Multicenter Retrospective Analysis Research Articles

Characteristics and outcomes of critically ill injured patients admitted to intensive care units after the earthquake in Southeast Turkiye: Multicenter retrospective analysis

Characteristics and outcomes of critically ill injured patients admitted to intensive care units after the earthquake in Southeast Turkiye: Multicenter retrospective analysis

Rituximab is a safe and effective alternative treatment for patients with autoimmune hepatitis: Results from the ColHai registry.

Small series suggest that rituximab could be effective as treatment for autoimmune hepatitis (AIH), although data are scarce. We aimed to evaluate the efficacy and safety of rituximab in different cohorts of patients with AIH. Multicentre retrospective analysis of the 35 patients with AIH and its variant forms treated with rituximab and included in the ColHai registry between 2015 and 2023. Most patients were female (83%), 10 (29%) had cirrhosis and four (11.4%) variant forms of AIH. Indication for rituximab were as follows: 14(40%) refractory AIH, 19(54%) concomitant autoimmune or haematological disorder, 2(6%) intolerance to prior treatments. In three (9%) subjects with a concomitant disorder, rituximab was the first therapy for AIH. Overall, 31 (89%) patients achieved or maintained complete biochemical response (CBR), including the three in first-line therapy. No difference in CBR was observed according to rituximab indication (refractory AIH 86% vs. concomitant disorders 90%, p = .824) or cirrhosis (80% vs. 92%, p = .319). Rituximab was associated with a significant reduction in corticosteroids (median dose: prior 20 vs. post 5 mg, p < .001) and the discontinuation of ≥1 immunosuppressant in 47% of patients. Flare-free rate at 1st, 2nd and 3rd year was 86%, 73% and 62% respectively. Flares were not associated with the development of liver failure and were successfully managed with repeated doses of rituximab and/or increased corticosteroids. Three (9%) patients experienced infusion-related adverse events (1 anaphylaxis and 2 flu-like symptoms) and five (14%) infections. Rituximab is safe and effective in patients with refractory AIH and those treated due to concomitant autoimmune or haematological disorders.

Percutaneous left atrial appendage occlusion can impair pulmonary vein isolation with pulse field ablation

Abstract Background Pulsed-field ablation (PFA) is a promising new ablation modality for pulmonary vein isolation (PVI). However, the feasibility in the presence of a percutaneous left atrial appendage occluder (LAAO) has not yet been investigated. We observed that PFA applications in the left pulmonary veins after LAAO can be interrupted. The aim of this analysis was to investigate the feasibility of PFA with a single-shot device for PVI after LAAO. Methods / Results: Retrospective multicenter analysis. A total of 16 patients (male 81.3%, mean age 71.6 +/-7.4) underwent PVI with PFA after LAAO at 5 different centers in Switzerland and Germany, from August 2021 until July 2023. In 5 patients PFA application at the left-sided PVs was aborted due to interference with the LAAO (Figure). In one patient, the left superior PV could be isolated by repositioning the PFA catheter, in 2 cases successful PVI was achieved after switching to radiofrequency ablation, and in 2 cases the respective left sided PV was not isolated. In all 5 patients the LAAO was an Amplatzer Amulet device (Amplatzer Amulet vs. other LAAO, p=0.069). Mean LAAO size was not significantly different among both groups. Conclusions LAAO can interfere with PFA applications around the left superior pulmonary vein. This effect may be associated with the design of the LAAO.

Anesthesia modality in endovascular treatment for distal medium vessel occlusion stroke: intention-to-treat propensity score-matched analysis

BackgroundThe optimal anesthesia modality during endovascular treatment (EVT) for distal medium vessel occlusion (DMVO) stroke is uncertain. We aimed to evaluate the association of the anesthesia modality with procedural and...

