Evaluation of the UroVysion™ Test for Predicting Recurrence and Progression in Patients Receiving BCG for High Grade Non-Muscle Invasive Bladder Cancer
Patients diagnosed with high grade non-muscle invasive bladder cancer (NMIBC) and treated with BCG remain at risk for recurrence and progression of disease. The UroVysion FISH assay (Urovysion) has been reported to predict response to BCG therapy. Herein, we validated the association of UroVysion results with recurrence/progression events.
We performed a multi-center prospective study that enrolled patients with primary high grade Ta-T1 tumors, CIS or recurrent NMIBC who initiated BCG therapy. UroVysion testing was performed on urine collected prior to first instillation of BCG therapy, at time of 6th instillation, and at 3-month surveillance. Clinicians were blinded to UroVysion results for specimens collected pre-BCG and at 6th instillation of BCG therapy. Patients were monitored for disease recurrence by cystoscopy following standard of care intervals. Follow up data was collected at time of recurrence or progression and/or at 3 months, 6 months, and 9 months.
The study included 119 patients (81% men) with stages of Ta (45.8%), T1 (21.7%), CIS alone (22.5%), Ta+CIS (2.5%), and T1+CIS (7.5%). At baseline, 41.4% (48/116) were Urovysion positive. Three patients had uninformative baseline results. There were 36 events, including 22 recurrences and 14 progressions. Median time to recurrence was 84.5 days from baseline. KM survival curves demonstrate significant reduced event free survival for Urovysion with a baseline and 6-week positive test (Figure). Patients with a positive Urovysion test at baseline prior to BCG therapy were more likely to experience recurrence or progression at 3 months (29.2% vs. 13.2%, p=0.034) and 6 months (14.6% vs 2.9%, p=0.021). Similarly, patients with a positive Urovysion test prior to receiving the 6th instillation were more likely to have an event at 3 months (30.3% vs. 15.1%, p=0.068) and at 6 months (18.2% vs 4.1%, p =0.016).
Approximately one-third of patients who receive BCG have recurrence or progression events. A positive Urovysion assay at baseline and at the conclusion of BCG therapy was associated with an increased likelihood of experiencing such an event at 3 and 6 months. These data may be utilized for guiding surveillance as well as clinical trial enrollment.
Funding: Abbott Molecular