Browsing by Subject "BCG Vaccine"
Now showing 1 - 4 of 4
- Results Per Page
- Sort Options
Item Open Access Evaluation of the Fluorescence In Situ Hybridization Test to Predict Recurrence and/or Progression of Disease after bacillus Calmette-Guérin for Primary High Grade Nonmuscle Invasive Bladder Cancer: Results from a Prospective Multicenter Trial.(The Journal of urology, 2019-11) Lotan, Yair; Inman, Brant A; Davis, Leah Gerber; Kassouf, Wassim; Messing, Edward; Daneshmand, Siamak; Canter, Daniel; Marble, H Tony; Joseph, Ajith M; Jewell, Susan; Boorjian, Stephen APURPOSE:Single center studies have shown that positive UroVysion® fluorescence in situ hybridization results were associated with recurrence of nonmuscle invasive bladder cancer treated with intravesical bacillus Calmette-Guérin. Our goal was to validate these findings. MATERIALS AND METHODS:We performed a prospective, multicenter diagnostic trial to determine whether the fluorescence in situ hybridization test could predict recurrence or progression in patients with primary high grade nonmuscle invasive bladder cancer who were scheduled to receive bacillus Calmette-Guérin. Fluorescence in situ hybridization testing was performed prior to the first bacillus Calmette-Guérin instillation, prior to the sixth instillation and at 3-month cystoscopy. The performance of fluorescence in situ hybridization was evaluated. RESULTS:A total of 150 patients were enrolled in analysis, including 68 with Ta disease, 41 with T1 disease, 26 with carcinoma in situ alone and 15 with papillary carcinoma plus carcinoma in situ. At 9 months of followup there were 46 events, including 37 recurrences and 9 progressions. For events with positive fluorescence in situ hybridization findings the HR was 2.59 (95% CI 1.42-4.73) for the baseline test, 1.94 (95% CI 1.04-3.59) for the 6-week test and 3.22 (95% CI 1.65-6.27) at 3 months. Patients with positive results at baseline, 6 weeks and 3 months had events 55% of the time and patients with negative results at each time point had no event 76% of the time. CONCLUSIONS:The study validated that a positive UroVysion fluorescence in situ hybridization test was associated with a 3.3-fold increased risk of recurrence. The test may be useful to risk stratify patients entering clinical trials in whom induction therapy fails. However, using the test to change management decisions is limited due to the discordance between results and outcomes as well as the variance of tests results with time.Item Open Access Evidence-based Assessment of Current and Emerging Bladder-sparing Therapies for Non-muscle-invasive Bladder Cancer After Bacillus Calmette-Guerin Therapy: A Systematic Review and Meta-analysis.(European urology oncology, 2020-06) Kamat, Ashish M; Lerner, Seth P; O'Donnell, Michael; Georgieva, Mihaela V; Yang, Min; Inman, Brant A; Kassouf, Wassim; Boorjian, Stephen A; Tyson, Mark D; Kulkarni, Girish S; Chang, Sam S; Konety, Badrinath R; Svatek, Robert S; Balar, Arjun; Witjes, J AlfredContext
Currently, there is no standard of care for patients with non-muscle-invasive bladder cancer (NMIBC) who recur despite bacillus Calmette-Guerin (BCG) therapy. Although radical cystectomy is recommended, many patients decline to undergo or are ineligible to receive it. Multiple agents are being investigated for use in this patient population.Objective
To systematically synthesize and describe the efficacy and safety of current and emerging treatments for NMIBC patients after treatment with BCG.Evidence acquisition
A systematic literature search of MEDLINE, Embase, and the Cochrane Controlled Register of Trials (period limited to January 2007-June 2019) was performed. Abstracts and presentations from major conference proceedings were also reviewed. Randomized controlled trials were assessed using the Cochrane risk of bias tool. Data for single-arm trials were pooled using a random-effect meta-analysis with the proportions approach. Trials were grouped based on the minimum number of prior BCG courses required before enrollment and further stratified based on the proportion of patients with carcinoma in situ (CIS).Evidence synthesis
Thirty publications were identified with data from 23 trials for meta-analysis, of which 17 were single arm. Efficacy and safety outcomes varied widely across studies. Heterogeneity across trials was reduced in subgroup analyses. The pooled 12-mo response rates were 24% (95% confidence interval [CI]: 16-32%) for trials with two or more prior BCG courses and 36% (95% CI: 25-47%) for those with one or more prior BCG courses. In a subgroup analysis, inclusion of ≥50% of patients with CIS was associated with a lower response.Conclusions
The variability in efficacy and safety outcomes highlights the need for consistent endpoint reporting and patient population definitions. With promising emerging treatments currently in development, efficacious and safe therapeutic options are urgently needed for this difficult-to-treat patient population.Patient summary
We examined the efficacy and safety outcomes of treatments for non-muscle-invasive bladder cancer after bacillus Calmette-Guerin therapy. Outcomes varied across studies and patient populations, but emerging treatments currently in development show promising efficacy.Item Open Access Impact of Bacillus Calmette-Guérin (BCG) vaccination on postoperative mortality in patients with perioperative SARS-CoV-2 infection.(BJS open, 2021-11) COVID Surg CollaborativeThere is little evidence around the potentially protective role of previous Bacillus Calmette-Guerin (BCG) vaccination on postoperative mortality in patients with perioperative SARS-CoV-2 vaccination. Prior BCG vaccination did not protect SARS-CoV-2 infected patients against postoperative pulmonary complications and 30-day mortality.Item Open Access Relational Mobility Predicts Faster Spread of COVID-19: A 39-Country Study.(Psychological science, 2020-10) Salvador, Cristina E; Berg, Martha K; Yu, Qinggang; San Martin, Alvaro; Kitayama, ShinobuIt has become increasingly clear that COVID-19 is transmitted between individuals. It stands to reason that the spread of the virus depends on sociocultural ecologies that facilitate or inhibit social contact. In particular, the community-level tendency to engage with strangers and freely choose friends, called relational mobility, creates increased opportunities to interact with a larger and more variable range of other people. It may therefore be associated with a faster spread of infectious diseases, including COVID-19. Here, we tested this possibility by analyzing growth curves of confirmed cases of and deaths due to COVID-19 in the first 30 days of the outbreaks in 39 countries. We found that growth was significantly accelerated as a function of a country-wise measure of relational mobility. This relationship was robust either with or without a set of control variables, including demographic variables, reporting bias, testing availability, and cultural dimensions of individualism, tightness, and government efficiency. Policy implications are also discussed.