Molecular assays related to cell proliferation correlate with stage an
d/or survival in a variety of tumors. We immunostained formalin-fixed,
paraffin-embedded tissue sections from 61 patients with gastric adeno
carcinoma (21 biopsy and 40 gastrectomy specimens) for cyclin A, cycli
n B1, p34(cdc2) p120, MIB1, and proliferating cell nuclear antigen (PC
NA) by automated methods. HER-2/neu gene amplification was analyzed by
automated fluorescence in situ hybridization (FISH). Immunostains, FI
SH results, and pathologic stage were compared with length of survival
. Forty-three percent of the cases showed amplification of HER-2/neu.
Sixty-two percent of cases showed positive immunostaining for cyclin A
, 38% for cyclin B1, 31% for p34(cdc2), 49% for p120, 69% for MIB1, an
d 33% for PCNA. On univariate analysis, pathologic stage (P =.003) and
HER-2/neu gene amplification (P <.001) correlated with length of surv
ival. Cyclin A, cyclin BI, p34cdc2 p120, MIDI, and PCNA did not correl
ate with survival. On multivariate analysis, pathologic stage (P =.015
) and HER-2/neu gene amplification (P =.002) independently predicted s
urvival. These correlations were unrelated to tubular or signet ring c
ell histologic characteristics or to location within the cardia or mor
e distally, Pathologic stage and HER-2/neu gene amplification by FISH
were independent prognostic factors in gastric cancer, but the various
proliferation markers that we studied did not correlate with survival
.