Low utility of CYFRA 21‐1 serum levels for diagnosis and follow‐up in bladder cancer patients

Abstract

We evaluated serum levels of soluble fragments of cytokeratin 19 (CYFRA 21-1) by immunoassay (ES-700; Roche Diagnostics, Mannheim, Germany) to assess its usefulness in the diagnosis and follow-up of bladder cancer. The study included 39 patients with a diagnosis of transitional cell carcinoma (group 1) and 190 patients (group 2) with no evidence of tumor. In group 2, 180 patients had a history of bladder cancer, and 10 had benign prostatic hyperplasia. Significant differences in CYFRA 21-1 concentrations between groups 1 and 2 (P<0.01) were noted. However, CYFRA 21-1 levels did not significantly differ between the patients with benign prostatic hyperplasia and those with bladder cancer (P=0.274). CYFRA 21-1 values were higher in invasive bladder cancer compared to that detected in superficial stages (P=0.011). Setting the optimal cutoff value at 2.5 ng/mL resulted in a sensitivity of 43.6% and a specificity of 82.1%. No statistical differences were found when we compared disease-free time among the 66 patients with recurrences (30.7 months with levels <2.5 ng/mL vs. 41.2 months with levels >2.5 ng/mL; P=0.248). The risk of recurrence in patients with levels lower than 2.5 ng/mL (0.79) was no different (P=0.097) from that found in patients with higher levels (1.69). CYFRA 21-1 serum levels do not provide enough sensitivity to justify its application in routine protocols for the detection and follow-up of bladder cancer.

Long non-coding RNA urothelial carcinoma–associated 1 as a tumor biomarker for the diagnosis of urinary bladder cancer

“…The UCA1 has attracted the researchers’ attention not only because of the application as biomarkers for cancer prognosis and predictors for metastasis 33 but also because of the potential use as a valuable diagnostic urine biomarker. In early studies, the associations between UBC and several biomarkers such as nuclear matrix protein 22 (NMP22), 36 microRNA-96 (miR-96), 37 soluble fragments of cytokeratin 19 (CYFRA 21-1) 38 were identified. However, the diagnostic value of UBC was unsatisfactory (the specificity or specificity was low).…”

Influencia del retraso en el procesamiento preanalítico de la orina en la determinación del NMP22

“…Sin embargo, en contra de este novedoso sistema a la cabecera del paciente, se revela su mayor coste económico, muy superior al de los inmunoensayos cuantitativos, como el ensayado en este estudio. En resumen, la exactitud y fiabilidad tanto de éste test cualitativo como el de sus homólogos cuantitativos, debería ser evaluada extensamente en los nuevos escenarios de combinación de distintos test que hoy se proponen 26,27 , para mejorar el diagnóstico del cáncer de vejiga y sus frecuentes recurrencias.…”