Real-world Adoption Research Articles

Real-world adoption of 3 months of adjuvant oxaliplatin chemotherapy in patients with stage III colorectal cancer (CRC).

83 Background: Based on the IDEA analysis, 3 months (mos) of adjuvant chemotherapy (ACT) with CAPOX has emerged as an option for both low-risk and high-risk stage III CRC. This has resource utilization, cost and toxicity benefits (particularly less neurotoxicity) without compromising efficacy. This study examines the patterns of uptake of CAPOX vs FOLFOX and duration of ACT in a contemporary post-COVID real-world cohort of patients (pts) in the province of British Columbia (BC), Canada. Methods: The provincial pharmacy database was used to identify pts with resected stage III CRC who received adjuvant CAPOX or FOLFOX between January 2021 and December 2022. Pts with rectal cancer requiring neoadjuvant chemotherapy or radiotherapy were excluded. Demographic, tumor, and treatment information was collected. “High-risk features” were defined as pT4 or pN2 tumors. “Urban” setting was defined based on the population size of the regional health authority. Descriptive statistical analyses were performed to examine baseline characteristics and Fisher’s exact test was used to examine univariate associations. Results: 452 pts were included, of which 234 (52%) and 218 (48%) were planned to receive 3 and 6 mos of ACT respectively (see table). Within the 3 mos group, 226 (97%) received CAPOX. Within the 6 mos group, there was a 51%/49% split between CAPOX/FOLFOX. By univariate analysis, factors associated with 3 mos of CAPOX vs 6 mos of ACT were age >70y (P=0.039), low/intermediate grade (P=0.005) and low-risk stage III disease (P<0.0001). 29% of pts planned for 6 mos of oxaliplatin ACT had low-risk disease, with 52% of these receiving CAPOX. Conclusions: 3 mos of adjuvant CAPOX is an accepted option for nearly all pts with stage III disease with consequent less neurotoxicity and fewer treatment visits. Yet, in this contemporary cohort, use of 3 mos of adjuvant CAPOX remains low and is associated with older age and low-risk disease. 6 mos of oxaliplatin is still being offered to pts with low-risk disease. Exploration of patient preferences, real-world treatment and time toxicities, and resource costs may improve more widespread adoption of 3 mos of adjuvant CAPOX in stage III CRC. [Table: see text]

Concomitant Treatment of Atrial Fibrillation in Isolated Coronary Artery Bypass Grafting

BackgroundSocietal guidelines support concomitant management of atrial fibrillation (AF) in patients undergoing cardiac surgery. To assess real-world adoption and outcomes, this study evaluated Medicare beneficiaries with AF who underwent isolated coronary artery bypass grafting (CABG) with surgical ablation (SA) or left atrial appendage obliteration (LAAO) or both procedures in combination (SA + LAAO). MethodsThe US Centers for Medicare & Medicaid Services inpatient claims database identified all patients with AF who underwent isolated CABG from 2018 to 2020. Diagnosis-related group and International Classification of Diseases-10th revision procedure codes defined covariates for doubly robust risk adjustment. ResultsA total of 19,524 patients with preoperative AF who underwent isolated CABG were stratified by SA + LAAO (3475 patients; 17.8%), LAAO only (4541 patients; 23.3%), or no AF treatment (11,508 patients; 58.9%). After doubly robust risk adjustment, longitudinal analysis highlighted that concomitant AF treatment with SA + LAAO (hazard ratio [HR], 0.74; P = .049) or LAAO alone (HR, 0.75; P = . 031) was associated with a significant reduction in readmission for stroke at 3 years compared with no AF treatment. Furthermore, SA + LAAO (HR, 0.86; P = .016) but not LAAO alone (HR, 0.97; P = .573) was associated with improved survival compared with no AF treatment. Finally, SA + LAAO was associated with a superior composite outcome of freedom from stroke or death at 3 years compared with LAAO alone (HR, 0.86;, P = .033) or no AF treatment (HR, 0.81; P = .001). ConclusionsIn Medicare beneficiaries with AF who underwent isolated CABG, concomitant AF treatment was associated with reduced 3-year readmission for stroke. SA + LAAO was associated with superior reduction in stroke or death at 3 years compared with LAAO alone or no AF treatment.

