Standard Of Care For Patients Research Articles

Use of water in dialysis and its impact on the environment.

The climate crisis poses significant challenges across various sectors, including healthcare, where resource consumption often exacerbates environmental issues. This review addresses concerns over current levels of water use for dialysis treatment, a critical procedure for patients with kidney failure. Despite its life-saving importance, the dialysis process consumes large quantities of water, contributing to water scarcity and increased carbon emissions associated with water treatment and distribution. Through a comprehensive analysis of current practices, we identify inefficiencies and propose sustainable alternatives aimed at reducing water usage in dialysis. Findings indicate that optimizing treatment protocols and considering innovative technologies can significantly mitigate the environmental impact while maintaining patient care standards. This review underscores the urgent need for the healthcare sector to adopt sustainable practices in response to the climate crisis.

A good response to furmonertinib fourth-line treatment of an advanced lung adenocarcinoma patient with EGFR exon20in and PIK3CA mutation: a case report and literature review

BackgroundLung cancer, including small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), is the most prevalent cancer globally and remains the leading cause of cancer-related mortality. Epidermal growth factor receptor (EGFR) mutations, frequently observed in female NSCLC patients, have revolutionized treatment strategies with the advent of tyrosine kinase inhibitors (TKIs). These therapies significantly improve survival and are considered the standard of care for patients harboring EGFR mutations. However, most patients eventually develop resistance to EGFR-TKIs, leading to disease progression. Resistance mechanisms are classified as either EGFR-dependent or EGFR-independent, the latter involving bypass pathway activation, including dysregulation of downstream signaling cascades. EGFR-independent resistance often renders all EGFR-TKIs ineffective, necessitating further investigation into resistance mechanisms.Case summaryWe report the case of a 63-year-old Chinese woman diagnosed with synchronous lung adenocarcinoma harboring an EGFR exon 21 far-loop insertion mutation and clear cell renal cell carcinoma (ccRCC). A multidisciplinary team recommended systemic therapy for the lung adenocarcinoma and clinical observation for ccRCC. First-line treatment with bevacizumab plus pemetrexed-carboplatin achieved a progression-free survival (PFS) of 7 months. Second-line treatment with sintilimab and nedaplatin resulted in a PFS of 4.9 months. Third-line therapy with sintilimab and anlotinib proved ineffective. In the fourth line, the patient received furmonertinib, a third-generation EGFR-TKI, based on the FAVOUR trial. This treatment achieved durable disease control with excellent tolerability, yielding a PFS of 27 months and ongoing clinical benefit.ConclusionThis case demonstrates that furmonertinib can provide significant clinical benefit to NSCLC patients with complex resistance mechanisms, including those involving the PIK3CA/mTOR pathway. These findings support its potential to overcome EGFR-TKI resistance and warrant further investigation in similar clinical contexts.

Optimizing Nurse Rostering: A Case Study Using Integer Programming to Enhance Operational Efficiency and Care Quality

Background/Objectives: This study addresses the complex challenge of Nurse Rostering (NR) in oncology departments, a critical component of healthcare management affecting operational efficiency and patient care quality. Given the intricate dynamics of healthcare settings, particularly in oncology clinics, where patient needs are acute and unpredictable, optimizing nurse schedules is paramount for enhancing care delivery and staff satisfaction. Methods: Employing advanced Integer Programming (IP) techniques, this research develops a comprehensive model to optimise NR. The methodology integrates a variety of constraints, including legal work hours, staff qualifications, and personal preferences, to generate equitable and efficient schedules. Through a case study approach, the model’s implementation is explored within a clinical setting, demonstrating its practical application and adaptability to real-world challenges. Results: The implementation of the IP model in a clinical setting revealed significant improvements in scheduling efficiency and staff satisfaction. The model successfully balanced workload distribution among nurses, accommodated individual preferences to a high degree, and ensured compliance with work-hour regulations, leading to optimised shift schedules that support both staff well-being and patient care standards. Conclusions: The findings underscore the effectiveness of IP in addressing the complexities of NR in oncology clinics. By facilitating a strategic allocation of nursing resources, the proposed model contributes to operational excellence in healthcare settings, underscoring the potential of Operations Research in enhancing healthcare delivery and management practices.

