Abstract

GARCIA PENALVER, C.; PEREZ BARRIOS, A.  and  LEIVA GALVIS, O.. Clinical usefulness of the immunocyt™ urinary test in the follow-up protocol of patients with urothelial neoplasms. Actas Urol Esp [online]. 2005, vol.29, n.6, pp.535-541. ISSN 0210-4806.

Objectives: The overall objective of this study was to carry out a prospective investigation of the usefulness of the IMMUNOCYT™ commercial kit in the follow-up of patients treated for bladder cancer and to evaluate its utility as a complement to urinary cytology and a possible tool for reducing the number of follow-up cystoscopies required. Subjects and methods: From September 2001 to December 2002, the ImmunoCyt™ test and urinary cytology were performed in urine simples from a total of 136 patients (115 with a history or suspicion of bladder cancer and 21 patients with other urological pathologies). Urine simples were fixed with an equal volume of 50% alcohol. Urinary cytology and the ImmunoCyt™ test were interpreted by a cytopathologist unacquainted with the result of the corresponding cytology and bladder biopsy report. Samples were staged and graded using the 1997 TNM classification of the UICC and the 1998 WHO/ISUP classification. Histopathological confirmation of lesions was available for 111 patients (81.6%). Results: The gender distribution was 89% men and 11% women. Mean age was 71.68 years (range 27 to 98 years). Overall sensitivity and specificity were 77.9% and 92.3% for the ImmunoCyt™ test and 47.9% and 100% for urinary cytology, respectively. The positive (PPV) and negative predictive values (NPV) were 96.4% and 61.7%, respectively, for the ImmunoCyt™ test and 100% and 36.7% for cytology. In Ta and low-grade carcinomas, the sensitivity of the ImmunoCyt™ test was 70% (n=20) and 76.4% (n=34) respectively, whereas it was 25% (n=28) and 29.7% (n=37), respectively, for urinary cytology. The differences observed between the sensitivities of the ImmunoCyt™ test and cytology were statistically significant (X² p<0.05) overall and for Ta and low-grade carcinomas. The sensitivity and specificity of the combination of both tests were 86.8% and 96.2%, respectively. The sensitivity of the combination of both tests for Ta and low-grade carcinomas was 80% (n=20) and 82.3% (n=34), respectively. The ImmunoCyt™ test was diagnostic in 36.2% of tumors overall. Conclusions: In view of the results obtained, we decided to change our follow-up protocol to reduce the number of follow-up cystoscopies by 32.2% in the first 5 years of postoperative follow-up (in a cohort of 140 patients who undergo surgery annually). This benefits patients by reducing the number of urinary infections and iatrogenesis originated by follow-up cystoscopy. In addition, this 32.2% reduction in the number of cystoscopies in 5 years will yield a savings of approximately 35,560 EUR to the health care system in 5 years.

Keywords : Bladder cancer; Cystoscopy; Urinary cytology.

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