Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden.
Department of Molecular Medicine and Surgery, Karolinska Institutet, 171 76, Stockholm, Sweden; Division of Cancer, Department of Breast, Endocrine Tumors and Sarcoma, Karolinska University Hospital, 171 64, Solna, Sweden.
Breast. 2022 Jun;63:16-23. doi: 10.1016/j.breast.2022.02.013. Epub 2022 Mar 1.
This report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND).
The ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1-2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQ-C30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing.
Overall, 976 questionnaires (501 in the SLN biopsy only group and 475 in the completion ALND group) were analysed, corresponding to a response rate of 82.6%. No significant group differences in overall HRQoL were identified. Participants receiving SLN biopsy only, reported significantly lower symptom scores on the EORTC subscales of pain, arm symptoms and breast symptoms. The Lymph-ICF domain scores of physical function, mental function and mobility activities were significantly in favour of the SLN biopsy only group.
One year after surgery, arm morbidity is significantly worse affected by ALND than by SLN biopsy only. The results underline the importance of ongoing attempts to safely de-escalate axillary surgery.
The trial was registered at clinicaltrials.gov prior to initiation (https://clinicaltrials.gov/ct2/show/NCT02240472).
本报告评估了在省略腋窝淋巴结清扫术（ALND）后，患者一年后的健康相关生活质量（HRQoL）和手臂报告发病率是否会受到影响。
正在进行的国际非劣效性 SENOMAC 试验将临床淋巴结阴性乳腺癌患者（T1-T3）随机分为完成 ALND 或不再进行腋窝手术的组。对于此分析，瑞典和丹麦于 2015 年 3 月至 2019 年 6 月间招募了前 1181 名患者，符合条件。2020 年 11 月从试验数据库中提取数据。本报告涵盖了 SENOMAC 试验的次要结局：HRQoL 和患者手臂报告发病率。EORTC QLQ-C30、EORTC QLQ-BR23 和 Lymph-ICF 问卷在术后早期和一年随访时完成。呈现了调整后的一年平均评分和组间平均差异，这些差异经过了多次测试校正。
总体而言，分析了 976 份问卷（仅 SLN 活检组 501 份，完成 ALND 组 475 份），应答率为 82.6%。总体 HRQoL 无显著组间差异。仅接受 SLN 活检的患者在 EORTC 子量表疼痛、手臂症状和乳房症状上报告的症状评分显著较低。仅 SLN 活检组的 Lymph-ICF 领域的生理功能、心理功能和移动活动的评分明显更高。
手术后一年，手臂发病率因 ALND 比仅 SLN 活检更显著地受到影响。结果强调了持续尝试安全地降低腋窝手术水平的重要性。
该试验在开始前于 clinicaltrials.gov 上进行了注册（https://clinicaltrials.gov/ct2/show/NCT02240472）。