Pixels to precision: Neuroradiology’s leap into 3D printing for personalized medicine

The realm of precision medicine, particularly its application within various sectors, shines notably in neuroradiology, where it leverages the advancements of three-dimensional (3D) printing technology. This synergy has significantly enhanced surgical planning, fostered the creation of tailor-made medical apparatus, bolstered medical pedagogy, and refined targeted therapeutic delivery. This review delves into the contemporary advancements and applications of 3D printing in neuroradiology, underscoring its pivotal role in refining surgical strategies, augmenting patient outcomes, and diminishing procedural risks. It further articulates the utility of 3D-printed anatomical models for enriched comprehension, simulation, and educational endeavors. In addition, it illuminates the horizon of bespoke medical devices and prosthetics, illustrating their utility in addressing specific cranial and spinal anomalies. This narrative extends to scrutinize how 3D printing underpins precision medicine by offering customized drug delivery mechanisms and therapies tailored to the patient’s unique medical blueprint. It navigates through the inherent challenges of 3D printing, including the financial implications, the need for procedural standardization, and the assurance of quality. Prospective trajectories and burgeoning avenues, such as material and technological innovations, the confluence with artificial intelligence, and the broadening scope of 3D printing in neurosurgical applications, are explored. Despite existing hurdles, the fusion of 3D printing with neuroradiology heralds a transformative era in precision medicine, poised to elevate patient care standards and pioneer novel surgical paradigms.

Modular Stems in Revision Hip Arthroplasty: A Three-Step Technique

Background: Complications such as periprosthetic fractures necessitate challenging revision surgeries. In particular, femoral stem revisions can be complicated by poor bone quality, making primary stability and leg length restoration difficult to achieve. Modular fluted tapered stems (MFTSs) have emerged as a viable option for these complex cases. This study aims to describe a reproducible three-step technique for femoral stem revision using MFTSs. The technique focuses on (1) obtaining distal primary stability, (2) restoring leg length, and (3) ensuring overall implant stability. Materials and methods: We conducted a retrospective analysis of ten patients who underwent revision THA using this three-step technique, with a minimum follow-up of 12 months. The mean patient age was 70.7 years, and the average follow-up was 24.2 months. Limits were the small sample size, the lack of clinical outcomes and the short-term follow-up. Results: There was no subsidence, a mean leg length discrepancy of 4 mm (p: 0.604), and no dislocations. However, heterotopic ossifications (HOs) were observed in 25% of patients, although no trochanteric migrations occurred. One patient experienced an intraoperative femoral fracture, which was successfully treated. Conclusions: This three-step approach can break down the revision procedure, making it more accessible to surgeons. The findings suggest that this technique is effective in achieving reliable outcomes in femoral stem revisions, potentially improving the standard of care for patients requiring complex THA revisions.

Neurological Pupil Index and Intracranial Hypertension in Patients With Acute Brain Injury

