Department of Breast and Sarcoma Surgery, National Institute of Oncology, Budapest, Hungary.
Clin Breast Cancer. 2013 Oct;13(5):364-70. doi: 10.1016/j.clbc.2013.04.004. Epub 2013 Jun 14.
The Hungarian National Institute of Oncology has just closed a single-center randomized clinical study. The Optimal Treatment of the Axilla-Surgery or Radiotherapy (OTOASOR) trial compares completion axillary lymph node dissection (cALND) with regional nodal irradiation (RNI) in patients with sentinel lymph node-positive (SLN+) primary invasive breast cancer. In the investigational treatment arm, patients received 50 Gy RNI instead of cALND. In these patients we had information only about the sentinel lymph node (SLN) status, but the further axillary nodal involvement remained unknown. The aim of this study was to investigate whether the result of cALND influenced the recommendation for adjuvant treatment in patients with SLN+ breast cancer.
Patients with SLN+ primary breast cancer were randomized for cALND (arm A, standard treatment) or RNI (arm B, investigational treatment). Adjuvant systemic treatments were given according to the standard institutional protocol, and patients were followed according to the actual institutional guidelines.
Between August 2002 and June 2009, 474 SLN+ patients were randomized to cALND (arm A, standard treatment = 244 patients) or RNI (arm B, investigational treatment = 230 patients). The 2 arms were well balanced according to the majority of main prognostic factors. However, more patients were premenopausal (34% vs. 27%; P = .095) and had pT2-3 tumors (57% vs. 40%; P = .003) in the completion axillary lymph node dissection (ALND) arm. On the other hand, there were more patients with known human epidermal growth factor receptor type 2 positive tumor (12% vs. 17%, P = .066) in the RNI arm. In the ALND and RNI arms, 78% (190/244) and 69% (159/230), respectively, received chemotherapy (P = .020). Endocrine therapy was administered in 87% (213/244) of the patients in the ALND arm and 89% (204/230) of the patients in the RNI arm (P = .372). Six patients (2.5%) on arm A and 13 patients (5.7%) on arm B received adjuvant trastuzumab treatment (P = not significant). Subgroup analyses explored that more frequent administration of adjuvant chemotherapy in arm A was associated with the higher percentage of premenopausal patients and patients with larger (pT2-3) tumors.
The result of cALND after positive SLN biopsy seems to have no major impact on the administration of adjuvant systemic therapy.
匈牙利国家肿瘤研究所刚刚完成了一项单中心随机临床试验。Optimal Treatment of the Axilla-Surgery or Radiotherapy（OTOASOR）试验比较了前哨淋巴结阳性（SLN+）原发性浸润性乳腺癌患者接受完全腋窝淋巴结清扫术（cALND）与区域淋巴结放疗（RNI）的效果。在研究性治疗组中，患者接受 50Gy 的 RNI 治疗，而不是 cALND。在这些患者中，我们仅获得了关于前哨淋巴结（SLN）状态的信息，但进一步的腋窝淋巴结受累情况仍不清楚。本研究旨在探讨 SLN+乳腺癌患者 cALND 结果是否会影响辅助治疗的推荐。
SLN+原发性乳腺癌患者被随机分为 cALND（A 组，标准治疗）或 RNI（B 组，研究性治疗）。辅助全身治疗根据标准机构方案进行，患者根据实际机构指南进行随访。
2002 年 8 月至 2009 年 6 月，474 例 SLN+患者被随机分为 cALND（A 组，标准治疗=244 例）或 RNI（B 组，研究性治疗=230 例）。根据大多数主要预后因素，这两个治疗组基本平衡。然而，cALND 组更多的患者为绝经前（34%比 27%；P=0.095），更多的患者肿瘤分期为 pT2-3（57%比 40%；P=0.003）。另一方面，RNI 组中已知人表皮生长因子受体 2 阳性肿瘤患者比例更高（12%比 17%，P=0.066）。在 cALND 和 RNI 组中，分别有 78%（190/244）和 69%（159/230）的患者接受了化疗（P=0.020）。在 cALND 组中，87%（213/244）的患者接受了内分泌治疗，在 RNI 组中，89%（204/230）的患者接受了内分泌治疗（P=0.372）。A 组中有 6 名（2.5%）患者和 B 组中有 13 名（5.7%）患者接受了辅助曲妥珠单抗治疗（P=无显著性差异）。亚组分析表明，A 组更频繁地使用辅助化疗与较高比例的绝经前患者和较大（pT2-3）肿瘤患者有关。
SLN 阳性活检后的 cALND 结果似乎对辅助全身治疗的应用没有重大影响。