Real-World Adoption of Mental Health Support Among Adolescents: Cross-Sectional Analysis of the California Health Interview Survey

Abstract Objective We aim to examine: (a) the extent to which patterns of adoption of counseling services and digital mental health interventions (DMHIs) shifted in recent years (2019–2021); (b) the impact of distress on adoption of mental health support; and (c) reasons related to adolescents’ low adoption of DMHIs when experiencing distress. Methods Data were from three cohorts of adolescents aged 12–17 years (n = 847 in 2019; n = 1,365 in 2020; n = 1,169 in 2021) recruited as part of the California Health Interview Survey. We estimated logistic regression models to examine the likelihood of using mental health support as a function of psychological distress, sociodemographic characteristics, and cohorts. We also analyzed adolescents’ self-reported reasons for not trying DMHIs as a function of distress. Results The proportion of adolescents reporting elevated psychological distress (∼50%) was higher than those adopting counseling services (<20%) or DMHIs (<10%). A higher level of distress was associated with a greater likelihood of receiving counseling (OR = 1.15), and using DMHIs to connect with a professional (Odds ratio (OR) = 1.11) and for self-help (OR = 1.17). Among those experiencing high distress, adolescents’ top reason for not adopting an online tool was a lack of perceived need (19.2%). Conclusion Adolescents’ main barriers to DMHI adoption included a lack of perceived need, which may be explained by a lack of mental health literacy. Thoughtful marketing and dissemination efforts are needed to increase mental health awareness and normalize adoption of counseling services and DMHIs.

Abstract 16475: Mitral Valve Transcatheter Edge to Edge Repair: A Real-World Analysis of Racial Differences in Uptake and Outcomes

Introduction: Recently, percutaneous mitral valve transcatheter edge to edge repair (TEER) with the MitraClip system has grown as a treatment option for mitral regurgitation. However, data describing the real-world adoption of this technology are limited, especially regarding differences by race and ethnicity. Research Question: What have been the trends in usage of mitral valve TEER during its early uptake in the United States, and has there been equitable adoption across racial and ethnic groups? Methods: In a comparative study using the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking database from Jan 1,2017 to Dec 31, 2022, we describe temporal changes in mitral valve TEER use within the VA system, and differences in uptake by race/ethnicity (White non-Hispanic, Black non-Hispanic, Hispanic). We further describe 30-day and 1-year mortality following TEER by race/ethnicity. Results: The rate of mitral valve TEER use increased significantly overall (p=0.008), and across each race/ethnic group studied ( Figure 1 ). However, relative to White non-Hispanic patients, Black non-Hispanic and Hispanic patients were less likely to receive mitral valve TEER (adjusted OR 0.45 [95% CI 0.28-0.70] and adjusted OR 0.47 [95% CI 0.19 -0.98] respectively) ( Figure 2 ). The adjusted 30-day and 1-year mortalities following mitral valve TEER were similar between races/ethnicities. Conclusions: Although patients benefit similarly following mitral valve TEER, adoption among non-Hispanic Black and Hispanic patients trails non-Hispanic White patients. This highlights the importance of identifying and addressing barriers to adoption among underrepresented groups.

Beginning to Address an Implementation Gap in Asthma: Clinicians' Views of Prescribing Reliever Budesonide-Formoterol Inhalers and SMART in the United States.

