A dose escalation/expansion study evaluating dose, safety, and efficacy of the novel tyrosine kinase inhibitor surufatinib, which inhibits VEGFR 1, 2, & 3, FGFR 1, and CSF1R, in US patients with neuroendocrine tumors.

Surufatinib, is a potent inhibitor of vascular endothelial growth factor receptors 1-3; fibroblast growth factor receptor-1; colony-stimulating factor 1 receptor. This Phase 1/1b escalation/expansion study in US patients with solid tumors evaluated 5 once daily (QD) surufatinib doses (3 + 3 design) to identify maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and evaluate safety and efficacy at the RP2D in 4 disease-specific expansion cohorts including pancreatic neuroendocrine tumors [pNET] and extrapancreatic NETs [epNET]. MTD and RP2D were 300 mg QD (escalation [n = 35]); 5 patients (15.6%) (Dose Limiting Toxicity [DLT] Evaluable Set [n = 32]) had DLTs. Pharmacokinetics were dose proportional. Estimated progression-free survival (PFS) rates at 11 months were 57.4% (95% confidence interval [CI]: 28.7, 78.2) and 51.1% (95% CI: 12.8, 80.3) for pNET and epNET expansion cohorts, respectively. Median PFS was 15.2 (95% CI: 5.2, not evaluable) and 11.5 (95% CI: 6.5,11.5) months. Response rates were 18.8% and 6.3%. The most frequent treatment-emergent adverse events (both cohorts) were fatigue (46.9%), hypertension (43.8%), proteinuria (37.5%), diarrhea (34.4%). Pharmacokinetics, safety, and antitumor efficacy of 300 mg QD oral surufatinib in US patients with pNETs and epNETs are consistent with previously reported studies in China and may support applicability of earlier surufatinib studies in US patients. Clinical trial registration: Clinicaltrials.gov NCT02549937.

The state of PSA counseling in male-to-female transgender patients in the U.S.

BACKGROUND: Morbidity and mortality from prostate cancer (PCa) are known to vary heavily based on socioeconomic and demographic risk factors. We sought to describe prescreening PSA (prostate-specific antigen) counseling (PPC) rates amongst male-to-female transgender (MtF-TG) patients and non-TG patients using the behavioral risk factor surveillance system (BRFSS). METHODS: We used the survey data from 2014, 2016, and 2018 BRFSS and included respondents aged 40-79 years who completed the "PCa screening" and "sexual orientation and gender identity" modules. We analyzed differences in age, education level, income level, marital status, and race/ethnicity using Pearson's χ2 tests. The association of PPC with MtF-TG status and other patient characteristics was evaluated using multivariate logistic regression. RESULTS: A total of 175,383 respondents were included, of which 0.3% identified as MtF-TG. Overall, 62.4% of respondents reported undergoing PPC. On univariate analysis, PPC rates were lower among MtF-TG respondents when compared to the non-TG group (58.3% vs. 62.4%, p = 0.03). MtF-TG respondents were also more likely to report lower education level (p < 0.01), lower-income level (p < 0.01), and were less likely to be white (p < 0.01) than non-TG respondents. However, multivariate analysis adjusting for these respondent features demonstrated an association between higher income and higher education levels with increased odds of PPC, but no association was demonstrated between MtF-TG status and PPC rates. PPC rates for the MtF-TG and non-TG populations did not change significantly over time. CONCLUSIONS: Although PPC was less frequently reported among MtF-TG respondents than in the non-TG group on univariate analysis, this association was not demonstrated when controlling for confounders, including education and income levels. Instead, on multivariate analysis, low education and income levels were more predictive of PPC rates. Further research is needed to ensure equivalent access to prescreening counseling for patients across the socioeconomic and gender identity spectrum.

Direct Oral Anticoagulants for Venous Thromboembolism Prophylaxis Following Robot-assisted Radical Cystectomy: A Retrospective Feasibility Study at a Single Academic Medical Center.

