SUO 2022

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting featured a bladder cancer session, including a presentation by Dr. Ashish Kamat discussing new definitions for intermediate risk non-muscle invasive bladder cancer. Dr. Kamat started his presentation by highlighting that non-muscle invasive bladder cancer accounts for 73% of all bladder cancer diagnoses, including 42% high-grade disease and most commonly high-grade Ta (63%) non-muscle invasive bladder cancer:

(UroToday.com) The second Prostate Cancer Session of the Annual Meeting of the Society of Urologic Oncology was held on Friday, December 2nd, 2022. In this session, Dr. Ana Aparicio presented on the role of biomarkers and somatic testing to guide treatment choice in advanced prostate cancer.

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting featured a bladder cancer session, including a presentation by Dr. Sarah Psutka discussing new trials and horizons for intermediate risk bladder cancer. Dr. Psutka started her presentation by highlighting the need to hone definitions and increasing precision of guideline-based care. However, the problem is the need to reduce the therapeutic burden for intermediate risk non-muscle invasive bladder cancer and improve outcomes, and the solution may be to use strategies to de-escalate therapeutic burden and improving treatment efficacy. In 2022 there will be 81,180 new bladder cancer diagnoses, with 61,000 of these being non-muscle invasive bladder cancer (mostly low/intermediate risk). Although there is variability in the definition of intermediate risk non-muscle invasive bladder cancer among the AUA/SUO, NCCN, EAU, and IBCG, there is generally agreement on treatment recommendations:

(UroToday.com) The 23rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA between November 30th and December 2nd, 2022 was host to a prostate cancer session. Dr. Samuel L. Washington III, MD, MAS presented the results of a population-based analysis evaluating geographic variations in the utilization of doublet therapy for metastatic prostate cancer patients.

(UroToday.com) The 23rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA between November 30th and December 2nd, 2022 was host to a prostate cancer session. Dr. Ashley Ross, MD, PhD presented the results of an external validation of a digital pathology-based artificial intelligence (AI) model predicting metastasis and death in high and very high risk men from the NRG/RTOG 9902 phase III trial.

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting featured a bladder cancer session, including a presentation by Dr. Roger Li discussing looking towards the future, focusing specifically on trials reading out in 24 months. Dr. Li started his presentation by highlighting that BCG is very effective. In a recent assessment of contemporary outcomes at a single institution of patients with non muscle-Invasive bladder cancer treated with BCG, the 1-year high-grade recurrence free survival rate was 81%, 1-year progression free survival rate was 97%, 1-year cancer-free survival rate was 95%, and 1-year overall survival rate was 99% over a median follow-up of 47.8 months.¹ Notably, this contemporary cohort had better outcomes for BCG than seen in historical studies. The full 1-, 3-, and 5-year survival analysis outcomes are as follows:

(UroToday.com) The 23rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA between November 30th and December 2nd, 2022 was host to a session on the real life impact of CxBladder tests for the diagnosis and surveillance of bladder cancer.

Dr. John Sfakianos began his presentation by noting that current guidelines for surveillance provide little concrete guidance for when surveillance may be stopped. The AUA currently provides the following guidance by risk category:

1. Low risk: After five years, shared decision making between patients and providers
2. Intermediate risk: No definitive stopping point
3. High risk: No definitive stopping point

Conversely, the EAU provides the following guidance:

• Low-risk tumors: After five years of follow-up, discontinuation of cystoscopy or its replacement with less invasive methods can be considered
• In patients with high risk, or very high-risk disease treated conservatively, recurrences after ten years of tumor-free survival are not unusual. As such, life-long follow-up is recommended.

Although cystoscopies have low, non-zero morbidity, they remain psychologically cumbersome for patients. Currently, urinary biomarkers are used as adjunct (or companion) tests to improve detection at the time of flexible cystoscopy or as replacement tests to reduce the number of flexible cystoscopies. Everyone’s goal, however, is to have a noninvasive monitoring method for patients with non-muscle invasive bladder cancer.

The following questions for surveillance of patients with non-muscle invasive bladder cancer remain:

• Can we use non-invasive methods to adjust surveillance schedules?
• Can we use non-invasive methods to stop cystoscopies when risk is very low?
• Can we use non-invasive methods to personalize scheduling?
• Do we have to adjust for never recurrence versus multiple recurrences? 

In order to answer these questions, we need to better understand the natural history of patients with bladder cancer. Dr. Sfakianos presented, as of yet, unpublished data from a cohort of 386 patients with non-muscle invasive bladder cancer, from Karolinska, Sweden, who were followed for a median of 10.8 years (IQR: 4.2 to 20.2 years). Of these 386 patients, 284 (73.6%) LG or HG Ta disease and 55 patients (14.2%) died of bladder cancer.

