Standard Of Care For Patients Research Articles

Omission of Axillary Lymph Node Dissection in Patients with Residual Nodal Disease After Neoadjuvant Chemotherapy.

Axillary management after neoadjuvant chemotherapy (NAC) is evolving but axillary lymph node dissection (ALND) remains the standard of care for patients with residual nodal disease. The results of the Alliance A011202 trial evaluating the oncologic safety of ALND omission in this cohort are pending but we hypothesize that ALND omission is already increasing. The National Cancer Database was queried to identify patients diagnosed with cT1-3N1M0 breast cancer who underwent NAC and had residual nodal disease (ypN1mi-2) from 2012 to 2021. Temporal trends in omission of completion ALND were assessed annually. Multivariable logistic and Cox regression models were used to identify factors associated with ALND omission and overall survival (OS), respectively. A total of 6101 patients were included; the majority presented with cT2 disease (57%), with 69% HER2+, 23% triple-negative, and 8% hormone receptor-positive/HER2-. Overall, 34% underwent sentinel lymph node biopsy (SLNB) alone. Rates of ALND were the lowest in the last 4years of observation. After adjustment, treatment at community centers (vs. academic) and lower pathologic nodal burden were associated with omission of ALND. ALND omission was associated with a higher unadjusted OS (5-year OS: 86% SLNB alone vs. 84% ALND; log-rank p=0.03), however this association was not maintained after adjustment. Despite the impending release of the Alliance A011202 results, omission of ALND in patients with residual nodal disease after NAC is increasing. This practice appears more prominent in community centers and in patients with a lower burden of residual nodal disease. No association with OS was noted.

249. OVERALL SURVIVAL OF PATIENTS WITH ESOPHAGEAL CANCER TREATED WITH DEFINITIVE CHEMORADIOTHERAPY: INSIGHTS FROM A RETROSPECTIVE STUDY

Abstract Background Neoadjuvant chemoradiotherapy followed by esophagectomy is the standard of care for patients with locally advanced esophageal cancer. However, definitive chemoradiotherapy (dCRT) may be considered as an alternative for those with unresectable disease, cervical location of the tumor or if a non-surgical approach is preferred based on the patient's condition. Heterogeneity in indications for dCRT makes it challenging to draw generalized conclusions regarding outcomes and survival. The aim of this study was to evaluate overall survival (OS) and recurrence patterns in patients with specified homogeneous indications for dCRT. Methods Patients with esophageal cancer treated with dCRT (50.4 Gy radiotherapy concomitant with 6 cycles of carboplatin/paclitaxel) between 2012-2022 in a tertiary referral center were identified from our institutional database. Primary endpoint was OS calculated from date of diagnosis until date of death or last day of follow-up, using the Kaplan Meier method. Secondary endpoints included the proportion of patients that completed the dCRT regimen, 30- and 90-day mortality following dCRT and disease recurrence. Results 162 patients were included, median follow-up was 74.6 months (IQR 46.2-99.3). The full dCRT regimen was completed by 116 (73.9%) patients. The 30- and 90-day mortality were 2.5% and 8.3%, respectively. The median OS was 23.7 months (95% CI 6.65-40.66) for cervical location of the tumor, 13.7 months (95% CI 7.92-29.8) for irresectable disease, 28.2 months (95% CI 12.10-44.22) for patients unfit for surgery and 20.6 months (95% CI 14.14-27.13) for those with preference for dCRT (p=0.15). Disease recurrence was observed in 74 patients (46%), located locoregional (46%), distant (19%) or both locoregional and distant (35%). Conclusion(s) Treatment with dCRT resulted in a 5-year OS of 35% and is associated with a high 90-day mortality. Disease recurrence was mostly locoregional located and was observed in 46% of patients. This emphasizes the critical necessity for enhanced treatment strategies centered on improving locoregional disease control.

