Enhancing bladder cancer care through the multidisciplinary clinic approach.

INTRODUCTION: To report the impact of our 25-year multidisciplinary care delivery model experience on patients with muscle invasive bladder cancer treated at our National Cancer Institute (NCI)-designated Sidney Kimmel Cancer Center at Jefferson University. To our knowledge, our multidisciplinary genitourinary cancer clinic (MDC) is the longest continuously operating center of its kind at an NCI Cancer Center in the United States. MATERIALS AND METHODS: We selected a recent group of patients with cT2-4 N0-1 M0 bladder cancer seen in the Sidney Kimmel Cancer Center Genitourinary Oncology MDC from January 2016 to September 2019. These patients were identified retrospectively. SEER-18 (Surveillance, Epidemiology, and End Results) database, November 2019 submission was queried to obtain patients with similarly staged disease diagnosed between 2015 and 2017. Completion rates of radical cystectomy, use of neoadjuvant therapies, and survival outcomes were compared between the two cohorts. RESULTS: Ninety-one patients from the MDC form this time period were identified; 65.9% underwent radical cystectomy and 71.8% received neoadjuvant therapy in the form of chemotherapy, immune checkpoint inhibition or a combination of the two - higher than reported national trends for neoadjuvant therapies. Progression of disease was seen in 24.2% of patients. A total of 8675 patients met inclusion criteria in the SEER database. Rates of radical cystectomy were significantly higher in MCD patients when compared to SEER derived data (65.9% vs. 37.7%, p =< 0.001). MCD patients had significantly better cancer-specific survival (mean 20.4 vs. 18.3 months p = 0.028, median survival not reached). CONCLUSION: Our long term experience caring for patients with genitourinary malignancies such as bladder cancer in a uniform multidisciplinary team results in a high utilization of neoadjuvant therapies. When compared to a contemporary SEER-derived cohort, multidisciplinary patients were more likely to undergo radical cystectomy and had longer cancer-specific survival.

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer.

PURPOSE: Prostate cancer is the most common cancer among men in the United States. The majority of prostate cancer treatment occurs in the ambulatory setting, and patients and their caregivers take on significant responsibility for monitoring and managing treatment and disease-related toxicity. Digital health coaching has shown promise as a tool to positively influence outcomes. We completed a single-arm pilot study to assess the feasibility of digital health coaching in men with prostate cancer. METHODS: Men with a history of prostate cancer requiring treatment in the past 2 years were eligible for inclusion. Participants engaged in a 12-week health coaching program, consisting of a combination of at least one telephone call and up to four digital nudges (defined as content delivered via text, e-mail, or app on the basis of the participant's preference) per week. Prostate cancer-specific content addressed one of the following topics each week: fatigue, pain management, healthy eating, exercise, managing incontinence, sexual health, managing stress and anxiety, financial toxicity, goal setting during treatment, managing side effects, communicating with the health care team, and medication adherence. Services were provided at no cost to the participant. RESULTS: A hundred patients were consented for the study, and 88 enrolled. The feasibility threshold of 60% was met with 63 of the 88 enrolled individuals completing the 3-month program (proportion = 71.6%; 90% CI, 62.6 to 79.4; P = .016). CONCLUSION: Digital health coaching for men with prostate cancer is feasible. These findings support further evaluation of digital health coaching for men with prostate cancer in larger randomized controlled trials.

Pretest Genetic Education Video Versus Genetic Counseling for Men Considering Prostate Cancer Germline Testing: A Patient-Choice Study to Address Urgent Practice Needs.