Long-term follow-up of this cohort showed:

1. There was a clear separation of the cancer-specific survival curves amongst patients with LG Ta, HG Ta and HG T1 disease, as demonstrated below:

1. Recurrence and progression rates beyond five years in patients with HG T1 disease are essentially a never occurrence and occur only rarely in patients with LG Ta disease.

As such, these results can inform how we tailor our surveillance strategies in these patients, as a function of survival time from initial diagnosis. Dr. Sfakianos next addressed how he uses Cxbladder in his practice, by risk category:

• Low-risk patients: For patients without recurrence by three years, he currently uses Cxbladder, a urinalysis, and urine cytology instead of cystoscopy
• Intermediate-risk patients: For patients without recurrence by five years, he currently uses Cxbladder, a urinalysis and urine cytology every 6 months instead of a cystoscopy
• High-risk patients: For patients without recurrence by five years, he currently uses Cxbladder, a urinalysis, and urine cytology every 6 months instead of a cystoscopy

Dr. Sfakianos next went on to present a case study highlighting the utility of Cxbladder from his own practice This was an 83-year-old male who initially presented with hematuria in 2017. The patient was found to have CIS of the bladder. He was treated with induction BCG and maintenance for 1 year which was completed in 2019. The patient had no evidence of disease recurrence and had undergone surveillance cystoscopies and urine tests every six months. The patient was doing well on surveillance until February 2020, when he was found to have a negative cystoscopic examination, but urine cytology showed evidence of malignant cells. Faced with this clinical dilemma, Dr. Sfakianos ordered Cxbladder Monitor test, which came back as 2.7 (below the pre-defined cut off of 3.5).

Despite the negative test result, Dr. Sfakianos took the “safe” option of taking the patient back to the operating room for random biopsies and an upper tract evaluation, with all the work up negative for presence of gross malignancy. He subsequently has had positive cytology results, but with negative cystoscopies and negative Cxbladder Monitor test results during his surveillance. His last evaluation as of May 2022 still showed no evidence of disease.

While peer-reviewed studies¹ have demonstrated that Cxbladder Monitor has an excellent negative predictive value in the range of 97 to 98.5%, Dr. Sfakianos’ group performed an internal “real world” analysis, that validated the findings from these prior studies. In this series of 161 patients with non-muscle invasive bladder cancer and 439 Cxbladder Monitor tests, all patients underwent a cystoscopy plus cytology with subsequent TURBT in case of a positive cystoscopy. This analysis demonstrated that overall, for all patients, the negative predictive value was 90.0%. For LG Ta and HG T1 patients, the corresponding negative predictive value (NPV)s were 80.2% and 97.0%, respectively.

Dr. Sfakianos concluded his talk by emphasizing that understanding the risk recurrence for the various NMIBC risk groups and having a test such as Cxbladder Monitor with a high NPV may allow us to improve/personalize noninvasive surveillance testing for our patients.

Presented by: John Sfakianos, MD, Assistant Professor of Urology and Urologic Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 23rd Annual Meeting of the Society of Urologic Oncology (SUO), Nov 30 – Dec 2, 2022. San Diego, CA

References:

1. Kavalieris L, et al. Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study. J Urol 2017;197(6):1419-26.

Related Content: From Science to Clinical Utility: Cxbladder Monitor- Bladder Cancer Surveillance for Patients with Urothelial Carcinoma - Tamer Aboushwareb, Neal Shore & Josh Meeks

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting featured a bladder cancer session, including a presentation by Dr. Seth Lerner discussing trials in the non-muscle invasive bladder cancer BCG naïve space, specifically early in the FDA regulation process. Dr. Lerner started by noting that in November 2021 the FDA held a workshop specifically for clinical trial design for non-muscle invasive bladder cancer. As part of this workshop was a session on BCG shortage, trial design for BCG-naïve patients, risk stratification, and definition of disease states, bladder-intact, and high-grade event free survival.

(UroToday.com) The 23^rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA between November 30^th and December 2^nd, 2022 was host to a session on the real life impact of CxBladder tests for the diagnosis and surveillance of bladder cancer.

Dr. Sima Porten began her presentation by noting that there has been an “explosion” of “at home” tests, many of which have been approved by the US FDA. The most prominent example of this is the Cologuard stool DNA tests for colorectal cancer screening that has seen widespread adoption in the United States.

(UroToday.com) At the second Prostate Cancer Session of the Annual Meeting of the Society of Urologic Oncology, Dr. Mark Preston discussed the role of neoadjuvant therapy prior to radical prostatectomy.