Invasive intracranial pressure (ICP) is the standard of care in patients with acute brain injury (ABI) with impaired consciousness. The Neurological Pupil Index (NPi) obtained by automated pupillometry is promising for noninvasively estimating ICP. To evaluate the association between repeated NPi and invasive ICP values. This study is a secondary analysis of the Outcome Prognostication of Acute Brain Injury With the Neurological Pupil Index (ORANGE), a multicenter, prospective, observational study of patients with ABI performed from October 1, 2020, to May 31, 2022, with follow-up at 6 months after ABI. The ORANGE study was performed at neurologic intensive care units of tertiary hospitals in Europe and North America. In ORANGE, 514 adult patients receiving mechanical ventilatory support were admitted to the intensive care unit after ABI. Invasive ICP monitoring and automated pupillometry assessment every 4 hours during the first 7 days, considered as a standard of care. Association between ICP and NPi values over time, using bayesian joint models, with linear and logistic mixed-effects longitudinal submodels. The study included 318 adult patients (median [IQR] age, 58 [43-69] years; 187 [58.8%] male) who required intensive care unit admission, intubation, and mechanical ventilatory support due to acute traumatic brain injury (n = 133 [41.8%]), intracerebral hemorrhage (n = 104 [32.7%]), or aneurysmal subarachnoid hemorrhage (n = 81 [25.5%]) and had automatic infrared pupillometry used as part of the standard evaluation practice and ICP monitoring. A total of 8692 ICP measurements were collected, with a median (IQR) of 31 (18-37) evaluations per patient. The median (IQR) NPi and ICP for the study population were 4.1 (3.5-4.5) and 10 (5-14) mm Hg, respectively. In a linear mixed model, the mean change in the NPi value, as a continuous variable, was -0.003 (95% credible interval [CrI], -0.006 to 0.000) for each 1-mm Hg ICP increase. No significant association between ICP and abnormal NPi (<3; odds ratio, 1.01; 95% CrI, 0.99-1.03) or absent NPi (0; odds ratio, 1.03; 95% CrI, 0.99-1.06) was observed. Although an abnormal NPi could indicate brainstem dysfunction, in this large and heterogeneous population of patients, NPi values were not significantly associated overall with ICP values. Repeated NPi measurements may not be a sufficient replacement for invasive monitoring. ClinicalTrials.gov Identifier: NCT04490005.

Influence of the treatment setting on the treatment of patients with rheumatoid arthritis or psoriatic arthritis within the delegation to rheumatological specialist assistants - A post hoc analysis of the StärkeR study

The StärkeR study has shown the non-inferiority of ateam-based form of care with delegation to rheumatological specialist assistants (RFA) compared to standard care in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA). Exploratory analyses regarding apossible influence of the treatment setting (specialist practice/outpatient clinic) on various outcome parameters in patients with RA or PsA in the context of delegation to RFA. Patients with RA or PsA and stable adjustment with low disease activity from 3 outpatient clinics and 14rheumatological specialist practices that participated in the StärkeR study were included in this post hoc analysis. The effectiveness of the team-based form of care depending on the treatment setting was investigated using interaction analyses in linear regression models with respect to disease activity, functional capacity, pain and fatigue, among others. Out of 588 patients 466 were treated in specialized practices and 92 in hospital outpatient clinics. The analyses showed asignificant interaction for one of nine outcomes examined: functional capacity (scale0-1) had slightly lower values in the hospital outpatient clinics compared to standard care (-0.07 [-0.12; -0.02]), while no such difference was found in the practices. For other outcomes, the team-based form of care in the practice setting tended to show an advantage. These exploratory analyses point to the potential benefits of evaluating different forms of care, such as the delegation of medical services to qualified RFA, in terms of benchmarking.

Survival outcomes of Durvalumab in combination to cisplatin and gemcitabine in advanced biliary tract cancer: real world results from a single Italian institution.

The TOPAZ-1 phase III trial showed a survival benefit with durvalumab plus gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC). To understand this combination's real-world efficacy and tolerability, we conducted a retrospective analysis of its first-line treatment outcomes. We included patients with unresectable, locally advanced, or metastatic BTC treated with cisplatin, gemcitabine plus durvalumab. The primary endpoint was overall survival (OS). 33 patients were enrolled. Median OS was NR and median PFS was 7.6 months, after a median follow up of 13.5 months. The investigator-assessed overall response rate was 34.5 %, with stable disease in 53.0 % of patients. High baseline CEA levels were associated with poor survival. Any grade adverse events (AEs) occurred in 97 % of patients. Immune-related AEs (irAEs) occurred in 16 % (grade >2: 6 %). Presence of TP53 mutation was related to a worse OS, conversely the presence of ARID1A genomic alteration was related to a better PFS. A tendence toward a better OS was found for BRCAness patients which did not reach the statistical significance. On the other hand, BRCAness patients showed significantly higher PFS compared to no BRCAness patients Conclusion: This real-world analysis largely confirmed the TOPAZ-1 findings, supporting gemcitabine, cisplatin, and durvalumab as a first-line standard of care for patients with advanced BTC.

