine therapy alone.