PURPOSE: Germline testing (GT) for prostate cancer (PCA) is now central to treatment and hereditary cancer assessment. With rising demand for and shortage of genetic counseling (GC), tools to deliver pretest informed consent across practice settings are needed to improve access to GT and precision care. Here, we report on Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWER), a patient-choice study for pretest video-based genetic education (VBGE) versus GC to inform urgent practice needs. PATIENTS AND METHODS: Men with PCA or at risk for PCA (family history of PCA) were eligible and could choose pretest VBGE or GC. Outcomes included decisional conflict for GT, change in genetics knowledge, satisfaction, and intention to share results with family and/or providers. Descriptive statistics summarized results with counts and percentages for categorical variables and mean ± standard deviation for continuous variables. Data were compared with Fisher's exact, chi-squared, or Wilcoxon two-sample tests. Mean change in genetics knowledge was compared with t tests. The significance level was set a priori at .05. RESULTS: Data on the first 127 participants were analyzed. Characteristics were White (85.8%), bachelor's degree (66.9%), and PCA diagnosis (90.6%). The majority chose VBGE (71%) versus GC (29%; P < .001). No differences were observed in decisional conflict for GT or satisfaction. Cancer genetics knowledge improved in both groups without significant difference (+0.9 VBGE, +1.8 GC, P = .056). Men who chose VBGE had higher intention to share GT results (96.4% VBGE v 86.4% GC, P = .02). Both groups had high rates of GT uptake (VBGE 94.4%, GC 92%). CONCLUSION: A substantial proportion of men opted for pretest VBGE, with comparable patient-reported outcomes and uptake of GT. The results support the use of pretest video to address the critical GC shortage in the precision era.

Implementation of Germline Testing for Prostate Cancer: Philadelphia Prostate Cancer Consensus Conference 2019.

PURPOSE: Germline testing (GT) is a central feature of prostate cancer (PCA) treatment, management, and hereditary cancer assessment. Critical needs include optimized multigene testing strategies that incorporate evolving genetic data, consistency in GT indications and management, and alternate genetic evaluation models that address the rising demand for genetic services. METHODS: A multidisciplinary consensus conference that included experts, stakeholders, and national organization leaders was convened in response to current practice challenges and to develop a genetic implementation framework. Evidence review informed questions using the modified Delphi model. The final framework included criteria with strong (> 75%) agreement (Recommend) or moderate (50% to 74%) agreement (Consider). RESULTS: Large germline panels and somatic testing were recommended for metastatic PCA. Reflex testing-initial testing of priority genes followed by expanded testing-was suggested for multiple scenarios. Metastatic disease or family history suggestive of hereditary PCA was recommended for GT. Additional family history and pathologic criteria garnered moderate consensus. Priority genes to test for metastatic disease treatment included BRCA2, BRCA1, and mismatch repair genes, with broader testing, such as ATM, for clinical trial eligibility. BRCA2 was recommended for active surveillance discussions. Screening starting at age 40 years or 10 years before the youngest PCA diagnosis in a family was recommended for BRCA2 carriers, with consideration in HOXB13, BRCA1, ATM, and mismatch repair carriers. Collaborative (point-of-care) evaluation models between health care and genetic providers was endorsed to address the genetic counseling shortage. The genetic evaluation framework included optimal pretest informed consent, post-test discussion, cascade testing, and technology-based approaches. CONCLUSION: This multidisciplinary, consensus-driven PCA genetic implementation framework provides novel guidance to clinicians and patients tailored to the precision era. Multiple research, education, and policy needs remain of importance.

Prospective study to define the clinical utility and benefit of Decipher testing in men following prostatectomy.

BACKGROUND: Genomic classifiers (GC) have been shown to improve risk stratification post prostatectomy. However, their clinical benefit has not been prospectively demonstrated. We sought to determine the impact of GC testing on postoperative management in men with prostate cancer post prostatectomy. METHODS: Two prospective registries of prostate cancer patients treated between 2014 and 2019 were included. All men underwent Decipher tumor testing for adverse features post prostatectomy (Decipher Biosciences, San Diego, CA). The clinical utility cohort, which measured the change in treatment decision-making, captured pre- and postgenomic treatment recommendations from urologists across diverse practice settings (n = 3455). The clinical benefit cohort, which examined the difference in outcome, was from a single academic institution whose tumor board predefined "best practices" based on GC results (n = 135). RESULTS: In the clinical utility cohort, providers' recommendations pregenomic testing were primarily observation (69%). GC testing changed recommendations for 39% of patients, translating to a number needed to test of 3 to change one treatment decision. In the clinical benefit cohort, 61% of patients had genomic high-risk tumors; those who received the recommended adjuvant radiation therapy (ART) had 2-year PSA recurrence of 3 vs. 25% for those who did not (HR 0.1 [95% CI 0.0-0.6], p = 0.013). For the genomic low/intermediate-risk patients, 93% followed recommendations for observation, with similar 2-year PSA recurrence rates compared with those who received ART (p = 0.93). CONCLUSIONS: The use of GC substantially altered treatment decision-making, with a number needed to test of only 3. Implementing best practices to routinely recommend ART for genomic-high patients led to larger than expected improvements in early biochemical endpoints, without jeopardizing outcomes for genomic-low/intermediate-risk patients.

