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"In this era of BCG shortage, we may be forced to develop new standards and alternative strategies for bladder preservation," writes Badar M. Mian, MD.

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

“Our study showed that at least with the regimen used in our trial, patients can have chemotherapy in addition to radiotherapy without any fear that it will impair their quality of life,” says researcher Robert A. Huddart, MD, PhD.

“In the OLYMPUS trial, more than half of patients receiving the gel had complete regression of their cancers, and most of the responses were durable. Based on these results, if UGN-101 is approved, it can be strongly considered as a kidney-sparing option for a challenging cancer," says John L. Gore, MD, MS.

“The results of our retrospective study support taking advantage of the Cxbladder test to identify patients who should be further evaluated for cancer and to spare those who likely do not have cancer from an unnecessary workup," says Badrinath Konety, MD, MBA.

“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard,” according to Richard Pazdur, MD.

The FDA has approved the anti-PD-1 therapy pembrolizumab (KEYTRUDA) as monotherapy for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, nonmuscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (PADCEV) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.

The BCG shortage, overuse of cystoscopy, and hematuria evaluation approaches are among the topics of the most-read Urology Times articles from 2019 on bladder cancer.

A study investigating discharge destination and perioperative complications after radical cystectomy provides useful data for risk stratification and preoperative counseling of patients 80 years of age and older, said Hayden M. Hill, MD, who presented the research at the American College of Surgeons Clinical Congress in San Francisco.

Financial toxicity is prevalent among patients with bladder cancer, according to findings from a cross-sectional study presented at the American College of Surgeons Clinical Congress in San Francisco.

"It’s critically important to not overemphasize the benefits or overlook the concerns related to new technology or surgical approaches as is too often the case in the marketing campaigns by various centers (both academic and community)," writes Badar M. Mian, MD.

Adding immunotherapy in the form of atezolizumab (Tecentriq) to platinum-based chemotherapy extends progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic urothelial carcinoma, according to results from a phase III study.

Access to novel therapies early in the regulatory process as a result of the FDA’s accelerated approval program can be valuable for many cancer patients, but the clinicians who are responsible for their care must have heightened vigilance for incoming data and FDA guidance about these drugs that have not gone through the “gold standard” of phase III testing.

Combined treatment with nivolumab (Opdivo), 1 mg/kg and ipilimumab (Yervoy), 3 mg/kg resulted in a 38% overall response rate in a study of platinum-pretreated metastatic urothelial cancer patients.

Despite recommendations for low-intensity cystoscopic surveillance in low-risk non-muscle invasive bladder cancer patients, U.S. Department of Veterans Affairs providers overused cystoscopy in 75% of these patients, according to a study published in Urology (2019; 131:112-9).

Study findings have implications for noninvasive markers to predict the course of UCC

Pembrolizumab (Keytruda) is showing encouraging antitumor activity in an ongoing phase II study including patients with high-risk, nonmuscle-invasive bladder cancer that is unresponsive to bacillus Calmette-Guérin treatment.

"There appears to be a strikingly high likelihood of increased morbidity and poor outcomes in patient who are not receiving definitive therapy," writes Badar M. Mian, MD.

“The variability in recommendations [for hematuria evaluation] and our study’s findings highlight implicit value judgments and a potentially high burden of harms not historically considered in many guidelines’ development process," says Matthew E. Nielsen, MD, MS.

Treatment combining the immunotherapy atezolizumab (Tecentriq) and platinum-based chemotherapy significantly improved progression-free survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma compared to chemotherapy alone.

The novel antibody-drug conjugate enfortumab vedotin produced an impressive 44% response rate in a phase II trial of urothelial cancer patients who had been treated with standard chemotherapy and a checkpoint inhibitor.

Smoking’s strong impact on bladder cancer risk among men and women is clear, but a new study shows quitting smoking can greatly reduce risk of the cancer among menopausal women.

As urologists maneuver through the third shortage of bacillus Calmette-Guérin during the past decade, there is a sense of urgency to find short- and long-term alternative treatments to the only FDA-approved BCG strain as a therapeutic agent for nonmuscle-invasive bladder cancer.

The combination of an IL-15 cytokine agonist known as N-803 and bacillus Calmette–Guérin (BCG) was well tolerated and offered promising activity in patients with nonmuscle-invasive bladder cancer (NMIBC) who did not respond to BCG therapy, according to phase I and II study results.















