Kim, Simon P.

175 Background: Biomedical research focused on the experiences of cancer patients in care delivery has progressed remarkably in recent years, including the emergence of Cancer Care Delivery Research (CCDR) within the NCI Community Oncology Research Program (NCORP). CCDR is a relatively new mechanism with the NCORP to support protocols that test questions beyond standard clinical trials for treatment or symptom control interventions. CCDR leverages the NCORP infrastructure to develop and test care delivery interventions in community hospital settings and in settings serving underserved and minority populations. CCDR enables researchers to conduct care delivery studies in critical places and in niche populations. Methods: We will describe our experience coordinating the first Alliance NCORP Research Base Cancer CCDR trial. Our trial – a four arm, cluster-randomized trial of decision aids among sites capable of oversampling minority men with a diagnosis of early stage prostate cancer – was the first CCDR trial in the Alliance NCORP Research Base. We will describe the opportunities and challenges we encountered. Results: We implemented a CCDR protocol even as the oversight for CCDR was being worked out in parallel. Curating partnerships outside of established channels of clinical trials, engaging minority serving institutions, and engaging surgical practices like urology illustrate some of the challenges of implementing a care-delivery trial in a diverse multi-site network. Research staff must learn the art of mitigating the disruption of care delivery research procedures within clinics. Additionally, the researcher’s skills are drawn upon at multiple points— establishing relationships, advocating for flexibility in implementing rules, cheerleading, connecting dots, and directing traffic. Conclusions: Our “lessons learned” presentation will provide an experiential account that will inform aspiring care delivery researchers in their work and describe some of the emerging aspects of the institutional implementation of new initiatives in modern cooperative group research. Our presentation will also inform key stakeholders about how to best facilitate this type of research.

Our objective was to evaluate the role of retroperitoneal lymph node dissection ( LND ) in non‐metastatic (M0) and metastatic (M1) renal cell carcinoma ( RCC ). We searched Medline, EMBASE , Web of Science and Scopus from database inception to 29 August 2017 for studies of patients who underwent partial or radical nephrectomy for M0 or M1 RCC . Two investigators independently selected studies for inclusion. Risk of bias was assessed using the Newcastle–Ottawa scale, Cochrane Collaboration tool and National Heart, Lung and Blood Institute Quality Assessment Tool. Random effects meta‐analysis was performed for all‐cause‐mortality. The GRADE approach was used to characterize quality of evidence. A total of 51 unique studies were included in the qualitative systematic review. Risk of bias was low in 41/51 (80%) studies. LND was not associated with all‐cause mortality in either M0 (hazard ratio [ HR ] 1.02, 95% confidence interval [ CI ] 0.92–1.12; I 2 = 0%; four studies), M1 ( HR 1.04, 95% CI 0.83–1.29; I 2 = 0%; two studies), or pooled M0 and M1 settings ( HR 1.00, 95% CI 0.92–1.09; I 2 = 0%; seven studies), with no statistically significant differences according to M stage subgroups ( P = 0.50). In the three studies that examined M0 subgroups with a high risk of nodal metastasis, LND was not associated with improved oncological outcomes. Studies on the association of extent of LND with survival reported inconsistent results. Meanwhile, a small proportion of patients with pN 1M0 disease demonstrate durable long‐term oncological control after surgery, with 10‐year cancer‐specific survival of 21–31%. Nodal involvement is independently associated with adverse prognosis in both M0 and M1 settings. GRADE quality of evidence was moderate or low for the outcomes examined. Although LND yields independent prognostic information, the existing literature does not support a therapeutic benefit to LND in either M0 or M1 RCC . High‐risk M0 patient groups warrant further study, as a subset of patients with isolated nodal metastases experience long‐term survival after surgical resection.

