Purpose: We postulated that the pathologic evaluation of the lymph nodes of
surgical specimens from patients with rectal cancer can have a substantial
impact on time to relapse and survival.
Patients and Methods: We analyzed data from 1,664 patients with T3, T4, or
node-positive rectal cancer treated in a national intergroup trial of adjuv
ant therapy with chemotherapy and radiation therapy. Associations between t
he number of lymph nodes found by the pathologist in the surgical specimen
and the time to relapse and survival outcomes were investigated.
Results: Patients were divided into groups by nodal status and the correspo
nding quartiles of numbers of nodes examined. The number of nodes examined
was significantly associated with time to relapse and survival among patien
ts who were node-negative. For the first through fourth quartiles, the 5-ye
ar relapse rates were 0.37, 0.34, 0.26, and 0.19 (P = .003), and the 5-year
survival rates were 0.68, 0.73, 0.72, and 0.82 (P = .02). No significant d
ifferences were found by quartiles among patients determined to be node-pos
itive. We propose that observed differences are primarily related to the in
correct determination of nodal status in node-negative patients. Approximat
ely 14 nodes need to be studied to define nodal status accurately.
Conclusion: These results suggest that the pathologic assessment of lymph n
odes in surgical specimens is often inaccurate and that examining greater n
umber of nodes increases the likelihood of proper staging. Some patients wh
o might benefit fram adjuvant therapy are misclassified as node-negative du
e to incomplete sampling of lymph nodes. J Clin Oncol 19:157-163. (C) 2001
by American Society of Clinical Oncology.