Fisher Exact Probability Test Research Articles

Health status and living conditions of fathers of multiple babies: Analysis of the Comprehensive Survey of Living Conditions

Objective This study explored the physical and mental health status and living conditions of fathers raising 0-year-old multiples in Japan compared with those raising singletons to gain insight into fathers' health issues and the need for support.Methods Household and health data from the Comprehensive Survey of Living Conditions (2016, 2019, and 2022) were used. Because of the small number of fathers with multiples in each dataset, three datasets were combined. The t-test and Fisher's exact probability test were used to compare fathers with multiples and singletons for various factors.Results Fathers with multiples were significantly more likely to sleep for < 5 h than those of singletons. There was no significant difference between both groups in the percentage of fathers with a K6 score of ≥ 10. However, the percentage of fathers with multiples exceeded the target set by the government. There were no differences in the counseling status regarding worries and stress. The proportion of consultations with public institutions was extremely low in both groups.Conclusion The analysis of representative data from Japan highlights health issues and the need for support for fathers with multiples. Fathers with multiples showed a high percentage of short sleep durations, worries, and stress related to childcare. The need for mental health support, accumulation of knowledge and experience on support for fathers with multiples, and development of support systems were suggested.

Characteristics of ResectionParameters in Robot-Assisted Total Knee Arthroplasty With the Ligament Balancing Workflow.

Robotic-assisted total knee arthroplasty (TKA) is a novel orthopedic technique. The workflow of robotic-assisted TKA is quite different from that of traditional manual TKA and may result incompletely different resection parameters. Understanding these parameters may help surgeons better perform robotic-assisted TKA. This study aims to analyze the specific resection parameters of robotic-assisted TKA. We retrospectively reviewed 85 MAKO-assisted TKA surgeries performed by three surgeons at our institution between May 2021 and November 2023. All patients had unilateral primary knee arthritis, and a Triathlon PS (Stryker) knee prosthesis was used. Intraoperative resection plan, radiological outcomes, and clinical outcomes were collected among them. The angle between the transepicondylar axis (TEA) and the femoral prosthesis axis was defined as rTEA, the angle between the posterior condylar axis (PCA) and the femoral prosthesis axis was defined as rPCA. The t-test and the Chi-square test (or Fisher's exact probability test) were used to determine differences in categorical variables. rTEA averaged 2.7° (range, 0°-6.7°), and rPCA averaged 4.9° (range, 0.2°-9.6°). The mean resection of the medial distal femur was 7.7 mm (range, 3.0-12.5), that of the lateral tibial plateau was 6.4 mm (range, 1.5-13.0), and that of the medial posterior condyle of the femur was 10.6 mm (range, 6.5-17.5), whereas that of the lateral posterior condyle of the femur was 6.7 mm (range, 2.0-13.0). Robotic-assisted TKA using the ligament balancing workflow generally resulted in greater external rotation than reported reference values for conventional manual TKA within the existing literature, with reference to both the TEA and PCA. In addition, tibial resection was generally less, and the joint line was generally shifted upwards.

Fracture resistance and behavior of endodontically treated maxillary premolars with varying ferrule heights and post numbers: A laboratory study.

To investigate how varying ferrule heights and the number of glass fiber posts affect fracture resistance and behavior of endodontically treated maxillary first premolars with substantial loss of tooth structure. Twenty-four extracted endodontically treated human maxillary first premolars were divided into three groups (n=8) based on ferrule height and post number. The groups were as follows: premolars of 2mm ferrule height that were restored with single posts (control group), premolars of 0.5mm ferrule height that were restored with single posts in palatal canals (single-post group), and premolars of 0.5mm ferrule height that were restored with double posts in palatal and buccal canals (double-post group). All groups were then restored with composite core and metal-ceramic crowns cemented with zinc phosphate cement. All specimens were subjected to 10,000 thermal cycles at temperatures of 5°C and 55°C, as well as 1.2 million cyclic loadings of 49N load at 1.2Hz using a chewing simulator. The specimens were loaded to fracture in a universal testing machine and fracture behavior was examined under stereomicroscope and divided into restorable and unrestorable fracture modes. Fracture loads and modes were analyzed by one-way ANOVA, Tukey's post hoc test, and Fisher's exact probability test (p≤0.05). The control group showed the highest mean fracture load (1127±172) of all groups (p<0.001). The specimens in the single-post group showed numerically higher mean fracture load (522±171) but with no significant difference compared to the ones in the double-post group (518±157; p>0.967). In the control group, 75% of specimens showed unrestorable fractures compared to 50% and 12.5% in single-post and double-post groups. The specimens in the control group had similar unrestorable fractures, starting from the coronal part and extending obliquely to the cervical third of the root below resin level. Two specimens in the control group showed unrestorable fractures in the middle third of the root. No middle-third root fractures were observed in single-post and double-post groups, and unrestorable fractures in both groups were similar to those of the control group. The single-post group had two specimens with core-post crown complex restorable fractures, while the control and double-post groups had one specimen each. The remaining specimens showed cervical-third root restorable fractures above resin level. The ferrule height significantly influences the fracture resistance of endodontically treated premolars compared to the number of placed posts. Nonetheless, more restorable fractures are seen in endodontically treated premolars restored with double posts than single posts regardless of ferrule height.