345. PERI-OPERATIVE SELECTIVE DECONTAMINATION OF THE DIGESTIVE TRACT TO PREVENT SEVERE INFECTIOUS COMPLICATIONS AFTER ESOPHAGECTOMY: A RANDOMIZED MULTICENTER CLINICAL TRIAL

Abstract Protocol presentation Rationale: Esophagectomy is a complex surgical procedure, associated with significant morbidity and mortality rates. Most postoperative complications are caused by infections (10–30%). These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract, leading to (respiratory) infections. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy that aims to prevent postoperative infections. Pathogenic aerobic gram-negative rods and yeasts are reduced, while anaerobic, protective microbiota are preserved. SDD has been shown to lower the risk for respiratory infections in an intensive care setting. Establishing SDD as effective addition to the standard care of esophagectomy patients is expected to increase their chance of survival. Objective Robust and prospective evaluation of SDD after esophagectomy as a protective strategy reducing postoperative pneumonia and other infectious complications, anastomotic leakage and mortality. Study design and population A randomized, controlled, open-label, multicentre trial, including 854 patients with primary resectable esophageal carcinoma ((y)cT1-4a N0-3 M0) planned for transthoracic esophagectomy. Intervention The intervention group receives SDD treatment additional to standard care. An oral suspension (10ml) containing amphotericin B (50 mg/ml), colistin sulphate (10 mg/ml), and tobramycin (8 mg/ml). Patients take the oral suspension four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose. All other facets of care are equal to the control group (standard care without SDD). Two microbial samples will be taken from the esophageal resection specimen (one proximal and one from the distal part) for culture to evaluate effectiveness and compliance of SDD application in control as well as in the intervention group. Furthermore, all participants will be asked to keep a diary. Main study parameters The cumulative incidence of postoperative pneumonia within 30 days after surgery. Secondary study parameters The cumulative incidence of all postoperative complications and re-operation within 30 days after surgery, all- cause mortality within 90 days, length of stay and readmissions within 6 months and quality of life, direct and indirect costs; a week before, 30 days-, 3 months and 6 months after surgery.

Multidisciplinary Applications of AI in Dentistry: Bibliometric Review

This review explores the impact of Artificial Intelligence (AI) in dentistry, reflecting on its potential to reshape traditional practices and meet the increasing demands for high-quality dental care. The aim of this research is to examine how AI has evolved in dentistry over the past two decades, driven by two pivotal questions: “What are the current emerging trends and developments in AI in dentistry?” and “What implications do these trends have for the future of AI in the dental field?”. Utilizing the Scopus database, a bibliometric analysis of the literature from 2000 to 2023 was conducted to address these inquiries. The findings reveal a significant increase in AI-related publications, especially between 2018 and 2023, underscoring a rapid expansion in AI applications that enhance diagnostic precision and treatment planning. Techniques such as Deep Learning (DL) and Neural Networks (NN) have transformed dental practices by enhancing diagnostic precision and reducing workload. AI technologies, particularly Convolutional Neural Networks (CNNs) and Artificial Neural Networks (ANNs), have improved the accuracy of radiographic analysis, from detecting dental pathologies to automating cephalometric evaluations, thereby optimizing treatment outcomes. This advocacy is underpinned by the need for AI applications in dentistry to be both efficacious and ethically sound, ensuring that they not only improve clinical outcomes but also adhere to the highest standards of patient care.

Strategies for adapting under pressure: an interview study in intensive care units

BackgroundHealthcare systems are operating under substantial pressures. Clinicians and managers are constantly having to make adaptations, which are typically improvised, highly variable and not coordinated across teams. This study aimed...

Effects of intermittent calorie restriction in non-diabetic patients with metabolic dysfunction-associated steatotic liver disease

Background & AimsWe compared the effects of a 12-week intermittent calorie restriction (ICR) and standard of care (SOC) diet on liver fat content (LFC) in metabolic dysfunction-associated steatotic liver disease (MASLD) patients. MethodsThis randomized controlled trial included patients with MRI-proton density fat fraction (PDFF) ≥8%. Patients were randomly assigned to the ICR (5:2 diet) or SOC (80% of the recommended calorie intake) groups and stratified according to the body mass index (≥ or <25 kg/m2). The primary outcome was the proportion of patients who achieved a relative LFC reduction as measured by MRI-PDFF ≥30%. ResultsSeventy-two participants underwent randomization (36 patients with and 36 without obesity), and 63 (34 patients with and 29 without obesity) completed the trial. At week 12, a higher proportion of patients in the ICR arm achieved a relative LFC reduction of ≥30% compared to the SOC arm (72.2% vs. 44.4%; P=0.033), which was more prominent in the group with obesity (61.1% vs. 27.7%; P=0.033) than in the group without obesity (83.3% vs. 61.1%; P=0.352). The relative weight reduction was insignificant between the ICR and SOC arms (-5.3% vs. -4.2%; P=0.273); however, it was higher in the ICR arm compared to the SOC arm (-5.5% vs. -2.9%; P=0.039) in the group with obesity. Changes in fibrosis, muscle and fat mass, and liver enzyme levels were similar between the two groups (all P>0.05). ConclusionsThe ICR diet reduced LFC more effectively than SOC in patients with MASLD, particularly in patients with obesity. Additional studies are warranted in larger and more diverse cohorts.