OBJECTIVES: To evaluate the use of direct oral anticoagulants following radical cystectomy for venous thromboembolism prophylaxis. We compared the experience of those who received venous thromboembolism prophylaxis following a robot-assisted radical cystectomy with either a direct oral anticoagulant or enoxaparin. METHODS: Medical records of 66 patients who underwent robot-assisted radical cystectomy between July 2017 and May 2020 at a single academic institution were reviewed retrospectively. Patients received extended prophylaxis with either a direct oral anticoagulant or enoxaparin before or following surgical discharge. Venous thromboembolic events and complications resulting in emergency department visits and readmissions were reviewed over a 90-day postoperative period. RESULTS: A total of 4 venous thromboembolic events within 90 days of surgery were observed. Among patients taking enoxaparin, 5% (2/37) developed a deep vein thrombosis and 3% (1/37) developed a pulmonary embolism. Among patients taking direct oral anticoagulants, 3% (1/29) developed a deep vein thrombosis. Zero patients in the enoxaparin group and 3% (1/29) of patients in the direct oral anticoagulant group experienced bleeding that required an emergency department visit. CONCLUSION: Direct oral anticoagulants performed comparably to enoxaparin in this feasibility study following robot-assisted radical cystectomy in 66 patients. No significant differences in the number of venous thromboembolisms or bleeding complications were observed. These data encourage future studies and support the prospect of direct oral anticoagulants as a potentially suitable oral alternative to injectable low molecular weight heparins for venous thromboembolism prophylaxis following radical cystectomy.

Optimizing Outcomes in Urological Surgery: Preoperative Care.

PURPOSE: Understanding best practices in preoperative care is critical for quality of care for our urology patients. We compiled a concise resource that provides recommendations for optimizing preoperative outcomes for patients undergoing urological surgery. MATERIALS AND METHODS: Urological preoperative care was defined as medical evaluation or treatment received in preparation for surgery or a procedure. The Preoperative White Paper Panel was comprised of practicing urologists and nurses. The topic was researched via literature published from 1980 through 2018 which focused on preoperative evaluation and safety. Best practice recommendations were also reviewed from specialty societies. Recommendations in this article reflect expert opinion from the Panel, and are based on review of available evidence and existing best practice statements. RESULTS: Preoperative optimization involves a good assessment and stratification of surgical risk for the patient about to undergo surgery or a procedure. This assessment starts with a timely history and physical evaluation, as well as review of underlying frailty and cognition. The assessment helps inform potential postoperative needs. Risk stratification calculators are available to determine potential cardiac and pulmonary morbidity as well as overall surgical risk. Optimization of endocrine and gastrointestinal comorbidities can also reduce complications for patients. Modifiable preoperative behaviors and needs such as malnutrition and smoking cessation should also be discussed before surgery. CONCLUSIONS: We summarize the preoperative factors that may impact surgical outcomes in urology. By understanding and applying best practices for preoperative care, urologists can optimize the quality of care for their patients.

Clinically node-positive (cN+) urothelial carcinoma of the bladder treated with chemotherapy and radical cystectomy: Clinical outcomes and development of a postoperative risk stratification model.

INTRODUCTION AND OBJECTIVE: Although node-positive (cN+) bladder cancer is considered Stage IV disease, a subset of patients is treated with chemotherapy and consolidative radical cystectomy (RC). We examined the clinical outcomes of such patients and developed a risk prediction model to facilitate risk-stratification and management. METHODS: We identified adult patients with cTany cN1-3 M0 urothelial carcinoma of the bladder treated with chemotherapy followed by RC from 2006 to 2013 in the NCDB. The associations of clinicopathologic features with overall survival (OS) were evaluated using Cox regression, and a simplified risk score was developed. RESULTS: A total of 491 patients received chemotherapy followed by RC. Median number of lymph nodes removed was 16 (interquartile range 9-25). At RC, 10% of patients were ypT0, and 35% were ypN0. Over a median follow-up of 18.7 months, 160 patients died of any cause. 1-, 5-, and 8-year OS were 69%, 34%, and 29%, respectively. On multivariable analysis, pT stage (hazard ratio [HR] 2.18; P = 0.003 for pT3, HR 2.65; P < 0.001 for pT4 vs.