Relationship between severe radiodermatitis and skin barrier functions in patients with head and neck cancer: A prospective observational study

ObjectiveSevere radiodermatitis with erosion is a painful condition that affects quality of life; therefore, developing methods for its prevention is an urgent issue. Therefore, this study aimed to determine the morphological characteristics of the development and healing processes of severe radiodermatitis in patients with head and neck cancer and to explore the association between skin barrier function and development of severe radiodermatitis. MethodsIn this prospective observational study, the cervical regions of patients with head and neck cancer who underwent radiotherapy at a university hospital from October 2022 to March 2023 were photographed, and morphological characteristics of the development and healing process of severe radiodermatitis were extracted using the qualitative sketch method. Skin barrier function, including skin microbiota and dermal echogenicity, was investigated before initiating radiotherapy, and its relationship with radiodermatitis was examined using the Mann–Whitney U test or Fisher's exact probability test. ResultsNine patients were followed for a median of 61 (range 55–87) days with a total of 88 observations. The morphological characteristics of severe radiodermatitis were “localized erosion–epithelialization” and “widespread erosion–crusting,” and compared to non-severe radiodermatitis, with low levels of Staphylococcus aureus (P ​= ​0.024), Staphylococcus hominis (P ​= ​0.024), and reduced dermal echogenicity (P ​= ​0.036). Furthermore, the “widespread erosion–crusting” was associated with a subepidermal low echogenic band. ConclusionsTo prevent severe radiodermatitis, in addition to moisturizing the irradiated area and protecting it from mechanical irritation, improving skin barrier function before radiotherapy initiation may be effective.

Clinical characteristics and associated factors of pediatric acute necrotizing encephalopathy: a retrospective study.

In the clinic, pediatric acute necrotizing encephalopathy (ANE) primarily affects children under five years of age and is characterized by severe brain damage and high mortality. However, some challenges remain regarding the diagnosis and treatment of ANE. In the present study, we analyzed the clinical characteristics and related factors of ANE with the aim of providing improved diagnostic and treatment strategies. Thirty-four pediatric ANE patients admitted to Zhejiang University School of Medicine Hospital between February 2019 and December 2023 were included in this study. To identify the factors associated with mortality, clinical, laboratory and imaging data were analyzed with independent-sample t tests, Mann‒Whitney U tests, Fisher's exact probability tests and receiver operating characteristic (ROC) curve analyses. In this cohort of 34 patients, the most common symptoms were fever, seizures, altered consciousness, vomiting, diarrhea and shock. The mortality rate was 55.9%. Laboratory tests revealed that patients who died had higher creatinine, lactate, activated partial thromboplastin time (APTT), thrombin time (TT), interleukin-6 (IL-6), interleukin-10 (IL-10), creatine kinase (CK), and D-dimer than survivors. Imaging examinations predominantly revealed symmetrical lesions in the thalamus. The fatal group displayed lower Glasgow Coma Scale (GCS) scores and severe complications. Other factors related to mortality included the arterial pH, GCS score and hospitalization duration. The most common symptoms of ANE are fever, seizures, altered consciousness, vomiting, diarrhea and shock, and ANE has a high mortality rate. The GCS score and arterial pH are critical biomarkers for assessing the severity of ANE.

Therapeutic effect of proprioceptive neuromuscular facilitation combined with muscle energy technique on post-stroke dysphagia.

According to the Global Burden of Disease Study the prevalence of stroke worldwide has significantly increased from 1990 to 2019, making it the second leading cause of death worldwide. Approximately 70%-80% of stroke patients are unable to live independently due to disability. To explore the therapeutic effect of proprioceptive neuromuscular facilitation (PNF) combined with muscle energy technique (MET) on post-stroke dysphagia. A total of 122 stroke patients with dysphagia admitted to our hospital from January 2017 to December 2020 were divided into the control group (n= 61) and the study group (n= 61). Patients in the control group received conventional rehabilitation plans, while those in the study group were given a combined therapy of MET and PNF. Standard Swallowing Function Assessment Scale (SSA), Videofluoroscopic Swallow Study (VFSS), Swallowing Quality of Life (SWAL-QOL) scores, Water Swallow Test (WST) grading, and efficacy indicators were compared between two group with t-tests, Wilcoxon signed-rank test, χ2 test or Fisher's exact probability test. After treatment, the study group showed lower SSA score (P= 0.036), and VFSS, P= 0.013 than the control group. The changes in SSA score (P= 0.013) and VFSS score (P< 0.001) in the study group were greater than the control group. Furthermore, after treatment, both the study group and the control group showed a decrease in WST grading (P< 0.001); and the degree of post-treatment WST grading decline in the study group was higher (P= 0.009). Besides, after treatment, the SWAL-QOL score of the study group was higher than the control group (P< 0.001); and the effective rate of patients in the study group was higher than that in the control group (P= 0.021). Compared with traditional rehabilitative training strategies, PNF combined with MET can effectively improve swallowing function, and enhance the quality of life in patients with post-stroke dysphagia.