Tumor-Infiltrating Lymphocyte Scoring in Neoadjuvant-Treated Breast Cancer.

Neoadjuvant chemotherapy (NAC) is now the standard of care for patients with locally advanced breast cancer (BC). TIL scoring is prognostic and adds predictive value to the residual cancer burden evaluation after NAC. However, NAC induces changes in the tumor, and the reliability of TIL scoring in post-NAC samples has not yet been studied. H&E- and dual CD3/CD20 chromogenic IHC-stained tissues were scored for stromal and intra-tumoral TIL by two experienced pathologists on pre- and post-treatment BC tissues. Digital TIL scoring was performed using the HALO® image analysis software (version 2.2). In patients with residual disease, we show a good inter-pathologist correlation for stromal TIL on H&E-stained tissues (CCC value 0.73). A good correlation for scoring with both staining methods (CCC 0.81) and the digital TIL scoring (CCC 0.77) was also observed. Overall concordance for TIL scoring in patients with a complete response was however poor. This study reveals there is good reliability for TIL scoring in patients with detectable residual tumors after NAC treatment, which is comparable to the scoring of untreated breast cancer patients. Based on the good consistency observed with digital TIL scoring, the development of a validated algorithm in the future might be advantageous.

Implementation of Regulations and Policies for Nursing Care Quality in Hospitals Worldwide

This systematic review examines the global implementation of regulations and policies aimed at enhancing the quality of nursing care in hospital settings. Through a comprehensive literature search, 20 studies were identified and analyzed. The review focuses on various regulatory frameworks, accreditation standards, and governmental policies that influence nursing care quality. The findings reveal that while regulations generally improve patient outcomes and care standards, challenges such as resource limitations, enforcement variability, and cultural resistance persist. The review concludes with recommendations for future research and policy development to address these challenges and improve nursing care quality globally.

The E3 ubiquitin ligase Herc1 modulates the response to nucleoside analogs in acute myeloid leukemia

AbstractFor several decades, induction therapy with nucleoside analogs, in particular cytarabine (Ara-C) and, to a lesser extent, fludarabine, has been the standard of care for patients diagnosed with acute myeloid leukemia (AML). However, the antitumor efficacy of nucleoside analogs is often limited by intrinsic and acquired drug resistance, thereby leading to poor therapeutic response and suboptimal clinical outcomes. In this study, we used genome-wide CRISPR-based pharmacogenomic screening to map the genetic factors that modulate the response to nucleoside analogs in AML and identified the E3 ubiquitin ligase, Herc1, as a key modulator of Ara-C response in the MLL/AF9 (MA) and the HOXA9/MEIS1 (HM) murine AML models, both in vitro and in vivo. Loss of HERC1 enhanced nucleoside analog–induced cell death in both murine and human AML cell lines by compromising cell cycle progression. In-depth proteomic analysis and subsequent validation identified deoxycytidine kinase as a novel target of Herc1 in MA and HM murine cells. We observed that HERC1 is overexpressed in AML when compared with other cancer types and that higher HERC1 expression was associated with shorter overall survival in patients with AML in the TCGA and BEAT-AML cohorts. Collectively, this study highlights the importance of HERC1 in the response of AML cells to nucleoside analogs, thereby establishing this E3 ubiquitin ligase as a novel predictive biomarker and potential therapeutic target for the treatment of AML.

Gender Disparity of Automatic Implantable Cardioverter-Defibrillator Placement for Primary Prevention: National Inpatient Sample Analysis.

Automatic implantable cardioverter-defibrillators (AICDs) for the primary prevention of sudden cardiac death have become standard care for patients with systolic heart failure (sHF) and ejection fraction ≤35%. While the prevalence of sHF and rates of hospitalization are higher in men, one would expect equivalent rates of implantation in women. We used the Healthcare Cost and Utilization Project's National Inpatient Sample (NIS) from 2009 to 2018 to identify patient visits with sHF and AICD implantation. The comorbidities and outcomes were compared based on gender. There were 15,247,854 inpatient admissions for sHF, of which 60.3% were males (95% CI: 60.1%-60.4%) and 39.8% females (95% CI: 39.7%-39.9%). Approximately 2% of patients (294,726) underwent the insertion of an AICD for primary prevention: 72.3% males (95% CI: 71.9%-72.7%) and 27.72% females (95% CI: 27.3%-28.1%). There was no significant difference in age (p = 0.29), length of stay (p = 0.09), and inpatient mortality (p = 0.18). In this study, women accounted for approximately 40% of patients admitted with the diagnosis of sHF; however, they accounted for less than 30% of patients who underwent the insertion of an AICD. Further research is needed to better understand this gender disparity and identify reasons for the lower rates of AICD placement in women.

