Bladder Cancer Guidelines Showcase Advent of Immunotherapy

Danielle Ternyila
Published: Sunday, Mar 24, 2019

Thomas W. Flaig, MD

Thomas W. Flaig, MD

For more than 30 years, the treatment landscape for patients with urothelial cancer had seen little change. However, recent therapeutic updates, which have been incorporated into the National Comprehensive Cancer Network (NCCN), showcase the evolution in the field.

Specifically for muscle-invasive bladder cancer, recommendations include cisplatin-based combination chemotherapy, as well as chemotherapy plus radiation therapy.

Moreover, for those with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, there has been the addition of 5 checkpoint inhibitors to the space.  

“The biggest change in data in the bladder cancer guidelines occurred last year with the advent of checkpoint inhibitors,” said Thomas W. Flaig, MD. “Those have been integrated, and there have been multiple drugs approved.”

One of these approvals includes the PD-1 inhibitor pembrolizumab (Keytruda), which was approved as a treatment for these patients following a prior line of cisplatin or carboplatin. While many other checkpoint inhibitors are being investigated in clinical trials, the only category 1 designation currently available in bladder cancer is for pembrolizumab.

At the 2019 NCCN Annual Conference, Flaig updated the audience on the latest changes and additions to the National Comprehensive Cancer Network (NCCN) guidelines for bladder cancer, including the role of checkpoint inhibitors and in which patient populations these agents could be most beneficial.

In an interview with OncLive, Flaig, professor, associate dean for clinical research, Genitourinary Cancer Program, Division of Medical Oncology, University of Colorado, Denver, discussed the latest updates to the NCCN guidelines for the treatment of patients with muscle-invasive bladder cancer. In addition, he highlights the latest approvals of checkpoint inhibitors in this patient population.

OncLive: What are the recent updates to the NCCN guidelines for muscle-invasive bladder cancer?

Flaig: The NCCN bladder cancer guidelines have been quite active over the last several years. Traditionally, if you go back 30 years, there was very little therapeutic development in bladder cancer. In the last 3 or 4 years, there have been 5 new checkpoint inhibitors added to the guidelines. In addition to that, we’ve recently looked at the treatment of muscle-invasive disease. These are patients with invasions to T2 to T4A and are treated with curative, radical approaches. The 2 category 1 designations for muscle-invasive bladder cancer is cisplatin-based chemotherapy followed by surgery versus a combination of chemotherapy and radiation therapy, of which both are category 1.

How are these updates being integrated into clinical practice?

There are a couple of major ways the guidelines have been integrated into clinical practice in the last year. One is, again, the inclusion of both cisplatin-based combination chemotherapy for muscle-invasive disease, as well as chemotherapy/radiation therapy as a category 1 [recommendation] for muscle-invasive disease.

In addition, the American Joint Committee on Cancer staging guidelines have changed. The NCCN guidelines panel was essentially confronted with new guidelines in which we had to apply data that were generated under old guidelines and see how they best fit. For example, the new category of stage IIIA disease, which is minimal lymph node involvement, or IIIB, which is more extensive regional involvement, is now incorporated into the guidelines. For these patients, you use aggressive chemotherapy upfront and then use more aggressive local therapy for those patients who have great responses as a part of the guidelines. If a patient has lymph node disease, receives down-staging chemotherapy and has a great response, you could consider radiation therapy or consolidative surgery in those patients, and that is a change.

Could you discuss some of the data supporting these updates?

The biggest change in data in the bladder cancer guidelines occurred last year with the advent of checkpoint inhibitors. Those have been integrated, and there have been multiple drugs approved. One of those, pembrolizumab, [was approved] in the post-platinum setting, so for patients who received cisplatin or carboplatin in the first-line setting, progressed, they then received pembrolizumab. That is a category 1 designation. Amongst immune checkpoint inhibitors, it is the only category 1 we have right now.


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