Treatment and disease management patterns for bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer in North America, Europe and Asia: A real-world data analysis.

Background: This study examined real-world treatment and management of bacillus Calmette-Guérin (BCG)-unresponsive patients across 3 continents, including patients unable or unwilling to undergo cystectomy. Materials and methods: Physicians actively involved in managing patients with nonmuscle invasive bladder cancer completed online case report forms for their 5 consecutive patients from the broad BCG-unresponsive population and a further 5 consecutive BCG-unresponsive patients who did not undergo cystectomy (in Japan, physicians provided a total of 5 patients across both cohorts). Results: Most patients had received 1 (37%) or 2 (24%) maintenance courses of BCG. Five or more maintenance BCG courses were received by patients in Japan (59%) and China (31%), while in Germany 76% of patients received only 1 course. Most patients became BCG-unresponsive during their first (44%) or second (22%) treatment course; in Germany, 77% became BCG-unresponsive during their first treatment course. Most countries did not provide another course of BCG after a patient first became unresponsive, whereas unresponsive patients in Japan and China were most likely to be retreated with BCG. "Untreated - on watch and wait" was the main treatment/management approach received post-BCG treatment for 42% or more of patients in most countries except China (39%) and the United States (36%). "Following treatment guidelines" was consistently the top reason for post-BCG treatment selection across all treatment options. Conclusions: This study confirmed the global unmet need for patients with nonmuscle invasive bladder cancer, and found that many patients experienced periods of no treatment after not responding to BCG therapy.

Multi-country clinical practice patterns, including use of biomarkers, among physicians' treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

BACKGROUND: Intravesical bacillus Calmette-Guérin (BCG) fails in a considerable proportion of non-muscle invasive bladder cancer (NMIBC) patients despite treatment per recommended protocol. This real-world study aimed to understand the current patterns of treatment and disease management for the broad BCG-unresponsive NMIBC patient population, alongside collecting sufficient data on patients who do not undergo cystectomy. METHODS: This was a multicenter, retrospective survey of physicians treating BCG-unresponsive NMIBC patients. Data were collected in eight countries - France, Germany, Spain, Italy, United Kingdom, United States, China, and Japan - between January and May 2019. The study consisted of a short online physician survey and a retrospective chart review of eligible BCG-unresponsive NMIBC patients. Physicians abstracted chart data for the last 10 (five patients in Japan) eligible BCG-unresponsive NMIBC patients meeting the inclusion criteria, and the data were analysed for all countries combined using descriptive statistics. Country-specific analyses were also carried out, as appropriate. RESULTS: Overall, 508 physicians participated in the study. Almost one-quarter (22.9%) of physicians' current NMIBC patient caseload was BCG-unresponsive, whereby BCG therapy was no longer considered an option. Half of physicians (49.4%) did not regularly use biomarker tests in their practice, with particularly few physicians undertaking biomarker testing in Spain and Japan. Biomarker testing varied considerably, with the proportions of physicians selecting 'none' ranging from 11.4% in China to 70.3% in Japan. Physicians reported transurethral resection of the bladder tumor (TURBT) and BCG as the most common current treatments received by their patients. Chemotherapy and anti-PD-L1 treatment options were considered impactful new therapies by 94.7% and 90.0% of physicians surveyed in this study, respectively. CONCLUSIONS: The most common treatments received by patients in this study were TURBT and BCG. Emerging new treatments are driven by exploring biomarkers, but in real-world clinical practice only half of physicians or fewer regularly tested their NMIBC patients for biomarkers; PD-1/PD-L1 was the most common biomarker test used. Most physicians reported that, in addition to chemotherapy, anti-PD-L1 was an impactful new therapy.

Incidence of type 2 diabetes among patients exposed to the combination of pravastatin and paroxetine.

PURPOSE: This study evaluated the effects of concomitant pravastatin and paroxetine use on the incidence of Type 2 Diabetes Mellitus (T2DM). METHODS: A new-user retrospective cohort design was employed using data selected from US health insurance claims databases (OptumInsight and MarketScan) between July 1, 2002, and December 31, 2009. Patients included were of age ≥18; newly prescribed pravastatin or paroxetine; and enrolled in the database for ≥180 days prior to the index date (i.e., first prescription of incident drug). Patients were assigned to either incident pravastatin or incident paroxetine user groups. Patients were followed until the study endpoint (T2DM), discontinuation of incident drug, second drug, or end of study/patient data. Cox proportional hazards models compared T2DM in users of pravastatin who were also taking paroxetine at index the date (combination users) versus pravastatinonly users. A similar analysis among users of paroxetine evaluated the use or non-use of pravastatin at index date. RESULTS: OptumInsight yielded 288,678 incident users of pravastatin or paroxetine; 443,137 were identified in MarketScan. The risk of T2DM among combination users compared to incident pravastatin only users was 1.05 (95% CI: 0.76, 1.44) and 0.94 (95% CI: 0.90, 0.97) in OptumInsight and MarketScan, respectively. The risk of T2DM among combination users compared to incident paroxetine only users was 1.03 (95% CI: 0.69, 1.54) in OptumInsight and 1.02 (95% CI: 0.97, 1.07) in MarketScan. CONCLUSION: The results indicate no increase in the risk of T2DM due to combined use of pravastatin and paroxetine compared to individual use of the two drugs; however, this study is limited by short mean follow-up.

The effect of hospital and surgeon volume on racial differences in recurrence-free survival after radical prostatectomy.

