Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial.
Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial.
复制标题
DOI：
10.1001/jama.2011.90
复制
发表时间：
2011-02-09
期刊：
影响因子：
--
通讯作者：
Morrow M
中科院分区：
文献类型：
--
作者：
Giuliano AE;Hunt KK;Ballman KV;Beitsch PD;Whitworth PW;Blumencranz PW;Leitch AM;Saha S;McCall LM;Morrow M
前哨淋巴结清扫术（SLND）可以准确识别早期乳腺癌的淋巴结转移。目的探讨乳腺癌前哨淋巴结（SLN）转移患者行腋窝淋巴结清扫（ALND）对生存率的影响。1999年5月至2004年12月，115家临床试验机构参与了美国外科医师学会肿瘤组Z 0011试验。在这项III期非劣效性试验中，SLN转移的患者被随机分配至ALND组或不再接受腋窝治疗。目标入组人数为1900名女性，在500例死亡后进行最终分析，但由于死亡率低于预期，试验提前结束。患有临床T1-T2浸润性乳腺癌、无可触及的腺病和1-2个前哨淋巴结（通过冷冻切片、触摸制备或永久切片上的苏木精和伊红染色确定含有转移灶）的女性。所有患者均行乳房肿瘤切除术和全乳切线照射。随机分配至ALND组的患者接受≥10个淋巴结的夹层。全身治疗由主治医生决定。总生存期（OS）是主要终点，单侧风险比为1.3或更低的非劣效性界值有利于ALND。无病生存期（DFS）是次要终点。445例随机分配至ALND组的患者和446例随机分配至SLND组的患者的临床和肿瘤特征相似。然而，ALND切除的淋巴结中位数为17个，SLND为2个。中位随访6.3年（末次随访日期：2010年3月4日），5年OS为91.8%（95% CI：89.1 - 94.5），ALND和92.5%（95% CI：90.0 - 95.1）; ALND和SLND的5年DFS分别为82.2%（95% CI：78.3 - 86.3）和83.9%（95% CI：80.2 - 87.9）。未校正时治疗相关OS的风险比为0.79（90% CI：0.56 - 1.11），校正年龄和辅助治疗后为0.87（90% CI：0.62 - 1.23）。在接受保乳和全身治疗的局限性SLN转移性乳腺癌患者中，与ALND相比，SLND的使用并未导致生存率降低。
Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer. To determine the impact of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. The 115 sites participating in the American College of Surgeons Oncology Group Z0011 trial enrolled patients from May 1999 to December 2004. In this phase III noninferiority trial, patients with SLN metastasis were randomized to ALND or no further axillary treatment. Targeted enrollment was 1900 women, with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Women with clinical T1–T2 invasive breast cancer, no palpable adenopathy, and 1–2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin and eosin staining on permanent section. All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of ≥10 nodes. Systemic therapy was at the discretion of the treating physician. Overall survival (OS) was the primary endpoint, with a noninferiority margin of a one-sided hazard ratio of 1.3 or less favoring ALND. Disease-free survival (DFS) was a secondary endpoint. 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 date 03/04/2010), 5-year OS was 91.8% (95% CI: 89.1 to 94.5) with ALND and 92.5% (95% CI: 90.0 to 95.1) with SLND alone; 5-year DFS was 82.2% (95% CI: 78.3 to 86.3) with ALND and 83.9% (95% CI: 80.2 to 87.9) with SLND alone. Hazard ratio for treatment-related OS was 0.79 (90% CI: 0.56 to 1.11) without adjustment and 0.87 (90% CI: 0.62 to 1.23) after adjusting for age and adjuvant therapy. Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND compared with ALND did not result in inferior survival.