62 Prognostic biomarker development using deep learning and spatial proteomics in papillary renal cell carcinoma

Abstract Background Papillary renal cell carcinoma (pRCC) is a prevalent but understudied kidney cancer pathology, constituting 15-20% of cases. While many patients achieve curative therapy using nephrectomy, others go on to develop progressive, metastatic disease with poor overall prognosis. In order to improve the current standards of care for pRCC patients, it is critical to identify new methods to identify high-risk patients likely to require more intense and risk-modulated follow-up. Our goals in this project are two-fold: (1) to identify prognostic patient clusters based on spatial architecture of tumor tissue, and (2) to identify a minimal subset of markers to accurately predict the defined clusters for clinical translation. Methods A tissue microarray of 100 pRCC patients was assayed using multiplex immunofluorescence with a 31-antibody panel with immune- and cancer-related proteins. We have developed novel algorithms to identify spatial neighborhoods and features. These features are then used to identify unsupervised clusters of patients. This new approach to classifying patients allows for a more specific and comprehensive description of each patient tumor’s spatial composition and association with diverse clinical outcomes. Next, we developed attention-based deep learning models capable of predicting these spatially-defined clusters directly from the underlying immunofluorescence images and subsequently profiled these for interpretability by retraining based on individual channels. We assessed each model iteratively on a validation set and a held-out test set for final model selection. We focussed on developing an accurate model with the minimal number of channels to enable development of a cost-efficient biomarker assay for the clinic. Results We performed a systematic analysis of the cellular and spatial phenotypes for each patient in our cohort and identified six (6) major spatial clusters. These clusters are based on the spatial neighborhood composition of the tumors (Fig 1A) and describe the composite effects of cell-cell interactions within a patient tumor. We identified one cluster in particular (cluster #6, mainly associated with spatial interaction of CD163+ macrophages) with a significantly worse prognosis than the other clusters. Using our advanced deep learning models, we have been able to achieve excellent validation accuracy in predicting a variety of clinical phenotypes and spatial features, including patient clusters and histological grade. We wished to then reduce the set of required features and began our efforts in predicting tumor vs. normal based on individual immunofluorescence channels and identified 6 channels with &amp;gt;75% individual predictive accuracy (Fig. 1B). Compositing all 6 markers further improves our accuracy to 90%. This success paves the way for exciting future prospects as we work to extend these efforts to identify a minimal clinically-applicable subset of protein markers. Conclusions The combination of computational spatial proteomics and deep learning models has the potential to identify new biomarkers specific to the spatial organization of patient tumors. We have identified a particular patient cluster with multiple associations with CD163+ macrophages demonstrating poor prognosis; selecting these patients may allow for tailored and more informed patient care. We are also working to enhance our deep learning models to circumvent the need for stepwise spatial analysis and, instead, allow for direct-from-image assessment of patients for particular spatial features indicative of various prognostic indicators. Our identified set of 6 markers serves as a basis for further refinements as we work to identify a minimal set of relevant markers able to predict various clinical outcomes from immunofluorescence imaging, offering a promising new avenue in the field of cancer pathology and biomarker development. DOD CDMRP Funding: yes

Clinical Outcome Comparison between CT-Guided Versus all MRI-Guided Scenarios in Brachytherapy for Cervical Cancer: A Single-Institute Experience

