Citations

PURPOSE In response to the COVID-19 pandemic, many cancer practices rapidly adopted telehealth services. However, there is a paucity of data regarding ongoing telehealth visit utilization beyond this initial response. The purpose of this study was to assess changes in variables associated with telehealth visit utilization over time. METHODS This is a cross-sectional, year-over-year, retrospective analysis of telehealth visits conducted across a multisite, multiregional cancer practice in the United States. Multivariable models examined the association of patient- and provider-level variables with telehealth utilization across outpatient visits conducted over three 8-week periods from July to August in 2019 (n = 32,537), 2020 (n = 33,399), and 2021 (n = 35,820). RESULTS The rate of telehealth utilization increased from <0.01% (2019) to 11% (2020) to 14% (2021). The most significant patient-level factors associated with increased telehealth utilization included nonrural residence and age ≤65 years. Among patients residing in rural settings, video visit utilization rates were significantly lower and phone visit utilization rates were significantly higher compared with patients from nonrural residences. Regarding provider-level factors, widening differences in telehealth utilization were observed at tertiary versus community-based practice settings. Increased telehealth utilization was not associated with duplicative care as per-patient and per-physician visit volumes in 2021 remained consistent with prepandemic levels. CONCLUSION We observed continuous expansion in telehealth visit utilization from 2020 to 2021. Our experiences suggest that telehealth can be integrated into cancer practices without evidence of duplicative care. Future work should examine sustainable reimbursement structures and policies to ensure accessibility of telehealth as a means to facilitate equitable, patient-centered cancer care.

AbstractBackgroundThe relation between cerebrospinal fluid (CSF) biomarkers of Alzheimer’s disease (AD) and neurodegeneration and brain regions of relevance for very early pathological processes in AD is poorly understood. This study aims to investigate cross‐sectional associations between the CSF biomarkers amyloid‐β1‐42 (Aβ42), total‐tau (T‐tau), phosphorylated‐tau (P‐tau), neurogranin (Ng) and neurofilament light (NfL) protein and normalized intracranial volumes of the hippocampus, amygdala, entorhinal cortex and basal forebrain observed on structural magnetic resonance imaging (MRI) in cognitively healthy 70‐year olds from the general population.MethodThe analyses included 226 cognitively normal individuals (clinical dementia rating of zero), examined during 2014‐2016 as part of the population‐based Gothenburg H70 Birth Cohort Studies in Sweden. The study participants had undergone lumbar puncture examination to extract CSF samples for biomarker measurements (pg/mL), MRI scan (volumes in mm³), and apolipoprotein E (APOE) genotyping. Linear regressions, adjusted for sex, were used to examine potential associations.ResultElevated CSF T‐tau, P‐tau, and Ng concentrations were associated with smaller volumes of the hippocampus, amygdala, and entorhinal cortex among individuals with amyloid pathology (p = 8×10−8 – 0.04) and among APOE ε4 carriers (p = 8×10−5 – 0.04). In addition, elevated CSF T‐tau, P‐tau, and Ng concentrations were associated with larger basal forebrain among individuals without pathological Aβ42 (p = 0.001 – 0.01) and among APOE ε4 non‐carriers (p = 0.004 – 0.02).ConclusionThe results of our study suggest that among cognitively normal adults who have amyloid pathology or genetic susceptibility to AD, there are associations between axonal degeneration, tangle pathology, and synapse loss and decreased volumes of AD vulnerable brain regions. The associations between elevated CSF biomarkers and larger basal forebrain in cognitively normal individuals were unexpected, but could possibly be explained by compensatory mechanisms or an inflammatory response (generating neuronal or glial swelling) as a very early reaction to the presence of increased levels of tau and Ng. Our findings highlight the clinical pathophysiological relevance of CSF biomarkers of AD and neurodegeneration and how they relate to AD specific brain regions seen on structural MRI in 70‐year‐olds that may be at risk to develop dementia.

Abstract Background As perception of penile curvature varies widely, we sought to understand how adults perceive curvature and how these opinions compare with those of patients with curvature, specifically Peyronie’s disease (PD). Aim To investigate the perspectives of curvature correction from adults with and without PD, as well as differences within demographics. Methods A cross-sectional survey was administered to adult patients and nonpatient companions in general urology clinics at 3 institutions across the United States. Men, women, and nonbinary participants were recruited. Patients were grouped as having PD vs andrology conditions without PD vs general urology conditions plus companions. The survey consisted of unlabeled 2-dimensional images of penis models with varying degrees of curvature. Participants selected images that they would want surgically corrected for themselves and their children. Univariable and multivariable analyses were performed to identify demographic variables associated with willingness to correct. Outcomes Our main outcome was to detect differences in threshold to correct curvature between those with and without PD. Results Participants were grouped as follows: PD (n = 141), andrology (n = 132), and general (n = 302) . Respectively, 12.8%, 18.9%, and 19.9% chose not to surgically correct any degree of curvature (P = .17). For those who chose surgical correction, the mean threshold for correction was 49.7°, 51.0°, and 51.0° (P = .48); for their children, the decision not to correct any degree of curvature was 21.3%, 25.4%, and 29.3% (P = .34), which was significantly higher than correction for themselves (P &lt; .001). The mean threshold for their children’s correction was 47.7°, 53.3°, and 49.4° for the PD, andrology, and general groups (P = .53), with thresholds no different vs themselves (P = .93). On multivariable analysis, no differences were seen in demographics within the PD and andrology groups. In the general group, participants aged 45 to 54 years and those who identified as LGBTQ (lesbian, gay, bisexual, transgender, queer) had a higher threshold for correction as compared with their counterparts when factoring other demographic variables (63.2° vs 48.8°, P = .001; 62.1° vs 50.4°, P = .05). Clinical Implications With changing times and viewpoints, this study stresses the importance of shared decision making and balancing risks and benefits to correction of penile curvature. Strengths and Limitations Strengths include the broad population surveyed. Limitations include the use of artificial models. Conclusion No significant differences were seen in the decision to surgically correct curvature between participants with and without PD, with participants being less likely to choose surgical correction for their children.