Tumor Heterogeneity of STEAP4 in Malignant Progression of Oral Squamous Cell Carcinoma.

Background: Recent research suggests that STEAP4, a metalloreductase in vivo, plays a crucial role in various types of tumorigeneses, especially in gastrointestinal cancers. However, few oncogenes have been reported in oral squamous cell carcinoma (OSCC). Therefore, this study aimed to explore the potential role of STEAP4 in OSCC. Methods: The expression level of STEAP4 in OSCC tissues and adjacent normal tissues, was detected using immunohistochemistry. Publicly available online tools were utilized to analyze the expression, prognostic significance, and related enriched pathways of STEAP4 in head and neck squamous cell carcinoma (HNSCC) and OSCC. The relationship between STEAP4 expression and clinicopathological parameters in OSCC patients was validated using the χ2 test and Fisher's exact probability test. Results: STEAP4 exhibited low expression in both HNSCC and OSCC. Whereas the prognosis for HNSCC patients was favorable, OSCC patients had poor outcomes. Genetic variability analysis revealed no alterations in STEAP4 in OSCC, whereas gene amplification was observed in HNSCC, suggesting tumor heterogeneity in STEAP4 among these cancer types. Conclusion: STEAP4, as a risk factor associated with poor patient prognosis, shows tumor heterogeneity in OSCC patients, that is potentially related to genetic mutations or differences in histological distribution of oral mucosa. These findings indicate that STEAP4 could serve as an independent predictor for assessing the prognosis of OSCC patients.

Evaluation of the Safety and Efficacy of Foldable One-Piece Intraocular Lens A1-UV for the Treatment of Cataracts: Summary of Two Clinical Trials

Objective: Through the combined analysis of data from two clinical trials, the clinical safety and efficacy of aspheric intraocular lens A1-UV implantation in cataract patients was evaluated at 1 year after surgery. Methods: A total of 239 subjects (239 eyes) were enrolled, including 117 subjects in the A1-UV group (study group), 61 subjects in the SN60WF group (control group 1) and AQBHL group (control group 2), respectively. Follow-up time points included: preoperative, intraoperative and postoperative 1~2days, 1 week, 1 month, 3 months, 6 months and 1 year. The evaluation indexes included: visual acuity, refraction, contrast sensitivity, intraocular pressure and complications. Statistical methods mainly include Wilcoxon rank-sum test, independent samples t-test, chi-square test or Fisher exact probability test. Results: The uncorrected distance visual acuity of the A1-UV group increased from logMAR 0.77±0.33 preoperatively to 0.15±0.22 at 1 year after surgery, from 0.74±0.33 in the SN60WF group to 0.18±0.23 at 1 year after surgery, and from 0.78±0.34 in the AQBHL group to 0.21±0.24 at 1 year after surgery. For best-corrected distance visual acuity, the A1-UV group increased from logMAR 0.60±0.36 preoperatively to 0.05±0.10 at 1 year after surgery, the SN60WF group increased from 0.59±0.36 preoperatively to 0.07±0.15 at 1 year after surgery, and the AQBHL group increased from 0.59±0.35 preoperatively to 0.08±0.11 at 1 year after operation. There was no significant difference between the A1-UV group and the other two groups (all P&gt;0.05). At different follow-up times after surgery, the residual diopters was significantly lower than that before operation (all P&lt;0.05), and the refractive error before operation was effectively corrected. The contrast sensitivity was high, and the visual function was better. The mean intraocular pressure of the subjects implanted with A1-UV was within the normal range during each follow-up period after surgery. None of the patients had serious adverse events related to intraocular lens. Conclusion: The efficacy and safety of A1-UV foldable one-piece intraocular lens in cataract treatment are good

Evaluating the impact of loperamide on irinotecan-induced adverse events: a disproportionality analysis of data from the World Health Organization pharmacovigilance database (VigiBase).