(UroToday.com) At the second Prostate Cancer Session of the Annual Meeting of the Society of Urologic Oncology, Dr. Zachary Klaassen discussed the very important topic of mental illness and suicidality in men with prostate cancer.

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting included the Joseph A. Smith, Jr. Mentorship Award Lecture, including a presentation by recipient Dr. Mark Litwin. Dr. Litwin started his presentation by highlighting that he is originally from South Carolina, with his family living in Charleston for 6 generations. Moving forward, he noted that while at Duke University in 1978 doing his undergraduate work, he met several influential people that helped shape his career. The first was John Feinstein, a renowned sports author, who was in several classes with Dr. Litwin and was a constant encouragement to pursue writing and journalism. The second was his close friend and urologic oncology colleague, Dr. Tom Jarrett. While at Duke, Dr. Litwin eventually became an assistant statistician for the basketball team, sitting in the Crow’s Nest of Cameron Indoor Stadium, fostering an early love for statistics that would eventually become the core of his health-services research career. Legendary Duke basketball coach Mike Krzyzewski had several common mantras and sayings, several of which Dr. Litwin included in the presentation that resonates with him:

(UroToday.com) The 23^rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA was host to a bladder cancer abstract session. Dr. Caretha Creasy, PhD, Vice President of Early Development at UroGen® Pharma, presented the early protocol for a phase 1 dose-escalation study of UGN-301 (Zalifrelimab) as monotherapy and in combination with other agents in patients with recurrent non-muscle invasive bladder cancer.

(UroToday.com) The 2022 Society of Urologic Oncology annual meeting featured a session on bladder cancer, including a presentation by Christine Lentowski discussing the trial design of a phase 3 single-arm study of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle invasive bladder cancer. UGN-102 is a mitomycin-containing reverse thermal gel in development for primary nonsurgical treatment of low grade intermediate risk non-muscle invasive bladder cancer.

(UroToday.com) The 23^rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA was host to a session on the real life impact of Cxbladder tests for the diagnosis and surveillance of bladder cancer. Dr. Sia Daneshmand began his presentation by highlighting the two commonly used urine-based tests in the field of urothelial cancer: cytology and FISH. Cytology, which identifies cells that have sloughed off tumor and are caught in voided urine, is plagued by poor sensitivity (59 - 62%), high rates of atypical or suspicious findings, and inter-reader variability, which limit its utility as a “rule out test”, particularly for low-grade disease. Fluorescence In Situ Hybridization (FISH) test, which similarly identifies whole cells that have sloughed off tumor and caught in voided urine, is typically used as a reflex test following atypical cytology results. FISH interpretation is quantitative and depends on the number of cells with aneuploidy, with moderate rates of non-diagnostic results. Furthermore, this test has poor sensitivity (39%) with high variability.

(UroToday.com) At the 2022 Prostate Cancer Session of the Annual Meeting of the Society of Urologic Oncology, Dr. Mohit Khera presented on the use of testosterone replacement therapy among patients with prostate cancer, including in the setting of screening, active surveillance, and after treatment for localized prostate cancer.

(UroToday.com) A poster session focusing on Bladder and Kidney cancer was held at the Annual Meeting of the Society of Urologic Oncology and in this session, Dr. Josh Gottlieb presented results of a multi-center study examining alternative routes of administration for UGN-101. 

(UroToday.com) The poster session focusing on Bladder and Kidney cancer was held at the Annual Meeting of the Society of Urologic Oncology. In this session, Dr. Phillip M. Pierorazio presented long-term outcomes for patients treated with UGN-101 for low-grade upper tract urothelial carcinoma (UTUC).

(UroToday.com) The 23^rd Annual Meeting of the Society of Urologic Oncology held in San Diego, CA was host to a prostate cancer session, with Dr. Laura Anne Sena discussing the recent advances in the field of bipolar androgen therapy in advanced prostate cancer.

(UroToday.com) The 2022 SUO annual meeting featured a session on prostate cancer, including a presentation by Dr. Brian Chapin discussing results from the phase 3 LIGHTHOUSE trial assessing the diagnostic performance and safety of ¹⁸F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer. Prostate-specific membrane antigen (PSMA) PET has become the mainstay for prostate cancer imaging. Radiohybrid (rh) PET radiopharmaceutical, ¹⁸F-rhPSMA-7.3, is a novel high affinity PSMA ligand. At the 2022 SUO winter meeting, Dr. Chapin and colleagues reported the first data on the diagnostic performance and safety of ¹⁸F-rhPSMA-7.3 from the phase 3 LIGHTHOUSE study (NCT04186819) that evaluated ¹⁸F-rhPSMA-7.3 in men with newly diagnosed prostate cancer planned to undergo radical prostatectomy.