334 Background: Radical cystectomy (RC) represents the standard of care for patients with muscle-invasive urothelial carcinoma of the urinary bladder (UCUB). Alternative organ-conserving treatments such as chemotherapy and/or radiotherapy have gained interest. We sought to compare survival outcomes of patients according to treatment modalities, in a stage-for-stage analysis. Methods: We relied on the Surveillance, Epidemiology, and End Results Medicare-linked database to identify 12,950 patients diagnosed with T2–T4a N0/x M0 UCUB between years 1992 and 2009. Treatment types include RC (n=5207), chemotherapy/radiation (n=2,669), and surveillance (n=5,074). Following instrumental variable analysis, Cox- and competing-risks regression analyses were performed for prediction of overall survival (OS) and cancer-specific mortality (CSM), respectively. All analyses were stratified according to disease stage (T2, T3, T4a). Results: After adjusting for potential confounders, OS was more favorable for RC relative to chemotherapy/radiation (hazard ratio [HR]: 1.57, 95% confidence interval [CI]: 1.02–2.40) or surveillance (HR: 1.82, 95% CI: 1.20–2.78) in patients with T2 UCUB. For the same stage, CSM rates were lower in the surgery group compared to chemotherapy/radiation (HR: 2.05, 95% CI: 1.14–3.67) or surveillance (HR: 1.95, 95% CI: 1.09–3.48). When analyses focused on individuals with more advanced disease (T3–T4a), no statistically significant difference was observed between chemotherapy/radiation relative to RC for both OS and CSM. Conclusions: In the current retrospective population-based cohort, RC was associated with improved survival outcomes relative to its alternative treatment counterparts. However, this effect was only observable in patients with T2 disease. Conversely, no difference between chemotherapy/radiation vs. surgery was noted in patients with more advanced disease stage.

89 Background: Lymph node counts have been proposed as a quality metric for patients undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). It is unclear whether surgical approach and hospital characteristics independently determine the number of lymph nodes removed at PLND. Therefore, we assessed the variation in lymph node counts from a population-based cohort of patients undergoing surgery for intermediate and high-risk prostate cancer. Methods: Using the National Cancer Database, we identified all surgically treated patients diagnosed with pre-treatment intermediate or high-risk prostate cancer from 2010 to 2011. The primary outcome was the number of lymph nodes retrieved at the time of RP. Generalized estimating equations were used to assess for differences in the adjusted number of lymph nodes retrieved after accounting for patient and hospital characteristics and surgical approach. Results: Overall, 35,876 patients were diagnosed with intermediate (61.2%) and high-risk (38.8%) prostate cancer and underwent RP and PLND. On multivariable analysis, open radical prostatectomy (ORP) and high volume and academic hospitals were independently associated with greater lymph node counts compared to robotic-assisted radical prostatectomy (RARP) and medium/low and community hospitals, respectively (all p<0.001). After adjusting for patient and hospital variables, higher adjusted lymph nodes counts were observed for ORP compared to RARP (7.1 vs. 6.1; p<0.001). Adjusted counts were also higher for high volume compared to medium/low volume hospitals (7.8 vs. 5.9; p<0.001), and academic compared to community hospitals (7.3 vs. 5.6; p<0.001). Conclusions: Among patients with aggressive prostate cancer treated with RP and PLND, lymph node counts varied by surgical approach and hospital characteristics.

137 Background: LUTS are one of the most common reasons patients visit urologists. These symptoms have not been typically associated with the development of prostate cancer (CaP). However, we hypothesized that visiting a physician for LUTS may modify the diagnostic intensity for CaP compared to population controls. Methods: We examined data from a longitudinal, population-based cohort of 2,447 men between 40 and 79 years old who were followed prospectively from 1990 to 2010. Participants completed the American Urological Association Symptom Index (AUASI) every two years. Self-reported moderate/severe LUTS were defined as an AUASI score >7 (n=1627). Data including the treatment for LUTS (n=874), prostate biopsy (PBx), family history of CaP and diagnosis of CaP were obtained through self-report and review of medical records. Associations between self-reported LUTS, treatment for LUTS, and risk of PBx or CaP were estimated using multivariate Cox proportional hazard models. Results: An interaction was noted between age and LUTS and PBx and CaP diagnosis. In younger men, the diagnosis and treatment of LUTS was associated with increased risk of PBx (HR 2.39: 95% CI 1.83, 3.13) and CaP (HR 3.47: 95% CI 2.38, 5.07). Conversely in older men, treatment for LUTS was associated with a decreased risk of PBx and CaP (Table). Self reported LUTS was not significantly associated with CaP diagnosis in younger men and was protective in older men (Table). Conclusions: There is a differential effect of LUTS on prostate cancer testing and diagnosis when stratified by age. The reason for this difference is unclear, but appears to be due largely to diagnostic intensity rather than a true biologic association between LUTS and CaP. [Table: see text]