AUA 2021

(UroToday.com) Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). While the risk of disease progression is non-negligible, a significant portion of the health care burden associated with this condition is due to recurrence. Previous studies have demonstrated that the use of blue light flexible cystoscopy (BLFC) may increase the detection of additional cancers missed with white light cystoscopy (WLC) alone. However, its role in the surveillance of patients following intravesical therapy has not been established. In a podium presentation at the American Urologic Association Virtual Annual Meeting, Dr. Seyedian and colleagues presented the results of their analysis examining this question.

(UroToday.com) Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). For patients with intermediate or high-risk NMIBC and those with carcinoma in situ (CIS), adjuvant treatment is guideline-recommended on the basis of proven benefits in disease recurrence. While bacillus calmette-guérin (BCG) is preferred in those with high-risk disease, both intravesical chemotherapy and BCG are options in intermediate-risk disease.

(UroToday.com) Advanced urothelial carcinoma has among the worst prognosis for tumors treated by genitourinary oncologists. Standard of care dictates that patients receive platinum-based induction chemotherapy. However, even with this treatment, rates of recurrence and disease progression are high and overall survival is quite short due to the development of chemotherapy resistance. In the JAVELIN Bladder 100 study which was reported at ASCO 2020 Virtual Annual Meeting and subsequently published, the addition of avelumab, a PD-L1 directed therapy, as first-line maintenance to best supportive care (BSC) demonstrated improvements in overall survival for patients who did not have disease progression during their initial cytotoxic chemotherapy induction. However, the optimal timing for starting avelumab after completing 1L chemotherapy is unknown.

• 58 out of 81 (72%) patients achieved a complete response at any time (three or six months), which compares favorably to historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and valrubicin, respectively
• Median duration of complete response in all responders is 19.9 months and 85% of patients enrolled in the study have avoided a cystectomy as of May 2021
• 61% probability of initial responders (complete response at three months) remaining disease free at 18 months
• 0% treatment- or immune-related adverse events (AEs) or serious adverse events (SAEs) reported

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Laurence Klotz discussing results of the Sentinel® Prostate Cancer Platform, a test for stratification of prostate cancer risk groups. The miR Sentinel® PCC4 Test measures the expressions of 442 small non-coding RNAs extracted from urinary exosomes to differentiate patients with no molecular evidence of prostate cancer from those with molecular evidence of prostate cancer. The test further classifies men with molecular evidence of prostate cancer into low-, intermediate- or high-risk disease. At the AUA meeting, Dr. Klotz and colleagues presented the results of their study comparing the miR Sentinel® PCC4 Test to systematic core needle biopsy in men presenting with initial suspicion of prostate cancer.

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Michel Pavic discussing results of the AB12003 trial assessing masitinib plus docetaxel as first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Masitinib is an oral, small molecule drug that targets mast cell and macrophage activity. These innate immune cells are critical components of the tumor microenvironment and are associated with prostate cancer progression. Previously, a small trial (AB07004) showed that masitinib plus docetaxel slowed progression in patients with mCRPC.

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Behfar Ehdaie discussing results of a phase IIb multicenter study assessing MRI-guided focused ultrasound focal therapy for intermediate-risk prostate cancer. Radical whole-gland therapy for prostate cancer can lead to significant side effects, including a decline in erectile function and urinary continence. Patients with Grade Group 2 or 3 prostate cancer are often ineligible for active surveillance or experience early disease progression (40% within 5 years in ProtecT¹) on active surveillance requiring radical therapy. Focal therapy has emerged as an alternative treatment with the goal to reduce side effects and maintain cancer control by targeting areas of known cancer with the prostate gland. Multicenter, retrospective studies have shown focal therapy for prostate cancer is safe and reported approximately 80% of men require no further prostate-cancer-directed treatment.² This study investigated whether targeted focal therapy using ExAblate MRI-guided focused ultrasound can safely treat Gleason Grade Group 2/3 prostate cancer patients in a single-arm, multicenter phase IIb clinical trial.