SN-38, the active metabolite of irinotecan, may cause adverse events necessitating treatment discontinuation and management. Diarrhea, which is treated with loperamide, is one such event. However, loperamide may delay SN-38 elimination, causing more adverse events. Therefore, understanding the adverse events caused by symptomatic drugs is crucial for safe drug therapy. This study aimed to assess the association between loperamide and irinotecan-induced adverse events. We analyzed data up to December 2022 from VigiBase, the World Health Organization's adverse event database. The study used reporting odds ratios (RORs) to evaluate the associations between concomitant medications and irinotecan-induced adverse events. Fisher's exact probability test was used to analyze the adverse events. Logistic regression analysis was performed to identify associated adverse event signals. Of the 32,520,983 cases analyzed, 57,454 involved the use of irinotecan. Among these, 1589 (2.8%) patients were co-treated with loperamide. Signals for neutropenia (ROR 1.37, 95% confidence interval (CI) 1.20-1.57, p < 0.001), anemia (ROR 1.81, 95% CI 1.43-2.30, p < 0.001), and alopecia (ROR 1.89, 95% CI 1.30-2.74, p < 0.01) were detected with concomitant loperamide. Multivariate logistic regression analysis confirmed that concomitant loperamide use was associated with signals for neutropenia, anemia, and alopecia. Our results suggest that loperamide increases the risk of irinotecan-induced adverse events and enhances irinotecan toxicity. The study methodology may be useful for predicting adverse event risk when choosing symptomatic therapy drugs during irinotecan use.

8192 A Two-Cycle Clinical Audit Testing Inpatient Management Of Hypophosphatemia In A UK District Hospital

Abstract Disclosure: J. Porto: None. E. Ssemmondo: None. N. Obike: None. A. Abobaker: None. R. March: None. N. Tun: None. T. Pawlak: None. Objective: A clinical audit was conducted to assess if there was any improvement in management of hypophosphatemia among patients admitted to the medical wards using the local Trust protocol, following structured edcational sessions to the junior doctors covering medical wards. Design and methodology: The 2 cycles of the audit were conducted between March 2020 and September 2021 in Scarborough district Hospital. The clinical notes of 52 patients (20 in the first cycle and 32 in the re-audit) with hypophosphatemia were reviewed. These were identified using the electronic laboratory results of patients within the study period. The aspects of the trust protocol for management of hypophosphatemia that were audited; documentation of symptoms associated with low phosphate levels, cardiac monitoring in severe hypophosphatemia, identification of the likely cause of hypophosphatemia, the presence or absence of associated acute kidney injury (AKI) and initiation of phosphate replacement. The results of the first audit were presented at the local hospital clinical governance meeting (August 2020). Following this, 2 teaching sessions and 2-case based discussion on hypophosphatemia were organised for all the doctors in the department of medicine. The re-audit was subsequently conducted after the fourth teaching session. The proportions of each audited item were compared between the first audit and the re-audit using Fisher exact probability test. Results:25% of patients in the first audit had severe hypophosphatemia compared to 28% in the re-audit. In patients with severe hypophosphataemia, only 33.3% had cardiac monitoring during the re-audit cycle compared to 60% in the first cycle, and the difference was not statistically significant (p=0.58). There was significant improvement in the documentation of symptoms of hypophosphataemia amongst inpatients during the re-audit cycle compared with the initial cycle; 62.5% vs only 10% (P 0.002). Most patients had an underlying cause of the hypophosphatemia identified (80% and 62.5%-first and second cycle respectively). AKI was associated with hypophosphataemia in 15% &amp; 34.4% (P 0.2) in the first and second cycles respectively. Despite low phosphate levels, 25% and 28.1% at the initial audit and the second cycle respectively did not receive any form of phosphate replacement. Conclusion: The two-cycle clinical audit showed that the teaching sessions on management of hypophosphatemia increased the awareness of the importance to document whether the patients were symptomatic or asymptomatic following the drop in their phosphate levels, which can help to identify patients at risk of developing complications, such as cardiac arrythmias. However, these sessions were not sufficient to improve overall management of patients with low phosphate levels. Presentation: 6/1/2024

Relationship among Childbirth, Onset of Lower Back Pain, and Health-Related Quality of Life in Female Patients with Lower Back Pain: A Retrospective Study

This study aimed to investigate the relationship between childbirth and lower back pain and determine the health-related quality of life of female patients with lower back pain. A total of 111 patients were divided into three groups: those who had given birth and developed lower back pain due to pregnancy, childbirth, or child-rearing movements (childbirth group, n=41), those who had given birth and developed lower back pain due to other causes (childbirth and other cause group, n=29), and those who were nulliparous (nulliparous group, n=41). A total of 22 physical therapists evaluated the patients during initial rehabilitation. Basic information and health-related quality of life were compared among the three groups using a one-way analysis of variance for the visual analog scale scores for lower back pain, summary scores (physical health [physical component summary] and mental health [mental component summary]), and subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) of the Short Form-8 Health Survey. These values were also compared with the national standard values for health-related quality of life. The chi-square test of independence was used to compare distributions, and Fisher's exact probability test was used for cells with an expected value of <5. Most participants had physical component summary scores below the national standard values. The visual analog scale scores for lower back pain were significantly higher in the birth group than in the nonbirth group. The physical component summary, physical functioning, and general health scores were significantly lower in the birth group than in the nonbirth group. Moreover, bodily pain scores were significantly lower in the birth group than in the other groups. For female patients with lower back pain due to pregnancy, childbirth, or childcare activities, physical conditions unique to postpartum women should be considered, and if necessary, instructions for activities of daily living should be provided.

