Case 1: Treatments for NMIBC Refractory to BCG

EXPERT PERSPECTIVE VIRTUAL TUMOR BOARD

Arlene O. Siefker-Radtke, MD:Thank you so much, Gordon. This really sounds like the typical case that presents to a lot of urology offices. What would you typically offer this patient?

Gordon Brown, DO:Yes, this is something that we see commonly in our clinical practices on a day-to-day basis. Our management of this patient population has changed a little bit over the last 12 to 24 months in a couple of different aspects. 1) The limitation of BCG [bacillus Calmette-Guérin] supply nationally has forced us really to reevaluate and further risk stratify patients for appropriate use of BCG within our clinical practices. And to that end, we’ve tried to relegate that use primarily to those patients who have high-risk localized disease. For example, those patients who have high-grade T1 disease or those patients who have CIS [carcinoma in situ] at the time of diagnosis, larger Ta high-grade disease at the time of diagnosis. All of those patients are preferentially given BCG, at least as a BCG induction.

The additional aspects that have changed our clinical practice here are the multitude of new therapeutic options, both on clinical trial primarily for patients with refractory BCG disease in the community. As it relates specifically to ongoing therapy for a patient like this, they’ve obviously demonstrated progression of their disease to adequate BCG therapy.

So the question becomes, potentially, what are some of the next steps? We oftentimes look to the use of additional intravesical chemotherapies, potentially look to the use of valrubicin. We also look potentially to discussion around early cystectomy in some cases, and also look to clinical trial enrollment certainly for this patient population.

Arlene O. Siefker-Radtke, MD:When would you consider additional BCG induction or maintenance? Never in a case like this?

Gordon Brown, DO:Showing rapid progression of his CIS within the first 6 months really defines that patient as a BCG-refractory patient. Going on to additional BCG, if the supply was available, it potentially puts him at risk for disease progression. This is really somebody who we would consider going on to subsequent novel therapy, clinical trial enrollment, or additional intravesical options.

The challenges with maintenance BCG at this point are that the supply simply isn’t there for us. So we’ve had to look to other options, specifically intravesical chemotherapies, either gemcitabine alone, which we normally would deliver as 1 g of gemcitabine and then 50 cc of saline as an induction course plus a month of maintenance course. There have been some recent data published by Michael O’Donnell, MD, looking at the combination use of gemcitabine with docetaxel in sequential fashion, similarly looking at the use of induction plus monthly maintenance. That’s of course in the BCG-naїve setting. But those options I think become reasonable in the BCG-refractory patient with a limited supply of drug available to us.

Transcript edited for clarity.