Abstract
Objectives:
To compare the side effect profiles following different instillation regimens of intravesical BCG immunotherapy for non-muscle invasive bladder cancer.
Patients and methods:
Profile scores for each of the commonly reported side effects of BCG therapy were collected from a total of 70 patients receiving a once weekly, six week course of BCG instillation as induction adjuvant treatment for non-muscle invasive bladder cancer. Of these patients, 47 received a series of one hour BCG instillations and 23 received a series of two hour instillations. Patients were asked to grade their symptoms each day of the six week course on a four point scale. Data on recurrence, progression to cystectomy and mortality were also collected for each of the patients.
Results:
The most significant symptoms experienced following BCG therapy were frequency, urgency and dysuria irrespective of regimen. Most patients did not experience significant symptoms following the first instillation. Symptoms were worse in the first two days following instillation in subsequent weeks. Unexpectedly, patients on the two hour regimen recorded lower side effect scores when compared to the one hour group for frequency, urgency, dysuria and arthralgia. These were statistically significant when analysed for variance (P values of 0.007, 0.0004, 0.02 and <0.0001 respectively). There was no statistically significant difference between groups for the other side effects studied. Over a four-year follow-up period, there were no statistically significant differences detected between the one hour or two hour regimens in terms of recurrence (odds ratio (OR)= 1.13, confidence interval (CI) = 0.41–3.11), time until first recurrence (P = 0.25) or grade of recurrence (P = 0.17). There was no significant odds reduction in favour of the one hour group compared to the two hour group in terms of recurrence of carcinoma-in situ (OR = 1.1, CI = 0.33–3.65), progression to cystectomy (OR = 0.98, CI = 0.22–4.30) or mortality from bladder cancer (OR = 0.63, CI = 0.18–2.25).
Conclusions:
During a six week regimen, the side effects of intravesical BCG immunotherapy become significant in the 2nd week of treatment and are worst on day two post-instillation. The severity of symptoms increases throughout the course of the treatment. A one hour treatment regimen produced a more significant side effect profile in terms of frequency, urgency, dysuria and arthralgia when compared to the two hour regimen. There was no detectable difference in clinical outcomes observed between the two groups. Continuing the practice of a two hour BCG instillation regimen is therefore recommended.
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