The Global Initiative for Asthma and National Asthma Education and Prevention Program recently made paradigm-shifting recommendations regarding inhaler management in asthma. The Global Initiative for Asthma now recommends that combination inhaled corticosteroid (ICS)-formoterol inhalers replace short-acting β-agonists as the preferred reliever therapy at all steps of asthma management. Although the most recent guidelines of the National Asthma Education and Prevention Program did not review reliever ICS-formoterol usage in mild asthma, they similarly recommended single maintenance and reliever therapy (SMART) at steps 3 and 4 of asthma management. Despite these recommendations, many clinicians-particularly in the United States-are not prescribing new inhaler paradigms. Clinician-level reasons for this implementation gap remain largely unexplored. To gain an in-depth understanding of the facilitators and barriers to prescribing reliever ICS-formoterol inhalers and SMART in the United States. Community and academic primary care providers, pulmonologists, and allergists who reported regularly caring for adults with asthma were interviewed. Interviews were recorded, transcribed, qualitatively coded, and analyzed using the Consolidated Framework for Implementation Research. Interviews were continued until theme saturation. Among 20 interviewed clinicians, only 6 clinicians described regularly prescribing ICS-formoterol inhalers as a reliever inhaler (either alone or within SMART). Significant barriers to new inhaler approaches included concerns surrounding a lack of Food and Drug Administration labeling for ICS-formoterol as a reliever therapy, a lack of awareness regarding a patient's formulary-preferred ICS-long-acting β-agonist choices, the high cost of combination inhalers, and time constraints. Facilitators to using new inhaler approaches included clinicians' beliefs that the latest inhaler recommendations are simpler and more congruent with real-world patients' behavior, and that a potential change in management strategy would offer a valuable opportunity for shared decision making. Although new guidelines exist in asthma, many clinicians described significant barriers to using them including medicolegal issues, pharmaceutical formulary confusion, and high drug costs. Nonetheless, most clinicians believed that the latest inhaler approaches would be more intuitive for their patients and would offer an opportunity for patient-centered collaboration and care. Stakeholders may find these results useful in future attempts to increase the real-world adoption of recent asthma recommendations.

Online semi-supervised learning for motor imagery EEG classification

ObjectiveTime-consuming data labeling in brain-computer interfaces (BCIs) raises many problems such as mental fatigue and is one key factor that hinders the real-world adoption of motor imagery (MI)-based BCIs. An alternative approach is to integrate readily available, as well as informative, unlabeled data online, whereas this approach is less investigated. ApproachWe proposed an online semi-supervised learning scheme to improve the classification performance of MI-based BCI. This scheme uses regularized weighted online sequential extreme learning machine (RWOS-ELM) as the base classifier and updates its model parameters with incoming balanced data chunk-by-chunk. In the initial stage, we designed a technique that combines the synthetic minority oversampling with the edited nearest neighbor rule for data augmentation to construct more discriminative initial classifiers. When used online, the incoming chunk of data is first pseudo-labeled by RWOS-ELM as well as an auxiliary classifier, and then balanced again by the above-mentioned technique. Initial classifiers are further updated based on these class-balanced data. Main resultsOffline experimental results on two publicly available MI datasets demonstrate the superiority of the proposed scheme over its counterparts. Further online experiments on six subjects show that their BCI performance gradually improved by learning from incoming unlabeled data. SignificanceOur proposed online semi-supervised learning scheme has higher computation and memory usage efficiency, which is promising for online MI-based BCIs, especially in the case of insufficient labeled training data.

The Glaze Icing Performance of a Robust Superhydrophobic Film Composed of Epoxy Resin and Polydimethylsiloxane

Ice accretion on transmission lines can cause operational difficulties and disastrous events. In this study, a micro/nano-structured epoxy resin/polydimethylsiloxane (EP/PDMS) film on glass, with water droplet contact angles (CA) observed as high as 160° and the water droplet sliding angle (SA) < 1° was fabricated by aerosol-assisted chemical vapor deposition (AACVD). The glaze icing performance of the superhydrophobic EP/PDMS films have been investigated by comparing the bare glass and room temperature vulcanized (RTV) silicon rubber-coated glass substrate representing the glass insulators and silicone rubber insulators, respectively. Compared with the bare glass and the RTV silicon rubber coating, the EP/PDMS superhydrophobic coating showed excellent performance in delaying glaze icing, especially in the early stages of icing. After 20 min of glaze icing with tilting angle of 90° at −5 and −10 °C, 38.9% and 85.7% of the RTV silicon rubber coating were covered, respectively, and less than 3% of the EP/PDMS coating was covered by ice when the blank glass sheet was completely covered. The EP/PDMS films also showed good mechanical robustness and long-term stability, which are important considerations in their widespread real-world adoption.