Prevalence of Medications Errors and Factors of Harmful Errors in Neonates and Paediatrics at Tertiary and Paediatric Hospitals: A Multicenter Study

Medication errors (ME) are human mistakes that may occur during drug use, prescribing administration or monitoring. This study aimed to determine the Prevalence of MEs among pediatric patients receiving tertiary treatment in pediatric speciality hospitals and describe their patterns and causes. Three institutions participated in a multicenter retrospective analysis. Reports of all MEs involving paediatrics aged ≤13 years who were hospitalised or visited the Emergency Department or outpatient clinics were reviewed 1 January 2019 - 31 December 2019. The National Coordinating Council for Medication Error Reporting and Prevention classification was used to categorise MEs and to define PRME (category CI) and patient–harming MEs (category EI). A retrospective study was conducted with a total of 318 MEs reported, with an overall prevalence of 0.9 per 1,000 patients. The Prevalence was markedly lower in the CHT (0.35 / 1,000 patients) than in KAMC and KFSH&amp;RC (1.73 and 3.5). The highest rate of MEs was observed in admitted wards (14.69 / 1,000 patients). Most commonly, MEs occurred at the prescribing stage (81.1%), were caused by a physician (83.3%), and were discovered by the pharmacist (85.5%). Improper medication dosage (34.0%), frequency (14.2%), and duration (10.4%) were the three most common forms of MEs. Paediatric inpatient treatment has a significant frequency of MEs, accounting for 24% of hospitalisations. The ME may not get to the patient if independent double-check prescriptions, accurate medication reconciliation of new prescriptions against the previously prescribed, and improved medicine labelling and packaging techniques are used.

Staphylococcus aureus bacteremia in alcoholics.

Alcoholism associates with increased Staphylococcus aureus bacteremia incidence and mortality. The objective was to compare disease progression, treatment and prognosis of Staphylococcus aureus bacteremia in alcoholics versus non-alcoholics. The study design was a multicenter retrospective analysis of methicillin-sensitive Staphylococcus aureus bacteremia with 90-day follow-up. Patients were stratified as alcoholics or non-alcoholics based on electronic health record data. Altogether 617 Staphylococcus aureus bacteremia patients were included of which 83 (13%) were alcoholics. Alcoholics, versus non-alcoholics, were younger, typically male and more commonly had community-acquired Staphylococcus aureus bacteremia. No differences in McCabe´s classification of underlying conditions was observed. Higher illness severity at blood culture sampling, including severe sepsis (25% vs. 7%) and intensive care unit admission (39% vs. 17%), was seen in alcoholics versus non-alcoholics. Clinical management, including infectious disease specialist (IDS) consultations and radiology, were provided equally. Alcoholics, versus non-alcoholics, had more pneumonia (49% vs. 35%) and fewer cases of endocarditis (7% vs. 16%). Mortality in alcoholics versus non-alcoholics was significantly higher at 14, 28 and 90 days (14% vs. 7%, 24% vs. 11% and 31% vs. 17%), respectively. Considering all prognostic parameters, male sex (OR 0.19, p = 0.021) and formal IDS consultation (OR 0.19, p = 0.029) were independent predictors of reduced mortality, whereas ultimately or rapidly fatal comorbidity in McCabe´s classification (OR 12.34, p < 0.001) was an independent predictor of mortality in alcoholics. Alcoholism deteriorates Staphylococcus aureus bacteremia prognosis, and our results suggests that this is predominantly through illness severity at bacteremia onset. Three quarters of Staphylococcus aureus bacteremia patients we studied had identified deep infection foci, and of them alcoholics had significantly less endocarditis but nearly half of them had pneumonia.

Palliative care inpatients in Switzerland (2012–2021): characteristics, in-hospital mortality and avoidable admissions

ObjectivesPalliative patients generally prefer to be cared for and die at home. Overly aggressive treatments place additional strain on already burdened patients and healthcare services, contributing to decreased quality of...

Clinical characteristics and prognosis of patients with newly diagnosed primary central nervous system lymphoma: a multicentre retrospective analysis.

Bruton's tyrosine kinase inhibitors (BTKi) exhibit superior efficacy in relapsed/refractory primary central nervous system lymphoma (PCNSL), but few studies have evaluated patients with newly diagnosed PCNSL, and even fewer studies have evaluated differences in efficacy between treatment with BTKi and traditional chemotherapy. This study retrospectively analyzed the clinical characteristics of 86 patients with PCNSL and identified predictors of poor prognosis for overall survival (OS). After excluding patients who only received palliative care, 82 patients were evaluated for efficacy and survival. According to the induction regimen, patients were divided into the traditional chemotherapy, BTKi combination therapy, and radiotherapy groups; the objective response rates (ORR) of the three groups were 71.4%, 96.2%, and 71.4% (P = 0.037), respectively. Both median progression-free survival and median duration of remission showed statistically significant differences (P = 0.019 and P = 0.030, respectively). The median OS of the BTKi-containing therapy group was also longer than that of the traditional chemotherapy group (not reached versus 47.8 (32.5-63.1) months, P = 0.038).Seventy-one patients who achieved an ORR were further analyzed, and achieved an ORR after four cycles of treatment and maintenance therapy had prolonged OS (P = 0.003 and P = 0.043, respectively). In conclusion, survival, and prognosis of patients with newly diagnosed PCNSL are influenced by the treatment regimen, with the BTKi-containing regimen showing great potential.

