IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer.

BACKGROUND: Patients with Bacillus Calmette­Guérin (BCG)­unresponsive non­muscle-invasive bladder cancer (NMIBC) have limited treatment options. The immune cell­activating interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI), also known as N-803, may act synergistically with BCG to elicit durable complete responses (CRs) in this patient population. METHODS: In this open-label, multicenter study, patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease were treated with intravesical NAI plus BCG (cohort A) or NAI alone (cohort C). Patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received NAI plus BCG (cohort B). The primary end point was the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival were secondary end points for cohort A. RESULTS: In cohort A, CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months (95% CI=9.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan­Meier estimated probability of avoiding cystectomy and of DSS was 89.2% and 100%, respectively. In cohort B (n=72), the Kaplan­Meier estimated DFS rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]). Most treatment-emergent adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%); three grade 3 immune-related treatment-emergent adverse events occurred. CONCLUSIONS: In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with a persistence of effect, cystectomy avoidance, and 100% bladder cancer­specific survival at 24 months. The study is ongoing, with an estimated target enrollment of 200 participants (Funded by ImmunityBio.)

Three-year Active Surveillance Outcomes in a Contemporary Community Urology Cohort in the United States.

OBJECTIVES: To determine the 3-year outcomes of men with prostate cancer managed with active surveillance (AS) in a cohort of geographically diverse community-based urology practices. AS is the management of choice for a majority of men with lower risk prostate cancer.1,2,3 Little is known about the contemporary "real-world" follow-up and adherence rates in the most common setting of urologic care, community (private) practice.4 METHODS: We retrospectively evaluated outcomes for men diagnosed between January 1, 2013 and May 31, 2014 with National Comprehensive Cancer Network (NCCN) very low, low and intermediate risk prostate cancer who selected AS in 9 large community urology practices. We used univariate and multivariate analyses to describe associations between race, age, insurance status, family history, comorbidity, clinical stage, Gleason score, NCCN risk-group, and PSA density with discontinuation of AS. RESULTS: Five hundred and forty-eight men on AS were followed for a median of 3.35 years. 89% (492) continued to follow-up with diagnosing practice. 32% (171) discontinued AS. On multivariate analysis, increasing NCCN risk classification (Hazard ratio [HR] 1.65, P = 0.02 and HR 2.09, P < 0.01 for low and intermediate risk vs very low risk) was significantly associated with discontinuation. Among those who discontinued AS, surgery and radiation were utilized equally (47% and 53%, respectively, P = 0.48). CONCLUSION: In this community-based cohort of men on AS, a minority was lost to follow-up and adherence to AS was similar to other reports. Disease characteristics more than sociodemographic characteristics correlated with adherence to AS, while surgery and radiotherapy were utilized equally among those discontinuing AS, both suggesting guideline concordant practice of medicine.

Contemporary Management of Incident Prostate Cancer in Large Community Urology Practices in the United States.

OBJECTIVE: To characterize the contemporary management of prostate cancer patients in large community practices. The optimal management of incident prostate cancer has changed in the last decades to include active surveillance for a large number of men. At the same time, many community practices have merged into larger groups. The adoption of evidence-based guidelines is of increasing importance, but poorly understood in this newer practice setting. METHODS: We conducted a retrospective chart review of men ≤75 years old with very low, low, and intermediate risk incident prostate cancer diagnosed between December 1, 2012 and March 31, 2014, in 9 geographically distributed large urology practices. We used descriptive statistics and multivariable regression to assess predictors of primary management choice. RESULTS: 2029 men were in the study cohort. A majority were white (68.7%). Total of 45.7% had intermediate risk, 36.2% low risk, and 17.9% had very low risk disease cancer. Active surveillance (AS) was the initial treatment for 74.7% of men with very low risk disease, 43.5% of men with low risk disease and 10.8% of men with intermediate risk disease. The probability of choosing surgery vs radiation for men with lower and intermediate risk disease was 0.54 (95% confidence interval: 0.42, 0.65) and 0.59 (95% confidence interval: 0.48, 0.69), respectively. CONCLUSION: We found that the initial management of lower risk prostate cancer in large community urology practices largely followed clinical characteristics, widespread adoption of active surveillance, and equal use of surgery and radiation. However, some variation by practice suggested a need for further investigation and continued improvement.

Review Article: Patient Centered Specialty Practice: A Value Based Care Solution for Urology Groups.

INTRODUCTION: Patient centered medical homes have been traditionally viewed as the most logical model for the treatment and coordination of care for individuals with various conditions, although there are certain diseases for which urology groups in the form of patient centered specialty practices are better suited. We assessed the current state of urology involvement in the patient centered medical home to suggest implementation strategies for which urology based, patient centered specialty practices should be the primary contact for advanced disease states. METHODS: We conducted a review of published studies using PubMed®/MEDLINE® from database inception to 2017. Studies that contained data on urology involvement in patient centered medical homes were included, as well as governmental and agency produced reports. RESULTS: There is a consensus in the literature regarding an escalation of cancer care costs that are not linked to improved patient satisfaction or outcomes. Emphasis is now being placed on innovative treatment models in oncology that are based on the patient centered model and alternative, value based payments as opposed to the traditional fee-for-service approach. The oncology medical home, in the form of a patient centered specialty practice, may mitigate some of the financial burden while providing a higher quality of care and improved patient satisfaction. CONCLUSIONS: By incorporating high quality cancer care standards such as those established by the Health and Medicine Division of the National Academies of Sciences, Engineering and Medicine, and the Centers for Medicare and Medicaid Services urology practices can position themselves as patient centered specialty practice facilities recognized by the National Committee for Quality Assurance, which are capable of becoming the primary medical homes for patients with chronic urological conditions.