Study of a New Tumor Marker, CYFRA21-1, in Malignant and Nonmalignant Diseases

Abstract

The diagnostic value of a new tumor marker, CYFRA 21-1, was studied in the sera of 50 controls, 206 patients with benign diseases and 469 patients with malignancies. Fifty controls showed mean serum concentrations of 1.2 ± 0.5 ng/ml. Using 3.3 ng/ml as the cutoff, abnormal CYFRA levels were found in 13.1% of patients with benign diseases, mainly in those with liver cirrhosis (29.4%) or renal failure (20.8%), and in 44.4% (180/405) of patients with active cancer. Neither healthy subjects nor no evidence of disease (64 cases) patients had serum levels higher than this limit. CYFRA 21-1 results were significantly higher in patients with active cancer than in those with benign diseases or without active tumors (p < 0.0001). CYFRA serum levels were significantly higher in patients with metastases (59.5%) than in those with locoregional disease (33.7%; p < 0.001). CYFRA 21-1 sensitivity in patients with lung cancer was related to tumor histology with abnormal levels in 65.6% of patients with non-small cell lung cancer and in 25% of patients with small cell lung cancer (p < 0.0001). In breast cancer, CYFRA 21-1 concentrations were significantly higher in patients with metastases and in patients with primary tumors but with nodal involvement (p < 0.001).

Serum CYFRA 21-1 (cytokeratin-19 fragments) is a useful tumour marker for detecting disease relapse and assessing treatment efficacy in breast cancer

“…In previous studies, 20 -30% of patients with one of these three benign diseases showed elevated levels of serum CYRFA 21-1 (Molina et al, 1994;Nakata et al, 1996). However, little is known about this tumour marker for breast cancer (Molina et al, 1994;Nakata et al, 2000;Giovanella et al, 2002;Rodriguez et al, 2002). According to serum CYFRA 21-1 levels at pre-and postoperation, the patients were divided into groups A, B, and C. Frequencies of recurrences were different between A and B (P ¼ 0.0312), A and C (P ¼ 0.0162), and A and B+C (P ¼ 0.007), but not B and C (P ¼ 0.1468), examined by w 2 test (Fisher's exact method).…”

“…We also demonstrated in a previous report (Nakata et al, 2000) that serum CYFRA 21-1 has not only a high positive rate for breast cancer but also high specificity for breast cancer, that is, 22 patients with benign mammary disease did not show elevated levels of serum CYFRA 21-1. Molina et al (1994) also reported that only 4% (one of 25) of patients with benign mammary disease had elevated levels of serum CYFRA 21-1.…”

“…Patients with nonmalignant disease also showed almost no elevation of serum CYFRA 21-1, except in cases of cirrhosis, renal failure, or infectious lung disease. In previous studies, 20 -30% of patients with one of these three benign diseases showed elevated levels of serum CYRFA 21-1 (Molina et al, 1994;Nakata et al, 1996). However, little is known about this tumour marker for breast cancer (Molina et al, 1994;Nakata et al, 2000;Giovanella et al, 2002;Rodriguez et al, 2002).…”

“…CYFRA 21-1 is unique in that its epitope is a polypeptide, which is most likely released following cell death (Stieber et al, 1993;Sheard et al, 2002). Elevated levels of serum CYRFA 21-1 titres have been observed in various malignancies, especially in lung cancer (Molina et al, 1994). Healthy individuals with an abnormal level of serum CYFRA 21-1 are quite rare (Molina et al, 1994;Nakata et al, 1996;Giovanella et al, 2002).…”

“…Elevated levels of serum CYRFA 21-1 titres have been observed in various malignancies, especially in lung cancer (Molina et al, 1994). Healthy individuals with an abnormal level of serum CYFRA 21-1 are quite rare (Molina et al, 1994;Nakata et al, 1996;Giovanella et al, 2002). Patients with nonmalignant disease also showed almost no elevation of serum CYFRA 21-1, except in cases of cirrhosis, renal failure, or infectious lung disease.…”