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SWOG S1007 试验中入组的低危、淋巴结阳性乳腺癌患者的放疗应用与局部区域复发发生率。

Radiotherapy Use and Incidence of Locoregional Recurrence in Patients With Favorable-Risk, Node-Positive Breast Cancer Enrolled in the SWOG S1007 Trial.

机构信息

Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.

SWOG, University of Washington, Seattle, Washington.

出版信息

JAMA Oncol. 2023 Aug 1;9(8):1083-1089. doi: 10.1001/jamaoncol.2023.1984.

Abstract

IMPORTANCE

Little is known about regional nodal irradiation (RNI) practice patterns or rates of locoregional recurrence (LRR) with and without RNI in patients with limited nodal disease and favorable biology treated with modern surgical and systemic therapy, including approaches that de-escalate those latter treatments.

OBJECTIVE

To investigate how often patients with low-recurrence score breast cancer with 1 to 3 nodes involved receive RNI, incidence and predictors of LRR, and associations between locoregional therapy and disease-free survival.

DESIGN, SETTING, AND PARTICIPANTS: In this secondary analysis of the SWOG S1007 trial, patients with hormone receptor-positive, ERBB2-negative breast cancer, and a Oncotype DX 21-gene Breast Recurrence Score assay result of no more than 25, were randomized to endocrine therapy alone vs chemotherapy then endocrine therapy. Prospectively collected radiotherapy information was collected from 4871 patients treated in diverse settings. Data were analyzed June 2022 to April 2023.

EXPOSURE

Receipt of RNI (targeting at least the supraclavicular region).

MAIN OUTCOME(S) AND MEASURE(S): Cumulative incidence of LRR was calculated by locoregional treatment received. Analyses were assessed for associations between invasive disease-free survival (IDFS) and locoregional therapy, adjusted for menopausal status, treatment group, recurrence score, tumor size, nodes involved, and axillary surgery. Radiotherapy information was recorded in the first year after randomization, so survival analyses were landmarked as starting at 1 year among those still at risk.

RESULTS

Of 4871 female patients (median [range] age, 57 [18-87] years) with radiotherapy forms, 3947 (81.0%) reported radiotherapy receipt. Of 3852 patients who received radiotherapy and had complete information on targets, 2274 (59.0%) received RNI. With a median follow-up of 6.1 years, the cumulative incidence of LRR by 5 years was 0.85% among patients who received breast-conserving surgery and radiotherapy with RNI; 0.55% after breast-conserving surgery with radiotherapy without RNI; 0.11% after mastectomy with postmastectomy radiotherapy; and 1.7% after mastectomy without radiotherapy. Similarly low LRR was observed within the group assigned to endocrine therapy without chemotherapy. The rate of IDFS did not differ by RNI receipt (premenopausal: hazard ratio [HR], 1.03; 95% CI, 0.74-1.43; P = .87; postmenopausal: HR, 0.85; 95% CI, 0.68-1.07; P = .16).

CONCLUSIONS AND RELEVANCE

In this secondary analysis of a clinical trial, RNI use was divided in the setting of biologically favorable N1 disease, and rates of LRR were low even in patients who did not receive RNI. Disease-free survival was not associated with RNI receipt; omission of chemotherapy among patients similar to those enrolled in the S1007 trial is not an independent indication for use of RNI.

摘要

重要性

对于接受现代手术和全身治疗的低淋巴结疾病和有利生物学特征的患者,包括降低这些治疗方法的方法,关于区域淋巴结照射(RNI)实践模式或有和没有 RNI 的局部区域复发(LRR)的发生率知之甚少。

目的

调查在接受现代手术和全身治疗的低复发评分乳腺癌患者中,有 1 至 3 个淋巴结受累的患者接受 RNI 的频率、LRR 的发生率和预测因素,以及局部区域治疗与无病生存之间的关系。

设计、地点和参与者:在 SWOG S1007 试验的二次分析中,入组了激素受体阳性、ERBB2 阴性、Oncotype DX 21 基因乳腺癌复发评分检测结果不超过 25 的乳腺癌患者,随机分为内分泌治疗组与化疗后内分泌治疗组。从在不同环境中接受治疗的 4871 名患者中前瞻性收集放疗信息。数据于 2022 年 6 月至 2023 年 4 月进行分析。

暴露

接受 RNI(至少针对锁骨上区域)。

主要结果和措施

通过接受的局部区域治疗计算 LRR 的累积发生率。评估了浸润性无病生存(IDFS)与局部区域治疗之间的关系,调整了绝经状态、治疗组、复发评分、肿瘤大小、受累淋巴结和腋窝手术。放疗信息记录在随机分组后的第一年,因此对于仍有风险的患者,生存分析以 1 年为起始时间进行标志。

结果

在有放疗形式的 4871 名女性患者(中位[范围]年龄,57 [18-87] 岁)中,3947 名(81.0%)报告了放疗接受情况。在接受放疗且有完整靶区信息的 3852 名患者中,2274 名(59.0%)接受了 RNI。中位随访 6.1 年后,5 年内 RNI 组保乳手术和放疗的 LRR 累积发生率为 0.85%;保乳手术和放疗无 RNI 组为 0.55%;乳房切除术和乳房切除术术后放疗组为 0.11%;乳房切除术和无放疗组为 1.7%。同样,在未接受化疗的内分泌治疗组中也观察到较低的 LRR。IDFS 率与 RNI 接受情况无关(绝经前:危险比 [HR],1.03;95%CI,0.74-1.43;P=0.87;绝经后:HR,0.85;95%CI,0.68-1.07;P=0.16)。

结论和相关性

在这项临床试验的二次分析中,RNI 的使用在生物学有利的 N1 疾病中进行了细分,即使在未接受 RNI 的患者中,LRR 的发生率也很低。无病生存与 RNI 接受情况无关;在类似于 S1007 试验中入组的患者中省略化疗并不是使用 RNI 的独立指征。

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