ESL

Real World Experience with a Zuma -1 Cohort 4 Adopted Approach to CRS and Icans in CAR-T Recipients

This research to practice full paper investigates software engineering students' perceptions of their contact with open source projects as a real-world experience. Working with open source projects (OSPs) has been shown as an interesting option in software engineering courses to bringing students closer to more realistic environments. However, when instructors use this approach, it is not clear whether students perceive the OSP as a real industrial software project, or whether they perceive the tasks they perform over OSPs as typical or close to industrial software project activities. The goal of this work was to identify students' perceptions of their interaction with an open source project as a real world experience. To do so, we performed three mixed-methods case studies with three different undergraduate classes. Each class had a different focus: i) software maintenance and evolution, ii) software testing, and iii) reverse engineering of software requirements. Results show that students perceived features that make OSPs close to industrial projects, realized that their OSP tasks are close to the ones in industrial projects, and also faced difficulties typical of working with real world software. Moreover, students forged a view of the skills needed for their future professional success. We conclude that students realized that performing tasks in OSPs was a real world experience they took part, contributing to their background both for the competencies they acquired and the difficulties they had to overcome.

Background: Neoadjuvant therapy (NA) is the base treatment for the majority of patients with early triple negative breast cancer (TNBC). The achievement of pathological complete response (pCR) after neoadjuvant treatment translates into improvements in long term outcomes. In the last decade, the arrival of new components or formulations have been assessed in clinical trials, such as carboplatin and nab-paclitaxel showing improvements in pCR rates or adverse events profiles. The aim of this study is to provide updated information on the efficacy of Carboplatin plus Nab-paclitaxel combined with other combinations (anthracyclines and immunotherapy) as neoadjuvant therapy in patients with TNBC in the real-world setting. Methods: We analyzed a cohort of patients treated with neoadjuvant therapy diagnosed with stage I-II TNBC and ER/PR-low status in a single tertiary hospital in Spain from June 2015 to February 2023. TNBC was defined as ER and PR <1% and HER-2 negative. ER/PR-low was defined as an expression of estrogen or progesterone receptors ≤ 10% by immunohistochemistry (IHC). Both Carboplatin (AUC 2) and Nab-paclitaxel (125 mg/m2) were administered on days 1 and 8 every 21 days. Anthracyclines (Doxorubicin or Liposomal Doxorubicin) were administered every 2 or 3 weeks, at the physician's discretion. Pembrolizumab 200 mg was administered every 21 days concomitantly with chemotherapy. The response to NA was classified according to the residual cancer burden (RCB). pCR was defined as ypT0/is/ypN0. Cox's stratified proportional hazard model was used for event free survival analysis. Event free survival was define disease progression that prevented definitive surgery, local or distant recurrence or death from any cause. Results: A total of 103 patients were included in the analysis. The median age at diagnosis was 53.1 years. The baseline caracteristhics of the patiens are in table 1. Regarding the systemic treatment, 91.2% of the patients were treated with anthracyclines sequentially and in 23% of these (n=30) a liposomal formulation was used. Dose-dense anthracyclines were used in the 23.7% of patients. Concomitant pembrolizumab was used in 27.1%(n=28) of the patients, 60.7% (n=17) of these were stage III at diagnosis. Only one patient did not undergo surgery due to intra-treatment systemic progression. The pCR rate (RCB-0) in the total population was 54.3%. Patients with residual disease after NA (n=47) were classified as RCB-I (17.4%), RCB-II (18.4%) and RCB-III (8.7%). The pCR rates according to different features is reported in Table1. The germline mutation carriers in HRD genes (n=14) obtained a pCR rate of 71,4%. In patients with concomitant use of pembrolizumab, the pCR rate was 60.7%. The pCR rate in TNBC and ER/PR-low groups were 54.2% and 55% respectively. The median follow-up time was 27.7 months. Tha hazard ratio for event of progression between pCR vs residual disease groups was 0.21, 95%CI: 0.06 to 0.76; (p=0.018), with 3 events in the RCB-0 group (n=53) and 12 events in the residual disease group (n=47). Conclusion: In the real world setting, the use of carboplatin-nabpaclitaxel plus other combinations, such as anthracyclines and immunotherapy obtain a higher rate of pathological complete response translating to improvements in long term outcomes. Citation Format: Manuel Alva Bianchi, Pablo Tolosa, Oscar Campos, Rodrigo Sanchez-Bayona, Carla Quevedo, Cristina Gonzalez, Laura Lema, Ainhoa Madariaga, Cristina González Deza, Lucia Parrilla, Mario Gonzalez, Cristina Martín-Arriscado, Luis Manso, Eva Ciruelos. Real world experience with Carboplatin plus Nab-paclitaxel as neoadjuvant therapy in patients with early triple negative breast cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-09-16.

