Ex vivo sentinel lymph node mapping in patients undergoing proctectomy for rectal cancer.

Purpose: Controversy exists over the utility of sentinel lymph node mapping in the treatment of rectal cancer. The purpose of this study was to evaluate the use of ex vivo sentinel lymph node mapping in the setting of proctectomy for rectal cancer, with and without multilevel sectioning and immunohistochemistry.

Methods: A prospective phase 2 clinical study of subjects undergoing proctectomy for rectal cancer from 2003 to 2008 was conducted. Sentinel lymph node mapping was performed with ex vivo injection of isosulfan blue. Sentinel lymph nodes were examined by hematoxylin and eosin evaluation, and when the results were negative, they were examined by multilevel sectioning and immunohistochemistry.

Results: The study population consisted of 58 subjects; 88% received neoadjuvant therapy. Tumors were downstaged in 25 (49%) subjects receiving neoadjuvant therapy, 24% were clinical complete responders, and 20% were pathologic complete responders. The mean total lymph node harvest was 12.1 nodes per patient. Twenty-five subjects had positive nodal disease on final pathology. The sentinel lymph node detection rate was 85%, with a mean sentinel lymph node harvest of 2.2 nodes per subject. Fifteen (26%) subjects had sentinel lymph node nodal metastasis on routine hematoxylin and eosin examination. Neither multilevel sectioning nor immunohistochemistry evaluation improved detection of sentinel lymph node positivity. The accuracy of sentinel lymph node mapping was 71%, the sensitivity was 53%, the negative predictive value was 79%, and the false negative rate was 47%. Seven subjects were determined to have nodal disease only in the sentinel lymph node.

Conclusion: Ex vivo sentinel lymph node mapping is feasible after proctectomy for rectal cancer but did not improve staging. Neither multilevel sectioning nor immunohistochemistry improved the sensitivity of sentinel lymph node mapping.