ObjectivesImage-guided adaptive brachytherapy (IGABT) is the standard of care for patients with cervical cancer. The objective of this study was to compare the treatment outcomes and adverse effects of computed tomography (CT)-guided and magnetic resonance imaging (MRI)-guided scenarios. Materials and MethodsData of patients with cervical cancer treated using external beam radiotherapy followed by IGABT from 2012 to 2016 were retrospectively reviewed. CT-guided IGABT was compared with the three modes of MRI-guided IGABT: pre-brachytherapy (MRI Pre-BT) without applicator insertion for fusion, planning MRI with applicator in-place in at least 1 fraction (MRI ≥1Fx), and MRI in every fraction (MRI EveryFx). Patient characteristics, oncologic outcomes, and late radiation toxicity were analyzed using descriptive, survival, and correlation statistics. ResultsOverall, 354 patients were evaluated with a median follow-up of 60 months. The 5-year overall survival (OS) rates were 61.5%, 65.2%, 54.4%, and 63.7% with CT-guided, MRI PreBT, MRI ≥1Fx, and MRI EveryFx IGABT, respectively with no significant differences (p = 0.522). The 5-year local control (LC) rates were 92.1%, 87.8%, 80.7%, and 76.5% (p = 0.133), respectively, with a significant difference observed between the CT-guided and MRI ≥1Fx (p = 0.018). The grade 3–4 late gastrointestinal toxicity rates were 6% in the CT-guided, MRI ≥1Fx, and MRI EveryFx, and 8% in MRI PreBT. The grade 3–4 late genitourinary toxicity rates were 4% in the CT-guided, 2% in MRI PreBT, 1% in MRI ≥1Fx, and none in MRI EveryFx. No significant differences were observed in the oncologic and toxicity outcomes among MRI PreBT, MRI ≥1Fx, and MRI EveryFx. ConclusionsCT-guided IGABT yielded an acceptable 5-year OS, LC, and toxicity profile compared with all MRI scenarios and is a potentially feasible option in resource-limited settings.

Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study

The standard of care for patients with intermediate-to-high risk renal cell carcinoma is partial or radical nephrectomy followed by surveillance. We aimed to investigate use of nivolumab before nephrectomy followed by adjuvant nivolumab in patients with high-risk renal cell carcinoma to determine recurrence-free survival compared with surgery only. In this open-label, randomised, phase 3 trial (PROSPER EA8143), patients were recruited from 183 community and academic sites across the USA and Canada. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, with previously untreated clinical stage T2 or greater or Tany N+ renal cell carcinoma of clear cell or non-clear cell histology planned for partial or radical nephrectomy. Selected patients with oligometastatic disease, who were disease free at other disease sites within 12 weeks of surgery, were eligible for inclusion. We randomly assigned (1:1) patients using permuted blocks (block size of 4) within stratum (clinical TNM stage) to either nivolumab plus surgery, or surgery only followed by surveillance. In the nivolumab group, nivolumab 480 mg was administered before surgery, followed by nine adjuvant doses. The primary endpoint was investigator-reviewed recurrence-free survival in patients with renal cell carcinoma assessed in all randomly assigned patients regardless of histology. Safety was assessed in all randomly assigned patients who started the assigned protocol treatment. This trial is registered with ClinicalTrials.gov, NCT03055013, and is closed to accrual. Between Feb 2, 2017, and June 2, 2021, 819 patients were randomly assigned to nivolumab plus surgery (404 [49%]) or surgery only (415 [51%]). 366 (91%) of 404 patients assigned to nivolumab plus surgery and 387 (93%) of 415 patients assigned to surgery only group started treatment. Median age was 61 years (IQR 53-69), 248 (30%) of 819 patients were female, 571 (70%) were male, 672 (88%) were White, and 77 (10%) were Hispanic or Latino. The Data and Safety Monitoring Committee stopped the trial at a planned interim analysis (March 25, 2022) because of futility. Median follow-up was 30·4 months (IQR 21·5-42·4) in the nivolumab group and 30·1 months (21·9-41·8) in the surgery only group. 381 (94%) of 404 patients in the nivolumab plus surgery group and 399 (96%) of 415 in the surgery only group had renal cell carcinoma and were included in the recurrence-free survival analysis. As of data cutoff (May 24, 2023), recurrence-free survival was not significantly different between nivolumab (125 [33%] of 381 had recurrence-free survival events) versus surgery only (133 [33%] of 399; hazard ratio 0·94 [95% CI 0·74-1·21]; one-sided p=0·32). The most common treatment-related grade 3-4 adverse events were elevated lipase (17 [5%] of 366 patients in the nivolumab plus surgery group vs none in the surgery only group), anaemia (seven [2%] vs nine [2%]), increased alanine aminotransferase (ten [3%] vs one [<1%]), abdominal pain (four [1%] vs six [2%]), and increased serum amylase (nine [2%] vs none). 177 (48%) patients in the nivolumab plus surgery group and 93 (24%) in the surgery only group had grade 3-5 adverse events due to any cause, the most common of which were anaemia (23 [6%] vs 19 [5%]), hypertension (27 [7%] vs nine [2%]), and elevated lipase (18 [5%] vs six [2%]). 48 (12%) of 404 patients in the nivolumab group and 40 (10%) of 415 in the surgery only group died, of which eight (2%) and three (1%), respectively, were determined to be treatment-related. Perioperative nivolumab before nephrectomy followed by adjuvant nivolumab did not improve recurrence-free survival versus surgery only followed by surveillance in patients with high-risk renal cell carcinoma. US National Institutes of Health National Cancer Institute and Bristol Myers Squibb.