Compliance with care standards and professional knowledge of operating theatre personnel before, during and after laparoscopic bariatric surgery: A study in public hospitals in Iran.

By adhering to care standards, many adverse outcomes for patients, such as pressure injuries, tissue necrosis and patient falls, can be prevented. The aim of this study was to investigate the level of compliance with care standards before, during and after various types of bariatric surgeries. This study was a cross-sectional descriptive study conducted in the operating theatres of selected teaching hospitals in Isfahan (Iran). The study sample consisted of all operating theatre personnel in the selected teaching hospitals who met the inclusion criteria. Compliance with care standards was measured using a researcher-developed checklist. A researcher-developed questionnaire with 43 true/false questions was used to evaluate the operating theatre personnel's professional knowledge. The data were analysed using SPSS version 20 and descriptive and inferential statistics. The mean score of adherence to care standards and the mean score of professional knowledge of operating theatre personnel regarding care of laparoscopic bariatric surgery were 78.35 ± 9.49 and 29.45 ± 6.17, respectively. There is no significant relationship between these two variables, with a two-tailed significance (Sig.) of 0.056 and a correlation coefficient (r) of 0.199. In general, it can be concluded that the specific knowledge of the local operating theatre personnel regarding minimally invasive laparoscopic surgery care is at an intermediate level. Requirements for training in this area were therefore successfully identified. In addition, not all operating theatre personnel adhere to the standards of care for patients undergoing laparoscopic bariatric surgery. This non-adherence could be due to insufficient training or the absence of established standards in hospitals.

Treatment of high risk myelodysplastic syndrome.

The myelodysplastic syndrome (MDS) is considered to be a heterogeneous myeloid malignancy with a common origin in the hematopoietic stem cell compartment, generally divided into lower and higher risk. While treatment goal for lower risk MDS (LR-MDS) is to decrease transfusion burden and transformation into acute leukemia major aim for high risk MDS is to prolong survival and ultimately cure. While novel agents such as luspatercept or imetelstat have recently been approved as new treatment options for LR-MDS, hypomethylating agents (HMA) remain currently the only approved non-transplant option for HR-MDS and is the standard of care for non-transplant-eligible patients. Combinations with other drugs as first-line treatment has to date not proven more efficacious than monotherapy in HR-MDS, and outcome after HMA failure is poor. The only potential cure and standard of care for eligible patients is allogeneic stem cell transplantation (HSCT) and even if the number of transplanted - especially older - MDS patients increased over time due to a better management and donor availability the majority of MDS patients will not be eligible for this curative approach. Current challenges encompass to decrease the relapse risk, the main cause of HSCT failure. This review will summarize current knowledge of options of transplant- and non-transplant treatment approaches for these patients and demonstrate the unmet clinical need for more effective therapies.

Evaluation of Antibiotic Usage Patterns, Patient Factors, and Economic Implications in ICU

Background: One of today's most significant public health issues is antibiotic resistance, which is caused by the overuse or abuse of antibiotics. Effective antimicrobial therapy is essential for treating patients in the intensive care unit (ICU), including those with severe sepsis, septic shock, and infections linked to healthcare. This study assesses the economic burden of broad-spectrum antibiotic usage on the overall cost of ICU care. Methods: An observational, cross-sectional study was conducted in the ICUs in a tertiary care center, over 1 month. Results: The gender distribution in the study shows a higher prevalence of male patients (60%) compared to female patients (40%), with a total sample size of 40 patients. Most of the patients were in the age group of 58–68 years (32.5%). The comorbidity scores indicate that a significant proportion of patients had a score of 4 (37.5%), which was also the most frequent score (mode). The most common length of stay was 2 days (mode), and the range extended from 1 to 9 days. Most patients had shorter stays, with 27.5% staying for 2 days and only a small fraction (2.5%) requiring a 9-day stay. Conclusion: The study emphasizes the need for a careful balance between cost-effective antibiotic treatment and optimal patient care to improve health outcomes and reduce financial strain. It highlights the crucial role of antimicrobial stewardship programs in promoting responsible antibiotic use, curbing resistance, and elevating patient care standards. Investing in diagnostics and educating healthcare providers about their advantages can further refine treatment approaches and long-term patient outcomes, particularly in resource-constrained environments.