Evaluation of clinical and laboratory characteristics of dengue viral infection and risk factors of dengue hemorrhagic fever: a multi-center retrospective analysis

BackgroundDengue Viral Infection (DVI) has become endemic in Pakistan since the first major outbreak in Karachi in 1996. Despite aggressive measures taken by relevant authorities, Pakistan has been dealing with a worsening dengue crisis for the past two decades. DHF is severe form of dengue infection which is linked with significant morbidity and mortality. Early identification of severe dengue infections can reduce the morbidity and mortality. In this context we planned current study in which we find out the different factors related with DHF as well as clinical laboratory features of DHF and compare them to DF so that patients can be best evaluated for DHF and managed accordingly at admission.MethodsRetrospective study conducted over a period of 6 years (2013–2018) in two tertiary care hospitals in Pakistan. Data were collected by using a pre-structured data collection form. Data were statistically analyzed to determine the clinical and laboratory characteristics of DVI and risk factors of dengue hemorrhagic fever (DHF).ResultsA total 512 dengue cases (34.05 ± 15.08 years; Male 69.53%) were reviewed. Most common clinical manifestations of DVI were fever (99.60%), headache (89.1%), chills (86.5%), rigors (86.5%), myalgia (72.3%). Less common clinical manifestations were vomiting (52.5%), arthralgia (50.2%) and skin rashes (47.5%). Furthermore, nasal bleeding (44.1%), gum bleeding (32.6%), pleural effusion (13.9%) and hematuria (13.1%) were more profound clinical presentations among DHF patients. Mortality rate was 1.5% in this study. Logistic regression analysis indicated that delayed hospitalization (OR: 2.30) and diabetes mellitus (OR:2.71), shortness of breath (OR:2.21), association with risk groups i.e., living near stagnant water, travelling to endemic areas, living in endemic regions (OR:1.95), and presence of warning signs (OR:2.18) were identified as risk factors of DHF. Statistically we found that there is strong association of diabetes mellitus (DM) with DHF while the patient suffering from DM individually had higher odds (2.71) of developing DHF than patients without disease.ConclusionsThe current study demonstrated that the clinical and laboratory profiles of DF and DHF are significantly distinct. Significant predictors of DHF were advanced age, diabetes mellitus, ascites, pleural effusion, thick gallbladder and delayed hospitalization. The identification of these factors at early stage provides opportunities for the clinicians to identify high risk patients and to reduce dengue-related morbidity and mortality.

Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany.

Eptinezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP mAb) and is used for migraine prophylaxis. Efficacy data are mainly from clinical trials, real-world data are hardly available yet. Reimbursement policy in Germany leads to eptinezumab mainly being used in patients having failed pre-treatment with other CGRP mAb. To date, it is unclear whether eptinezumab is efficacious and well tolerated in this population and how the treatment response differs from patients who are naive to CGRP mAbs. We analysed clinical routine data of 79 patients (episodic migraine (EM): n = 19; chronic migraine (CM): n = 60) from four different centres in Germany. All patients were treated with eptinezumab (100mg). Differences in monthly headache (MHD), migraine (MMD) and acute medication days (AMD) after three months were analysed. The correlation of response with the number of CGRP mAb failures was evaluated. Significance level has been corrected (alpha = 0.017). After three months MHD, MMD and AMD were significantly reduced. In EM, the median reduction for MHD was 4.0 days (IQR: -6.5 to -1.0; p = 0.001), for MMD 3.0 days (IQR: -5.5 to -1.5; p < 0.001) and for AMD 2.0 days (IQR: -5.0 to -0.5; p = 0.006). In CM, median reduction of MHD was 4 days (IQR: -8.0 to 0.0; p < 0.001), 3.0 days (IQR: -6.0 to-1.0; p < 0.001) for MMD and 1.0 day (IQR: -5.0 to 0.0; p < 0.001) for AMD. All patients were resistant to conventional preventive therapies and most to CGRP mAbs. Fourteen patients had never received a CGRP mAb and 65 patients had received at least one mAb without sufficient effectiveness and/or intolerability (one: n = 20, two: n = 28, three: n = 17). There was a significant association between the number of prior therapies and the 30% MHD responder rate (none: 78.6%, one: 45.0%, two: 32.1%, three: 23.5%, p = 0.010). Regarding tolerability, 10.4% (8/77) reported mild side effects. The effectiveness of eptinezumab is significantly reduced in patients who have not previously responded to other CGRP mAbs. However, limitations such as the retrospective nature of the analysis, the small sample size and the short treatment period with only the lower dose of eptinezumab must be considered when interpreting the results.

Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group.

Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions. This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting. A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07-1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11-1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn. Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

Ki67 Tumor Expression Predicts Treatment Benefit Achieved by Macroscopic Radical Lung-Preserving Surgery in Pleural Mesothelioma-A Retrospective Multicenter Analysis.

Pleural mesothelioma (PM), linked to asbestos-induced inflammation, carries a poor prognosis. Therapy ranges from therapy limitation to aggressive multimodality treatment. Given the uncertainty about treatment benefits for patients, this study aimed to assess the role of Ki67 as a prognostic and predictive parameter in PM. Ki67 was measured in the specimens of 70 PM patients (17 female, 53 male) from two centers and correlated to overall survival (OS) and therapy outcome. The median OS was 16.1 months. The level of Ki67 expression was divided into low (≤15%) and high (>15%). A low value of Ki67 expression was associated with a longer OS (Ki67 ≤ 15%: 31.2 (95% CI 6.5-55.8) months vs. Ki67 > 15%: 11.1 (95% CI 7.7-14.6) months, p = 0.012). The 5-year survival represents 22% in the low Ki67 expression group, in contrast to 5% in the high Ki67 expression group. We found a significant interaction term of Ki67 with multimodality treatment (p = 0.031) translating to an OS of 48.1 months in the low expression Ki67 group compared to 24.3 months in the high Ki67 expression group when receiving surgery within multimodality therapy. Therefore, Ki67 stands out as a validated prognostic and, most importantly, novel predictive biomarker for treatment benefits, particularly regarding surgery within multimodality therapy.

Deep learning based digital pathology for predicting treatment response to first-line PD-1 blockade in advanced gastric cancer

BackgroundAdvanced unresectable gastric cancer (GC) patients were previously treated with chemotherapy alone as the first-line therapy. However, with the Food and Drug Administration’s (FDA) 2022 approval of programmed cell death protein 1 (PD-1) inhibitor combined with chemotherapy as the first-li ne treatment for advanced unresectable GC, patients have significantly benefited. However, the significant costs and potential adverse effects necessitate precise patient selection. In recent years, the advent of deep learning (DL) has revolutionized the medical field, particularly in predicting tumor treatment responses. Our study utilizes DL to analyze pathological images, aiming to predict first-line PD-1 combined chemotherapy response for advanced-stage GC.MethodsIn this multicenter retrospective analysis, Hematoxylin and Eosin (H&E)-stained slides were collected from advanced GC patients across four medical centers. Treatment response was evaluated according to iRECIST 1.1 criteria after a comprehensive first-line PD-1 immunotherapy combined with chemotherapy. Three DL models were employed in an ensemble approach to create the immune checkpoint inhibitors Response Score (ICIsRS) as a novel histopathological biomarker derived from Whole Slide Images (WSIs).ResultsAnalyzing 148,181 patches from 313 WSIs of 264 advanced GC patients, the ensemble model exhibited superior predictive accuracy, leading to the creation of ICIsNet. The model demonstrated robust performance across four testing datasets, achieving AUC values of 0.92, 0.95, 0.96, and 1 respectively. The boxplot, constructed from the ICIsRS, reveals statistically significant disparities between the well response and poor response (all p-values < = 0.001).ConclusionICIsRS, a DL-derived biomarker from WSIs, effectively predicts advanced GC patients’ responses to PD-1 combined chemotherapy, offering a novel approach for personalized treatment planning and allowing for more individualized and potentially effective treatment strategies based on a patient’s unique response situations.

