The Value of the ImmunoCyt/uCyt+ Test in the Detection and Follow-up of Carcinoma In Situ of the Urinary Bladder

Background: Urine bound tests, which have been developed for the early detection of urothelial cancer (UC), do not seem to match cytology in the detection of carcinoma in situ (CIS) as their sensitivity in the case of CIS is poor. ImmunoCyt/uCyt+™ in CIS seems promising, but the number of analysed CIS is still small. The aim of the present study was to assess the value of this test in the detection and follow-up of carcinoma in situ of the urinary bladder. Patients and Methods: Thirty-five patients, with histologically verified CIS of the urinary bladder, were included in the study. At the first diagnosis, patients underwent cytology, cystoscopy, bioptical bladder mapping and ImmunoCyt/uCyt+™. All patients underwent BCG instillation therapy. The patients were followed with cytology, ImmunoCyt/uCyt+™, cystoscopy and bladder mapping after every BCG cycle and then every 3 months. Results: At the first CIS diagnosis, the sensitivity of cytology and ImmunoCyt/uCyt+™ was 100%. At the first control after therapy, cytology detected 81.8% of recurrences and ImmunoCyt/uCyt+™ detected 90.9%. At the second control, both tests each detected 50% of recurrences. At every control, the combination of both the tests together gave a sensitivity of 100%. The specificity of cytology after therapy improved from 88.2% at the first control up to 100% at the third control. The specificity of ImmunoCyt/uCyt+™ after BCG initially decreased from 70.6% to 55.5% and finally increased to 88.9%. Conclusion: ImmunoCyt/uCyt+™ is as sensitive as cytology in the first diagnosis of CIS. In the follow-up, even if it is less sensitive, its combination with cytology leads to detection of 100% of the recurrences. Despite decreasing specificity after therapy, the value remains acceptable and increases during maintenance therapy. The ImmunoCyt/uCyt+™ test could play an important role in controlling the response of patients to instillation therapies or in the modification of their application schedules.