The BMI Paradox and Robotic Assisted Partial Nephrectomy.

Introduction: Partial nephrectomy (PN), has become the gold standard for the surgical management of small renal masses, due to excellent oncologic control with concomitant preservation of nephron units. However, data regarding the association of obesity with perioperative outcomes following PN are mixed. Therefore, the association between obesity (using BMI) and post-operative complications (POC) rate following Robotic assisted laparoscopic PN (RPNx) was tested. Methods: Two hundred and fifty-one adult patients who underwent RPNx from 1/2011 to 5/2017 at a single institution, with at least 90 days follow-up were identified and included. No patients were excluded. Electronic medical records were reviewed to record all POC within 90 days of surgery. A piecewise generalized linear model for binary outcomes (logistic) was used to model the proportion of subjects with POC by their BMI. The slope of the line is adjusted to a BMI of 30 Kg/m2. Results: BMI is significantly associated with POC rate. POC rate decreased with increasing BMI below the inflection point of 30 Kg/m2 (0.848[0.756, 0.952]) (OR [95% CI], p = 0.005). POC rate was found to increase with increasing BMI above the BMI inflection of 30 Kg/m2 (1.102 [1.027, 1.182], p = 0.0071). Conclusions: In this cohort study, BMI showed an association with PC. It may be important to take BMI into account in surgical and clinical management considerations of RPNx, since higher rates of POC are associated with patients who are underweight, morbidly obese, and even with normal BMI. Further research is required on larger cohorts of RPNx patients to provide better description of this phenomenon and elucidate the role of BMI in development of POC.

The Perioperative Morbidity of Transurethral Resection of Bladder Tumor: Implications for Quality Improvement.

OBJECTIVES: To characterize the perioperative morbidity of transurethral resection of bladder tumor (TURBT) in order to identify important determinants of both quality and cost in the delivery bladder cancer care. METHODS: We identified 24,100 patients aged 18-89 years who underwent TURBT from 2010 to 2015 in the National Surgical Quality Improvement Program database. Multivariable logistic regression was performed to evaluate the associations of patient features and tumor size (<2 cm, 2-5 cm, or >5 cm) with 30-day perioperative outcomes. RESULTS: Thirty-day postoperative complications occurred in 5.1% of patients, perioperative blood transfusion in 1.5% of patients, hospital readmission in 3.7% of patients, reoperation in 1.5% of patients, and mortality in 0.8% of patients. The most common reasons for readmission were bleeding (29%) and infectious (21%) complications. Although several patient features were associated with increased perioperative morbidity on multivariable analysis, including congestive heart failure, renal failure, higher American Society of Anesthesiology class, and dependent functional status, only larger tumor size was independently associated with increased risks of all perioperative endpoints. CONCLUSION: Perioperative morbidity following TURBT is substantial and represents an important target for quality improvement. Extent of resection, patient functional status, and specific comorbidities are independently associated with increased risks of perioperative morbidity and mortality. These results have implications for patient counseling, perioperative management, and quality improvement programs.

Translating Science Into Business Innovation: The Case of Open Food and Nutrition Data Hackathons.

In this article, we explore the use of hackathons and open data in corporations' open innovation portfolios, addressing a new way for companies to tap into the creativity and innovation of early-stage startup culture, in this case applied to the food and nutrition sector. We study the first Open Food Data Hackdays, held on 10-11 February 2017 in Lausanne and Zurich. The aim of the overall project that the Hackdays event was part of was to use open food and nutrition data as a driver for business innovation. We see hackathons as a new tool in the innovation manager's toolkit, a kind of live crowdsourcing exercise that goes beyond traditional ideation and develops a variety of prototypes and new ideas for business innovation. Companies then have the option of working with entrepreneurs and taking some the ideas forward.