Relationship between Clinicopathological Factors of Breast Cancer and Lymph Node Metastasis in Young Women

Aim : To determine the incidence of lymph node metastasis in breast cancer of young women and its relationship with clinicopathologic factors. Methods : The study used an analytic observational design and a cross-sectional approach. Bivariate analysis was performed with Fisher's exact probability test to determine the association of clinicopathologic factors with lymph node metastasis. Results: N1 lymph node metastases could be found in most of the young women breast cancer patients at 42.9%, followed by N3 and N2 at 11.4% and 8.6%, respectively. On the other hand, 37.1% of patients showed no lymph node metastasis. Fisher's exact probability test showed that of the six clinicopathological factors, only tumour size was associated with lymph node metastasis with a p-value of 0.031. Conclusion : The incidence rate of lymph node metastasis in breast cancer of young women was 42.9% for N1, 11.4% for N3, and 8.6% for N2. There was a significant association between tumour size and lymph node metastasis.

Analysis of the long-term prognosis of transjugular intrahepatic portosystemic shunt treatment for esophagogastric variceal hemorrhage concomitant with sarcopenia in cirrhotic patients

Objective: To explore whether transjugular intrahepatic portosystemic shunt (TIPS) can improve the prognosis of esophagogastric variceal bleeding (EGVB) combined with sarcopenia in cirrhotic patients. Methods: A retrospective cohort study was performed. A total of 464 cases with cirrhotic EGVB who received standard or TIPS treatment between January 2017 and December 2019 were selected. Regular follow-up was performed for the long-term after treatment. The primary outcome was transplantation-free survival. The secondary endpoints were rebleeding and overt hepatic encephalopathy (OHE). The obtained data were statistically analyzed. The t-test and Wilcoxon rank-sum test were used to compare continuous variables between groups. The χ2 test, or Fisher's exact probability test, was used to compare categorical variables between groups. Results: The age of the included patients was 55.27±13.86 years, and 286 cases were male. There were 203 cases of combined sarcopenia and 261 cases of non-combined sarcopenia. The median follow-up period was 43 months. The two groups had no statistically significant difference in follow-up time. There was no statistically significant difference in transplant-free survival between the TIPS group and the standard treatment group in the overall cohort (HR=1.31, 95%CI: 0.97-1.78, P=0.08). The TIPS patient group with cirrhosis combined with sarcopenia had longer transplant-free survival (median survival: 47.76 vs. 52.45, χ2=4.09; HR=1.55, 95CI: 1.01~2.38, P=0.04). There was no statistically significant difference in transplant-free survival between the two kinds of treatments for patients without sarcopenia (HR=1.22, 95%CI: 0.78~1.88, P=0.39). Rebleeding time was prolonged in TIPS patients with or without sarcopenia combination (patients without combined sarcopenia: median rebleeding time: 39.48 vs. 53.61, χ2=18.68; R=2.47, 95CI: 1.67~3.65, P<0.01; patients with sarcopenia: median rebleeding time: 39.91 vs. 50.68, χ2=12.36; HR=2.20, 95CI: 1.42~3.40, P<0.01). TIPS patients had an increased 1-year OHE incidence rate compared to the standard treatment group (sarcopenia patients: 6.93% vs. 16.67%, χ2=3.87, P=0.049; patients without sarcopenia combination: 2.19% vs. 9.68%, χ2=8.85, P=0.01). There was no statistically significant difference in the long-term OHE incidence rate between the two kinds of treatment groups (P>0.05). Conclusion: TIPS can significantly prolong transplant-free survival compared to standard treatment as a secondary prevention of EGVB concomitant with sarcopenia in patients with cirrhosis. However, its advantage is not prominent for patients with cirrhosis in EGVB without sarcopenia.

Histopathologic Features of Drug Reaction With Eosinophilia and Systemic Symptoms.