The mediating role of professional identity between work environment and caring behavior: a cross-sectional survey among hospice nurses in China

BackgroundAs core members of hospice care team, the hospice nurses’ ability to care for patients not only directly affects the standard of patient care, but also significantly impacts patient quality of life. It can be seen that it is very meaningful for patients to improve the caring behavior of hospice nurses. Therefore, it is necessary to deeply explore the influencing factors of nurses’ caring behavior and further clarify the mechanism between them.MethodsThe STROBE guideline was performed to report this study. We conducted a cross-sectional survey from December 2023 to February 2024. In this study, 392 hospice nurses were recruited from tertiary public hospitals in East China by convenient sampling method. Participants were investigated using the Practice Environment Scale, Professional Identity Scale, and Caring Behaviors Inventory. Structural equation modelling was utilized to verify the research hypotheses.ResultsThe results revealed that there were significant and positive correlations between work environment, professional identity and caring behavior. Furthermore, professional identity partially mediated the relationship between work environment and caring behavior.ConclusionWork environment is critical to improving hospice nurses’ caring behavior. Professional identity plays an intermediary role impacting how work environment promotes caring behavior among Chinese hospice nurses. Nursing managers should have a correct understanding of the relationship between them. Targeted measures and coping strategies need to be actively taken to create a better working environment for hospice nurses. This would enhance professional identity, and thereby promote caring behavior.

Multiomics reveals tumor microenvironment remodeling in locally advanced gastric and gastroesophageal junction cancer following neoadjuvant immunotherapy and chemotherapy

BackgroundPerioperative chemotherapy is the standard of care for patients with locally advanced gastric and gastroesophageal junction cancer. Recent evidence demonstrated the addition of programmed cell death protein 1 (PD-1) inhibitors...

Efficacy and safety of preoperative intravenous iron versus standard care in colorectal cancer patients with iron deficiency anemia: a systematic review and meta-analysis.

Anemia, particularly iron deficiency (ID) anemia, is common in colorectal cancer (CRC) patients, affecting up to 58% of individuals. This study aimed to compare the effectiveness and safety of preoperative intravenous iron (IVI) with standard care (no iron or oral iron) in CRC patients with ID anemia. A systematic search across multiple databases identified studies comparing IVI versus no iron or oral iron in CRC patients with ID anemia. Pooled data were analyzed for changes in hemoglobin (Hb) levels, need for red blood cell transfusions (RBCT), overall mean number of transfused RBC units, overall survival (OS), disease-free survival (DFS), and complications. The authors analyzed data from 11 studies with 2024 patients and found that IVI significantly increased Hb levels at crucial time points: preoperative (MD=1.17, 95% CI [0.95-1.40], P<0.01), postoperative day one (MD=1.32, 95% CI [0.89-1.76], P<0.01), hospital discharge (MD=0.76, 95% CI [0.28-1.24], P=0.002), and 30 days postoperative (MD=1.57, 95% CI [1.27-1.87], P<0.01). IVI significantly decreased the overall need for RBCT, particularly in the postoperative period (RR=0.69, 95% CI [0.52-0.92], P=0.01). It also reduced the mean number of transfused RBC units, total complications, and wound dehiscence. However, there were no significant differences in total death, hospital stay, infections, paralytic ileus, OS, or DFS. Preoperative IVI significantly increased Hb levels at critical time points and markedly reduced the overall need for RBCT, complications, and wound dehiscence. To further validate these findings and ensure robust conclusions, more well-designed randomized controlled trials are warranted.