The association of lymph node dissection with 30-day perioperative morbidity among men undergoing minimally invasive radical prostatectomy: analysis of the National Surgical Quality Improvement Program (NSQIP).

BACKGROUND: The incremental morbidity of lymph node dissection (LND) among men undergoing radical prostatectomy remains uncertain. We therefore evaluated  the association of LND with perioperative morbidity among men undergoing minimally invasive radical prostatectomy (MIRP). METHODS: We identified 29,012 men aged 35-89 who underwent MIRP from 2010-2015 in the National Surgical Quality Improvement Program (NSQIP) database, of whom 47% underwent concomitant LND. The associations of LND with 30-day perioperative morbidity and mortality were evaluated using logistic regression, adjusted for patient features. RESULTS: Median age at surgery was 63 (IQR 57, 67) years. There were statistically significant, but clinically insignificant, differences in several baseline characteristics stratified by performance of LND, including older age at surgery (p < 0.001), higher American Society of Anesthesiology (ASA) class (p < 0.001), and longer operative time (p < 0.001) for men who underwent LND. Overall, 30-day complications occurred in 4.3% of patients. There were no statistically significant differences in rates of 30-day complications (4.2 vs. 4.4%, p = 0.44), perioperative blood transfusion (1.7 vs. 1.7%, p = 0.99), hospital readmission (3.6 vs. 4.0%, p = 0.09), reoperation (1.1 vs. 1.1%, p = 0.80), or 30-day mortality (0.1 vs. 0.2%, p = 0.56) between patients who underwent MIRP alone or MIRP with LND, respectively. On multivariable analysis, LND was not significantly associated with an increased risk of perioperative morbidity or 30-day mortality. CONCLUSIONS: LND at the time of MIRP does not appear to be associated with an increased risk of perioperative morbidity.

The Role of a Standardized Clinical Care Pathway in Patient Satisfaction and Quality of Life Outcomes after Robotic Assisted Laparoscopic Radical Prostatectomy.

INTRODUCTION: Clinical care pathways reduce length of stay, variability in practice and costs, yet avoid compromising quality of care or increasing complications. In this study we describe a standardized care pathway, focusing on preoperative and postoperative education as well as immediate postoperative patient care after robotic assisted laparoscopic radical prostatectomy. METHODS: A standardized robotic assisted laparoscopic radical prostatectomy care pathway was introduced at our institution in July 2014. A total of 108 men who underwent robotic assisted laparoscopic radical prostatectomy during 2014 were enrolled in this retrospective chart review and were subsequently mailed a quality of life survey. Data regarding length of stay and number of unplanned calls to the urology office or visits to the emergency department were collected from the chart review. The mailed survey was composed of original questions as well as questions adapted from the FACT-P (Functional Assessment of Cancer Therapy-Prostate). Patients who underwent robotic assisted laparoscopic radical prostatectomy between January and June 2014 were compared to those who underwent the same surgery between July and December 2014. RESULTS: Demographically the 2 cohorts of men who underwent robotic assisted laparoscopic radical prostatectomy were similar. There was a significant reduction in postoperative length of stay in the post-care pathway cohort. Hospital readmissions were reduced by 75%. Despite earlier discharge home, there was no difference in the number of postoperative calls to the urology office or visits to the emergency department, or in overall patient satisfaction. CONCLUSIONS: The implementation of a standardized care pathway for patients undergoing robotic assisted laparoscopic radical prostatectomy at our institution resulted in a reduced postoperative length of stay and readmission rate. Despite a more rapid discharge from the hospital, patient satisfaction and postoperative quality of life were not negatively impacted.