New Treatment Option (Other Than Surgery) for Non-Muscle Invasive Bladder Cancer

The first half of 2020 has overwhelmed us with an ongoing firehose of big news. In this relentless news climate, it is understandable that news that normally might get more attention has flown below the radar.

I believe one story in that vein for bladder cancer patients was the approval of pembrolizumab (Keytruda) in January for certain patients with non-muscle invasive high-grade bladder cancer that hasn’t responded to BCG.

What did the FDA approve?

Pembrolizumab (Keytruda) has been around for several years as a treatment option for advanced bladder cancer. What is new here is that it has now been approved to treat non-muscle invasive high-grade disease if BCG has failed to work.

In January, the FDA approved the use of pembrolizumab for patients with carcinoma in situ (CIS) who may or may not also have papillary tumors.1

The approval was based on a clinical trial that demonstrated that 41% of patients (based on 96 patients) had a complete response to treatment with pembrolizumab. The median duration of the response was 16.2 months. Of the patients with a complete response, 46% had a complete response that lasted at least 12 months. Treatment consisted of 200 mg every three weeks. Fewer than 10% of patients experienced adverse reactions.

CIS affects a subset of patients - but it's a more aggressive version of non-muscle invasive disease

Bladder cancer can present via several different types of tumors, including papillary, sessile, and carcinoma in situ (CIS). And it is possible to have more than one of these types.

CIS is estimated to affect only about 10 percent of patients upon diagnosis. CIS tumors are flat and non-muscle invasive but are known to be more aggressive and carry a higher risk of metastasis. A survey of relevant studies found that within five years of diagnosis, 40% to 60% of patients with CIS develop invasive disease.2

Why is this approval a big deal?

As many patients know, historically, if BCG doesn’t work the next option is often bladder removal (radical cystectomy). This FDA approval creates another medical treatment choice as an alternative to surgery. And patients who have been told they need their bladder removed understand the significance of having another option.

Leading bladder cancer specialist Dr. Gary Steinberg of New York University summed it up to UroToday as follows:

The approval of pembrolizumab is paradigm-changing and offers patients a possible therapy to preserve their native bladder function while eliminating their cancer,” says Dr. Steinberg. “This is a breakthrough for some patients and most likely will lead to new combinations of therapy for this aggressive form of localized bladder cancer that will hopefully benefit additional patients. This will lead to further research and innovative treatments for the bladder cancer community and clearly is a significant advance.

Which type of doctor will oversee this treatment?

One interesting question this approval raises is which type of doctor will be the one to administer the systemic pembrolizumab for these patients?

There has historically, been a clear line between the role of urologists (cystoscopies, BCG, surgeries including TURBTs and radical cystectomies) and the role of medical oncologists who administer systemic chemotherapy prior to or after bladder removal. They also treat advanced bladder cancer patients with systemic and immunotherapy drugs.

It will likely require collaboration between medical oncologists and urologists

It is an interesting question and likely to result in an evolving collaboration between the urologists and medical oncologists. And it is more likely to be a challenge in the community setting (as opposed to at large academic cancer centers where urologists and medical oncologists typically work closely together).4

The relatively new (with approvals starting in 2016) immunotherapy drugs like pembrolizumab do carry the potential for serious side effects. Medical oncologists are the specialists who have worked most extensively with these drugs and will be able to help inform and guide urologists in their use.

It continues to be an exciting and hopeful time for bladder cancer patients. Still, too many people suffer from and die from this disease. But every new approval, every new option on the table is an additional sliver of hope.

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