OBJECTIVE: This study investigates associations between hospital and surgeon volume, and racial differences in recurrence after surgery for prostate cancer. METHODS: Data from the 1991 to 2002 Surveillance, Epidemiology, and End-Results-Medicare database were examined for 962 black and 7387 white men who received surgery for prostate cancer within 6 months of diagnosis during 1993-1999. Cox regression models were used to estimate the relationships between volume (grouped in tertiles), recurrence or death, and race, controlling for age, Gleason grade, and comorbidity score. RESULTS: Prostate cancer recurrence-free survival rates improved with hospital and surgical volume. Black men were more likely to experience recurrence than white men [hazard ratio (HR) = 1.34; 95% confidence interval (CI): 1.20-1.50]. Stratification by hospital volume revealed that racial differences persisted for medium and high volume hospitals, even after covariate adjustments (medium HR = 1.30, 95% CI: 1.04-1.61; high HR = 1.36, 95% CI: 1.07-1.73). Racial differences persisted within medium and high levels of surgeon volume as well (medium HR = 1.43, 95% CI: 1.10-1.85; high HR = 1.57, 95% CI: 1.14-2.16). CONCLUSIONS: High hospital and physician volumes were not associated with reduced racial differences in recurrence-free survival after prostate cancer surgery, contrary to expectation. This study suggests that social and behavioral characteristics, and some aspects of access, may play a larger role than organizational or systemic characteristics with regard to recurrence-free survival for this population.

Val153Met polymorphism of catechol-O-methyltransferase and prevalence of uterine leiomyomata.

The catechol-O-methyltransferase (COMT) gene encodes enzymes that inactivate catechol estrogens and may have a protective role in estrogen-induced tumorigenesis, such as uterine leiomyoma (fibroids). Val158Met is a common single-nucleotide polymorphism of the COMT gene (Ex4-12 G>A; rs4680) that results in a lower activity enzyme, increasing susceptibility to tumorigenesis. The purpose of this study was to evaluate the relation between the COMTVal158Met polymorphism and uterine fibroids. Participants were 972 premenopausal African American (n = 576) and white (n = 396) women from a cross-sectional sample of women in the National Institute of Environmental Health Science's Uterine Fibroid Study. Blood was collected from participants for DNA, and telephone interviews and questionnaires were completed to gather demographic and reproductive history. Prevalence ratios and 95% confidence intervals were estimated using race-specific log-risk regression models. Effect measure modification by age, body mass index, oral contraceptive use, full-term births, smoking, and alcohol use were also evaluated. Distributions of genotypes and fibroid prevalence varied by race. No associations between fibroids and Val158Met were observed among African American or white participants. This study suggests that variation in this polymorphism alone does not affect fibroid prevalence. Additional research is needed to examine other variations and haplotypes within the COMT gene.

Differences in resident characteristics and prevalence of urinary incontinence in nursing homes in the southeastern United States.

BACKGROUND: Relatively little is known about differences in the prevalence of urinary incontinence (UI) by race and region in the United States. OBJECTIVES: To use the 1999-2002 Centers for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS), Atlanta Region, to investigate the prevalence of UI among African American and Caucasian residents of nursing homes (NH) in the southeastern United States. METHODS: A repeated-measures, two time-period design was employed. Data for 95,911 residents in 7,640 NH were extracted using the study's inclusion and exclusion criteria. Residents' admission and annual assessment records were accessed; UI presence and relevant indicators were captured; and admission and postadmission UI prevalence rates were determined by region, state, race, and gender. Logistic regression, adjusting for residents' demographics, morbidity status, bed mobility, and cognitive and functional statuses, was conducted also. RESULTS: The majority of residents were Caucasian (82.4%) and women (76.5%) with mean (+/-SD) age of 82.7 +/- 7.58 years. Regional UI prevalence was 65.4% at admission and 74.3% postadmission. Postadmission, 73.5% of Caucasian and 78.1% of African Americans were incontinent. Similarly, 72.2% of men and 75% of women were incontinent. For African Americans postadmission, adjusted odds of UI were OR = 1.07 (95% CI: 1.01, 1.14). DISCUSSION: Prevalence of UI was high in this region and the odds of UI was significantly higher among African Americans in two of eight states, suggesting racial disparity in this condition in these states. Factors contributing to this disparity should be explored to increase quality care to vulnerable populations.

Perceptions of participation in an observational epidemiologic study of cancer among African Americans.

PURPOSE: Recruitment and retention of African Americans in cancer research studies has become increasingly important. However, little is known about factors bearing on recruitment and retention in etiologic observational studies of cancer. We assessed perceptions and attitudes of African Americans towards participation in an observational epidemiologic study of cancer, and attitudes toward the data collection process. METHODS: Five focus groups, each lasting approximately 2 hours, were conducted. Participants were comprised of men and women between 41-65 years of age. A total of 35 adults from three rural and two urban counties in North Carolina participated. Data were analyzed using NVivo software. RESULTS: Four key themes emerged on the perception of participation and retention in an epidemiologic study of cancer: (1) fear of cancer prognosis; (2) conflicts between mistrust and trust in researchers; (3) comprehension of prospective study purpose, structure, and participation strategies; and (4) the necessity for and obligation to provide feedback. CONCLUSION: Results indicate that African Americans would be willing to participate in epidemiologic studies to identify etiologic risk factors for cancer. However, culturally appropriate efforts to thoroughly inform them of study process and progress are deemed essential for successful recruitment and retention.