• Annals of surgery · Jun 2007

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Alexander Stojadinovic, Aviram Nissan, Mladjan Protic, Carol F Adair, Diana Prus, Slavica Usaj, Robin S Howard, Dragan Radovanovic, Milan Breberina, Craig D Shriver, Ronit Grinbaum, Jeffery M Nelson, Tommy A Brown, Herbert R Freund, John F Potter, Tamar Peretz, and George E Peoples.
    • 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. alexander.stojadinovic@na.amedd.army.mil
    • Ann. Surg. 2007 Jun 1;245(6):846-57.

    BackgroundThe 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.PurposeThis 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 MethodsBetween 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.ResultsSignificant 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.ConclusionSLN 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.

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