State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, China.
Breast Cancer Res Treat. 2022 Dec;196(3):613-622. doi: 10.1007/s10549-022-06746-6. Epub 2022 Oct 7.
Findings from randomized clinical trials have shown that survival in patients with sentinel lymph node (SLN)-negative breast cancer is noninferior with SLN biopsy (SLNB) alone versus further axillary lymph node dissection (ALND). However, the long-term outcome of these two surgical approaches in pN0 breast cancer patients in real-world setting remains uncertain.
We included patients diagnosed with pathologically staged T1-2N0M0 breast cancer between 2000 and 2015 in surveillance, epidemiology, and end results 18-registry database. Patients were considered to have undergone SLNB alone if they had ≤ 5 examined lymph nodes (ELNs), and ALND if they had ≥ 10 ELNs. The outcomes included overall survival (OS) and breast cancer-specific survival. Propensity score analyses by weighting and matching and multivariable Cox regression analysis were performed to minimize treatment selection bias.
We included 309,430 patients (253,501 SLNB and 55,929 ALND). In the weighted cohort, ALND was associated with significantly lower OS (hazard ratio [HR] 1.13; 95% confidence interval [CI] 1.10-1.16) and BCSS (HR 1.16; 95% CI 1.10-1.22) compared with SLNB alone. Both the propensity score-matching model and multivariable Cox model demonstrated a survival benefit for SLNB when compared with ALND. Subgroup analyses for key variables did not change these findings.
We found statistically significant differences in OS and BCSS between SLNB and ALND, though the magnitude of these differences was small. Our findings further support that SLNB alone should be the standard of care for patients who do not have metastatic lymph nodes identified during breast cancer surgery.
随机临床试验的结果表明,对于前哨淋巴结(SLN)阴性的乳腺癌患者,单独进行 SLN 活检(SLNB)与进一步进行腋窝淋巴结清扫术(ALND)的生存非劣效性。然而,在真实世界环境中,pN0 乳腺癌患者这两种手术方法的长期结果仍不确定。
我们纳入了 2000 年至 2015 年间在监测、流行病学和最终结果 18 注册数据库中诊断为病理分期为 T1-2N0M0 乳腺癌的患者。如果患者的检查淋巴结(ELN)数量≤5,则认为其接受了单独的 SLNB,如果 ELN 数量≥10,则认为其接受了 ALND。结果包括总生存(OS)和乳腺癌特异性生存(BCSS)。通过加权和匹配以及多变量 Cox 回归分析进行倾向评分分析,以最小化治疗选择偏倚。
我们纳入了 309430 名患者(253501 名接受了 SLNB,55929 名接受了 ALND)。在加权队列中,与单独进行 SLNB 相比,ALND 与 OS(风险比 [HR] 1.13;95%置信区间 [CI] 1.10-1.16)和 BCSS(HR 1.16;95% CI 1.10-1.22)显著降低相关。倾向评分匹配模型和多变量 Cox 模型均表明,与 ALND 相比,SLNB 具有生存优势。对关键变量的亚组分析并未改变这些发现。
我们发现 SLNB 与 ALND 之间在 OS 和 BCSS 方面存在统计学显著差异,尽管这些差异的幅度较小。我们的研究结果进一步支持对于在乳腺癌手术期间未发现转移性淋巴结的患者,单独进行 SLNB 应作为标准治疗方法。