Case 1: Impact of the BCG Shortage in Bladder Cancer

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Arlene O. Siefker-Radtke, MD:When there’s no clinical trial, intravesical therapy with gemcitabine, or gemcitabine/Taxol, what do you think is used most frequently or is the current standard?

Gordon Brown, DO:I think currently the standard probably would be, based on the published data, a combination of gemcitabine and docetaxel based on Michael O’Donnell, MD’s literature. Historically, up until just recently, we’ve used gemcitabine as a standard of care. I think that that paradigm has shifted now to the use of sequential therapy with gemcitabine and docetaxel in the same patient population.

Arlene O. Siefker-Radtke, MD:So we are seeing the standard starting to change over time, moving from gemcitabine to gemcitabine/paclitaxel. But I have to ask you, in the setting of a BCG [bacillus Calmette-Guérin] shortage, I understand they’re recommending only use of a third of a vial or partial vial use to allow BCG to be available for more patients. Do you think that that could have impacted this patient’s care?

Gordon Brown, DO:It’s possible. The current AUA [American Urological Association] and SUO [Society of Urologic Oncology] recommendation as it relates to BCG therapy really relegates the use, as we discussed to those patients who are at highest risk of recurrence and progression of their disease over time. And those patients who have low risk or those patients who have intermediate-risk disease really should be precluded from BCG use. In the setting where we have an initial patient who has high-grade disease, whether it’s T1 or CIS [carcinoma in situ] and they’re BCG-naїve, they should be prioritized to undergo induction therapy. If the supply is available, we can dose reduce to one-half or one-third dose and follow-up.

There’s no suggestion that on this patient per se that they had a dose-reduced regimen going forward. I guess if we’re assuming they were treated in the current climate, we’d have to assume so. However, the data would suggest that we can dose reduce and still have tumor effect as it relates to that therapy going forward. It has made us, in a practical sense, reevaluate and risk stratify these patients fairly aggressively and identify those patients up front who would best be suited to undergo BCG therapy.

What’s helped us with that is the use of advanced cystoscopic techniques where we’ve been able to further stage patients more appropriately, and allow patients to undergo more complete resections of their tumor at the time of their diagnosis, and potentially find multifocal disease that was previously unidentified. There are some good data out there that were recently published by Yair Lotan MD in 2019, which looked at some recommendations on the use of blue light cystoscopy in not only the diagnosis but the surveillance of these patients over time. And they recommend in those patients who have high-risk disease that they have blue light cystoscopy at 3 months, and then at 6 months, and every 6 months thereafter during the course of their surveillance.

So use of that technology has allowed us, I believe, to further maximally treat these patients up front, which obviously is the cornerstone of their therapy, and to identify previously potentially missed multifocal disease, all of which has been demonstrated in both prospective trials as well as meta-analyses to reduce recurrence risk over time. The impact on progression has not really been demonstrated in any great degree yet.

Transcript edited for clarity.