2529 Background: Tumor expression of the antiphagocytic protein CD47 (integrin associated protein) may lead to immunotherapy resistance (IO-R). PF-07257876 is a novel, IgG1, Fc-active, bispecific antibody targeting CD47 and PD-L1 designed to reverse IO-R, decrease anemia risk, and eliminate a priming dose. We report a Phase 1 dose escalation study (NCT04881045) in patients (pts) with advanced solid tumors, both IO-refractory and IO-naïve. Methods: The study enrolled pts ≥18 yrs with advanced non–small-cell lung carcinoma (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 expression >1% post anti-PD-1/PD-L1 therapy. Pts with other PD-L1+ tumors known to express CD47 were included (prior IO not required). Pts received PF-07257876 at escalating dose levels in 28-day cycles. Primary objectives were safety (dose-limiting toxicity [DLT] rate), tolerability, and determination of Recommended Phase 2 Dose (RP2D). Secondary and exploratory objectives included pharmacokinetics (PK), blood receptor occupancy (RO), CD47 levels by immunohistochemistry (IHC), tissue biopsy findings, and objective response rate (ORR) per RECIST v.1.1. Results: As of 20OCT2022, 18 pts were enrolled (NSCLC: n = 6; SCCHN: n = 4; other: n = 8). Median (range) age 68 (46–79) yrs. PF-07257876 was given at ascending doses, 150-2400 mg by subcutaneous (SC) injection or SC infusion every 2 weeks. 16 (89%) pts had treatment-related adverse events (TRAEs): Grades 1/2: n = 12 (67%); Grade 3: n = 1 (6%); Grade 4: n = 3 (17%); no Grade 5. Most common TRAEs: injection site reaction/erythema (n = 13, 72%), thrombocytopenia (n = 6, 33%), anemia (n = 5, 28%), and nausea (n = 4, 22%). DLTs occurred in 2 of 3 pts at the highest tested dose (Grade 4 neutropenia and thrombocytopenia, n = 1; Grade 4 thrombocytopenia, n = 1; both pts recovered). One pt with IO-R SCCHN had a confirmed partial response (duration of response 16 wks). ORR was 5.6% (1/18). Drug exposure increase after 1st dose was not dose proportional. Blood RO was > 95% for PD-L1 and > 70% for CD47 with drug exposure. All pts’ baseline CD47 IHC levels were moderate to high. Pharmacodynamics cytokine profiling showed notable dose-response increases of IFNg, TNFa, CXCL9/10, CCL3/4, without IL-6 increase. Conclusions: PF-07257876 was well tolerated with manageable toxicity. Incidence and grade of anemia or thrombocytopenia were manageable. Target engagement of CD47 and PD-L1 in peripheral blood was high. Innate and adaptive cytokine modulation was observed. Antitumor activity was modest. Expansion is ongoing at 1800 mg. Clinical trial information: NCT04881045 .

Abstract Introduction Perception of penile curvature (PC) varies widely, and correction of PC is in the eye of the beholder. Objective We sought to investigate if patients with Peyronie’s Disease (PD) had differing opinions on correction of PC compared to general andrology (AD) patients without PD and general urology (URO) patients. Methods A cross-sectional survey was administered to adult patients in andrology and general urology clinics at 3 geographically separate institutions. Patients were grouped with having PD vs AD vs URO conditions. The survey consisted of unlabeled images of penis models with varying degrees of PC (range 10-90°). Respondents were asked to select the images they would want surgically corrected. Univariable and multivariable analyses were performed to identify demographic variables associated with willingness to consider correction. Results Ninety-four PD, 106 AD, and 302 URO patients were recruited. When comparing the 3 groups, besides obvious gender differences with PD patients, PD patients were less in 25-34 age range and more in 55-64 age range (p=0.01 and p=0.007). PD was less represented in Mid-Atlantic (p&lt;0.001). 8% of PD, 12% of AD, and 20% of URO patients chose not to surgically correct any degree of PC (p=0.001). Among those who endorsed willingness to surgically correct PC, the average threshold for correction was 52.5° (SD 13) for PD, 37.2° (SD 29.5) for AD, and 51.0° (SD 19.9) for URO patients. When comparing PD patients with AD patients, no difference in the decision to surgically correct was found (p=0.42). This was also found to be the case when comparing PD with URO (p=0.46) and PD+AD patients vs URO (p=0.67). On univariable analysis, among AD patients, those ages 55-64 were more willing to undergo PC correction at lower degrees of PC (p=0.03) but did not hold up on multivariable analysis (p=0.40). No other demographic factors among PD and AD groups were found to have an impact on willingness to undergo PC correction (Table 1). Conclusions No significant differences were seen in the decision to surgically correct PC when comparing the perspectives of patients with PD, AD, and URO. Roughly 10% of all of these patients would defer on surgical management of any degree of PC. Despite having PC, no demographic differences were seen among PD patients’ willingness to correct PC. Disclosure No