Spatial distribution of biopsy cores and the detection of intra-lesion pathologic heterogeneity.

OBJECTIVES: The objective of this study was to determine if spatial distribution of multiparametric magnetic resonance imaging-transrectal ultrasound (mpMRI-TRUS) fusion biopsy cores to the index lesion reveals trends in the detection of intra-lesion Gleason heterogeneity and a more optimal prostate biopsy strategy. METHODS: Index lesion was the lesion with longest diameter on T2-weighted (T2W)-MRI. In cohort 1, fusion biopsy cores biopsies were taken in areas in the center of the target as well as 1 cm laterally on each side. For cohort 2, targeted biopsies were taken from the center of the lesion only. Heterogeneity was defined as difference in maximum Gleason score obtained from fusion cores in the center of the index lesion versus cores obtained from the periphery (cohort 1), or any difference in maximum Gleason score obtained from fusion cores targeted to the index lesion (cohort 2) compared with systematic 12 cores TRUS biopsy. RESULTS: Ninety-nine consecutive patients (35 and 64 in cohorts 1 and 2, respectively) with median age (SD) and prostate-specific antigen (PSA) of 66.9 (±5.9) and 9.7 (±8.2) respectively, were included. Age, PSA, Prostate Imaging Reporting and Data System (PI-RADS) score, and preoperative MRI lesion size were not significantly different between cohorts. Gleason heterogeneity was observed at a significantly higher rate in cohort 1 versus cohort 2 (58% versus 24%; p = 0.041). In cohort 1, cores obtained from the center of the lesion had higher Gleason score than cores obtained from the periphery of the targeted lesion in 57% of cases. CONCLUSIONS: We demonstrate that there is observable tumor heterogeneity in biopsy specimens, and that increased number of cores, as well as cores focused on the center and periphery of the largest lesion in the prostate, provide more comprehensive diagnostic information about the patient's clinical risk category than taking nonspecific cores targeted within the tumor.

Clinical Influences in the Multidisciplinary Management of Small Renal Masses at a Tertiary Referral Center.

INTRODUCTION: We designed a multidisciplinary Small Renal Mass Center to help patients decide among treatment options and individualize therapy for small renal masses. In this model physicians and support staff from multiple specialties work as a team to evaluate and devise a treatment plan for patients at the same organized visit. METHODS: We retrospectively reviewed the records of 263 patients seen from 2009 to 2014. Monitored patient characteristics included age, Charlson comorbidity index, body mass index, nephrometry score, tumor size and estimated glomerular filtration rate. Univariate and multivariate analyses were performed to identify patient characteristics associated with each treatment choice. RESULTS: Of the cohort 88 patients elected active surveillance, 64 underwent ablation and 111 were treated with surgery, including partial and radical nephrectomy in 74 and 37, respectively. There were significant associations between treatment modality and age, Charlson comorbidity index, tumor size and estimated glomerular filtration rate. Mean patient age at presentation was 61.1 years. Patients with a high Charlson comorbidity index score (greater than 5) or a decreased estimated glomerular filtration rate (less than 60 ml/minute/1.73 m2) were more likely to undergo active surveillance (41.6% and 35%) and ablative therapy (29.6% and 34%) vs partial nephrectomy (10.6% and 9%, respectively, each p <0.001). On multivariable analysis age, tumor size and estimated glomerular filtration rate remained significantly associated with modality after adjustment for all other factors (each p <0.001). CONCLUSIONS: The Small Renal Mass Center enables patients to assess the various treatment modalities for a small renal mass in a single setting. By providing simultaneous access to the various specialists it provides an invaluable opportunity for informed patient decision making.

Risk factors for biochemical recurrence after robotic assisted radical prostatectomy: a single surgeon experience.