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Rafael Sanchez-Salas discussing results of the IMPROVE trial assessing surgical technique in the context of recovery of urinary continence after radical prostatectomy. Post-radical prostatectomy urinary incontinence is not uncommon. Both pelvic floor muscle training and duloxetine have been shown to be effective in improving post-radical prostatectomy urinary incontinence in retrospective series. This trial aimed to assess the efficacy of pelvic floor muscle training and duloxetine in urinary continence recovery after robot-assisted radical prostatectomy.

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session including a presentation by Dr. Sarah Welsh discussing translational results of the NAXIVA trial, a phase 2 neoadjuvant trial of axitinib for reducing the extent of venous tumor thrombus in clear cell renal cell cancer with venous invasion. Venous tumor thrombus extension occurs in 4-15% of cases of renal cell cancer, and although surgery is performed with curative intent, mortality is high (5-15%). The concept of neoadjuvant targeted therapy to downstage venous tumor thrombus prior to extirpative surgery is appealing in order to reduce the extent of the venous tumor thrombus surgery, and potentially reduce morbidity and mortality of the operation. The NAXIVA trial provided the first level II evidence in this patient group, assessing the response of venous tumor thrombus to axitinib. The primary endpoint, first presented at GU ASCO 2021, of the percentage of evaluable patients with an improvement in venous tumor thrombus according to the Mayo classification was positive at 26.58%. Additionally, 35.29% of patients had a change in the surgical approach to a less invasive option. Median percent reduction in venous tumor thrombus height was 21.49%. Response rate (RECIST) was 61.90% with stable disease, 14.29% with a partial response, and 9.52% with progressive disease. In this presentation, Dr. Welsh and colleagues presented the results of translational studies examining the role of the tumor microenvironment and response to axitinib.

(UroToday.com) The AUA 2021 virtual annual meeting included a late-breaking abstract session with a presentation by Dr. Karim Chamie discussing long-term recurrence free survival following UGN-101 treatment for low-grade upper tract urothelial carcinoma.

(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Andrei Iagaru discussing the prospective evaluation of 18F-DCFPyL PET/CT in biochemically recurrent prostate cancer and the detection of extra-pelvic oligometastases. ¹⁸F-DCFPyl has been shown to have intense uptake in the bladder, kidneys, salivary glands, and lacrimal glands, with weak uptake in the liver, spleen, and bowel:

• New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate
• Phase 3 EMPOWUR trial post-hoc subgroup analyses showed once-daily GEMTESA was associated with significantly reduced daily urgency episodes and micturitions in patients with OAB wet and dry (with and without urge urinary incontinence [UUI] per diary day, respectively) vs. placebo
• Presented at the virtual AUA 2021 annual meeting, these data further support safety and efficacy of GEMTESA for treatment of OAB in patients with symptoms of UUI, urgency, and urinary frequency

(UroToday.com) In this study by Linehan and colleagues, the authors focus on the outcomes of female patients from the OLYMPUS trial [NCT02793128], in which patients with low grade upper tract urothelial carcinoma (LG-UTUC) were treated with a novel reverse thermal gel containing mitomycin.

(UroToday.com) In this study by Kaushik and colleagues, the authors explored the impact of yoga on men with newly diagnosed prostate cancer before and after prostatectomy. They found that yoga has important effects on quality of life (QoL), antitumor immune response, and inflammatory response.

(UroToday.com) In this presentation at the American Urologic Association (AUA) annual meeting, Dr. Kelly Stratton presents the initial results of the ABC trial, an open-label Phase Ib trial of BCG therapy in conjunction with avelumab for patients with BCG unresponsive non-muscle invasive bladder cancer (NMIBC). From a safety standpoint, they found that induction therapy with combined BCG and avelumab was safe and well-tolerated.

(UroToday.com) In this late breaking abstract, Zhao and colleagues delved into the reporting of tobacco use in contemporary GU clinical trials and found that it is rarely collected or reported. Considering the impact of smoking on the development of GU malignancies, this is a deficiency that needs to be addressed.