Lessons learned from statewide contingency management rollouts addressing stimulant use in the Northwestern United States

Increases in stimulant drug use (such as methamphetamine) and related deaths creates an imperative for community settings to adopt evidence-based practices to help people who use stimulants. Contingency management (CM) is a behavioral intervention with decades of research demonstrating efficacy for the treatment of stimulant use disorder, but real-world adoption has been slow, due to well-known implementation barriers, including difficulty funding reinforcers, and stigma. This paper describes the training and technical assistance (TTA) efforts and lessons learned for two state-wide stimulant-focused CM implementation projects in the Northwestern United States (Montana and Washington). A total of 154 providers from 35 community-based service sites received didactic training in CM beginning in 2021. Seventeen of these sites, ten of eleven in Montana (90.9%) and seven of 24 in Washington (29.2%), went on to implement contingency management programs adherent to their state's established CM protocol and received ongoing TTA in the form of implementation coaching calls. These findings illustrate that site-specific barriers such as logistical fit precluded implementation in more than 50% of the trained sites; however, strategies for site-specific tailoring within the required protocol aided implementation, resulting in successful CM program launch in a diverse cross-section of service sites across the states. The lessons learned add to the body of literature describing CM implementation barriers and solutions.

Stable Superhydrophobic and Antimicrobial ZnO/Polytetrafluoroethylene Films via Radio Frequency (RF) Magnetron Sputtering.

In this study, superhydrophobic ZnO/Polytetrafluoroethylene (ZnO/PTFE) films with water droplet contact angles (CA) observed as high as 165° and water droplet sliding angles of (SA) <1° have been prepared on glass substrates by RF magnetron sputtering. The PTFE was wrapped on a nano-rod made of a ZnO film with superhydrophobic properties while providing excellent UV resistance compared to hexadecyltrimethoxysilane (HDTMS) hydrophobic agents. The upper surface of the rough ZnO film was coated with PTFE, and most of the underlying coating was bare ZnO, which could well make contact with bacteria. For the Gram-negative strain, E. coli, the cell viability count of the ZnO/PTFE sample (3.5 log reduction, 99.96%) was conspicuously lower than that of the ZnO/HDTMS sample (1.2 log reduction, 93.87%) under 1 h illumination of UV light, which showed that the ZnO/PTFE sample has a better photocatalytic property than the ZnO/ HDTMS films. The ZnO/PTFE films also showed good mechanical robustness, which is an important consideration in their widespread real-world adoption.

MT53 Real World Patient Acceptance of Digital Therapeutics: A Review

Patient engagement is critical to the adoption of any healthcare technology including Digital Therapeutics (DTx). This review focuses on factors impacting the real-world adoption of DTx by evaluating patients’ acceptability/acceptance across different therapeutic areas.

European practice patterns for antiplatelet management in NSTE-ACS patients: Results from the REal-world ADoption survey focus on Acute antiPlatelet Treatment (READAPT) survey

BackgroundThe 2020 European Society of Cardiology (ESC) guidelines for the diagnosis and management of patients with non-ST elevation-acute coronary syndrome (NSTE-ACS) recommend early invasive coronary angiography in high-risk patients and no routine pre-treatment with oral P2Y12 receptor inhibitor in NSTE-ACS patients prior to defining coronary anatomy. ObjectiveTo assess the implementation of this recommendation in the real-life setting. MethodsA web-survey in 17 European countries collected physician profiles and their perceptions of the diagnosis, medical and invasive management of NSTE-ACS patients at their hospital. A sample size of at least 1100 responders permitted the estimation of proportions with a precision of at least ±3.0%. ResultsAmong the 3024 targeted participants, 1154 provided valid feedback defined as a 50% response rate of answers to the survey questions. Overall, >60% of the participants declared full implementation of the guidelines at their institution. The time delay from admission to coronary angiography and PCI was reported to be <24 h in over 75% of the hospitals while pre-treatment was intended in >50% of NSTE-ACS patients. Ad-hoc percutaneous coronary intervention (PCI) was performed in >70% of the cases while intravenous platelet inhibition was rarely used (<10%). Between countries differences in practice patterns for antiplatelet management for NSTE-ACS were observed, suggesting heterogeneous implementation of the guidelines. ConclusionsThis survey indicates that the implementation of 2020 NSTE-ACS guidelines on early invasive management and pre-treatment is heterogeneous, potentially due by local logistical constraints.

