比较前哨淋巴结评估与标准病理评估用于结肠癌分期的前瞻性随机研究：美国军事癌症研究所临床试验组GI-01研究结果
Prospective randomized study comparing sentinel lymph node evaluation with standard pathologic evaluation for the staging of colon carcinoma: results from the United States Military Cancer Institute Clinical Trials Group Study GI-01.
作者信息
Stojadinovic Alexander, Nissan Aviram, Protic Mladjan, Adair Carol F, Prus Diana, Usaj Slavica, Howard Robin S, Radovanovic Dragan, Breberina Milan, Shriver Craig D, Grinbaum Ronit, Nelson Jeffery M, Brown Tommy A, Freund Herbert R, Potter John F, Peretz Tamar, Peoples George E
机构信息
Department of Surgery, Division of Surgical Oncology, and United States Military Cancer Institute, Walter Reed Army Medical Center, 6900 Georgia Avenue N.W., Washington, D.C. 20307, USA.
出版信息
Ann Surg. 2007 Jun;245(6):846-57. doi: 10.1097/01.sla.0000256390.13550.26.
BACKGROUND
The principal role of sentinel lymph node (SLN) sampling and ultrastaging in colon cancer is enhanced staging accuracy. The utility of this technique for patients with colon cancer remains controversial.
PURPOSE
This multicenter randomized trial was conducted to determine if focused assessment of the SLN with step sectioning and immunohistochemistry (IHC) enhances the ability to stage the regional nodal basin over conventional histopathology in patients with resectable colon cancer.
PATIENTS AND METHODS
Between August 2002 and April 2006 we randomly assigned 161 patients with stage I-III colon cancer to standard histopathologic evaluation or SLN mapping (ex vivo, subserosal, peritumoral, 1% isosulfan blue dye) and ultrastaging with pan-cytokeratin IHC in conjunction with standard histopathology. SLN-positive disease was defined as individual tumor cells or cell aggregates identified by hematoxylin and eosin (H&E) and/or IHC. Primary end point was the rate of nodal upstaging.
RESULTS
Significant nodal upstaging was identified with SLN ultrastaging (Control vs. SLN: 38.7% vs. 57.3%, P = 0.019). When SLNs with cell aggregates < or =0.2 mm in size were excluded, no statistically significant difference in node-positive rate was apparent between the control and SLN arms (38.7% vs. 39.0%, P = 0.97). However, a 10.7% (6/56) nodal upstaging was identified by evaluation of H&E stained step sections of SLNs among study arm patients who would have otherwise been staged node-negative (N0) by conventional pathologic assessment alone.
CONCLUSION
SLN mapping, step sectioning, and immunohistochemistry (IHC) identifies small volume nodal disease and improves staging in patients with resectable colon cancer. A prospective trial is ongoing to determine the clinical significance of colon cancer micrometastasis in sentinel lymph nodes.
背景
前哨淋巴结（SLN）取样及超分期在结肠癌中的主要作用是提高分期准确性。该技术在结肠癌患者中的效用仍存在争议。
目的
开展这项多中心随机试验，以确定在可切除结肠癌患者中，采用阶梯切片和免疫组化（IHC）对SLN进行重点评估是否比传统组织病理学更能提高区域淋巴结分期的能力。
患者与方法
在2002年8月至2006年4月期间，我们将161例I-III期结肠癌患者随机分配至标准组织病理学评估组或SLN定位组（体外、浆膜下、肿瘤周围，1%异硫蓝染料），并结合标准组织病理学采用全细胞角蛋白IHC进行超分期。SLN阳性疾病定义为通过苏木精和伊红（H&E）及/或IHC鉴定出的单个肿瘤细胞或细胞聚集体。主要终点是淋巴结分期上调率。
结果
SLN超分期发现有显著的淋巴结分期上调（对照组 vs. SLN组：38.7% vs. 57.3%，P = 0.019）。当排除细胞聚集体大小≤0.2 mm的SLN时，对照组和SLN组之间的淋巴结阳性率无统计学显著差异（38.7% vs. 39.0%，P = 0.97）。然而，在研究组中，通过对SLN的H&E染色阶梯切片进行评估，发现10.7%（6/56）的患者出现了淋巴结分期上调，而这些患者若仅通过传统病理评估本应分期为淋巴结阴性（N0）。
结论
SLN定位、阶梯切片和免疫组化（IHC）可识别小体积淋巴结疾病，并改善可切除结肠癌患者的分期。一项前瞻性试验正在进行，以确定结肠癌前哨淋巴结微转移的临床意义。
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