Introduction This study sought to compare healthcare resource utilization (HCRU), costs, and workplace productivity among patients with depression, with and without overactive bladder (OAB). Methods This retrospective, case–control cohort analysis compares HCRU, costs, and workplace productivity among propensity score matched patients with depression and OAB (case cohort) and patients with depression without OAB (control cohort). Patients were aged 18 years or older, insured/on Medicare, and had diagnosed depression and an antidepressant medication claim pre index. First OAB-related event was index for cases; controls were assigned a proxy (study period 12 months). Comparisons of HCRU and costs and regression models assessed the relationship between OAB and costs. For the workplace productivity subset analyses cases and controls were balanced on baseline covariates for the short-term disability analyses but as they were unbalanced for the absentee analyses, multivariate regression analyses were used for this subset. Results The study criteria were met by 39,085 cases and 308,736 controls, from which, 37,997 patients were successfully matched 1:1 (mean age 55 years; 81% female). Most depression-related HCRU measures were similar across cohorts; however, outpatient visits, ER visits, and number of unique depression medications were significantly higher (all p < 0.05) among cases. Cases also had 13% higher total depression-related costs ( p < 0.0001). Total mean (standard deviation [SD]) depression-related costs were $1796 ($4235) for cases versus $1597 ($3863) for controls ( p < 0.0001). For workplace productivity (absentee data: cases [ n = 686], controls [ n = 642]; short-term disability data: cases [ n = 4395], controls [ n = 4433]) absentee outcomes were similar across cohorts. However, a higher percentage of cases used short-term disability benefits compared to controls (21.3% versus 16.9%; p < 0.0001) and cases experienced more case days (11.0 versus 8.6 mean days) and received higher mean payments than controls ($1226 versus $1033; p < 0.0001) in this subset. Conclusions OAB was associated with 13% higher depression-related costs and 4.4% more cases used short-term disability benefits. Electronic Supplementary Material The online version of this article (10.1007/s12325-020-01485-w) contains supplementary material, which is available to authorized users.
33 Background: ENZA showed efficacy in chemotherapy-naïve men with mCRPC in a clinical trial setting (PREVAIL). We report real-world outcomes with ENZA for this population in a urology practice setting. Methods: This retrospective cohort study included men with prostate cancer newly initiating ENZA in the IntrinsiQ Specialty Solutions™ urology electronic medical records database between September 1, 2014 and February 28, 2018. Due to the approved indication in the study time frame, prescription of ENZA (first claim date = index date) was used as a proxy for mCRPC. Patients with evidence of prior chemotherapy and/or abiraterone were excluded. PSA value closest to index date (±30 days) was used as baseline. Men were followed until the earliest of: discontinuing ENZA, leaving practice, death, or study end. Best PSA response (largest decline or smallest increase in absence of decline from baseline), PSA declines of ≥50% and ≥90%, undetectable PSA, and time to PSA progression were analyzed. Results: We identified 931 eligible men. Most (>95%) were ≥60 years old; hypertension (54.6%) and diabetes (17.0%) were the most common comorbidities. Median (interquartile range [IQR]) baseline PSA was 9.0 (2, 37) ng/dL. Median (IQR) follow-up time was 12.5 (7.6, 19.4) months, during which a median (IQR) of 4 (3, 6) PSA tests were observed. Median time between two adjacent PSA tests was 2.0 months. A ≥50% and ≥90% PSA decline was observed in 55.0% and 23.8%, respectively. Best PSA response was a median (IQR) PSA decline of 58% (-89%, 1%), with 14.2% reaching an undetectable PSA value. Median time to PSA progression was 18.5 months (95% confidence interval 15.6, 23.7). Conclusions: This real-world study supports the effectiveness of ENZA in patients with mCRPC. The median PSA at treatment was much lower than PREVAIL, potentially explaining the longer time to PSA progression vs. PREVAIL. However, a lower proportion had PSA declines of ≥50% and ≥90% vs. PREVAIL, which may be attributed to more frequent PSA monitoring within a clinical trial setting and thus more opportunity to capture the true best PSA response.
Background: Chemotherapy combined with immunotherapy before radical cystectomy (RC) is anticipated to improve survival of muscle-invasive bladder cancer (MIBC) patients(pts). We investigated the efficacy and safety of camrelizumab in combination with gemcitabine plus cisplatin (GC) as neoadjuvant therapy in MIBC pts.Methods: This prospective, multicenter, study enrolled histopathological confirmed urothelial bladder cancer pts (cT2-T4aN0-1M0). The eligible pts should tolerate cisplatin and plan to undergo RC. The neoadjuvant therapy included 3 cycles of camrelizumab (200mg, on day 1 of a 21-day cycle) in combination of GC (1,000mg/m 2 gemcitabine on days 1 and 8, 70mg/m 2 cisplatin on day 2 of a 21-day cycle). The primary endpoint was pathological complete response (pCR, pT0N0). The secondary endpoints included pathological downstaging response (pT1N0) and safety. This was a Simon's two-stage design, if more than 5 out of 20 evaluable pts in stage one had pCR, 51 more pts will be enrolled in stage two, otherwise, this study will be terminated.Results: By April 2021, 19 eligible pts were enrolled. Twelve pts completed 3 cycles of neoadjuvant therapy. Eleven pts underwent cystectomy (10 RC and 1 partial cystectomy due to lung metastases). The median time to cystectomy was 4.3 weeks. pCR (pT0N0) was achieved in 6 pts (54.5 %), pathological downstaging (pT1N0) was achieved in 7 pts (63.6 %). Adverse Events of any grade occurred in 18 pts (95 %). Grade 3 treatment emergent AEs occurred in 8 pts (42 %), 3 pts (17%) reported treatment related hospitalization/prolonged hospitalization. No grade 3 immunerelated AEs occurred. Two pts (11 %) had grade 1 reactive cutaneous capillary endothelial proliferation.Conclusions: Camrelizumab in combination with gemcitabine plus cisplatin as neoadjuvant therapy for MIBC pts was tolerable and the efficacy met the criteria to enter the second stage.Clinical trial identification: ChiCTR2000032359.
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