Integrating digital interventions with clinical practice in youth mental health services.

Integrating digital technologies with clinical practice promises to improve access and enhance care in the context of high service demand and constrained capacity. We outline the emerging research in the integration of digital tools in clinical care, known as blended care, and provide case examples of mental health technology platforms currently in use, summarise findings regarding novel technologies such as virtual reality, and outline real-world implementation challenges and potential solutions. Recent evidence shows that blended care approaches are clinically effective and improve service efficiency. Youth-specific technologies such as moderated online social therapy (MOST) are achieving a range of positive clinical and functional outcomes, while emerging technologies like virtual reality have strong evidence in anxiety disorder, and accumulating evidence in psychotic conditions. Implementation science frameworks show promise in helping overcome the common challenges faced in real-world adoption and ongoing use. The integrated, blended use of digital mental health technologies with face-to-face clinical care has the potential to improve care quality for young people while helping overcome the growing challenges faced by youth mental health service providers.

Adaptation of High Spatio-Temporal Resolution Weather/Load Forecast in Real-World Distributed Energy-System Operation

Despite significant advances in distributed renewable energy systems (DRES), the technology still faces several substantial challenges that prevent the large-scale adoption of these systems into a country’s energy sector. The intermittency of renewables, uncertainties associated with real-time multi-horizon weather and load forecasts, and lack of comprehensive control systems are among the main technical and regulatory challenges for the real-world adoption of DRES. This paper outlines the current state of knowledge in the real-world operation of DRES and also describes pathways and methodologies that enable and facilitate the uptake of DRES in a country’s energy sector.

Disparities in Antifibrotic Medication Utilization Among Veterans With Idiopathic Pulmonary Fibrosis

Two antifibrotic medications, pirfenidone and nintedanib, are approved for the treatment of idiopathic pulmonary fibrosis (IPF). Little is known about their real-world adoption. What are the real-world antifibrotic utilization rates and factors associated with uptake among a national cohort of veterans with IPF? This study identified veterans with IPF who received care either provided by the Veterans Affairs (VA) Healthcare System or non-VA care paid for by the VA. Patients who had filled at least one antifibrotic prescription through the VA pharmacy or Medicare Part D between October 15, 2014, and December 31, 2019, were identified. Hierarchical logistic regression models were used to examine factors associated with antifibrotic uptake, accounting for comorbidities, facility clustering, and follow-up time. Fine-Gray models were used to evaluate antifibrotic use by demographic factors, accounting for the competing risk of death. Among 14,792 veterans with IPF, 17%received antifibrotics. There were significant disparities in adoption, with lower uptake associated with female sex (adjusted OR, 0.41; 95%CI, 0.27-0.63; P< .001), Black race (adjusted OR, 0.60; 95%CI, 0.49-0.73; P< .001), and rural residence (adjusted OR, 0.88; 95%CI, 0.80-0.97; P= .012). Veterans who received their index diagnosis of IPF outside the VA were less likely to receive antifibrotic therapy (adjusted OR, 0.15; 95%CI, 0.10-0.22; P< .001). This study is the first to evaluate the real-world adoption of antifibrotic medications among veterans with IPF. Overall uptake was low, and there were significant disparities in use. Interventions to address these issues deserve further investigation.