Descriptive analysis of incidence and risk factors for short intramedullary nail breakage in femoral intertrochanteric fractures: a multicenter (TRON group) retrospective study.

The incidence of hip fractures is increasing. Femoral intertrochanteric fractures make up 50% of hip fractures and are treated by intramedullary nails. Implant breakage is a recognized complication that can have rare and serious implications. This study aimed to investigate implant breakage rates after surgical treatment for femoral intertrochanteric fractures. This was a retrospective multicenter analysis. All 1854 patients who underwent surgical treatment for femoral intertrochanteric fractures were selected from 12 hospitals (TRON group) between 2016 and 2020. Exclusion criteria included implants other than those specified and follow-up periods less than threemonths. Demographic data, surgical details, and radiographic assessments were collected from medical records and X-ray evaluations. Among the 983 study patients, consisting of 245 males (24.9%) and 738 females (75.1%), the implant breakage rate was 0.31%, with three confirmed cases. The average age was 83.9years. The mean follow-up period was 640.9days. Two cases were linked to ASULOCK implants, and one to an OLSII implant. Statistical analysis showed a significantly higher incidence of ASULOCK implant breakage (p < 0.001). In the two cases of ASULOCK implant breakage and one case of OLSII implant breakage, breakage in all three implants occurred at the anti-rotation screws. There were no implant breakages of the main body of the implants; all breakages occurred in the additional anti-rotation screw. The necessity of the anti-rotation screw will require further discussion. These results can potentially inform clinical decisions and guide further research in preventing implant breakage.

Comparative Analysis of Response to Cardiac Resynchronisation Therapy Upgrades in Patients with Implantable Cardioverter-Defibrillators and Pacemakers.

Introduction: The efficacy of de novo cardiac resynchronisation therapy (CRT) in patients with heart failure (HF), left ventricular systolic dysfunction (LVSD), and a broad QRS morphology is well established. However, the optimal stage for upgrading patients with existing pacemakers (PPMs) or implantable cardioverter-defibrillators (ICDs) and HF with high-burden right ventricular (RV) pacing remains uncertain. Thus, this multicentre retrospective analysis compared patients with pre-existing PPMs or ICDs who underwent CRT upgrades to investigate the appropriate stage for CRT implantation in these patients and to assess the validity of treating both PPM and ICD recipients under the same recommendation level in the current guidelines. Materials and Methods: A total of 151 participants underwent analysis in this study, comprising 93 upgrades to cardiac resynchronisation therapy with pacemaker (CRT-P) and 58 upgrades to cardiac resynchronisation therapy with defibrillator (CRT-D) across three centres in the UK. The aim of the study was to investigate the safety and efficacy of upgrading to CRT from an existing conventional pacemaker or an ICD in the context of high-burden RV pacing. The analysis was conducted separately for each group, assessing changes in echocardiographic parameters, functional New York Heart Association (NYHA) class, and procedure-related complications. Results: The PPM group had a higher percentage RVP burden compared to the ICD group. Post-upgrade, NYHA functional class and EF and LV volumes improved in both groups; however, the response to an upgrade from a pacemaker was greater compared to an upgrade from an ICD. Post-procedural complication risks were similar across the two subgroups but significantly higher compared to de novo implantation. Conclusions: Within the CRT-P subgroup, participants exhibited better responses than their CRT-D counterparts, evident both in echocardiographic improvements and clinical outcomes. Furthermore, patients with non-ischemic cardiomyopathy (NICM) were better responders than those with ischaemic cardiomyopathy. These findings suggest that international guidelines should consider approaching each subgroup separately in the future.

Abstract PO1-06-04: Immune checkpoint inhibitors for triple-negative inflammatory breast cancer (INCORPORATE): an international multicenter retrospective analysis

Abstract Background: Inflammatory breast cancer (IBC) is an aggressive clinical presentation of breast cancer (BC). Immune checkpoint inhibitors (ICIs) combined with chemotherapy provided an overall survival (OS) benefit in the metastatic setting and an even-free survival (EFS) benefit in patients (pts) with early triple-negative (TN) BC, respectively. Patients with TN-IBC were under-represented or excluded in pivotal trials and commonly not evaluated in subgroup analyses. Methods: We conducted a retrospective, multicenter, international, observational study to evaluate the clinical benefit of ICIs in pts with TN-IBC (defined as cT4d per AJCC TNM, 8th ed., ER &amp;lt; 1% and PgR &amp;lt; 1%, HER2: negative). Pts with early-stage TN-IBC were included if they received an ICI combined with neoadjuvant chemotherapy (NACT) (Group 1). Pts with metastatic TN-IBC were included if they received ICI monotherapy or in association with first-line chemotherapy (Group 2). Treatment was administered according to guideline recommendations (in PD-L1+ metastatic IBC and regardless of PD-L1 in early IBC), in clinical trials, or off-label (regardless of PD-L1 expression status in metastatic IBC). Endpoints were pathological complete response (pCR) and 1-year EFS rate for group 1 (calculated from date of first cycle of NACT to any recurrence or death), and progression-free survival (PFS) for group 2. Correlative analyses were provided (significance at p-value &amp;lt; 0.05). Results: We included 59 pts from 8 international referral centers. 15 pts had early IBC (Group 1), and 44 pts had metastatic disease (Group 2). Patient characteristics and outcomes are shown in Table 1. Among the 15 pts from Group 1, 10 received anthracycline, taxane and carboplatin-based (AC-CbT) NACT with pembrolizumab, 3 neoadjuvant paclitaxel-carboplatin chemotherapy with pembrolizumab, 2 neoadjuvant nab-paclitaxel with atezolizumab. One pt progressed on NACT, 2 pts are still receiving NACT. Among 13 pts evaluable for response, 6/13 (46%) achieved a pCR. After a median follow-up of 7.1 months, the median EFS was 12.9 months and the 1-year EFS rate was 70%. The median OS was 15.7 months. Among pts from Group 2, PD-L1 status was positive (IC 1% or CPS 10) in 27/44 pts (61%), negative in 5/44 pts (11%) and unknown in 6/44 pts (13%). At a median follow-up of 24.3 months, median PFS and OS were 4.1 and 15.7 months. As backbone chemotherapy in first line setting, 6 pts received AC-CbT regardless of PD-L1 status (mPFS: 8.6 months), 21 taxane-based/anthracycline-free chemotherapy (mPFS: 5.3 months), 14 other chemotherapy regimens (mPFS: 2.1 months) and 3 single-agent immunotherapy (mPFS: 50.1 months). Three of 6 patients who received AC-CbT underwent surgery and radiotherapy. In Group 2, after adjusting for the number of metastatic sites (&amp;gt;1 vs. 0-1), PD-L1 status (positive vs. negative vs. unknown) and de novo metastatic disease (yes vs. no), AC-CbT chemotherapy (HR 0.05; 95% CI: 0.01-0.56; p=.015) and taxane-based chemotherapy (HR 0.20; 95% CI: 0.06-0.68; p=.009) were both associated with longer PFS. Conclusions: This multicenter retrospective analysis of TN-IBC treated with combination of chemotherapy and IOs showed relatively low pathology response, EFS and clinical benefit suggesting need to further investigate the role of immunotherapy in this aggressive disease. Table 1. Patient characteristics and outcomes Citation Format: Carmine Valenza, Dario Trapani, Paola Zagami, Gabriele Antonarelli, Luca Boscolo Bielo, Eleonora Nicolò, Joana Mourato Ribeiro, Lorenzo Guidi, Carolina REDUZZI, Martina Spotti, Elisabetta Munzone, Javier Cortés, Barbara Pistilli, Sara Tolaney, Naoto Ueno, Rachel Layman, Massimo Cristofanilli, Lisa Carey, Filipa Lynce, Wendy Woodward, Giuseppe Curigliano. Immune checkpoint inhibitors for triple-negative inflammatory breast cancer (INCORPORATE): an international multicenter retrospective analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-06-04.

Safety and Efficacy of Extended Therapy with [177Lu]Lu-PSMA: A German Multicenter Study.

Prospective results have demonstrated favorable safety and efficacy of [177Lu]Lu-PSMA radiopharmaceutical therapy for up to 6 cycles in men with metastatic castration-resistant prostate cancer. However, no systematic data are available outlining the feasibility of extended therapy beyond 6 cycles. We aim to evaluate the safety and efficacy of extended [177Lu]Lu-PSMA radiopharmaceutical therapy in patients who have received more than 6 cycles. Methods: In total, 111 patients were included in this multicenter retrospective analysis. Based on individual decisions, patients underwent uninterrupted continuation of therapy (continuous treatment) or reexposure after a therapy break (rechallenge treatment) between 2014 and 2023. Overall survival, 50% prostate-specific antigen (PSA) decline (measured 8-12 wk after treatment initiation or rechallenge), PSMA PET response, and grades per Common Terminology Criteria for Adverse Events were assessed. χ2 tests, multivariable Cox regression analysis, and log-rank tests were applied for statistical analyses. Results: Patients received extended treatment with [177Lu]Lu-PSMA, either as a continuous treatment (43/111, 38.7%) or as a rechallenge (68/111, 61.3%) treatment, with median cumulative doses of 57.4 or 60.8 GBq, respectively. Overall survival from the initiation of [177Lu]Lu-PSMA was 31.3, 23.2, and 40.2 mo for the entire cohort, the continuous treatment group, and the rechallenge treatment group, respectively. The initial 50% PSA decline was significantly higher in the retreated group than in the continuous group (57/63 [90.4%] vs. 26/42 [61.9%]; P = 0.006). A 50% PSA decline was observed in 23 of 62 patients (37.1%) after the first rechallenge. The rate of grades 3-4 toxicity was comparable between continuous and rechallenge treatments (anemia, 7/43 [16.3%] vs. 13/68 [19.1%)], P = 0.6; leukocytopenia, 1/43 [2.3%] vs. 2/67 [3.0%], P = 0.3; thrombocytopenia, 3/43 [7.0%] vs. 3/68 [4.4%], P = 0.3; renal, 2/43 [4.7%] vs. 5/68 [7.4%], P = 0.2). Conclusion: Extended therapy with [177Lu]Lu-PSMA is safe and has not been associated with increased grades 3-4 toxicity. Patient candidates for extended treatment experienced a favorable median survival of 31.3 mo from the first administration. Response under [177Lu]Lu-PSMA rechallenge demonstrated preserved efficacy of [177Lu]Lu-PSMA after a treatment break.

Influence of induction therapy and antiretroviral regimen on outcomes in kidney transplant recipients living with human immunodeficiency.

Kidney transplantation has a survival benefit for people with human immunodeficiency virus (HIV) and end-stage kidney disease, however increased rates of rejection remain an issue. Questions remain regarding the impact of induction immunosuppression therapy and antiretroviral (ARV) choice on long-term outcomes. We performed a multicenter retrospective analysis of outcomes in recipients with HIV who received kidneys from donors without HIV transplanted between 2004 and 2019. The association between induction and ARV regimens and long-term outcomes including rejection, graft, and recipient survival over 5 years was investigated using Cox regression modeling. Seventy-eight kidney transplants (KT) performed in 77 recipients at five US transplant centers were included, with median follow up of 7.1 (4.3-10.7) years. Overall recipient and graft survival were 83% and 67%, respectively. Rejection occurred in 37% (29/78). Recipients with rejection were more likely to be younger, recipients of deceased donor organs, and Black. Receipt of rabbit anti-thymocyte globulin (rATG) induction without protease-inhibitor (PI)-based ARVs was associated with 83% lower risk of rejection (adjusted hazard ratio (aHR) 0.17 (95% CI 0.05-0.63), p =.007) and a non-statistically significantly lower risk of graft failure (aHR 0.18 (0.03-1.16), p =.07) when compared to those who received other induction and ARV combinations. In this multicenter retrospective study, we found a trend toward lower rejection and improved graft survival among those who received both rATG for induction and PI-sparing ARVs.

Abstract PO1-28-03: Impact of the Oncotype DX® test over time and association with clinicopathological characteristics of Peruvian patients with early breast cancer: Experience in the last 15 years

Abstract Introduction: Gene expression assays provide prognostic and therapy-predictive information that complements management of early breast cancer patients. Oncotype DX® had showed prognostic and prediction of adjuvant chemotherapy benefit. The present study evaluates the impact of Oncotype DX® on therapeutic decision-making for 15 years and explores the association of clinicopathological characteristics with the Recurrence Score (RS) in Peruvian patients with early breast cancer. Material and methods: A retrospective multicenter analysis of 759 breast cancer patients treated in three oncological centers in Lima-Peru (Instituto Nacional de Enfermedades Neoplásicas, Oncosalud and Ricardo Palma) between 2007 and 2022 was conducted. Risk groups were classified according to Oncotype DX® result and menopausal status. For premenopausal women ≤ 50 years: low (RS=0-20), intermediate (RS=21-25) and high-risk (RS=26-100). A descriptive analysis was evaluated to observe the trend and profile of the patients who used the Oncotype test in 5 time periods (2007-2009, 2010-2013, 2014-2016, 2017-2019, 2020-2022). Subsequently, chi-square, t-test, analysis of variance and Poisson linear regression tests were applied to compare clinicopathological features with RS. Finally, univariate and multivariate analyses were performed using Cox logistic regression to identify the probability of association with the high-risk group. Results: 642 patients were included, 78.5% were postmenopausal, and 64.2% had clinical stage (CS) I. Overall, 63.4% had no recommendation for chemotherapy and only 5.6% had recurrence. 74.8% were classified as low-risk according to the Oncotype DX® result. Postmenopausal patients had negative lymph nodes (95.4%), the majority had undergone conservative surgery (71.8%) and had a low rate of breast reconstruction (11.9%). An increase in the use of Oncotype DX® was observed over time, especially in premenopausal patients (from 4.5% in 2007 to 36.9% in 2022). A significant association was found between luminal B subtype (p &amp;lt; 0.0001), histological grade 3 (p &amp;lt; 0.0001) and T3 vs. T1/2 (p=0.025). In univariate analysis, luminal B subtype (vs. luminal A, OR=5.56, 95% CI, 2.80-12.3, p&amp;lt; 0.001), T3 (vs. T1/2, OR=2.84, 95% CI, 0.13-30.0, p=0.006), histological grade 3 (vs. 1/2, OR=13.1, 95% CI, 5.35-39.6, p&amp;lt; 0.001) and histology (other vs. ductal/lobulillar/mucinous, OR=2.94, 95% CI, 0.57-13.5, p=0.003) provided a higher probability of obtaining a high-risk RS result. Similar results were found in multivariate analysis. Conclusion: The use of the Oncotype DX® had a significant impact on therapeutic decision-making in Peruvian patients with early breast cancer, with an increase of use in the last 15 years. A high-risk RS was associated with luminal B subtype, histological grade 3 and T3 tumor size, which could facilitate risk stratification and provide valuable information for the need of adjuvant chemotherapy. Keywords: Early breast cancer, Oncotype DX®, clinicopathological characteristics, Recurrence Score (RS), Peru Oncotype PERU Table Citation Format: Steffi Katheryne Gonzalez Bocanegra, Guillermo valencia Mesías, Yomali Aroa Ferreyra Chombo, Karoll Tatiana Meza Garcia, Mariano Lopez-Pereyra, Jorge Torres Maldonado, Edgar Fermín Yan Quiroz, Zaida Morante Cruz, Jose Cotrina-Concha, Henry Gómez, Gabriela Calderon Valencia, Mauricio León Rivera. Impact of the Oncotype DX® test over time and association with clinicopathological characteristics of Peruvian patients with early breast cancer: Experience in the last 15 years [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-28-03.

Development and external validation of a perioperative clinical model for predicting myocardial injury after major abdominal surgery: A retrospective cohort study

PurposeWe aimed to develop and validate a predictive model for myocardial injury in individuals undergoing major abdominal surgery. MethodsThis multicenter retrospective cohort analysis included 3546 patients aged ≥45 years who underwent major abdominal surgeries at two Chinese tertiary hospitals. The primary outcome was myocardial injury after noncardiac surgery (MINS), defined as prognostically relevant myocardial injury due to ischemia that occurs during or within 30 days after noncardiac surgery. The LASSO algorithm and logistic regression were used to construct a predictive model for postoperative MINS in the development cohort, and the performance of this prediction model was validated in an external independent cohort. ResultsA total of 3546 patients were included in our study. MINS manifested in 338 (9.53 %) patients after surgery. The definitive predictive model for MINS was developed by incorporating age, American Society of Anesthesiologists (ASA) classification, preoperative hemoglobin concentration, preoperative serum ALB concentration, blood loss, total infusion volume, and operation time. The area under the curve (AUC) of our model was 0.838 and 0.821 in the derivation and validation cohorts, respectively. ConclusionsPreoperative hemoglobin levels, preoperative serum ALB concentrations, infusion volume, and blood loss are independent predictors of MINS. Our predictive model can prove valuable in identifying patients at moderate-to-high risk prior to non-cardiac surgery.