Facing the COVID-19 pandemic: An Italian feasibility study of a mixed in-person/telerehabilitation intervention for cancer patients.

The COVID-19 pandemic impacted healthcare organizations, necessitating a rapid transition from in-person to virtual care. Our study explored the feasibility of a mixed in-person/telerehabilitation intervention for cancer patients and its effects on cancer-related fatigue (CRF), quality of life (QoL), physical function, patient satisfaction, and perceived usefulness. TRACE 2020 is an observational prospective study that enrolled adult cancer patients, between January 2021 and March 2023, who were eligible for a rehabilitation program to be provided also in telerehabilitation. Patients were assessed at baseline and after the rehabilitation program. Adherence to sessions, reasons for non-adherence and adverse events were collected. Of the 23 patients enrolled, 87% received a mixed intervention, with an average of 60% in-person sessions and 40% telerehabilitation sessions. Adherence was very high (91%). Evaluation scales showed an improvement in CRF, QoL, and lower limb strength and a relevant increase in patients' level of physical activity (PA). Most patients reported good satisfaction; the few criticisms mainly concerned difficulties in connectivity, lack of physical contact and difficulties in understanding how to perform exercises during telerehabilitation sessions. The physiotherapist underlined the usefulness of the innovative approach and suggested ways to facilitate future implementation. A mixed intervention including telerehabilitation is feasible and accepted by cancer patients. It may have a positive effect on their CRF, QoL, and level of PA and render patient care more flexible. The findings suggest what characteristics the target population for telerehabilitation should have, in order to integrate telerehabilitation in standard care for cancer patients.

Artificial Intelligence in Otology, Rhinology, and Laryngology: A Narrative Review of Its Current and Evolving Picture.

With technological advancements, artificial intelligence (AI) has progressed to become a ubiquitous part of human life. Its aspects in otorhinolaryngology are varied and are continuously evolving. Currently, AI has applications in hearing aids, imaging technologies, interpretation of auditory brain stem systems, and many more in otology. In rhinology, AI is seen to impact navigation, robotic surgeries, and the determination of various anomalies. Detection of voice pathologies and imaging are some areas of laryngology where AI is being used. This review gives an outlook on the diverse elements, applications, and advancements of AI in otorhinolaryngology. The various subfields of AI including machine learning, neural networks, and deep learning are also discussed. Clinical integration of AI and otorhinolaryngology has immense potential to revolutionize the healthcare system and improve the standards of patient care. The current applications of AI and its future scopes in developing this field are highlighted in this review.

Tackling challenges in rare diseases: The ISGACA approach on non-pancreatic cancers in the periampullary region

ObjectiveRare but aggressive cancer types like non-pancreatic periampullary cancers pose unique challenges for cancer research due to their low incidence rates and lack of consensus on optimal treatment strategies, therefore necessitating a collaborative approach. The International Study Group on non-pancreatic peri-Ampullary CAncer (ISGACA) aimed to build a collaborative initiative to pool expertise, funding opportunities, and data from over 60 medical centers, in order to improve outcomes for underrepresented patients with rare cancers. MethodsThe ISGACA approach predefined a stepwise approach including a research scope, establishing a dedicated steering committee, creating a recognizable brand, identifying research gaps, following a well-defined timeline, ensuring robust data collection, addressing legal and ethical considerations, securing financial resources, investing in research ethics training and statistical expertise, raising awareness, creating uniformity, and initiating prospective studies. ResultsOverall, 60 medical centers joined the ISGACA consortium (41 in Europe, 15 in North-America, three in Asia, one in Australia). The database includes 4309 patients. Nine publications and several ongoing studies which in turn allowed for a successful application of research grants. Subsequently, an international consensus meeting established uniform definitions and classifications, and one prospective multicenter international clinical trial has been initiated. ConclusionBy sharing knowledge, expertise, and clinical data, the ISGACA approach has not only gathered sufficient evidence to secure grants and ethical approvals for prospective studies, but also demonstrates options for standardizing patient care and improving outcomes for patients with rare cancers. The ISGACA approach offers a detailed methodology for initiating research on rare cancers and could serve as a replicable model for future research initiatives.