Sequence of Second Generation Tyrosine Kinase Inhibitors (TKIs) in the Treatment of Patients with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia - Real World Experience in the UK

e17526 Background: Human papillomavirus (HPV) is one of the main risk factors associated with squamous cell carcinoma of the head and neck (SCCHN). Although it is a prognostic factor, SCCHN patients are not routinely tested for HPV status because it may not be informative for therapy initiation. The objective of this study was to understand the real world testing patterns, and treatment decision of SCCHN patients. Methods: Real world data was gathered using Adelphi’s Disease-Specific Programme (DSP) - a real world, cross-sectional survey conducted in the USA, France, Germany and the UK (April - September 2016). The DSP incorporated 182 physician interviews (54 US, 128 EU) covering all stages of SCCHN caseloads and treatment patterns. Physicians also provided data for 8 consecutive consulting SCCHN patients regarding treatment patterns, progression, and symptoms. Results: A total of 2193 SCCHN patient cases were captured. HPV testing was carried out in 42% of patients within the DSP data set with no particular difference across the 4 countries. Of those tested, 35% of patients were HPV positive. Testing was mainly performed at the local level (51%, onsite or local hospital) apart from Germany where central testing was higher (73%). In over half of patients cases (54%) , physicians are unaware of the type of test performed for the HPV status determination; in fact, up to 10 different types of tests were used to determine the HPV status in this real world experience. Platinum based cetuximab and fluorouracil was used in 30% of the HPV positive patients while 20% received platinum monotherapy. In 2nd line, docetaxel/paclitaxel monotherapy was used in 22% of the patients. HPV negative patients also mainly received platinum based cetuximab and fluorouracil (27%) in 1st line, while in 2ndline, docetaxel/paclitaxel monotherapy was used in 20% of the patients. Conclusions: This analysis of real world treatment patterns and outcomes among SCCHN patients shows that HPV testing is not widely carried out for either patient characterization or to guide treatment decisions within this disease. Therapy choices were generally consistent standard clinical guidelines.

Virtual reality (VR) technology has advanced significantly in recent years, with many potential applications. However, it is unclear how well VR simulations mimic real-world experiences, particularly in terms of eye–hand coordination. This study compares eye–hand coordination from a previously validated real-world object interaction task to the same task re-created in controller-mediated VR. We recorded eye and body movements and segmented participants’ gaze data using the movement data. In the real-world condition, participants wore a head-mounted eye tracker and motion capture markers and moved a pasta box into and out of a set of shelves. In the VR condition, participants wore a VR headset and moved a virtual box using handheld controllers. Unsurprisingly, VR participants took longer to complete the task. Before picking up or dropping off the box, participants in the real world visually fixated the box about half a second before their hand arrived at the area of action. This 500-ms minimum fixation time before the hand arrived was preserved in VR. Real-world participants disengaged their eyes from the box almost immediately after their hand initiated or terminated the interaction, but VR participants stayed fixated on the box for much longer after it was picked up or dropped off. We speculate that the limited haptic feedback during object interactions in VR forces users to maintain visual fixation on objects longer than in the real world, altering eye–hand coordination. These findings suggest that current VR technology does not replicate real-world experience in terms of eye–hand coordination.

Real-World Experience with Isatuximab in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Iona-MM Second Interim Analysis

IntroductionRandomized controlled trials have demonstrated a reduction in the decline of lung function and a reduced risk of acute exacerbation in patients with idiopathic pulmonary fibrosis treated with the antifibrotic prifenidone. The present study aimed to investigate the real-world effectiveness and safety profile of pirfenidone treatment for patients with IPF in Taiwan.MethodsBetween January 1, 2019 and December 31, 2020, we enrolled 50 patients who were newly diagnosed with IPF and had at least 12 months follow-up period after pirfenidone administration.ResultThe primary outcome of pharmacologic effect showed that the mean differences in the absolute values of forced vital capacity from baseline were 0.2 liter (n = 36), 0.13 liter (n = 32), 0.04 liter (n = 26), and − 0.004 liter (n = 26) after 3, 6, 9, and 12 months of administration, respectively. A slight improvement in quality of life, including scores of chronic obstructive pulmonary disease assessment test and St. George’s respiratory questionnaire scores. The most common adverse effects were gastrointestinal upset and dermatological problems. No new safety concerns were observed in the present study.ConclusionOur real-world study describe for the first time in Taiwan, the use of pirfenidone over a 12 months period. This drug preserves the lung function and improves quality of life with tolerable side effects.

