How will bladder Ca care change with new drug approvals?

February 24, 2020

"It certainly looks like these new therapies will provide better results. From the research and literature, it looks like significant improvement," says one urologist.

Urology Times reached out to three urologists (selected randomly) and asked them each the following question: How will bladder cancer care change with new drug approvals?

"It will have significant impact for nonmuscle-invasive bladder cancer. The availability of solutions like Bacillus Calmette-Guérin [BCG] has become so sporadic, we just can’t acquire BCG in a safe and efficient fashion. Since we can’t get it, we need to find some new and novel approaches. This will make a significant impact.

The newer therapies hold promise even above the BCG, but BCG was, and remains, a very important medicine. It’s just harder to find. So it’s a great opportunity and the timing is good. Since there’s a dire need, industry will come in and help us fill that need, so from that perspective it’s great we have these new medicines.

It will be for refractory cases of BCG, without some of the potential side effects of BCG. Although in my experience BCG has been pretty safe, Keytruda [pembrolizumab] is really a step beyond BCG.

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It certainly looks like these new therapies will provide better results. From the research and literature, it looks like significant improvement. Keytruda can have side effects such as pneumonitis, but it is an effective treatment and when you’re treating a lethal disease, it’s a matter of weighing the potential side effects, which are reasonable in number, with the new medicines.

I’m looking forward to using them, not just for refractory disease or BCG-refractory disease, but also in lieu of BCG if it’s not available, and for the many people who are not inclined to have a cystectomy.”

Jeffrey Ranta, MD / Wellsboro, PA

Next:"Some of these will be coming through, but not in the setting in which most of us will use them."“Some of these will be coming through, but not in the setting in which most of us will use them. I’m still using the same paradigm of treatment for nonmuscle-invasive bladder cancer. A lot of these drugs were used following failures of primary therapy, not as the primary go-to.

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The data from BCG trials is good data and has been around for a while, so we really don’t need to change what we do. The only reason it might replace what I normally use is because we’re constantly faced with shortages of generic products. That’s what might change the paradigm. Their role will be as a result of continued shortages unless they truly show themselves superior to current treatment options.

I refer metastatic disease to oncologists and don’t know if these drugs will be better for them. But I don’t think it will replace our effective paradigm unless the AUA endorses the changes. I don’t know where we’ll end up with these new medications with respect to urothelial tract diseases, whether of the bladder or upper tract.

There is a problem sometimes getting not only BCG, but [non-urologic treatments such as] epinephrine. That price skyrocketed even though it’s generic. The government has to address those shortages. I don’t think people realized how many of these drugs were manufactured in Puerto Rico. That’s why there’s such a shortage.

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But the new therapies still have not filtered down to community urologists so that we’re changing our algorithms.”

Micaela Aleman, MD / Austin, TX

Next:"It’ll be a huge change."“It’ll be a huge change. We’ve been using things like BCG for intermediate- and high-risk, nonmuscle-invasive bladder cancer for decades. I’m not familiar with all the new products, but the most exciting is Keytruda, a checkpoint inhibitor, recently FDA approved for BCG-unresponsive cancer. It’s a huge change because so many patients go down that pipeline.

Checkpoint inhibitors changed the game starting with melanoma.

In the last few years, Keytruda has been a mainstay for treating advanced metastatic bladder cancers.

Urologists all have patients with unresectable bladder tumors. Initially, we were putting them through chemotherapy, which they would ultimately fail. Metastatic transitional cell carcinoma was a terminal diagnosis. But checkpoint inhibitors changed that. We have so many patients I am still scoping 5 years later. Now they’re all NED-no evidence of disease-and it’s fantastic.

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These agents were tested in patients with metastatic disease, end-stage. Now, they’re introducing it for patients who don’t have metastatic disease but other high-grade features.

Checkpoint inhibitors were such a game changer in melanoma and other cancers, especially advanced bladder cancer, they said, ‘Let’s use them earlier in patients who are not metastatic, but who have nonmuscle-invasive disease that’s high grade and recurrent, or most importantly, have failed BCG.’

Keytruda is most exciting for community urologists because it works for regular high-grade bladder cancer that does not respond to BCG. It’s like, Hey, we’ve got a backup other than cystectomy.’ A lot of older frail individuals can’t tolerate surgery or chemo; that’s where checkpoints inhibitors come in.”

Christopher Runz, DO / Chestertown, MD

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