Background. Carcinoembryonic antigen (CEA) is a well-described human t
umor-associated antigen most useful clinically in colon cancer. Howeve
r, the clinical usefulness of CEA is limited by the marker's overall p
oor specificity and low sensitivity in patients with minimal disease.
CA 195 is a recently discovered human tumor-associated glycoprotein th
at can be measured in serum using an immunoradiometric assay. CA 195 i
s expressed on the membrane of human colon cancer cells and shares an
epitope with the Lewis A blood group antigens. The authors initiated a
study to compare the clinical utility of serum CA 195 with CEA in pat
ients with advanced cancer. A control population was studied to assess
the effects of age, gender, alcohol, and tobacco on the measured leve
ls of serum CA 195. Methods. Using a solid-phase two-site immunoradiom
etric assay, serum CA 195 and CEA levels were measured in 71 control s
ubjects and 167 patients with a prior diagnosis of cancer. The tumor h
istologic types included breast cancer, 49 patients; colon cancer, 38;
prostate cancer, 24; lung cancer, 22; gastrointestinal noncolon cance
r, 7; and miscellaneous, 27. Among patients with a history of cancer,
124 (74%) had active metastatic disease, and 43 (26%) were without evi
dence of active disease. The control population was composed of subjec
ts without a history of malignancy. Clinical data collected from them
included age, gender, smoking history, and alcohol consumption. Result
s. In this laboratory, the normal ranges established for CA 195 and CE
A in the control group were: 0.0-8.3 U/ml and 0.2-4.2 ng/ml, respectiv
ely. In the control subjects, the serum CA 195 level, unlike that of C
EA, was not affected by age, gender, alcohol consumption, or tobacco u
se. In the study population, CA 195 had either equivalent or inferior
specificity and sensitivity to CEA in all tumor types. A determination
of the additive specificity and sensitivity of CA 195 and CEA did not
significantly improve its clinical utility compared with CEA alone. H
owever, CA 195 was significantly elevated in three patients with a pri
or history of colon cancer thought to be without evidence of active di
sease. Because all three of these patients had a relapse within the ne
xt 1-15 months, CA 195 might identify early relapses of colon cancer i
n some patients. Conclusions. Based on these results, it was concluded
that CA 195 is not superior to CEA as an indicator of disease activit
y in advanced colon cancer or other solid tumors. However, studies uti
lizing CA 195 in the detection of early relapses of colon cancer may b
e warranted. A review of the English literature revealed that CA 195 m
ight be a useful marker in pancreatic cancer.