Cancer of the uterine cervix: sensitivity and specificity of serum Cyfra 21.1 determinations

The purpose was to evaluate the usefulness of serum Cyfra 21.1 assay for the monitoring of patients with uterine cervix cancer.

Pre-treatment sera and complete follow-up of the patients were available for SCC and Cyfra 21.1 for 79 patients Another group of 50 patients was studied to evaluate the specificity, sensitivity, negative or positive predictive values of the markers. The cut-off value for Cyfra 21.1 (1.1 ng/ml) was established by ROC curve analysis.

A positive or negative concordance between SCC and Cyfra 21.1 was observed in 65.8% of the cases. Positive SCC and negative Cyfra 21.1 were found in 22.8% of the sera, while the inverse was observed in 11.4% of the cases. The mean concentrations of SCC and Cyfra 21.1 were correlated to FIGO stages, with Cyfra 21.1 being elevated in 100% of stages III and IV. Cyfra 21.1 was also correlated with the extension of the cancer, and to the presence of metastases. The mean concentrations of both markers were significantly higher in the sera of patients with constant progression (P < or = 0.0019). Analysis of 186 results from 91 patients followed-up with a median of 3.29 years showed a sensitivity of 89.5% for Cyfra 21.1, 75.0% for SCC, and a specificity of 86.4% and 99.1%, respectively. The positive predictive values were 91.9% for Cyfra 21.1 and 98.3% for SCC, and the negative predictive values 92.7% and 85.2%, respectively. Median lead times, calculated from the records of 18 selected patients with complete resection of the tumour, were found to be 60 days for Cyfra 21.1 and 50 days for SCC (P > 0.05).

In cervical cancer Cyfra 21.1 is very well-correlated to the tumour burden and the extent of the disease. In the case of recurrence, this marker rises more often than SCC. We therefore propose the use of Cyfra 21.1 for the monitoring of cervical cancer.