ObjectivesTo study the 30-month safety and effectiveness of Cladribine tablets (CladT) in relapsing multiple sclerosis (RMS) months in a real-world setting. MethodsRetrospective single-centre observational study in Qatar (January 2018–Feb 2023). Clinical and MRI data, lymphocyte counts and adverse events (AE) were recorded for patients with RMS who received at least one course of CladT. ResultsForty-six patients were included (mean follow-up 22 months); 34 (74 %) were female, 22 (48 %) were disease-modifying therapy (DMT) naïve, 16 (35 %) had switched from platform DMT and 8 (17 %) from high efficacy (HE) DMD. Mean age was 26.7±7.2 y, mean disease duration was 7.2±6.0 y. Common reasons for treatment with CladT were MS activity (91 %), pregnancy planning (17 %), AE (20 %), compliance (9 %). 44/46 ( 96 %) received the year 2 course of CladT. Annualised relapse rate (ARR) fell from 1.02 (baseline) to 0.1, 0, 0.1, 0.1 and 0.1 for years 1–5 post-treatment, respectively; 87.5–100 % were free of relapses at these times, vs. 21 % at baseline. There were no relapses in year 2; 78 %, 100 %, 84 %, 80 % and 100 %, respectively, were free of GD+ MRI lesions at years 1–5, vs. 31 % at baseline. Most clinical AE were mild (1 moderate, no severe AE); 12 contracted Covid-19 (no hospitalisations). Grade 3 lymphopenia occurred in 5 patients. ConclusionsCladT appeared to be effective and safe in our retrospective study, irrespective of prior treatments, consistent with other real world data that support the early use of CladT in the management of RRMS.

Background: Guidelines recommend using the CHA 2 DS 2 -VASc score to determine anticoagulation decisions in atrial fibrillation (AF) patients, including those who undergo pulmonary vein isolation (PVI), however this may not consistently occur in the real-world setting because of other clinical factors. We sought to evaluate the anticoagulation prescription patterns in AF patients 1 year PVI at our institution. Methods: Consecutive AF patients undergoing PVI in our prospective registry during 2014-2018 who were alive at 1-year post-PVI were studied. Anticoagulation prescription rates at this time-point were adjudicated, and correlated to CHA 2 DS 2 -VASc score, sex and maintenance of normal sinus rhythm (NSR) at 1 year. Results: Amongst 4596 patients undergoing PVI, mean age was 64.1±10.0 years, 3308 (71.2%) were male, and based on CHA 2 DS 2 -VASc Score anticoagulation was not indicated, can be considered and indicated in 872 (19.0%), 1183 (25.7%) and 2541 (55.3%) patients respectively. At 1-year after PVI, 3504 (76.2%) patients were on anticoagulation, and 792 (17.2%) had recurrence of AF. Anticoagulation rates by sex, CHA 2 DS 2 -VASc Score category and NSR at 1-year after PVI are illustrated in the Figure. Anticoagulation was continued in over half of AF patients without classic CHA 2 DS 2 -VASc indication particularly in those with AF recurrence and women, while they were mildly under-prescribed in those with indication, especially for those without AF recurrence and men. Conclusion: In a large real world cohort of patients post PVI, anticoagulation is prescribed independent of CHA 2 DS 2 -VASc score, and is affected by both sex and NSR status. Factors determining continuous anticoagulation after successful PVI may include parameters not covered in the CHA 2 DS 2 -VASc score such as return of atrial mechanical function on echocardiography, valve disease or extra-cardiac pathologies.

