AUA 2018: Patient Centered Outcomes of Intravesical BCG Plus Interferon

San Francisco, CA (UroToday.com) The ongoing Phase 2 BCG/IFN national trial is a trial evaluating the efficacy and primarily the safety of BCG and concurrent IFN (interferon) for the treatment of BCG-naïve and BCG-refractory NMIBC (non-muscle invasive bladder cancer). In detail, patients were treated with full dose BCG for BCG naive (BCG-N), 1/3 dose BCG for prior BCG failures (BCG-F), and 1/10 dose BCG for patients deemed BCG intolerant (BCG-I)) plus IFN for 6 weekly treatments. 

Yet, the focus of the current abstract is not on the trial results. Rather, it focused more on patient-reported outcomes (PRO); in this case, as it relates to BCG tolerance. They utilize 2 new PRO metrics for the study. A Quality of life index (QoL), which is a validated 4-part questionnaire evaluating patients′ views of various aspects of their life, was administered prior to and immediately following completion of induction therapy. A Quantitative symptom score (QSS), which is a survey of common side effects (ie dysuria, urgency, frequency, hematuria) rated from none (0) to severe (3), was completed immediately prior to each instillation, after each instillation, and daily following each instillation until the next instillation. The QoL index at least has been validated, but the QSS score has not.

Of the 984 study patients who submitted at least 1 survey of either type, response rates were moderate. 777 pre-induction and 786 post-induction QoL surveys were collected. An average of 713 QSS surveys were submitted after each instillation. 

  • There were 533 BCG-N, 415 BCG-F, and 37 BCG-I patients
When looking at the QoL surveys, there was statistically significant but clinically insignificant change in pre-to-post QoL scores in the BCG-N and BCG-F groups; there was no difference in the BCG-I group. There were no differences in the mean change in QoL score between all groups (p=0.74). 

With regards to QSS scores, all side effects were worse immediately after instillation and dissipated over the following 2-3 days. Frequency, urgency, and dysuria were the most severe side effects in all groups. BCG-I patients tended to have more severe symptoms than BCG-N and BCG-F but a significant difference in symptom severity trend during treatment was only seen in bladder pain/spasms.

Based on this, it would appear that BCG/IFN was tolerated well by all groups, regardless of prior BCG exposure, with no clinically significant difference in QoL after BCG induction. In all groups, symptoms were worst immediately after instillation but rapidly improved. BCG-I patients tended to have worse severity scores. 

The authors note that this can provide some general guidance for physicians and to patients regarding BCG tolerability. It is by no means a perfectly tolerated medication but is tolerated relatively well. 

The oncologic outcomes of BCG/IFN are still pending from the study. Their initial presentation today demonstrates similar RFS rates for all three groups (45-59% 2-year RFS). 


Presented by: Ryan Steinberg, MD, University of Iowa, Iowa City, US
Co-Authors: Lewis Thomas, Sarah Mott, Michael O'Donnell,  Iowa City, IA

Written by: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, @tchandra_uromd at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA
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