PROGNOSTIC-SIGNIFICANCE OF SERUM FRAGMENTS OF CYTOKERATIN-19 MEASUREDBY CYFRA-21-1 IN CERVICAL-CANCER

Pretreatment sera of 78 patients with squamous cell cervical cancer we re tested for the presence of cytokeratin 19 (CK 19) fragments to dete rmine the relationship among this parameter, tumor stage, various hist opathologic characteristics, and prognosis. For the quantitative deter mination of CK 19 fragments in serum, the enzyme assay Cyfra 21-1 was used. This assay, based on the simultaneous sandwich principle, utiliz es two different monoclonal antibodies. The test was considered positi ve when levels of Cyfra 21-1 were greater than or equal to 1.2 mu g/li ter. Cyfra 21-1 was positive in the majority of patients and in all pa tients with advanced disease (FIGO III or IVa). A highly significant r elationship was found between pretreatment Cyfra 21-1 level and FIGO s tage (P < 0.0001). Mean Cyfra 21-1 concentration was elevated in the c ase of macroinvasive disease (FIGO Ib, IIa, IIb, III, IVa). A distinct relationship was found between tumor size (P < 0.001; r = 0.73) and C yfra 21-1 level. In the univariate Cox analysis Cyfra 21-1 level was s ignificantly related to both disease-free interval (P < 0.0001) and su rvival (P < 0.0001) of patients. Patients with an increased Cyfra 21-1 level had a significantly worse prognosis. However, in the stepwise C ox regression analysis, these variables had no additional value over k nown prognostic factors such as FIGO stage and tumor size. It is concl uded that Cyfra 21-1 may be of significance as an additional marker in the management of patients with cervical cancer, but further investig ation is needed. (C) 1994 Academic Press, Inc.