Management of ulcerative colitis in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease updated in 2023.

Ulcerative colitis (UC) is a chronic inflammation of the gastrointestinal tract and is characterized by alternating periods of inflammation and remission. Although UC incidence is lower in Taiwan than in Western countries, its impact remains considerable, demanding updated guidelines for addressing local healthcare challenges and patient needs. The revised guidelines employ international standards and recent research, emphasizing practical implementation within the Taiwanese healthcare system. Since the inception of the guidelines in 2017, the Taiwan Society of Inflammatory Bowel Disease has acknowledged the need for ongoing revisions to incorporate emerging therapeutic options and evolving disease management practices. This updated guideline aims to align UC management with local contexts, ensuring comprehensive and context-specific recommendations, thereby raising the standard of care for UC patients in Taiwan. By adapting and optimizing international protocols for local relevance, these efforts seek to enhance health outcomes for patients with UC.

Displaced humeral shaft fractures: Assessment of fracture union and complications following dual plate fixation using an anterior approach

The humeral bone is subject to torsional forces. In case of displaced shaft fractures, internal fixation remains the standard of care. This retrospective two-center study assessed the fracture union rate and complications after dual 3.5 mm locking compression plate (LCP) fixation using an anterolateral approach. Over a 9-year period, 38 patients underwent surgery in two centers. They had a mean age of 53.7 years (15–97, ± standard deviation (SD) 26) and there were three open fracture cases (7.9 %). The dominant side was affected in 21 cases (55.3 %) and there were 11 polytrauma patients (29 %). Mean operative time was 78 min (40–124, ± 19.8 SD). Patients were treated with dual 3.5 mm LCP fixation (6 screws on either side of the fracture line, anterolateral approach without a tourniquet). The first two orthogonal views showing at least 3 cortical bridges out of 4 determined fracture healing, as assessed by two independent raters. Pre- and postoperative complications were tabulated. Clinical outcomes included range of motion (ROM) and return to activities, while functional outcomes were assessed with the Disability of the Arm Shoulder and Hand (DASH), the Constant score, the Subjective Shoulder Score (SSV) and the Mayo Elbow Performance Score (MEPS). Minimum follow-up was 1 year. Four patients were given a shoulder immobilizer to wear for 3 weeks; immediate mobilization was the standard of care for the other patients. Fracture union was achieved in all cases within a mean of 11.7 weeks (6–28 ± 7.1 SD) without any heterotopic ossification of the brachialis muscle. There were eight patients with preoperative radial nerve palsy and two cases of postoperative palsy. There was one surgical site infection (2.6 %). Return to work for active patients was possible in 87 % of cases within a mean of 23 weeks (6–72 ± 11 SD). The Constant score was 84.6 (35–100, ± 13.4 SD), the SSV score was 80.7 (60–100, ± 8.2 SD), the DASH score was 13.5 (0–38.3, ± 8.8 SD) and the MEPS score was 85 (55–100, ± 11.9 SD). Traditional fixation methods provide little control over torsional forces, leading to non-union rates between 3 % and 12 % and delayed union (12 to 20 weeks). The simplicity of the technique described here, and the short operative time, may help explain the low infection rate. Dual plate fixation makes it possible to use more screws and allows nerve exploration and decompression in case of preoperative nerve palsy. Dual plate fixation to treat humeral shaft fractures is a simple and reliable technique.

Site-specific therapy guided by a 90-gene expression assay versus empirical chemotherapy in patients with cancer of unknown primary (Fudan CUP-001): a randomised controlled trial

