Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.
Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.
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DOI：
10.1016/s1470-2045(10)70207-2
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发表时间：
2010-10
期刊：
影响因子：
51.1
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
--
作者：
Krag, David N.;Anderson, Stewart J.;Julian, Thomas B.;Brown, Ann M.;Harlow, Seth P.;Costantino, Joseph P.;Ashikaga, Takamaru;Weaver, Donald L.;Mamounas, Eleftherios P.;Jalovec, Lynne M.;Frazier, Thomas G.;Noyes, R. Dirk;Robidoux, Andre;Scarth, Hugh M. C.;Wolmark, Norman
前哨淋巴结手术旨在最大限度地减少淋巴结手术的副作用，但仍提供与腋窝淋巴结清扫术相当的结局。NSABP方案B-32的目的是确定乳腺癌患者前哨淋巴结切除术是否能达到与腋窝淋巴结清扫术相同的生存率和区域控制率，但副作用更少。5611例浸润性乳腺癌患者被随机分配到前哨淋巴结切除加腋窝淋巴结清扫（第1组）或仅在前哨淋巴结阳性时进行前哨淋巴结切除加腋窝淋巴结清扫（第2组）。在NSABP生物统计中心进行随机分配，并通过使用偏倚硬币最小化方法完成。分层变量为入组时的年龄（≤ 49，≥ 50）、临床肿瘤大小（≤ 2.0 cm，2.1 - 4 cm，≥ 4.1 cm）和手术计划（乳房肿瘤切除术，乳房切除术）。使用蓝色染料和放射性示踪剂进行前哨淋巴结切除。按照方案中的预先规定，根据随机分组对随机化时评估为病理学阴性前哨淋巴结的患者（3989例患者）进行终点数据分析。对所有有随访信息的患者（无论其合格性状态如何）进行终点分析（3986例患者）。研究的主要终点是总生存期。包括所有死亡，无论原因如何。有随访信息的3986例前哨淋巴结阴性患者的平均研究时间为95.6个月（范围：70.1 - 126.7个月）。在3986例有随访信息的前哨淋巴结阴性患者中，共报告了309例死亡。第1组和第2组总生存期的对数秩比较得出未校正的风险比为1.20（95%置信区间[CI]; 0.96 - 1.50，P = 0.12）。第1组和第2组的8年总生存期Kaplan-Meier估计值分别为91.8%和90.3%。无病生存期的治疗比较产生的未校正风险比为1.05（95% CI：0.90 - 1.22，P=0.54）。第1组和第2组的8年无病生存期Kaplan-Meier估计值分别为82.4%和81.5%。第1组有8例区域淋巴结复发为首发事件，第2组有14例（P=0.22）。患者继续随访，以进行长期生存和区域控制评价。两组的总生存期、无病生存期和区域控制率在统计学上相当。当前哨淋巴结阴性时，对于临床淋巴结阴性的乳腺癌患者，单独进行前哨淋巴结手术而不进行进一步的腋窝淋巴结清扫是一种适当、安全和有效的治疗方法。
Sentinel node surgery was designed to minimize side effects of lymph node surgery but still offer outcomes equivalent to axillary dissection. The aims of NSABP Protocol B-32 were to determine whether sentinel node resection in breast cancer patients achieves the same survival and regional control as axillary dissection but with fewer side effects. 5611 women with invasive breast cancer were randomly assigned to sentinel node resection plus axillary dissection (Group 1) or to sentinel node resection alone with axillary dissection only if sentinel nodes were positive (Group 2). Random assignment was done at the NSABP Biostatistical Center and accomplished via using a biased coin minimization approach. Stratification variables were age at entry (≤ 49,≥ 50), clinical tumor size (≤ 2.0 cm, 2.1 – 4 cm, ≥ 4.1 cm), and surgical plan (lumpectomy, mastectomy). Sentinel node resection was done using blue dye and radioactive tracer. As pre-specified in the protocol, analyses of endpoint data were performed according to the randomized group assignments on patients who were assessed at the time of randomization as having pathologically negative sentinel nodes (3989 patients). The endpoint analyses were performed on all such patients who had follow-up information regardless of their eligibility status (3986 patients). The primary endpoint for the study was overall survival. All deaths regardless of cause were included. The mean time on study for the 3986 sentinel node-negative patients with follow-up information was 95.6 months (range: 70.1 – 126.7 months). A total of 309 deaths were reported in the 3986 sentinel node-negative patients with follow-up information. Log-rank comparison of overall survival in Groups 1 and 2 yielded an unadjusted hazard ratio of 1.20 (95% confidence interval [CI]; 0.96 –1.50, P = 0.12). Eight-year Kaplan-Meier estimates for overall survival are 91.8% in Group 1 and 90.3% in Group 2. Treatment comparisons for disease-free survival yielded an unadjusted hazard ratio of 1.05 (95% CI: 0.90 – 1.22, P=0.54). Eight-year Kaplan-Meier estimates for disease-free survival are 82.4% in Group 1 and 81.5% in Group 2. There were 8 regional node recurrences as first events in Group 1 and 14 in Group 2 (P=0.22). Patients are continuing follow up for longer term evaluation of survival and regional control. Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the sentinel node is negative, sentinel node surgery alone with no further axillary dissection is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes.