bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anatomical neuromuscular variations determined by magnetic resonance imaging in chronic pelvic pain
Authors: Peng Yuanyuan , Sach Toos , Chow Jason , Abbott Jason 
Published: December 2024

Background: The diagnosis of neuromuscular pelvic pain is challenging. Despite the increasing use of magnetic resonance imaging (MRI) in the assessment of pudendal neuralgia, there are limited data describing radiological variations of the nerve. Additionally, the utility of MRI in the assessment of pelvic floor tension myalgia is unknown. Aims: To describe the anatomical variations of the pudendal nerve and dimensions of pelvic muscles in patients investigated for neuromuscular pelvic pain using a combined MRI protocol. Materials and methods: A retrospective audit of MRI reports for 136 patients referred to a single radiologist was conducted. Reported data included the appearances of the pudendal nerve and its perineural structures, and the maximal thicknesses of pelvic muscles. Results: Several anatomical variations were identified in the course of the pudendal nerve at or above the ischial spine. Likely/highly likely nerve compression at this level was present in 34.6% of hemipelves. Variations associated with compression included delayed separation of the sacrospinous and sacrotuberous ligaments ( p < 0.0001), close apposition of ligaments ( p < 0.0001), interligamentous bands ( p = 0.033), coccygeal muscle contributions to the sacrospinous ligament ( p = 0.014) and proximal ( p < 0.0001) and thickened falciform ligaments ( p < 0.0001). Variations below the ischial spine were uncommon. Conclusions: This study represents a quantitative and qualitative expansion to the radioanatomical basis of pudendal nerve entrapment on MRI, and highlights the limitations of MRI obtaining reproducible measurements of pelvic muscles. Images from asymptomatic controls and further prospective evaluation of treatment outcomes is required to determine the clinical significance of MRI findings in the assessment of pudendal neuralgia.
Impact of Protein Energy Malnutrition on Hospitalized Patients with Hodgkin's Lymphoma: A United States Population-Based Cohort Study
Authors: Syal Arshi , Arya Yajur , Byfield Karecia , Casipit Bruce Adrian , Dourado Claudia , Varadi Gabor 
Published: December 2024

Background
Advances in chemotherapeutics have increased survival in patients with Hodgkin's lymphoma. With prolonged survival, these patients are often predisposed to co-morbidities, including cancer-related cachexia, muscle wasting, and adverse effects of chemotherapy. As a result, these patients suffer from varying degrees of protein-energy malnutrition (PEM). However, the impact of PEM on outcomes among patients with Hodgkin's lymphoma needs further exploration.
Methods
We utilized the 2020 National Inpatient Sample (NIS) Database to conduct this retrospective cohort study. We identified patients with Hodgkin's lymphoma and PEM using appropriate ICD-10 diagnostic codes. We stratified patients with Hodgkin's lymphoma based on the presence or absence of PEM. A survey multivariable logistic and linear regression analysis was used to calculate adjusted odds ratios (ORs) for the primary and secondary outcomes. A p-value of &lt;0.05 was considered statistically significant. The aim of this study was to investigate the impact of PEM on in-hospital mortality, hospital length of stay (LOS), and total hospitalization charges among hospitalized patients with Hodgkin's lymphoma.
Results
We identified a total of 3705 hospitalized patients with Hodgkin's lymphoma, of which 13.36% (495/3705) had comorbid PEM. The overall in-hospital mortality among patients with Hodgkin's lymphoma was 2.97% (110/3705). Among those with concomitant PEM, the mortality rate was significantly higher at 9.09% (45/495, p&lt;0.001). Utilizing a stepwise survey multivariable logistic regression model that adjusted for patient and hospital level confounders, PEM was found to be an independent predictor of increased in-hospital mortality (adjusted OR 3.71; 95% (confidence interval [CI] 1.23-11.21; p=0.02), longer LOS (coefficient 2.88; CI 0.49-5.28; p=0.018), higher total hospitalization charges ($41649; CI $4818-$78481; p=0.027), as well as increased need for mechanical ventilation (adjusted OR 4.28; CI 1.50-12.18; p=0.006).
Conclusion
Our analysis demonstrated that PEM was widely prevalent in patients with Hodgkin's lymphoma. It was associated with worse outcomes, including significantly increased in-hospital mortality, longer LOS, total cost of healthcare utilization, as well as increased need for mechanical ventilation. Efforts should be made to promote nutritional assessment and screening mechanisms to include early nutritional support as indicated. Prospective studies with larger sample size are needed to better understand these associations.
A CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-Engager
Authors: Olson Kara , DiLillo David , Sineshchekova Olga , Mohrs Katja , McCarthy Craig , Ahmed Hassan , Rizvi Sahar , Quatela Steven , Navarro Elizabeth , Lin Cuiyan , Dorvilliers Amanda , Kroog Glenn S. , Rodriguez Lorenc Karen , Ullman Erica , Hermann Aynur , Smith Eric , Kirshner Jessica , Olson William , Lin John 
Published: December 2024

Improving therapies for relapsed/refractory multiple myeloma (RRMM) remains an unmet medical need, as despite improvements in treatment management, there is still no curative therapy and relapse remains a persistent problem. The emergence of T cell targeted immunotherapies, including BCMAxCD3 bispecific antibodies (bsAbs), has marked a significant advancement in patient outcomes. Among these, the BCMAxCD3 bispecific antibody, linvoseltamab, has emerged as a potential best-in-class option for RRMM; however, deeper and more durable responses in this patient population are still required.
In RRMM, linvoseltamab activates T cells by engaging the T cell receptor (TCR)/CD3 complex in the presence of BCMA-expressing MM tumor cells leading to tumor cell killing. However, for optimal activation, T cells require engagement of costimulatory receptor signaling (e.g., CD28) in addition to the TCR/CD3 complex. CD28-targeting bsAbs, including REGN5668 (MUC16xCD28) and REGN5837 (CD22xCD28), are an emerging class of therapeutics capable of providing targeted costimulation and enhancing T cell effector function in combination with CD3-targeted bsAbs. In MM, CD38 is a cell-surface, multifunctional ectoenzyme that is highly expressed on MM blasts, making it a good candidate for a CD28-targeted bsAb. Thus, here we examine whether providing CD28 costimulatory signaling via a novel CD38xCD28 bsAb in the context of BCMAxCD3 bsAb therapy (linvoseltamab) can drive enhanced antitumor activity in preclinical models.
We explored combining a novel CD38xCD28 bsAb antibody, REGN7945, with linvoseltamab. This combination potently enhanced linvoseltamab's anti-tumor activity by delivering a critical costimulatory signal to CD28-expressing T cells, augmenting T cell activation, cytokine production, and cytotoxicity in vitro. We demonstrated strong enhancement of linvoseltamab's anti-tumor activity with REGN7945 in multiple in vivo murine xenograft MM models. Further, in immunocompetent mice genetically engineered to express human CD3, CD28, BCMA, and CD38, we demonstrated potent combinatorial efficacy of linvoseltamab and REGN7945 to treat syngeneic murine tumors.
Based on these promising preclinical results, a Phase 1 clinical trial is planned to evaluate the safety, tolerability, and preliminary efficacy of the CD38xCD28 bsAb REGN7945 and the BCMAxCD3 bsAb linvoseltamab in patients with RRMM. This innovative approach, leveraging the combinatorial potential of CD38xCD28 costimulation with linvoseltamab's targeted cytolytic activity, represents a novel therapeutic strategy with the potential to improve RRMM treatment outcomes.
Shengxuening Tablets for the Treatment of Cancer Related Anemia in Hematologic Malignancies: A Multicenter, Prospective, Randomized Controlled Clinical Trial
Authors: Fang Jiamin , Liu Xiaoyan , Zhou Fuling 
Published: December 2024

Abstract I ntroduction : Cancer related anemia (CRA) is a prevalent comorbidity associated with malignant tumors. Presently, treatments for CRA primarily comprise blood transfusion therapy, erythropoiesis-stimulating agent therapy, and iron supplementation. Conventional oral iron exhibits low bioavailability and significant gastrointestinal irritation, whereas intravenous iron offers rapid iron replenishment. However, excessive iron supplementation may lead to iron overload, and intravenous drug delivery is less accepted among hematological oncology patients. Shengxuening tablets demonstrate clinical efficacy in treating CRA among patients with hematologic malignancies by enhancing endogenous EPO production, stimulating bone marrow hematopoiesis, and regulating iron metabolism.To evaluate the effect of Shengxuening tablets on improving anemia and regulating iron metabolism in patients with hematologic malignancies combined with CRA.
Methods: Patients who met the enrollment criteria were randomly divided into the trial group and the control group. Patients in the trial group received oral treatment with Shengxuening tablets 1 week before chemotherapy, while those in the control group received oral treatment with ferrous succinate 1 week before chemotherapy. The primary endpoints were changes in blood routine after 1 month of treatment. The secondary endpoints were iron metabolism indexes related indexes.
Results:Until July 20, 2024, a total of 48 patients were enrolled in the multiple myeloma group and randomized into two groups: a trial group consisting of 31 patients and a control group consisting of 17 patients. Since the enrollment process has not yet been completed, we only statistically analyzed part of the data that have been obtained so far. Prior to treatment initiation, there was no statistically significant difference in blood routine and iron metabolism indexes between the two groups (P&gt;0.05). After treatment, the mean corpuscular hemoglobin concentration (MCHC) of the trial group increased significantly (P&lt;0.05), while no statistically significant difference was observed in the blood routine indexes of the control group before and after treatment. As of now, apart from two cases of gastrointestinal adverse reactions observed in the control group, no other evident drug-related adverse reactions have been noted.
C onclusion :The use of Shengxuening tablets for the treatment of CRA in patients with multiple myeloma can achieve more ideal efficacy than ferrous succinate and has a manageable safety profile.
Teclistamab in Relapsed and Refractory Multiple Myeloma Patients - Czech Multi-Center Real World Evidence Analysis
Authors: Stork Martin , Radocha Jakub , Jelinek Tomas , Spicka Ivan , Pika Tomas , Jungova Alexandra , Straub Jan , Minarik Jiri , Boichuk Ivanna , Fric Dominik , Novakova Denisa , Popkova Tereza , Polcerova Lenka , Maisnar Vladimir , Pour Ludek , Hajek Roman 
Published: December 2024

Background
Teclistamab is a bispecific antibody designed to target multiple myeloma (MM) cells by simultaneously binding to B-cell maturation antigen (BCMA) on MM cells and CD3 on T cells, facilitating a T-cell-mediated anti-tumor immune response. In the MajesTEC-1 clinical trial, teclistamab demonstrated high efficacy in heavily pretreated relapsed and refractory MM (RRMM) patients. As approximately 40% of MM patients are ineligible for clinical trials, the importance of real-world evidence (RWE) data on the efficacy and safety of teclistamab becomes increasingly significant.
Aims
We conducted a RWE analysis of teclistamab monotherapy in heavily pretreated RRMM patients. Additionally, we evaluated the efficacy of teclistamab in patients with a reduced dosing frequency.
Patients and methods
A total of 48 RRMM patients were treated with teclistamab between 2023 and 2024 outside clinical trials across all major Czech hematology centers. Teclistamab was administered either on a standard schedule (weekly for at least six months) or a reduced frequency schedule (every other week), based on the physician's decision. The response was evaluated according to the IMWG Response Criteria. Patient data were collected and analyzed from the Czech Registry of Monoclonal Gammopathies (RMG).
Results
The median age at the first teclistamab administration was 65.5 years (range 46-76). The median number of previous treatment lines was 5 (range 3-13), with 66.7% (32/48) of patients being penta-refractory (refractory to 2 proteasome inhibitors, 2 IMiDs, and an anti-CD38 antibody). The overall response rate (ORR), defined as partial response (PR) or better was 61.7% (27/44 evaluable patients) and the rate of very good partial response (VGPR) or better was 54.5% (24/44). The median follow-up was 4 months (range 1-13). The median progression-free survival (PFS) was 9.4 months (95% CI: 6.4-NA). Median overall survival (OS) was not reached with 58.9% (95% CI: 43.8-79.2) survival after 12 months. In 25.0% (12/48) of patients, teclistamab was administered every other week. The estimated proportion of patients without a PFS event at 6 months of follow-up was comparable regardless of the dosing schedule (weekly: 62.3% (95% CI: 47.4-81.9) vs. non-weekly: 81.5% (95% CI: 61.1-100.0); p=0.226). The OS data, based on the dosing scheme, were immature.
Conclusion
Our RWE data demonstrate high efficacy of teclistamab monotherapy in heavily pretreated RRMM population, comparable to MajesTEC-1 registration trial results. Preliminary data suggest that non-weekly dosing could be similarly effective compared to the standard protocol.
IDH-1 Somatic Mutations Are More Commonly Observed Among Patients with Concomitant Myelodysplastic Syndromes (MDS) and Autoimmune Rheumatoid Diseases (AIRD)
Authors: Komrokji Rami S. , Al Ali Najla H. , Xie Zhuoer , Komrokji Zena , Jabbour Joseph E. , Chan Onyee , Yun Seongseok , Kuykendall Andrew T. , Walker Alison R. , Lancet Jeffrey E , Padron Eric , Sallman David 
Published: December 2024

Introduction
We previously reported that autoimmune diseases (AID) are commonly observed in MDS patients (pts) (28%) including autoimmune rheumatic diseases (AIRD). There is increase recognition of the association of certain acquired somatic mutations and inflammation. Recent study reported enrichment of AIRD among chronic myeloid neoplasms (MN) pts with high prevalence of IDH mutations suggestive causative association particularly between IDH mutations and seronegative rheumatoid arthritis (Hong et al, Blood 2024). Here, we compare the genomic landscape of MDS pts with concomitant defined AIRD to those without.
Methods
We identified MDS pts with concomitant AIRD. We selected Rheumatoid arthritis (RA) and systemic lupus (SLE) as AIRD given more objective diagnostic criteria and accurate data capturing. We compared those MDS pts with AIRD to MDS pts without.
Results
We compared 79 MDS pts with AIRD to 2469 MDS pts without in our database. AIRD were more observed among female MDS pts compared to non-AIRD MDS pts (59% vs 32%, p &lt; 0.0005). There was no difference in age, race, t-MDS, WHO 2022 classification, IPSS-M risk stratification. There was no difference in baseline myeloblasts% or blood counts.
Among 21 common somatic mutations tested, IDH-1 somatic mutation was the only mutation observed more among AIRD MDS pts compared to non-AIRD MDS pts (11% vs 3%, p &lt;0.0005). Among male AIRD MDS pts rate of IDH-1 was 15% vs 3% and 8% vs 3% among females AIRD MDS pts compared to non-AIRD MDS pts. (p &lt;.0005)
There was no difference among AIRD- MDS pts and non-AIRD MDS pts in median overall survival. There was a non-statistically significant trend for worse median OS among AIRD MDS pts with IDH-1 mutation (30 mo vs 40 mo).
Conclusions
Our data confirm recently reported observation that IDH-1 somatic mutations are enriched among myeloid neoplasms patients with AIRD. Further studies to explore the underlying mechanism, and potential therapeutic implications with targeted IDH-1 inhibitors are warranted.
Real-World Data of Maintenance Therapy for Newly Diagnosed Multiple Myeloma: Ixazomib Versus Lenalidomide
Authors: Xu Yang , Zhang Xuzhao , Wang Luyao , Fan Yili , Chen Boxiao , Yang Luyu , Zhang Jiawei 
Published: December 2024

Introduction: Lenalidomide and ixazomib are both effective maintenance therapy options for patients with multiple myeloma (MM). However, there is a lack of clinical studies directly comparing the efficacy and safety of these two agents. In this report, we present real-world data on the maintenance therapy of lenalidomide versus ixazomib in patients with newly-diagnosed MM (NDMM).
Methods: A retrospective real-world analysis was carried out between September 25, 2019 and June 20, 2023. The study included multiple myeloma patients who achieved a best response of partial response (PR) or higher following induction and/or consolidation therapy. Ixazomib was administered at a weekly dose of 3-4mg for 3 doses within a 28-day cycle, and lenalidomide was given at a daily dose of 10-25mg until disease progression. Adverse events were graded based on CTCAEv4.0 criteria, with the primary endpoints focusing on progression-free survival (PFS) and the incidence of adverse events.