<h3>Introduction</h3> Vedolizumab (VDZ) is a humanised monoclonal IgG-1 antibody that is used in the treatment of inflammatory bowel disease (IBD). Unlike with anti-TNF therapy the benefit of therapeutic drug monitoring (TDM) of VDZ remains debatable. A number of trials have suggested that VDZ trough levels post induction of &gt;18–20 μg/ml are associated with better clinical outcomes.^{1 2} However, data regarding levels in the maintenance phase is less convincing but likely to be lower.¹ Real-world data is lacking, and the use of Vedolizumab drug monitoring is not widely used outside tertiary centres. The aim of this study was to evaluate our current practice at a busy London district general hospital. <h3>Methods</h3> A retrospective study of all patients undergoing VDZ TDM at our unit between July 2017 and December 2019. Data collected included indication and timing of level, value and whether the level resulted in a change in management. <h3>Results</h3> 67 patients were established on VDZ between July 2017 and December 2019. 15 patients (22.4%) had VDZ levels performed with 4 patients undergoing more than one level during this time giving a total of 22 levels performed. Levels were undertaken in the majority of patients for secondary loss of response (LOR) (16/22). A small number were taken during maintenance (4/22), post induction (1/22), and after recapturing response (1/22). Out of the 22 drug levels analysed, 10 (45.5%) were classified as trough levels (within 1 week of a VDZ infusion). Trough levels ranged between 5 μg/ml and 32.7 μg/ml with a median of 15.8 μg/ml. We used a cut-off of 18 μg/ml when interpreting levels. All trough levels taken were performed due to LOR. 6 (60%) levels taken in 4 patients were &lt;18 μg/ml with the remaining 4 levels ≥18 μg/ml. The outcomes of the 4 patients who had sub-therapeutic trough levels were analysed. 2 patients recaptured response after either a course of corticosteroids or optimising 5-ASA therapy. 2 were switched to other therapeutic options (Infliximab and Ustekinumab). A further 3 non-trough levels (in 2 patients) analysed were sub-therapeutic. 1 recaptured response after optimisation and 1 responded to a 3 month period of escalated 4-weekly VDZ therapy. All patients with levels ≥18 μg/ml have continued VDZ therapy with good response. <h3>Conclusions</h3> In our real-world setting, using a cut-off of &lt;18 μg/ml for levels carried out in LOR is helpful in identifying the need to either escalate/optimise or switch agent. However, VDZ levels are being underutilised and are only being taken as trough in 45.5% of patients. There remains uncertainty as to how maintenance levels should be interpreted and national guidance after more studies would be welcome. <h3>References</h3> Papamichael K, Cheifetz A, Melmed G, <i>et al</i>. Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases. <i>Clinical Gastroenterology and Hepatology</i> 2019;<b>17</b>:1655–1668. Ward M, Sparrow M and Roblin X. Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: current data and future directions. Therapeutics Advances in Gastroenterology. 2018:11;1–10.

BackgroundCamrelizumab has shown promising survival benefits in treatment-naïve advanced non-small cell lung cancer (NSCLC) patients when used in combination with chemotherapy. However, its effectiveness and safety outside the clinical trial setting are largely unknown. Therefore, we conducted NOAH-LC-101, a prospective multicenter cohort study, to investigate the real-world effectiveness and safety of camrelizumab on a large cohort of advanced NSCLC patients in daily clinical practice.MethodsAll consecutive patients aged ≥18 years with confirmed advanced NSCLC scheduled for camrelizumab treatment were screened for inclusion at 43 hospitals in China. The primary outcome was progression-free survival (PFS). The secondary outcomes included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.ResultsBetween August 2019 and February 2021, 403 patients were included. The median age of participants was 65 years (range, 27–87 years). There were 57 (14.1%) participants with an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥2. Most participants received camrelizumab in the second or later lines (68.7%) and plus chemotherapy (64.8%). The median PFS was 12.6 [95% confidence interval (CI): 10.7–17.0] months and median OS was 22.3 months [95% CI: 19.3–not reached (NR)]. The ORR was 28.8% (95% CI: 24.4–33.5%) and DCR was 79.9% (95% CI: 75.7–83.7%). Adverse events of any grade occurred in 348 (86.4%) participants. No new safety signals were identified. Reactive cutaneous capillary endothelial proliferation was observed in 75 (18.6%) patients, all of which were grade 1–2.ConclusionsThis study demonstrates the effectiveness and safety of camrelizumab in a large sample of real-world NSCLC patients. The results are generally consistent with those previously reported in pivotal clinical trials. This study supports the clinical use of camrelizumab in a broader patient population (ChiCTR1900026089).

AYA ALL: Real World Experience from a Tertiary Care Center in North India

Ph Positive ALL: Real World Experience from a Tertiary Care Center in North India

With power becoming a major constraint for multi-processor embedded systems, it is becoming important for designers to characterize and model processor power dissipation. It is critical for these processor power models to be useable across various modeling abstractions in an electronic system level (ESL) design flow, to guide early design decisions. In this paper, we propose a unified processor power modeling methodology for the creation of power models at multiple granularity levels that can be quickly mapped to an ESL design flow. Our experimental results based on applying the proposed methodology on an OpenRISC processor demonstrate the usefulness of having multiple power models. The generated models range from very high-level two-state and architectural/ISS models that can be used in transaction level models (TLM), to extremely detailed cycle-accurate models that enable early exploration of power optimization techniques. These models offer a designer tremendous flexibility to trade off estimation accuracy with estimation/simulation effort.