John Wayne Cancer Institute at Saint John's Health Center, 2200 Santa Monica Blvd, Santa Monica, CA 90404, USA.
JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
CONTEXT: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. OBJECTIVE: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. DESIGN, SETTING, AND PATIENTS: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollment was 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. INTERVENTIONS: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. MAIN OUTCOME MEASURES: Overall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. RESULTS: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%) with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. CONCLUSION: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.
背景：前哨淋巴结清扫术（SLND）可准确识别早期乳腺癌的淋巴结转移，但尚不清楚进一步的淋巴结清扫是否会影响生存。 目的：确定完全腋窝淋巴结清扫术（ALND）对有前哨淋巴结（SLN）转移的乳腺癌患者生存的影响。 设计、地点和患者：美国外科医师学会肿瘤学组 Z0011 试验，是一项在 115 个地点进行的 3 期非劣效性试验，招募的患者来自 1999 年 5 月至 2004 年 12 月。患者为临床 T1-T2 浸润性乳腺癌、无可触及的淋巴结病且 1 至 2 个 SLN 中含有通过冷冻切片、触摸准备或苏木精-伊红染色在永久切片上确定的转移的女性。目标入组人数为 1900 名女性，在 500 例死亡后进行最终分析，但试验提前关闭，因为死亡率低于预期。 干预措施：所有患者均接受乳房肿瘤切除术和切线式全乳房照射。通过 SLND 发现 SLN 转移的患者被随机分配接受 ALND 或不进行进一步的腋窝治疗。随机分配接受 ALND 的患者接受 10 个或更多淋巴结的解剖。全身治疗由治疗医生决定。 主要终点：总生存是主要终点，单侧危险比的非劣效性边界小于 1.3，表明 SLND 单独治疗不劣于 ALND。无病生存是次要终点。 结果：在随机分配接受 ALND 的 445 例患者和随机分配接受 SLND 单独治疗的 446 例患者之间，临床和肿瘤特征相似。然而，ALND 组切除的中位数为 17 个，而 SLND 单独治疗组为 2 个。在中位随访 6.3 年（最后一次随访为 2010 年 3 月 4 日）时，ALND 的 5 年总生存率为 91.8%（95%置信区间[CI]，89.1%-94.5%），SLND 单独治疗的 5 年总生存率为 92.5%（95% CI，90.0%-95.1%）；ALND 的 5 年无病生存率为 82.2%（95% CI，78.3%-86.3%），SLND 单独治疗的 5 年无病生存率为 83.9%（95% CI，80.2%-87.9%）。未调整时，治疗相关总生存的风险比为 0.79（90% CI，0.56-1.11），调整年龄和辅助治疗后为 0.87（90% CI，0.62-1.23）。 结论：在接受保乳和全身治疗的有限 SLN 转移性乳腺癌患者中，与 ALND 相比，单独使用 SLND 并未导致生存劣化。 试验注册：clinicaltrials.gov 标识符：NCT00003855。
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