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a severe cutaneous adverse reaction occurring 2 to 8 weeks after medication initiation. Diagnosis is clinical; RegiSCAR scoring includes biopsy "suggestive of DRESS," undefined in the literature. This study correlates DRESS dermatopathology, culprit drugs, disease course, and outcome severity compared with maculopapular drug reactions (MDR). Between 2014 and 2023, a retrospective cohort study at a tertiary care institute reviewed 55 patients with DRESS, assessing demographics, culprit drug, illness course, and histopathology. Biopsies of 15 patients with DRESS and 15 MDR patients were graded by a predefined histopathological scoring system. Statistical analysis (significant P -value<0.05) included the Fisher exact probability, ANOVA, and correlation tests. Among 55 patients with DRESS (mean age 50.13, 28 female/27 male), 15 (mean age 50.4, 7 female/8 male) had diagnostic biopsies. Compared with MDR patients, patients with DRESS exhibited significantly more interface dermatitis ( P = 0.04), lichenoid dermatitis ( P = 0.0007), pigment incontinence ( P = 0.04), and periadnexal interface dermatitis ( P = 0.002). MDR biopsies displayed perivascular inflammation and higher eosinophils than DRESS, trending toward significance. Key histopathologic features are interface dermatitis, periadnexal interface dermatitis, lichenoid dermatitis, pigment incontinence, and neutrophils dominance over eosinophils indicate DRESS clinically.

Sivelestat Inhibits Vascular Endothelial Injury Induced by Inflammatory Response and Improves the Prognosis of Hemorrhagic Fever with Renal Syndrome in Children: An Ambispective Cohort Study.

In Asia, Hanta virus (HTNV) results in severe hemorrhagic fever with renal syndrome (HFRS). The efficacy of sivelestat in treating children with HTNV-induced HFRS remains unclear. An ambispective cohort study was performed on children diagnosed with HFRS and hospitalized at the Children's Hospital Affiliated to Xi'an Jiaotong University from August 2018 to 2023. Patients who received neutrophil elastin-inhibitor infusion between August 2019 and August 2023 were assigned to the sivelestat group, while patients who did not were assigned to the control group. The independent sample t test was used for inter-group analysis. The Chi-square test and Fisher's exact probability test were used for categorical variables. Spearman correlation test was used to evaluate the correlation between two sets of continuous variables. Kaplan-Meier survival curve and Log -Rank test was used to evaluate the difference in cumulative probability of survival between the two groups. No significant differences were observed between the two groups in gender, age, contact history, body mass index, HFRS severity, clinical indexes at admission. Compared to the control group, the sivelestat group exhibited a significant decrease in the interleukin-8 level at 48 h (28.5±3 vs 34.5±3.5) and 72 h (21.3±4.5 vs 31.5±5.6) (P<0.05), as well as the ICAM-1 level at 48 h (553±122 vs 784±187) and 72 h (452±130 vs 623±85) (P<0.05). The concentration of VCAM-1 in the sivelestat group exhibited a consistent downward trend. Moreover, the level of VCAM-1 was significantly lower than that in the control group at 24 h (1760±289 vs 2180±445), 48 h (1450±441 vs 1890±267), and 72 h (1149±338 vs 1500±396) (P<0.05). Kaplan-Meier curve analysis revealed a statistically significant difference in the cumulative probability of survival between two groups (P = 0.041). In the secondary outcomes, the sivelestat group demonstrated a decrease in the utilization rate of mechanical ventilation and continuous renal replacement therapy (CRRT). Sivelestat may suppress neutrophil-mediated inflammatory response to reduce endothelial and organ damage, and improve clinical outcomes in children with severe hemorrhagic fever and renal syndrome.

Des-gamma-carboxy prothrombin (DCP) as a prognostic biomarker in patients with advanced hepatocellular carcinoma treated with atezolizumab/bevacizumab.

e16167 Background: Causes of variable disease response to first-line treatment with atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma (HCC) remain unclear. Identifying tumor markers that predict treatment response and provide prognostic information may help clinicians optimize treatment strategies and patient outcomes. The role of des-gamma-carboxy prothrombin (DCP) is not well established in Hepatitis B Virus non-endemic areas. This study aimed to investigate DCP as a predictive biomarker of treatment response as well as explore prognostic implications of DCP in patients with advanced HCC. Methods: This single-center retrospective analysis evaluated DCP and radiographic response in patients with advanced HCC who received atezolizumab/bevacizumab in the first-line setting. DCP was measured at the time of best response, determined by radiographic evaluation, and compared to day one of atezolizumab/bevacizumab initiation. Elevated DCP was defined as &gt; = 7.5 ng/mL. DCP response was defined as a decrease of &gt; = 50% at response assessment compared with baseline. Comparisons of treatment effects were performed using two-tailed Fisher Exact Probability Test. Overall survival (OS) was defined as the interval between the first treatment and either the date of death or the last follow-up visit. OS was analyzed using the Kaplan–Meier method and compared between groups using the log-rank test. Results: A total of 53 patients with advanced HCC treated with atezolizumab/bevacizumab were included. Radiographic treatment responses were complete response 3.8%, partial response 22.6%, stable disease 52.8% and progression of disease 20.8%, respectively. On day one of treatment 70% of patients had an elevated DCP. Patients with DCP response had ORR of 69% (odds ratio, 15.75; 95% CI, 3.50 – 70.9; p = 0.0002) and disease control rate of 100% (p = 0.047). Conversely, patients with &gt; = 50% increase in DCP at response evaluation compared to day one of treatment had ORR of 4.5% and no response rate of 95% (p = 0.0035). Furthermore, patients who had &gt; = 50% increase in DCP had median OS of 15.4 months compared to patients without &gt; = 50% increase in DCP who had median OS of 28.4 months (HR = 2.48; 95% CI, 1.035 – 5.93; p = 0.042). There was no difference in ORR, or OS, between patients who had elevated DCP on day one of treatment and those who did not. Conclusions: DCP response correlates with objective radiographic response in patients with advanced HCC treated with atezolizumab plus bevacizumab in the first-line setting. DCP increase of &gt; = 50% correlates with decreased median OS and may serve as a negative prognostic biomarker in such patients.