Results: A total of 115 patients with NDMM were included, with 60 patients receiving ixazomib and 55 patients on lenalidomide maintenance. The patients' characteristics, cytogenetics, and disease staging between groups were well-balanced. The median follow-up periods were 33 and 29 months for the ixazomib and lenalidomide groups, respectively. There was no significant difference in PFS between the ixazomib and lenalidomide groups, with a median PFS of 39 versus 35 months, P=0.706. Following ixazomib maintenance, 35 out of 60 patients (58.3%) reached a response of ≥CR, while 56 patients (93.3%) achieved ≥VGPR, and 23 patients (38.3%) experienced a deepened response. After lenalidomide maintenance, 29 patients (52.7%) achieved ≥CR, 49 patients (89.1%) achieved ≥VGPR, and 15 patients (27.3%) showed an improved response. Subgroup analysis revealed that cytogenetic risk, R-ISS staging, ASCT, extramedullary disease, and remission status prior to maintenance did not have a significant impact on median PFS between the lenalidomide and ixazomib groups. In the lenalidomide group, high-risk cytogenetics were correlated with a shorter median PFS compared to standard-risk (SR) ,18 months vs. 35 months, P=0.022; whereas this association was not observed in the ixazomib group, HR vs. SR: 35 months vs. not reached, P=0.543. The incidence of neutropenia in the ixazomib group was lower than in the lenalidomide group, 35.1% vs. 58.5%, P=0.014. No severe drug-related AEs were reported in either group, and there were no statistically significant differences in non-hematological AEs between the two groups.
Conclusion: In patients with NDMM, maintenance therapy utilizing ixazomib or lenalidomide results in similar response rates and progression-free survival (PFS). Ixazomib appears to mitigate the adverse impacts of high-risk cytogenetics while maintaining a manageable toxicity profile.
Clinical Characteristics and Prognostic Analysis of Non-Amyloid Monoclonal Gammopathy of Renal Significance (MGRS) in China
Authors: Song Yuhang , Liu Yang , Liu Junru , Li Juan , Lu Jin , Zhuang Junling 
Published: December 2024

Objective: To analyze the treatment efficacy and prognostic factors of patients with non-amyloid monoclonal gammopathy of renal significance (MGRS) across multiple centers, aiming to inform clinical management and improve patient outcomes.
Methods: A retrospective study was conducted on 136 non-amyloid MGRS patients from four major hospitals in China. Patients were diagnosed through kidney biopsy, and clinical data were collected, including demographics, laboratory results, pathology types, genetic testing results, and treatment regimens. Median follow-up period was 33.5 months. The endpoints included renal response, progression, and hematologic efficacy according to the International Society of Amyloidosis (ISA) criteria.
Results: The study included 136 patients, with a variety of MGRS pathologies , among which MIDD was the most frequent type (64 patients), followed by 20 PGNMID, 19 LCPT and 19 cryoglobulinemic nephropathy There were 104 patients receiving anti-plasma cell therapies, among which 71 were treated with bortezomib-based regimens. Baseline serum free light chain level &gt;400mg/L were found to be an independent risk factor for poor hematologic response to first-line therapy (P=0.042, HR=5.98). Deep hematologic remission was a significant protective factor (p=0.006, HR=20) for renal response. The presence of t (11; 14) translocation was identified as an independent risk factor (p=0.029, HR=0.138) for poor renal response . Patients achieving deep hematologic remission (not achieved vs 104m, p=0.001) and negative t (11; 14) translocation (104m vs 43m, p=0.001) had better renal progression-free survival rates.
Conclusion: Although MGRS composes heterogenous diseases, this study underscores the significance of baseline serum free light chain and t(11; 14) translocation in predicting treatment response in non-amyloid MGRS patients , and the connection between hematological response and renal response.
Keywords: Non-amyloid MGRS, renal response, hematologic efficacy, serum free light chain, t (11; 14) translocation, personalized treatment.