Adjuvant therapy in renal cell carcinoma (RCC): progress, at last.

In the United States, there is expected to be about 82,000 cases of renal cell carcinoma (RCC) in 2024. At diagnosis, approximately 65% of patients with RCC will have disease localized to the kidney. For decades, the standard of care for patients with localized RCC has been surgery, which is often curative, followed by radiographic surveillance. However, after nephrectomy, patients may have up to 50% risk of recurrence. Thus, there has been a longstanding effort to reduce the recurrence of kidney cancer in the adjuvant setting after nephrectomy and/or metastasectomy. Over the past 30 years, a number of different therapeutic agents have been tested in the adjuvant setting including cytokines, autologous tumor cell vaccines, vascular endothelial growth factor (VEGF) pathway inhibitors, mammalian target of rapamycin (mTOR) inhibitors, and most recently immune checkpoint inhibitors (ICIs). The vast majority of these adjuvant trials in RCC have shown no significant clinical benefit for patients. In 2021, the KEYNOTE-564 trial demonstrated that adjuvant pembrolizumab improved progression-free survival and more recently showed an overall survival benefit for patients with high risk of recurrence of clear cell RCC (ccRCC). These findings have ushered in a new standard of care for patients with ccRCC at high risk of recurrence after nephrectomy. Here, we provide an overview of the major adjuvant trials in RCC, with a focus on ccRCC, and provide a framework for the management of patients with high risk localized ccRCC.

A Review of Current and Future Antibody Drug Conjugates in Breast Cancer.

Antibody-drug conjugates (ADCs) are a novel class of anti-cancer agents that have changed the standard of care for patients with breast cancer. Their targeted approach delivers potent anti-cancer drugs to cancer cells bearing specific surface antigens, thereby maximizing anti-cancer effects and minimizing systemic toxicity. Currently, there are three ADCs available for use in breast cancer: trastuzumab emtansine for HER2 positive breast cancer (early stage and metastatic), trastuzumab deruxtecan for HER2 positive and HER2 low breast cancer (metastatic) and sacituzumab govitecan for triple negative and hormone receptor positive (HR +), HER2 negative breast cancer(metastatic). Trials have shown that these drugs have improved both progression free survival and overall survival in the metastatic setting, and trastuzumab emtansine has improved overall survival in early-stage breast cancer as well. The future of this class of compounds is very exciting. This field is rapidly evolving with new ADCs being investigated and clinical trials looking at the use of known ADCs in earlier stage disease.

Evaluation of a deep learning software for automated measurements on full-leg standing radiographs

BackgroundPrecise lower limb measurements are crucial for assessing musculoskeletal health; fully automated solutions have the potential to enhance standardization and reproducibility of these measurements. This study compared the measurements performed by BoneMetrics (Gleamer, Paris, France), a commercial artificial intelligence (AI)-based software, to expert manual measurements on anteroposterior full-leg standing radiographs.MethodsA retrospective analysis was conducted on a dataset comprising consecutive anteroposterior full-leg standing radiographs obtained from four imaging institutions. Key anatomical landmarks to define the hip–knee–ankle angle, pelvic obliquity, leg length, femoral length, and tibial length were annotated independently by two expert musculoskeletal radiologists and served as the ground truth. The performance of the AI was compared against these reference measurements using the mean absolute error, Bland–Altman analyses, and intraclass correlation coefficients.ResultsA total of 175 anteroposterior full–leg standing radiographs from 167 patients were included in the final dataset (mean age = 49.9 ± 23.6 years old; 103 women and 64 men). Mean absolute error values were 0.30° (95% confidence interval [CI] [0.28, 0.32]) for the hip–knee–ankle angle, 0.75 mm (95% CI [0.60, 0.88]) for pelvic obliquity, 1.03 mm (95% CI [0.91,1.14]) for leg length from the top of the femoral head, 1.45 mm (95% CI [1.33, 1.60]) for leg length from the center of the femoral head, 0.95 mm (95% CI [0.85, 1.04]) for femoral length from the top of the femoral head, 1.23 mm (95% CI [1.12, 1.32]) for femoral length from the center of the femoral head, and 1.38 mm (95% CI [1.21, 1.52]) for tibial length. The Bland–Altman analyses revealed no systematic bias across all measurements. Additionally, the software exhibited excellent agreement with the gold-standard measurements with intraclass correlation coefficient (ICC) values above 0.97 for all parameters.ConclusionsAutomated measurements on anteroposterior full-leg standing radiographs offer a reliable alternative to manual assessments. The use of AI in musculoskeletal radiology has the potential to support physicians in their daily practice without compromising patient care standards.

