Abstract
A significant number of patients with intermediate- or high-risk bladder cancer treated with intravesical Bacillus Calmette–Guérin (BCG) immunotherapy are non-responders to this treatment. Since we cannot predict in which patients BCG therapy will fail, markers for responders are needed. UroVysion® is a multitarget fluorescence in situ hybridization (FISH) test for bladder cancer detection. The aim of this study was to evaluate whether FISH can be used to early identify recurrence during treatment with BCG. In a multicenter, prospective study, three bladder washouts at different time points during treatment (t0 = week 0, pre-BCG, t1 = 6 weeks following TURB, t2 = 3 months following TURB) were collected for FISH from patients with bladder cancer treated with BCG between 2008 and 2013. Data on bladder cancer recurrence and duration of BCG maintenance therapy were recorded. Thirty-six (31.6%) out of 114 patients developed a recurrence after a median of 6 months (range 2–32). No significant association was found between a positive FISH test at t0 or t1 and risk of recurrence (p = 0.79 and p = 0.29). A positive t2 FISH test was associated with a higher risk of recurrence (p = 0.001). Patients with a positive FISH test 3 months following TURB had a 4.0–4.6 times greater risk of developing a recurrence compared to patients with a negative FISH. Patients with a positive FISH test 3 months following TURB and induction BCG therapy have a higher risk of developing tumor recurrence. FISH can therefore be a useful additional tool for physicians when determining a treatment strategy.
Highlights
Non-muscle-invasive bladder cancer (NMIBC) is a heterogeneous histopathological condition with different prognoses
A significant number of patients with intermediate- or high-risk bladder cancer treated with intravesical Bacillus Calmette–Guerin (BCG) immunotherapy are nonresponders to this treatment
Prospective study, three bladder washouts at different time points during treatment (t0 = week 0, pre-BCG, t1 = 6 weeks following TURB, t2 = 3 months following TURB) were collected for fluorescence in situ hybridization (FISH) from patients with bladder cancer treated with BCG between 2008 and 2013
Summary
Non-muscle-invasive bladder cancer (NMIBC) is a heterogeneous histopathological condition with different prognoses. For intermediate- or high-risk NMIBC, adjuvant intravesical therapy with Bacillus Calmette–Guerin (BCG) is recommended in the guidelines of the European Association of Urology and the American Urological Association [1, 2]. BCG treatment may induce local side effects in 62.8% and systemic side effects in 30.6% of patients with possible fatal outcome [4]. This may lead to interruption or discontinuation of BCG treatment in up to 20% of patients [5]. BCG failure can be divided into different types: BCG intolerant, refractory and relapsing. BCG intolerant patients have to stop due to side effects, whereas BCG refractory patients do not respond to
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