BACKGROUND: Radical prostatectomy is a standard surgical treatment of clinically localized prostate cancer. Margin status has been found to be an independent predictor of biochemical recurrence (BCR) after open radical prostatectomy in several large series but this is still controversy in Robotic Assisted Radical Prostatectomy (RARP) series. We therefore wanted to investigate the prognostic significance of positive surgical margin (PSM) and other pathological factors on BCR in patients treated with RARP by a single surgeon. METHODS: Prospectively collected data of 439 patients treated with RARP between October 2005 and June 2013 by a single surgeon at a single institution were analyzed. BCR was defined as follow-up PSA level > 0.2 ng/ml on two separate occasions or patients who had to undergo salvage therapy. Kaplan Meier curves and Log Rank test were used to compare the risk of BCR. Univariate and Multivariate Cox Regression analyses were performed to determine the prognostic impact of age, BMI, prostate weight, PSA prior to surgery, pathological T-stage, pathological Gleason sum, PSM and operative period. RESULTS: In this study period, 34 out of 439 had BCR, giving an overall BCR rate of 7.7% for this cohort. Overall 2- and 3-year BCR-free survival rates were 93% and 88%, respectively. Patients with a PSM had a 2-year BCR free survival of 88% compared to 94% in those with negative margins (p < .0001). On the multivariate analysis, PSM as well as pathological Gleason sum > = 8, PSA, pathological stage and operative period were significantly associated with BCR. CONCLUSIONS: In our case series of RARP performed by a single surgeon, PSM as well as pathological Gleason sum, PSA, pathological stage and early operative period for this surgeon were the independent predictors of BCR.

Implementing hexaminolevulinate HCl blue light cystoscopy: a nursing perspective.

Hexaminolevulinate HCl is a diagnostic imaging agent used with blue light during cystoscopy to help detect non-muscle-invasive bladder cancer. Blue light cystoscopy performed using hexaminolevulinate HCl has been found to detect more papillary non-muscle-invasive bladder tumors than cystoscopy performed using standard white light. Because bladder instillation and retention requirements of hexaminolevulinate during cystoscopy can affect patient flow in the perioperative setting, this technique necessitates changes in nursing practice and care of patients with known or suspected non-muscle-invasive bladder cancer. Nursing personnel at one facility followed the AORN guidelines for preoperative patient care in the ambulatory setting to address staffing, preoperative nursing assessment, anesthesia evaluation, and preoperative teaching related to implementing blue light cystoscopy.

Predictors of positive surgical margins after radical prostatectomy at a single institution: preoperative and pathologic factors, and the impact of surgeon variability and technique on incidence and location.

INTRODUCTION: To identify and assess predictive factors for positive surgical margins (PSM) in patients undergoing radical prostatectomy (RP). MATERIALS AND METHODS: An Institution Review Board (IRB) approved retrospective review of 1751 patients that underwent RP from March 2000 to June 2013 was performed. Identified were 1740 patients whom had not received neoadjuvant therapy; these were used for the purpose of this analysis. Univariate and multivariate analysis were performed to determine factors associated with and predictive of PSMs, divided into preoperative and pathological. Variables analyzed include age, body mass index (BMI), race, surgeon, surgical modality, pathologic T-stage and Gleason sum, extracapsular extension (ECE), seminal vesicle involvement (SVI), perineural invasion (PNI) and prostate weight. Finally, each surgical technique was analyzed to determine the most common site of PSM. RESULTS: Rate of PSM was 23.6%. Our analysis showed that preoperative prostate-specific antigen (PSA) level ≥ 10ng/mL, and pathologic T3/T4-stage and PNI significantly predicted PSM. Age > 60 years and prostate weight > 60 g were predictive against PSM. Gleason score ≥ 7 and PSM were significant risk factors for biochemical recurrence (BCR). Surgical approach did not affect the rate of PSM. Open RP was associated with a higher apical PSM rate (38.5%) and robotic RP with a higher posterolateral PSM rate (52.3%). CONCLUSIONS: High preoperative PSA levels, and advanced TNM-staging predicted positive surgical margins in our cohort. Patients with PSM were subsequently found to have higher risk of BCR.