Cytokeratins are polypeptides which constitute a subclass of intermedi
ate filaments in epithelial cells. The serum tumour marker M3/M21 is b
ased on monoclonal antibodies against the epitopes M3 and M21 of cytok
eratin 18. In the present study, we measured M3/M21 serum levels in 50
patients with FIGO stage IB-IIB cervical cancer and in 50 control sub
jects using a two-site radiometric immunoassay directed against solubl
e fragments of cytokeratin 18. Median serum levels of M3/M21 in patien
ts with cervical cancer and in normal controls were 70.6 U/ml (range 0
-397.7) and 6.5 U/ml (range 0-205.2), respectively (Mann-Whitney U-tes
t, P = 0.0001). Median serum levels of M3/M21 prior to therapy and 4 w
eeks after therapy were 104.2 U/ml (range 24.6-397.7) and 39.3 U/ml (r
ange 0-234.7), respectively (Mann-Whitney U-test, P = 0.004). We found
a significant correlation between elevated M3/M21 serum levels and me
tastatic disease in pelvic lymph nodes (Mann-Whitney U-test, P = 0.002
). 24 patients relapsed after complete remission. In these patients, e
levated M3/M21 serum levels before the detection of relapse by compute
d tomography was observed in 13 cases. Considering these preliminary r
esults, further studies with an increased number of patients are justi
fied to clarify the prognostic value and the monitoring abilities of M
3/M21 in cervical cancer patients. (C) 1997 Elsevier Science Ltd.