Objectives Highly visible hospital quality reporting stakeholders in the USA such as the US News & World Report (USNWR) and the Centers for Medicare & Medicaid Services (CMS) play an important health systems role via their transparent public reporting of hospital outcomes and performance. However, during the pandemic, many such quality measurement stakeholders and pay-for-performance programmes in the USA and Europe have eschewed the traditional risk adjustment paradigm, instead choosing to pre-emptively exclude months or years of pandemic era performance data due largely to hospitals’ perceived COVID-19 burdens. These data exclusions may lead patients to draw misleading conclusions about where to seek care, while also masking genuine improvements or deteriorations in hospital quality that may have occurred during the pandemic. Here, we assessed to what extent hospitals’ COVID-19 burdens (proportion of hospitalised patients with COVID-19) were associated with their non-COVID 30-day mortality rates from March through November 2020 to inform whether inclusion of pandemic-era data may still be appropriate. Design This was a retrospective cohort study using the 100% CMS Inpatient Standard Analytic File and Master Beneficiary Summary File to include all US Medicare inpatient encounters with admission dates from 1 April 2020 through 30 November 2020, excluding COVID-19 encounters. Using linear regression, we modelled the association between hospitals’ COVID-19 proportions and observed/expected (O/E) ratios, testing whether the relationship was non-linear. We calculated alternative hospital O/E ratios after selective pandemic data exclusions mirroring the USNWR data exclusion methodology. Setting and participants We analysed 4 182 226 consecutive Medicare inpatient encounters from across 2601 US hospitals. Results The association between hospital COVID-19 proportion and non-COVID O/E 30-day mortality was statistically significant (p<0.0001), but weakly correlated (r2=0.06). The median (IQR) pairwise relative difference in hospital O/E ratios comparing the alternative analysis with the original analysis was +3.7% (−2.5%, +6.7%), with 1908/2571 (74.2%) of hospitals having relative differences within ±10%. Conclusions For non-COVID patient outcomes such as mortality, evidence-based inclusion of pandemic-era data is methodologically plausible and must be explored rather than exclusion of months or years of relevant patient outcomes data.

Background: A recent subanalysis of the EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) suggests a stronger benefit of early rhythm control (ERC) in patients with atrial fibrillation and a high comorbidity burden when compared to patients with a lower comorbidity burden. Methods: We identified 109 739 patients with newly diagnosed atrial fibrillation in a large United States deidentified administrative claims database (OptumLabs) and 11 625 patients in the population-based UKB (UK Biobank). ERC was defined as atrial fibrillation ablation or antiarrhythmic drug therapy within the first year after atrial fibrillation diagnosis. Patients were classified as (1) ERC and high comorbidity burden (CHA 2 DS 2 -VASc score ≥4); (2) ERC and lower comorbidity burden (CHA 2 DS 2 -VASc score 2–3); (3) no ERC and high comorbidity burden; and (4) no ERC and lower comorbidity burden. Patients without an elevated comorbidity burden (CHA 2 DS 2 -VASc score 0–1) were excluded. Propensity score overlap weighting and cox proportional hazards regression were used to balance patients and compare groups for the primary composite outcome of all-cause mortality, stroke, or hospitalization with the diagnoses heart failure or myocardial infarction as well as for a primary composite safety outcome of death, stroke, and serious adverse events related to ERC. Results: In both cohorts, ERC was associated with a reduced risk for the primary composite outcome in patients with a high comorbidity burden (OptumLabs: hazard ratio, 0.83 [95% CI 0.72–0.95]; P =0.006; UKB: hazard ratio, 0.77 [95% CI, 0.63–0.94]; P =0.009). In patients with a lower comorbidity burden, the difference in outcomes was not significant (OptumLabs: hazard ratio, 0.92 [95% CI, 0.54–1.57]; P =0.767; UKB: hazard ratio, 0.94 [95% CI, 0.83–1.06]; P =0.310). The comorbidity burden interacted with ERC in the UKB (interaction- P =0.027) but not in OptumLabs (interaction- P =0.720). ERC was not associated with an increased risk for the primary safety outcome. Conclusions: ERC is safe and may be more favorable in a population-based sample of patients with high a comorbidity burden (CHA 2 DS 2 -VASc score ≥4).