Differentiating mixed epithelial and stromal tumor family from predominantly cystic renal cell carcinoma using magnetic resonance imaging-based Bosniak classification system version 2019.

To differentiate mixed epithelial and stromal tumor family (MESTF) of the kidney from predominantly cystic renal cell carcinoma (RCC) using the magnetic resonance imaging (MRI)-based Bosniak classification system version 2019 (v2019). The study included 36 consecutive patients with MESTF and 77 with predominantly cystic RCC who underwent preoperative renal MRI. One radiologist evaluated and documented the clinical and MRI characteristics (age, sex, laterality, R.E.N.A.L. Nephrometry Score [RNS], surgical approach, the signal intensity on T2-weighted imaging, restricted diffusion and enhancement features in corticomedullary phase). Blinded to clinical and pathological information, another two radiologists independently evaluated Bosniak category of all masses. Interobserver agreement based on Bosniak classification system v2019 was measured by the weighted Cohen/Conger's Kappa coefficient. Furthermore, predominantly cystic RCCs and MESTFs were divided into low (categories I, II, and IIF) and high-class (categories III, and IV) tumors. The independent sample t test (Mann-Whitney U test) or Pearson Chi-square test (Fisher's exact probability test) was utilized to compare clinical and imaging characteristics between MESTFs and predominantly cystic RCCs. The performance of the Bosniak classification system v2019 in distinguishing MESTF from predominantly cystic RCC was investigated via receiver operating characteristic curve analysis. MESTF and predominantly cystic RCC groups significantly differed in terms of age, lesion size, RNS, restricted diffusion, and obvious enhancement in corticomedullary phase, but not sex, laterality, surgical approach, and the signal intensity on T2WI. Interobserver agreement was substantially based on the Bosniak classification system v2019. There were 24 low-class tumors and 12 high-class tumors in the MESTF group. Meanwhile, 13 low-class tumors and 64 high-class tumors were observed in the predominantly cystic RCC group. The distribution of low- or high-class tumors significantly differed between the MESTF and predominantly cystic RCC groups. Bosniak classification system v2019 had excellent discrimination (cutoff value = category III), and an area under curve value was 0.81; accuracy, 80.5%; sensitivity, 87.0%; and specificity, 66.7%. The MRI-based Bosniak classification system v2019 can effectively distinguish MESTF from predominantly cystic RCC if category III was used as a cutoff reference.

Abstract PO2-05-12: Retrospective analysis on therapeutic efficacy and predictive indicators of eribulin plus anti-angiogenic drugs for metastatic breast cancer

