Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.
Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.
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DOI：
10.1001/jama.2017.11470
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发表时间：
2017-09-12
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影响因子：
--
通讯作者：
Morrow M
中科院分区：
文献类型：
--
作者：
Giuliano AE;Ballman KV;McCall L;Beitsch PD;Brennan MB;Kelemen PR;Ollila DW;Hansen NM;Whitworth PW;Blumencranz PW;Leitch AM;Saha S;Hunt KK;Morrow M
2005年首次报道了美国外科医师学会肿瘤学小组Z0011(ACOSOG Z0011)试验的结果，平均随访时间为6.3年。有必要进行更长时间的随访，因为大多数患者患有雌激素受体阳性的肿瘤，这些肿瘤可能在以后的病程中复发(ACOSOG现在是肿瘤学临床试验联盟的一部分)。目的：探讨保乳治疗与单纯前哨淋巴结清扫术(SLND)而不行腋窝淋巴结清扫术(ALND)治疗的前哨淋巴结转移患者的10年总生存率是否不低于腋窝清扫术患者。ACOSOG Z0011第三阶段随机临床试验从1999年5月至2004年12月在115个地点(学术和社区医疗中心)招募了患者。最后一次随访日期是2015年9月29日，在ACOSOG Z0011(联盟)试验中。符合条件的患者是临床上患有T1或T2浸润性乳腺癌、无明显腋窝淋巴结病变、以及1至2个前哨淋巴结有转移的女性。所有患者都计划了肿块切除术，计划了全乳房切向放射治疗，并辅以系统治疗。禁止第三场辐射。主要结果是总存活率，非劣势风险比(HR)为1.3。次要结果是无病生存。在891名被随机分组的妇女中(中位年龄55岁)，856人(96%)完成了试验(446人在SLND组，445人在ALND组)。在中位随访期9.3年(四分位数范围6.93-10.34年)，单纯SLND组和ALND组的10年总生存率分别为86.3%和83.6%(HR，0.85[单侧95%CI，0-1.16]；非劣势P=0.02)。SLND组和ALND组的10年无瘤生存率分别为80.2%和78.2%(HR，0.85[95%CI，0.62-1.17]；P=0.32)。从5年到10年，仅SLND组有1例区域复发，而ALND组无一例复发。两组间的十年区域复发率无显著差异。在T1或T2浸润性原发乳腺癌、无明显腋窝淋巴结病变、有1至2个前哨淋巴结转移的妇女中，仅接受前哨淋巴结清扫的患者的10年总存活率不低于腋窝淋巴结清扫的患者的总存活率。这些发现并不支持根据10年结果在该患者群体中常规使用腋窝淋巴结清扫术。ClinicalTrials.gov标识：NCT00003855
The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor–positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93–10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95%CI, 0–1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95%CI, 0.62–1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. clinicaltrials.gov Identifier: NCT00003855
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