Citations

Abstract Introduction: Black men are disproportionately affected by prostate cancer (CaP) and havebeen found to experience more aggressive forms of cancer. The Minority Prostate Cancer(MiCaP) Research Digest is a dissemination platform with the goal of spreading community-based and culturally relevant ways to provide prostate cancer discoveries, interventions, andclinical trials among Black men. In collecting pretest data, the MiCaP team was also able tocollect data on whether participants had been tested for CaP in the last year. We were also ableto collect data on various social determinant variables to test for association. Methods: Black men living in the United States ages 35 to 70 were recruited for this studythrough community-based methods. Participants were randomly assigned to an interventiongroup that received the MiCaP information material and a control group that watched a generalvideo. Both groups received baseline and follow-up surveys to assess their knowledge relatedto CaP clinical trials, testing, and treatment. Associations of characteristics from the baselinesurvey were evaluated using logistic regression models. Results: A total of 220 responses are included in this dataset. The majority of participants wereborn in the United States (93.06%), single (49.52%), attended/graduated college (35.65%),between 60 and 69 years (25.58%), had full-time employment (52.07%), and had a householdincome between 20,000 and 39,999 (21.66%). Only about 35% had read or heard about clinicaltrials within the last year. Logistic regression found a positive association between the followingvariables and getting tested for prostate cancer in the past year: if participants had heard ofcurrent prostate cancer research or discoveries, if an immediate family member had beendiagnosed with prostate cancer, age, and level of education. No association was found betweeninsurance status, utilization of healthcare, clinical trial participation, or clinical trial knowledge. Conclusion: There is an association between being aware of CaP discoveries, diagnosis of familymembers, education, and age with prostate cancer screening. Future work should be done tofurther explore this association and how to overcome the barriers those determinants mightprovide in screening. These data and future data on this can be used to further community-based interventions delivered in culturally relevant ways with the goal of encouraging positivehealth behaviors to reduce CaP in Black men. Citation Format: Jessica Otero Machuca, Parisa Fathi, Daniel Lee, Kim Walsh-Childers, Folakemi Odedina. Potential predictors of prostate cancer screening: Findings from the MiCaP research digest study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1972.

Abstract Background: The CaPTC prostate cancer (CaP) Familial Cohort study (CaPFCS) was launched in 2017 to explore the CaP risk factors of African Black men (ABM). The study design is a prospective study that observes and follows healthy ABM and ABM diagnosed with CaP. Aim: The specific aim is to provide recommendations on statistical considerations for cohort studies focused on cancer disparities, based on lessons learned from the CaPTC CaPFCS. Methodology: Study participants were ABM in Cameroon, Nigeria, and the US. Using validated measures, data were collected mostly by self-administered or research assistant administered survey using paper survey (especially in Cameroon and Nigeria) with the responses transferred to REDCap by research coordinators. The statistical analysis for the CaPTC CaPFCS focused on the baseline epidemiological, behavioral, clinical and anthropometric measures of Black men. A total of 819 participants were included in the analyses. Statistical analyses included descriptive statistics (sample median, range, frequency and percentages) and unadjusted logistic regression models. Results: Data collection for the CaPTC CaPFCS were by multiple investigators/research coordinators at multiple sites in Cameroon, Nigeria, and the US. In preparation for the data analyses, we noted data entry errors and/or misinterpretation of data entry, which required extensive cleaning of the database prior to the analyses. The biostatisticians spent significant effort cleaning and ensuring data validity prior to the analyses. Confounding variables is another statistical consideration for cohort studies, such as the CaPTC CaPFCS. There was variability observed across age, education levels, employment status, household income and CaP diagnosis based