Empirical chemotherapy remains the standard of care in patients with unfavourable cancer of unknown primary (CUP). Gene-expression profiling assays have been developed to identify the tissue of origin in patients with CUP; however, their clinical benefit has not yet been demonstrated. We aimed to evaluate the efficacy and safety of site-specific therapy directed by a 90-gene expression assay compared with empirical chemotherapy in patients with CUP. This randomised controlled trial was conducted at Fudan University Shanghai Cancer Center (Shanghai, China). We enrolled patients aged 18-75 years, with previously untreated CUP (histologically confirmed metastatic adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, or poorly differentiated neoplasms) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, who were not amenable to local radical treatment. Patients were randomly assigned (1:1) by the Pocock and Simon minimisation method to receive either site-specific therapy or empirical chemotherapy (taxane [175 mg/m2 by intravenous infusion on day 1] plus platinum [cisplatin 75 mg/m2 or carboplatin area under the curve 5 by intravenous infusion on day 1], or gemcitabine [1000 mg/m2 by intravenous infusion on days 1 and 8] plus platinum [same as above]). The minimisation factors were ECOG performance status and the extent of the disease. Clinicians and patients were not masked to interventions. The tumour origin in the site-specific therapy group was predicted by the 90-gene expression assay and treatments were administered accordingly. The primary endpoint was progression-free survival in the intention-to-treat population. The trial has been completed and the analysis is final. This study is registered with ClinicalTrials.gov (NCT03278600). Between Sept 18, 2017, and March 18, 2021, 182 patients (105 [58%] male, 77 [42%] female) were randomly assigned to receive site-specific therapy (n=91) or empirical chemotherapy (n=91). The five most commonly predicted tissues of origin in the site-specific therapy group were gastro-oesophagus (14 [15%]), lung (12 [13%]), ovary (11 [12%]), cervix (11 [12%]), and breast (nine [10%]). At the data cutoff date (April 30, 2023), median follow-up was 33·3 months (IQR 30·4-51·0) for the site-specific therapy group and 30·9 months (27·6-35·5) for the empirical chemotherapy group. Median progression-free survival was significantly longer with site-specific therapy than with empirical chemotherapy (9·6 months [95% CI 8·4-11·9] vs 6·6 months [5·5-7·9]; unadjusted hazard ratio 0·68 [95% CI 0·49-0·93]; p=0·017). Among the 167 patients who started planned treatment, 46 (56%) of 82 patients in the site-specific therapy group and 52 (61%) of 85 patients in the empirical chemotherapy group had grade 3 or worse treatment-related adverse events; the most frequent of these in the site-specific therapy and empirical chemotherapy groups were decreased neutrophil count (36 [44%] vs 42 [49%]), decreased white blood cell count (17 [21%] vs 26 [31%]), and anaemia (ten [12%] vs nine [11%]). Treatment-related serious adverse events were reported in five (6%) patients in the site-specific therapy group and two (2%) in the empirical chemotherapy group. No treatment-related deaths were observed. This single-centre randomised trial showed that site-specific therapy guided by the 90-gene expression assay could improve progression-free survival compared with empirical chemotherapy among patients with previously untreated CUP. Site-specific prediction by the 90-gene expression assay might provide more disease information and expand the therapeutic armamentarium in these patients. Clinical Research Plan of Shanghai Hospital Development Center, Program for Shanghai Outstanding Academic Leader, and Shanghai Anticancer Association SOAR PROJECT. For the Chinese translation of the abstract see Supplementary Materials section.

Diagnosis and management of isolated serous tubal intraepithelial carcinoma: A qualitative focus group study.

A Serous Tubal Intraepithelial Carcinoma (STIC) without concomitant invasive carcinoma is occasionally identified and associated with a high risk of subsequent peritoneal carcinomatosis. Management needs optimisation. This study explores professionals' opinions and clinical practices regarding the diagnosis, counselling, treatment and follow-up of isolated STIC to facilitate clinical decision making and optimise the direction of future research. A secondary aim is to assess international clinical guidelines. Focus group study. Four online sessions. International panel (n = 12 countries) of gynaecologists, gynaecologic oncologists, pathologists and medical oncologists (n = 49). A semi-structured interview guide was used. Two independent researchers analysed transcripts by open and axial coding. Results were organised in domains. Relevant (inter)national guidelines were screened for recommendations regarding isolated STIC. Professionals' opinions and clinical practices regarding isolated STIC management. Regarding pathology, most professionals identified the SEE-FIM protocol as standard of care for high-risk patients, whereas variation exists in the histopathological examination of fallopian tubes in the general population. Confirmation of STIC diagnosis by a specialised pathologist was recommended. Regarding work-up and follow-up after STIC diagnosis, there was variety and discordance. Data on outcomes is limited. As for treatment, chemotherapy and PARP inhibitors were not recommended by most. Eleven guidelines provided limited recommendations. We identified recommendations and highlighted knowledge gaps in the diagnosis and management of isolated STIC. Moreover, recommendations in clinical guidelines are limited. There is an agreed need for international collaboration for the prospective registration of isolated STIC.