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【NEJM】隐匿性转移是前哨淋巴结初检阴性乳腺癌
Donald L. Weaver, M.D., Takamaru Ashikaga, Ph.D., David N. Krag, M.D., Joan M. Skelly, M.S., Stewart J. Anderson, Ph.D., Seth P. Harlow, M.D., Thomas B. Julian, M.D., Eleftherios P. Mamounas, M.D., and Norman Wolmark, M.D.
January 19, 2011
http://www.nejm.org/doi/full/10.1056/NEJMoa1008108
Background Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking.
Methods We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension.
Results Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease–free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively.
Conclusions Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.)
ses on Survival in Node-Negative Breast Cancer.pdf (574.7k) 在线查看 Effect of Occult Metastases on Survival in Node-Negative Breast Cancer
隐匿性转移对淋巴结阴性乳腺癌生存的影响
Background Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking.
背景：回顾性分析和临床观察表明，隐匿性淋巴结转移是乳腺癌患者复发或生存的重要预后因子。但一直缺乏关于前哨淋巴结转移随机临床试验的前瞻性数据。
Methods We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension.
方法：我们随机分配女性乳腺癌患者接受前哨淋巴结活检和腋窝淋巴结清扫或只接受前哨淋巴结活检。前哨淋巴结病理学阴性患者的前哨淋巴结石蜡切片用于评估切片中更隐匿的转移。在双宽距附加组织水平上同时使用常规染色和免疫组化染色来检测细胞角蛋白。主治医生不了解这些发现，也未用于临床治疗决策。设计肿瘤部位的初期评价标准用来检测所有最大直径＞2 mm的大转移。
Results Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease–free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively.
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作者:admin@医学,生命科学 2011-02-16 23:22
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