on country of residence. CaP diagnosis was not reported by any of the ABM in the US, which may be due to the fact that they were all recruited within the community and no recruitment took place in the clinic. Finally, the CaPTC CaPFCS has several variables. Performing a lot of statistical tests may result in false-positive findings at P<0.05. Conclusion: The advantage of the CaPFCS is that it allows the CaPTC investigators to study epidemiological, behavioral, clinical and anthropometric variables associated with CaP over time. Being a longitudinal cohort study, investigators can track the changes in exposure and outcomes over time.However, statistical considerations need to be at the fore-front of multi-center, transatlantic cancer disparity studies such as the CaPTC CaPFCS, from data collection to data entry. The use of web-based survey with the ability to enter data directly into REDCaP will significantly reduce (if not totally eliminate) the need for database cleaning. There are multiple strategies that can be used to reduce confounder effect, including statistical adjustment and multivariate analysis to adjust for the confounders. The use of propensity score methods have especially been found to be effective in controlling baseline confounding factors. Citation Format: Daniel Lee, Michael Heckman, Zhongwei Peng, Emeka Iweala, Ademola Popoola, Paul Jibrin, Mohammed Faruk, Anthonia Sowumi, Omolara Fatiregun, Nkegoum Blaise, Catherine Oladoyinbo, Ifeoma Okoye, Abdulkadir Ayo Salako, Abidemi Omonisi, Iya Eze Bassey, Kayode Adeniji, Nggada Haruna Asura, Ernest Kaninjing, Oluwole Kukoyi, Fathi Parisa, Ruth Enuka, Oluwaseyi Toye, Jennifer Crook, CaPTC Investigators, Folakemi Odedina. Importance of statistical considerations in multi-center, transatlantic cancer disparity studies: Lessons learned from the CaPTC prostate cancer familial cohort study [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr C004.

This combined American Neurotology Society, American Otological Society, and American Academy of Otolaryngology – Head and Neck Surgery Foundation document aims to provide guidance during the coronavirus disease of 2019 (COVID-19) on 1) “priority” of care for otologic and neurotologic patients in the office and operating room, and 2) optimal utilization of personal protective equipment. Given the paucity of evidence to inform otologic and neurotologic best practices during COVID-19, the recommendations herein are based on relevant peer-reviewed articles, the Centers for Disease Control and Prevention COVID-19 guidelines, United States and international hospital policies, and expert opinion. The suggestions presented here are not meant to be definitive, and best practices will undoubtedly change with increasing knowledge and high-quality data related to COVID-19. Interpretation of this guidance document is dependent on local factors including prevalence of COVID-19 in the surgeons’ local community. This is not intended to set a standard of care, and should not supersede the clinician's best judgement when managing specific clinical concerns and/or regional conditions. Access to otologic and neurotologic care during and after the COVID-19 pandemic is dependent upon adequate protection of physicians, audiologists, and ancillary support staff. Otolaryngologists and associated staff are at high risk for COVID-19 disease transmission based on close contact with mucosal surfaces of the upper aerodigestive tract during diagnostic evaluation and therapeutic procedures. While many otologic and neurotologic conditions are not imminently life threatening, they have a major impact on communication, daily functioning, and quality of life. In addition, progression of disease and delay in treatment can result in cranial nerve deficits, intracranial and life-threatening complications, and/or irreversible consequences. In this regard, many otologic and neurotologic conditions should rightfully be considered “urgent,” and almost all require timely attention to permit optimal outcomes. It is reasonable to proceed with otologic and neurotologic clinic visits and operative cases based on input from expert opinion of otologic care providers, clinic/hospital administration, infection prevention and control specialists, and local and state public health leaders. Significant regional variations in COVID-19 prevalence exist; therefore, physicians working with local municipalities are best suited to make determinations on the appropriateness and timing of otologic and neurotologic care.