An asset-backed decentralised finance instrument for food supply chains – A case study from the livestock export industry

Decentralised finance (DeFi) has emerged as a blockchain-enabled innovation in supply chains that makes use of supporting infrastructure to transform financial services by reducing or removing the need for intermediaries. While an increasing number of pilot projects have been exploring DeFi applications for use by small and medium enterprises (SMEs) in various finance scenarios, there is not yet a real-world adoption of DeFi beyond these projects to unlock their potential for progressing the digitisation of supply chain finance (SCF). This paper reports on a university-industry collaborative study to leverage the use of blockchain-based DeFi technology in two ways: (i) to benefit SMEs by reducing their cost of finance and increasing ease of access to funding, and; (ii) to address the prevalent asymmetric information risks and costs in a supply chain finance context. The research informed the design and development of a DeFi architecture for asset tracking in agricultural supply chains implemented and evaluated in a real-world pilot adoption with a producer in the Australian livestock industry. The use case shows that there are numerous risks pertaining to the adoption of DeFi for SCF. In response, the paper suggests new ways for supply chain SMEs to secure benefits from their investment in DeFi based on the key findings derived from evaluating our use cases.

Artificial Intelligence and Machine Learning in Dialysis: Ready for Prime Time?

Artificial Intelligence and Machine Learning in Dialysis: Ready for Prime Time?

Worldwide survey on implantation of and outcomes for conduction system pacing with His bundle and left bundle branch area pacing leads.

Adoption and outcomes for conduction system pacing (CSP), which includes His bundle pacing (HBP) or left bundle branch area pacing (LBBAP), in real-world settings are incompletely understood. We sought to describe real-world adoption of CSP lead implantation and subsequent outcomes. We performed an online cross-sectional survey on the implantation and outcomes associated with CSP, between November 15, 2020, and February 15, 2021. We described survey responses and reported HBP and LBBAP outcomes for bradycardia pacing and cardiac resynchronization CRT indications, separately. The analysis cohort included 140 institutions, located on 5 continents, who contributed data to the worldwide survey on CSP. Of these, 127 institutions (90.7%) reported experience implanting CSP leads. CSP and overall device implantation volumes were reported by 84 institutions. In 2019, the median proportion of device implants with CSP, HBP, and/or LBBAP leads attempted were 4.4% (interquartile range [IQR], 1.9-12.5%; range, 0.4-100%), 3.3% (IQR, 1.3-7.1%; range, 0.2-87.0%), and 2.5% (IQR, 0.5-24.0%; range, 0.1-55.6%), respectively. For bradycardia pacing indications, HBP leads, as compared to LBBAP leads, had higher reported implant threshold (median [IQR]: 1.5V [1.3-2.0V] vs 0.8V [0.6-1.0V], p = 0.0008) and lower ventricular sensing (median [IQR]: 4.0mV [3.0-5.0mV] vs. 10.0mV [7.0-12.0mV], p < 0.0001). In conclusion, CSP lead implantation has been broadly adopted but has yet to become the default approach at most surveyed institutions. As the indications and data for CSP continue to evolve, strategies to educate and promote CSP lead implantation at institutions without CSP lead implantation experience would be necessary.

An Autonomous Modular Mobility Paradigm

In the United States, public transit vehicles have a very low average load factor (10.1–12.4%), resulting in an excessive waste of seat capacity and poor fuel economy per passenger mile served. This problem is gravely exacerbated by the COVID-19 pandemic, which at its peak had caused more than 70% reduction in transit ridership nationwide. On the other hand, the rapid uptake of e-commerce, also accelerated by the pandemic, has put tremendous pressure on last-mile delivery. A <italic xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">co-modality</i> system that integrates transit services with last-mile logistics offers a promising solution to better utilization/sharing of vehicle capacity and supporting infrastructure. Here we show such a system may be implemented based on Autonomous Modular Vehicle Technology (AMVT). At the core of AMVT is the ability to operate a fleet of modular autonomous vehicles or pods that can be moved, stationed, joined, and separated in real time. Coupling modularity with autonomy is poised to enable co-modality and beyond. We describe an AMVT bimodality system that provides integrated public transit and last-mile logistics services with a fleet of pods and discuss relevant research challenges and opportunities, research approaches, and real-world adoption issues.

Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel (axi-cel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL): Real-World Practice Patterns and Outcomes

Introduction: To minimize toxicities associated with axi-cel, several exploratory safety management cohorts were added to the ZUMA-1 study. In cohort 6 (n = 40), prophylactic (ppx) corticosteroid (CS) use beginning on day 0 was assessed as an intervention strategy to decrease grade ≥ 3 cytokine release syndrome (CRS)/ immune effector cell associated neurotoxicity (ICANS). No grade ≥3 CRS was observed and Grade ≥3 ICANS was observed in 13% of cases without any difference in objective response rate (ORR) or complete response rate (CR) when compared to cohorts that did not use ppx treatment. Based on these findings, the FDA approved an update to the prescribing information for axi-cel to include use of ppx CS across all approved indications in January 2022. However, ppx CS use is not a mandatory standard treatment and has not been universally adopted. We sought to establish the real-world practice patterns of ppx CS use and clinical outcomes. Methods: To assess real-world practice patterns of ppx CS use with axi-cel for R/R LBCL, we sent a 5-question survey to 22 centers across the US axi-cel certified treatment centers. Next, to assess the clinical outcomes of pts receiving ppx CS, we conducted a multicenter retrospective review of pts with R/R LBCL undergoing axi-cel since the FDA approval for prophylactic indication. Baseline characteristics were compared between the no ppx vs. the ppx CS groups. Axi-cel-related toxicities CRS and ICANS were graded based on ASTCT 2019 guidelines. Updated data will be presented at the meeting with more pts and longer follow up. Results: Of the 22 centers, 17 (77%) responded to the questionnaire, with 11/22 (50%) using ppx CS (figure 1). Six centers that had not adopted the ppx steroids cited various reasons such as limited data on efficacy, presence of clinical trial using ppx CS, and unclear effect on CAR-T expansion. 7 of 11 centers using ppx CS only use it for a subset of patients and 3 of 11 use it in all patients receiving axi-cel. The subset of patients selected for ppx CS was based on general institutional guidelines or treating physician preference. Criteria for those with institutional guidelines were variable but included high disease burden, older patients with comorbidities, and those requiring chemotherapy for bridging. A total of 22 pts at 4 centers received axi-cel between Jan 31, 2022, and June 15, 2022. A historical cohort of 22 pts was added to the no ppx CS group for those infused in 2021. Eleven (58%) pts received ppx CS and baseline characteristics at the time of apheresis are shown in Table 1. These were comparable between the 2 groups except for a shorter median time from apheresis to CAR-T infusion in the no ppx CS group. Among the entire cohort, 71% of patients required bridging therapy and only 20% (9/44) met ZUMA-1 eligibility criteria at the time of lymphodepletion. Any grade CRS occurred in 91% (40/44) pts, with grade ≥2 CRS in 43% (19/44). Any grade ICANS occurred in 61% (27/44) pts, with grade ≥2 ICANS in 43% (19/44) pts. The rates of grade ≥2 CRS, ICANS, the median time to CRS onset, ICANS onset, CRS duration, and ICANS duration were comparable between the 2 groups. Ten pts (23%) developed infectious complications within 30 days of CART. The day 30 ORR was 80% and was comparable between the 2 groups. In the ppx CS group (n = 22), 5 pts had progressed and 2 had died (both disease progression) at the time of data cut-off. Median event-free survival and overall survival had not been reached in either group (excluding historical cohort), due to short median follow-up of 15 weeks. Conclusions: Real-world adoption of ppx CS to mitigate toxicities of axi-cel varies considerably across sites in the US for multiple reasons. Since the FDA label change at least 50% of the centers surveyed had adopted the use of ppx CS. No significant differences in efficacy or CAR-T-associated toxicities were noted in the 2 groups, potentially due to selective use with patients at presumed higher risk of severe CRS and ICANS. A larger dataset and longer follow-up is needed for risk-stratified analysis and will be presented at the meeting. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

A fluidic relaxation oscillator for reprogrammable sequential actuation in soft robots

A fluidic relaxation oscillator for reprogrammable sequential actuation in soft robots