Simultaneous approach in tandem occlusion: a safe, effective, and faster way to achieve recanalization

BackgroundEndovascular thrombectomy (EVT) is the standard of care for patients with acute ischemic stroke (AIS) and intracranial vessel occlusion. Tandem occlusions (TO) comprise 20% of all anterior circulation AIS and...

A Phase 1/2 study of teclistamab, a humanized BCMA × CD3 bispecific Ab in Japanese patients with relapsed/refractory MM.

We characterized the safety and efficacy of the bispecific antibody teclistamab in Japanese patients with relapsed/refractory multiple myeloma (RRMM). Patients were pretreated with a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and anti-CD38 monoclonal antibody (mAb). The primary endpoint was frequency and type of treatment-emergent adverse events (TEAEs) in phase 1, and overall response rate (ORR; ≥ partial response [PR]) in phase 2. In phase 1, 14 patients received once-weekly (QW) subcutaneous teclistamab (0.72mg/kg [n = 5]; 1.5mg/kg [n = 5]; 3mg/kg [n = 4]). No dose-limiting toxicities were observed. As of April 2024, 26 phase-2 patients received the recommended phase-2 dose (QW) (RP2D: 1.5mg/kg) of teclistamab. Biweekly (Q2W) dosing was allowed after maintaining response for ≥ 6months. At a median follow-up of 14.32months, ORR was 76.9% (≥ very good PR: 76.9%; ≥ complete response: 65.4%). Median duration of response, progression-free survival, and overall survival were not reached. Common TEAEs included CRS (grade ≤ 2), neutropenia, and infections. No patient had immune effector cell-associated neurotoxicity syndrome (ICANS) and dose reductions. Teclistamab demonstrated deep and durable responses in Japanese patients with RRMM, consistent with the global pivotal MajesTEC-1 study, supporting the potential for a new standard of care for Japanese RRMM patients.

Switching from ligand to receptor anti-calcitonin gene-related peptide (CGRP) antibodies or vice versa in non-responders: A controlled cohort study.

Limited options exist for migraine prevention after stopping anti-calcitonin gene-related peptide monoclonal antibodies. A systematic review examining the benefits of switching between different classes (ligand vs. receptor monoclonal antibody) is essential, alongside well-designed real-world studies. In this cohort study 67 patients were included, who discontinued their first treatment with erenumab or fremanezumab. Patients (n = 31) switched to another monoclonal antibody class within 3 months, whilst those in the control group (n = 36) received standard care. Allocation to either group relied largely on the availability of alternative monoclonal antibody treatments, introducing pseudo-random allocation. Changes in monthly migraine days were compared between groups 3 months post-discontinuation of the first monoclonal antibody or initiation of a different monoclonal antibody class. A multivariate regression model was conducted that accounted for potential confounding factors. The groups were comparable at baseline and poor treatment response was the main reason for treatment discontinuation of the first monoclonal antibody. The switching cohort experienced a reduction of 3.9 monthly migraine days (95% confidence interval -6.4, -1.3, p = 0.004) compared with the control group. Transitioning to a different anti-calcitonin gene-related peptide monoclonal class yields reduction in monthly migraine days compared to returning to standard care for patients with inadequate initial treatment response.