AbstractIntroductionA recent study reported that diffuse left ventricular (LV) fibrosis is a predictor of atrial fibrillation (AF) recurrence following catheter ablation, by measuring postcontrast cardiac T1 (an error prone metric as per the 2017 Society for Cardiovascular Magnetic Resonance consensus statement) using an inversion‐recovery pulse sequence (an error prone method in arrhythmia) in AF ablation candidates. The purpose of this study was to verify the prior study, by measuring extracellular volume (ECV) fraction (an accurate metric) using a saturation‐recovery pulse sequence (accurate method in arrhythmia).Methods and ResultsThis study examined 100 AF patients (mean age = 62 ± 11 years, 69 males and 31 females, 67 paroxysmal [pAF] and 33 persistent [peAF]) who underwent a preablation cardiovascular magnetic resonance (CMR) exam. LV ECV and left atrial (LA) and LV functional parameters were quantified using standard analysis methods. During an average follow‐up period of 457 ± 261 days with 4 ± 3 rhythm checks per patient, 72 patients maintained sinus rhythm. Between those who maintained sinus rhythm (n = 72) and those who reverted to AF (n = 28), the only clinical characteristic that was significantly different was age (60 ± 12 years vs 66 ± 9 years); for CMR metrics, neither mean LV ECV (25.1 ± 3.3% vs 24.7 ± 3.7%), native LV T1 (1093.8 ± 73.5 ms vs 1070.2 ± 115.9 ms), left ventricular ejection fraction (54.1 ± 11.2% vs 55.7 ± 7.1%), nor LA end diastolic volume/body surface area (42.4 ± 14.8 mL/m2 vs 43.4 ± 19.6 mL/m2) were significantly different (P ≥ .23). According to Cox regression tests, none of the clinical and imaging variables predict AF recurrence.ConclusionNeither LV ECV nor other CMR metrics predict recurrence of AF following catheter ablation.

Background: Early data from anti-CD19 chimeric antigen receptor (CAR) T-cell trials suggest that concurrent infection can lead to poor outcomes. 1,2 The relationship between CAR T-cell mediated inflammatory responses and infections is not well-established. With CAR T-cell therapies more readily available, practitioners must identify which patient, disease and CAR T-cell specific parameters are associated with an increased risk of infection to optimize outcomes. We provide a comprehensive analysis of infection risk within the first 30 days after CAR T-cell infusion across multiple types of CAR T-cell trials targeting distinct antigens. Methods: This was a single-center, retrospective study conducted at the National Cancer Institute analyzing infectious complications in subjects who underwent CAR T-cell therapy on one of four phase I clinical trials, targeting CD19, CD22, B-cell maturation antigen (BCMA) or disialoganglioside (GD2) from 2012 though 2018. Baseline characteristics are in Table 1. The primary objective was to establish the incidence of infections between initiation of lymphodepleting (LD) chemotherapy through day 30 after CAR T-cell infusion. The secondary objective was to identify risk factors for infection. Patients were censored at relapse and/or initiation of alternative therapy, including treatment for relapse or consolidative hematopoietic stem cell transplantation (HSCT). Univariate screening methods were used to identify parameters associated with increased risk of infection Results: Amongst 144 subjects, 52 (36.1%) received anti-CD19 CAR T-cells (CAR-T); 53 (36.8%) received anti-CD22 CAR-T, 26 (18.1%) received anti-BCMA CAR-T; and 13 (9%) received anti-GD2 CAR-T. The median age was 18 years (range: 4 to 66). Sixty-one (42.4%) had undergone at least one prior allogeneic hematopoietic stem cell transplant (HSCT) and 24 (16.7%) had at least one prior autologous HSCT. Sixty-eight (47.2%) had a history of a recent infection within 100 days of initiation of LD chemotherapy, of which 17 were a major chronic infection and 9 were considered severe. Fifty-eight (40.3%) subjects experienced a total of 103 infections from initiation of LD chemotherapy through day 30 post CAR T-cell infusion, with the median time to first infection being 6 days post-CAR infusion. Twenty-eight (19.4%) subjects had more than 1 infection; 20 (13.9%) subjects had C. difficile infection. The 103 infections consisted of 47 (45.6%) distinct episodes of focal bacterial infections (e.g., sinusitis, pneumonia, urinary tract infection), 25 (24.2%) episodes of bacteremia, 22 (21.4%) viral infections, and 9 (8.7%) invasive fungal infections. Fourteen infections (13.6%) occurred between initiation of LD chemotherapy and day 