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Targeted Nodal Assessment Improves Survival in Early Colon Cancer: Prospective Randomized USMCI Clinical Trials Group GI-01 Study, Final Results
Aviram Nissan*1, Mladjan Protic2, Anton Bilchik3, Robin Howard4, George E Peoples*5, Alexander Stojadinovic*4
1Rabin Medical Center, Petah Tikva, Israel2Clinic of Abdominal, Endocrine, and Transplantation Surgery, Novi Sad, Serbia3University of California, Los Angeles, CA;4Walter Reed National Military Medical Center, Bethesda, MD;5Brooke Army Medical Center, Fort Sam Houston, TX

OBJECTIVE: We have previously shown in a prospective randomized trial (PRT) that targeted nodal assessment (TNA) improves staging in early colon cancer (CC). We evaluated long-term oncological outcome in this mature PRT comparing standard pathological assessment to nodal ultra-staging in early CC.
METHODS: This was a PRT conducted over an 8-year period in 192 patients with non-metastatic colon adenocarcinoma randomized to standard nodal histopathological evaluation (Control) or TNA and ultra-staging (TNAus; step sectioning and immunohistochemistry). Disease-free survival (DFS) was compared between groups.
RESULTS: Control (n=94) and TNAus (n=98) groups with Stage I-III CC were comparable, except for median (IQ range) total lymph nodes (LNs) assessed [13 (10-18) vs. 16 (12-22), respectively, p=0.002).
Median (IQ range) follow-up was 46 (29-70) months. Disease recurrence in early CC (Stage I/II) was 26% in Control and 11% in TNAus groups. Five-year DFS was 71% and 86% (p=0.041) in Control and TNAus groups, respectively.
The only significant difference between these groups was total LNs assessed in the subset of Stage I/II CC patients [Control: 13 (8-18) vs. TNAus: 15 (12-21); p=0.016]. Use of adjuvant chemotherapy was similar between groups.
CONCLUSIONS: Targeted nodal assessment and ultra-staging optimizes staging accuracy and improves disease-free survival in early colon cancer. This is the first prospective randomized trial demonstrating improved DFS with nodal ultra-staging in early CC.

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