End of induction patient reported outcomes predict clinical remission and endoscopic improvement with vedolizumab and adalimumab in ulcerative colitis.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly emphasized as endpoints in clinical trials of ulcerative colitis (UC). However, the prognostic value of early improvement in PROs for long-term outcomes remains unclear. METHODS: This was a post-hoc analysis of 611 vedolizumab-treated or adalimumab-treated patients in the VARSITY trial (Clinicaltrial.gov: NCT02497469). Stool frequency (SF) and rectal bleeding score (RBS) as reported in the Mayo score at post-induction (week 6 and 14) was assessed for their association with one-year endoscopic improvement (EI), defined as Mayo endoscopic subscore <2; histo-endoscopic mucosal improvement (HEMI), defined as EI and Geboes highest grade <3.2, clinical remission (CR), defined as total Mayo score ≤2; and PRO-2 remission, defined as RBS of 0 and SF ≤1. Multivariable logistic regression models adjusted for confounders assessed the relationships between post-induction PROs and outcomes of interest at one-year. RESULTS: Patients with severe SF at week 6 were significantly less likely to achieve one-year EI compared to those with non-severe SF [aOR 0.40 (95% CI: 0.24-0.68), p < .001]. Absence of rectal bleeding at week 6 was associated with greater odds of achieving EI at one-year [aOR 2.21 (95% CI: 1.58-3.09), p < .001]. These findings were consistent across comparisons at week 14. Similar findings were observed for the outcomes of one-year HEMI, CR and PRO-2 remission. No difference was observed between the modified partial Mayo score and modified PRO-2 score. CONCLUSIONS: Post-induction PROs strongly predict the odds of CR and EI in UC and simplified evaluations can be used to assess early response to UC therapies.

A prospective, randomized, pilot trial of a polyethylene glycol (PEG)-coated collagen patch (Hemopatch®) for intraoperative hemostasis during deceased donor renal transplant.

INTRODUCTION: The objective of this study was to evaluate the safety and feasibility of using a polyethylene glycol (PEG)-coated collagen patch (Hemopatch®) in patients undergoing deceased donor renal transplant. The primary outcome was the amount of intraoperative estimated blood loss in those patients receiving the patch compared to without. Secondary outcomes were the subjective achievement of hemostasis, perigraft collection, and drop in hemoglobin 48 hours postoperatively. METHODS: We performed a single-center, prospective, randomized trial. Patients scheduled to undergo deceased donor renal transplant surgery were randomized to receive the PEG-coated patch or standard hemostasis (i.e., electrocautery and clips). RESULTS: A total of 30 patients were enrolled over 15 months and randomized to receive the PEG-coated patch (n=15) or standard hemostasis (n=15). The mean age was 62.5 years. As determined by the operating surgeon, hemostasis was successfully achieved in all 15 cases using the PEG-coated patch. In the PEG-coated patch group, there was a trend towards less estimated blood loss (237 cc vs. 327 cc; p=0.11) and a lower drop in hemoglobin 48 hours postoperatively (22.27 g/L vs. 29.53 g/L; p=0.09) compared to the standard hemostasis group. Perigraft collection was similar between groups (27% vs. 40%; p=0.43). Subgroup analysis on patients who received anticoagulation therapy revealed no significant difference in blood loss between groups. CONCLUSIONS: Based on our single-center experience, the PEG-coated patch (Hemopatch®) is a safe and feasible option to aid hemostasis during deceased donor renal transplant surgery. Hemostasis was successfully achieved in all cases using the PEG-coated patch.

Population-Based Analysis Of The Use Of Radium-223 For Bone-Metastatic Castration-Resistant Prostate Cancer In Ontario, And Of Factors Associated With Treatment Completion And Outcome.

INTRODUCTION: Radium-223 (Ra223) prolongs the survival and improves the quality of life of men with metastatic, castration-resistant prostate cancer (mCRPC) to bones. However, compared to other mCRPC therapies, using Ra223 comes with its unique challenges. Hence, we aimed to identify Ra223 utilization patterns under real-world conditions, as well as factors predicting treatment completion and outcome. METHODS: In this retrospective chart analysis, 198 mCRPC patients were identified that had received Ra223 outside of clinical trials or access programs from January 2015 to October 2016 at four cancer centres in Ontario. The main outcomes studied were Ra223 completion rate, reasons for early treatment discontinuation, overall survival, and survival differences in patients completing Ra223 therapy versus patients receiving <6 cycles of Ra223. In addition, patient and disease characteristics were analysed to identify predictors of treatment completion and survival. RESULTS: In this cohort of patients mostly pretreated with abiraterone and/or enzalutamide (92.4%), almost half of which had also received docetaxel (48.5%), the Ra223 completion rate was 46.5%, and the actuarial median survival was 13.3 months. The main reason for early Ra223 discontinuation was disease progression, and Ra223 non-completion was associated with poorer outcome (median survival 8.1 months [6.0-12.2] versus 18.7 months [15.3-22.3] in men completing Ra223, p<0.0001). Lymph node metastases and a high baseline prostate-specific antigen (PSA) were independent predictors of early treatment discontinuation. Multivariable Cox proportional hazards models revealed early Ra223 discontinuation, baseline anemia, high PSA, prior skeletal-related events, visceral metastases, and being referred to another centre for Ra223 therapy as predictors of worse outcome. CONCLUSION: Despite a lower completion rate than observed under clinical trial conditions, the real-world results achieved with Ra223 are encouraging. If prospectively validated, predictive patient and disease characteristics identified in our cohort might become instrumental to identify mCRPC patients likely to complete and to most benefit from Ra223 therapy.

Epidemiology of prostate and kidney cancer in the Aboriginal population of Canada: A systematic review.

INTRODUCTION: Prostate and kidney cancer rates in the Aboriginal population of Canada is a growing issue. METHODS: A systematic review of prostate and kidney cancer epidemiology in the Aboriginal population of Canada was performed with international comparison and evaluation of present epidemiological disparities. PubMed, Medline, and Embase (from January 1946 to June 2016), relevant government-published reports, and the websites of organizations contributing to prostate or kidney cancer guidelines were searched. We included studies that informed any of the three epidemiological questions this review is focused on answering. RESULTS: Two systematic reviews, two meta-analyses, five literature reviews, and 21 single-study papers were included. The incidence and mortality rates of kidney cancer were elevated among Canadian Aboriginals when compared to the provincial or national population and to several international regions. No studies reported data on survival. Prostate cancer incidence, mortality, and survival rates were lower in Aboriginals provincially, nationally, and internationally, with incidence and survival reaching statistical significance. Elevated rate of risk factors for kidney cancer was a significant finding among Canadian Aboriginals. Aboriginals were screened for prostate cancer less than the general Canadian population, a trend also observed in the U.S. CONCLUSIONS: The elevated incidence and mortality of kidney cancer among Canadian Aboriginals is most likely attributable to the rise in lifestyle-based risk factors. Two correlations concerning prostate cancer are made. However, due to temporal and regional disparities in data, further investigation is required to elucidate these observations.