0 (prior to CAR T-cell infusion). Fever and neutropenia, without a source, was documented as a distinct entity in 85 patients (59.0%). Using univariate statistical screening methods, we identified 4 parameters that were individually associated with an increased risk of infection: increasing number of prior therapies (p=0.0034), prior history of recent infection within the past 100 days (p=0.0064), age > 18 (p =0.028), or enrollment on the CD22 CAR trial (p=0.0028). Eliminating the trial, since that is not generalizable, and combining these into a multivariable logistic regression model identified age > 18, prior history of infection and prior lines of therapies jointly associated with an increased risk of infection. Using these parameters, a predictive model was developed, which, when applied to the data set used to develop the model, can correctly predict 69 of 86 patients without an infection (80.3%; CI: 70.3-88.0%) as well as 32 of 58 patients with an infection (55.2%; 95% CI: 41.5- 68.3%). Conclusion: In this retrospective analysis, we provide the largest experience to date analyzing infection in the setting of CAR T-cell therapy across multiple CAR constructs. Our study demonstrates that adult age, prior history of infection, increased number of prior therapies and enrollment on a particular CAR T-cell trial, in this case the CD22 CAR-T trial, may lead to a higher risk of infection than in those without these risk factors. Further investigations are underway to evaluate clinical outcomes with infection which occur in the peri CAR T-cell setting and potential strategies to minimize infection risk. Generalizability of this model will be tested in an independent data set. Disclosures Lee: Kite, a Gilead Company: Research Funding; Harpoon Therapeutics: Consultancy; Juno Therapeutics: Other: External Advisory Board; ACI Clinical on behalf of Celgene:: Other: Independent Central Quality Review Committee. Mackall:Obsidian: Research Funding; Lyell: Consultancy, Equity Ownership, Other: Founder, Research Funding; Nektar: Other: Scientific Advisory Board; PACT: Other: Scientific Advisory Board; Bryologyx: Other: Scientific Advisory Board; Vor: Other: Scientific Advisory Board; Roche: Other: Scientific Advisory Board; Adaptimmune LLC: Other: Scientific Advisory Board; Glaxo-Smith-Kline: Other: Scientific Advisory Board; Allogene: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Apricity Health: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Unum Therapeutics: Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Kochenderfer:Kite and Celgene: Research Funding; Bluebird and CRISPR Therapeutics: Other: received royalties on licensing of his inventions. OffLabel Disclosure: Conditioning chemotherapy for CAR T-cell therapy; this is a retrospective study that used different lymphodepletion regimens.

Objective The aim of the study was to determine the rate of return to baseline functional status 3 months after surgery for pelvic organ prolapse (POP) in women 65 years or older. Methods This is a multicenter prospective cohort study of women older than 65 years undergoing POP surgery. Functional status was determined by the Activities Assessment Scale at the preoperative visit and 3 months after surgery. We compared a variety of clinical variables and preoperative functional status scores for women who worsened, improved, or returned to baseline functional status after surgery using univariable and multivariable analysis. Results A total of 192 women were enrolled in the study. Of 176 women who completed both sets of questionnaires, 59% improved, 35% returned, and 6% worsened from their baseline functional status. Variables significantly associated with postoperative functional status score were depression ( P < 0.002) and preoperative functional status score ( P < 0.001). The group that improved from baseline had the lowest (worst) preoperative functional status score (78.7 ± 16.4), whereas the group that worsened after surgery had the highest (best) preoperative functional status score (98.6 ± 2.2). After adjusting for age and depression, higher preoperative functional status score was predictive of failure to return to baseline functional status. Conclusions Most older women undergoing surgery for POP, including those with low preoperative functional status, return to or improve from their baseline functional status within 3 months of surgery. Women with higher functional status before surgery are less likely to report improvement in physical functioning after surgery.