Abstract Background: Eribulin has been widely used for the treatment of metastatic breast cancer (MBC). It has been found that eribulin can work in synergy with Bevacizumab or Anlotinib to achieve anti-angiogenic effects and possible synergistic enhancement. To optimize the efficacy of eribulin usage in late-line MBC patients, it is essential to delve deeper into the effects of combined treatments and gather more real-world clinical outcomes. Therefore, we evaluated the efficacy and safety of eribulin plus the anti-angiogenic drugs in late-line MBC patients. Objective: This study aims to retrospectively analyze the therapeutic efficacy and safety of eribulin plus anti-angiogenic drugs in treating metastatic breast cancer and explore predictive indicators of the therapeutic efficacy of eribulin in treating MBC. Methods: A retrospective review study was performed. 40 Patients diagnosed with MBC and treated with eribulin in Xi’an international medical center hospital from May 2020 to May 2021 were enrolled in this study. Patients were evaluable for this study and divided into two groups based on whether they received eribulin monotherapy or combined therapy. 22 patients were treated with eribulin monotherapy, and 18 were treated with eribulin and anti-angiogenic drugs (Bevacizumab and Anlotinib). Patients’ treatment parameters and characteristics were recorded. The Kaplan-Meier method was used to calculate the median PFS and corresponding 95% confidence interval (CI), and the Cox regression model was used for multivariate analysis of predictive indicators. The Fisher exact probability test was used to compare the difference in adverse reactions between the two groups, with a level of significance set at p-value &amp;lt; 0.05. Results: All study patients have an average of 5 treatment lines and a median progression-free survival (mPFS) of 4.2 months. The eribulin plus anti-angiogenic drug treatment group had a significantly prolonged mPFS compared to the group without anti-angiogenic drug treatment (7.0 months vs 2.0 months, p &amp;lt; 0.001, log-rank). Multivariate analysis identified that the combination of anti-angiogenic therapy (HR = 0.043, p = 0.004) and the occurrence of grade 3-4 neutropenia after treatment were two predictive factors for longer PFS (HR = 0.322, p = 0.009). In contrast, prior resistance to taxanes was predictive of shorter PFS (HR = 4.583, p = 0.019). Other factors, including age, Eastern Cooperative Oncology Group (ECOG) performance status, hormone receptor (HR) type, expression status, human epidermal growth factor receptor-2 (HER-2) expression status, Ki-67 level, number of metastatic lesions, and number of prior lines of Eribulin therapy, were not significantly associated with PFS. The results of Fisher’s exact test show that there was no significant increase in treatment-related adverse events (all grades) after combination with anti-angiogenic drugs. Conclusion: A combination of eribulin and anti-angiogenic therapy has significantly prolonged mPFS in the treatment of MBC patients. Other factors such as prior non-taxane resistance, grade 3-4 neutropenia occurrence after treatment, and combined anti-angiogenic therapy can be used as biomarkers for predicting treatment efficacy. The adverse events are manageable and the safety of combined therapy can be guaranteed. Therefore, the eribulin plus anti-angiogenic combination may act as a potential therapy for late-line MBC patients with clinically beneficial therapeutic effects. Keywords: metastatic breast cancer, eribulin, anti-angiogenic therapy, retrospective analysis Citation Format: Junmei Zhang, Xuezheng Wang, Hongjuan Du, Yan Xue. Retrospective analysis on therapeutic efficacy and predictive indicators of eribulin plus anti-angiogenic drugs for metastatic breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-05-12.

Reassessment of practice of Chinese surgeons since introduction of the watch and wait strategy after neoadjuvant therapy for rectal cancer

Objective: To investigate perspectives and changes in treatment selection by Chinese surgeons since introduction of the watch-and-wait approach after neoadjuvant therapy for rectal cancer. Methods: A cross-sectional survey was conducted using a questionnaire distributed through the "Wenjuanxing" online survey platform. The survey focused on the recognition and practices of Chinese surgeons regarding the strategy of watch-and-wait after neoadjuvant therapy for rectal cancer and was disseminated within the China Watch-and-Wait Database (CWWD) WeChat group. This group targets surgeons of deputy chief physician level and above in surgical, radiotherapy, or internal medicine departments of nationally accredited tumor-specialist or comprehensive hospitals (at provincial or municipal levels) who are involved in colorectal cancer diagnosis and treatment. From 13 to 16 December 2023, 321 questionnaires were sent with questionnaire links in the CWWD WeChat group. The questionnaires comprised 32 questions encompassing: (1) basic physician characteristics (including surgical volume); (2) assessment methods and criteria for clinical complete response (cCR); (3) patients eligible for watch-and-wait; (4) neoadjuvant therapies and other measures for achieving cCR; (5) willingness to implement watch-and-wait and factors influencing that willingness; (6) risks and monitoring of watch-and-wait; (7) subsequent treatment and follow-up post watch-and-wait; (8) suggestions for development of the CWWD. Descriptive statistics were employed for data analysis, with intergroup comparisons conducted using the χ2 or Fisher's exact probability tests. Results: The response rate was 31.5%, comprising 101 responses from the 321 individuals in the WeChat group. Respondents comprised 101 physicians from 70 centers across 23 provinces, municipalities, and autonomous regions nationwide, 85.1% (86/101) of whom represented provincial tertiary hospitals. Among the respondents, 87.1% (88/101) had implemented the watch-and-wait strategy. The approval rate (65.6%, 21/32) and proportion of patients often informed (68.8%, 22/32) were both significantly higher for doctors in oncology hospitals than for those in general hospitals (27.7%, 18/65; 32.4%, 22/68) (χ2=12.83, P<0.001; χ2=11.70, P=0.001, respectively). The most used methods for diagnosing cCR were digital rectal examination (90.1%, 91/101), colonoscopy (91.1%, 92/101), and rectal T2-weighted magnetic resonance imaging (86.1%, 87/101). Criteria used to identify cCR comprised absence of a palpable mass on digital rectal examination (87.1%, 88/101), flat white scars or new capillaries on colonoscopy (77.2%, 78/101), absence of evident tumor signals on rectal T2-weighted sequences or T2WI low signals or signals equivalent to the intestinal wall (83.2%, 84/101), and absence of tumor hyperintensity on diffusion-weighted imaging with no corresponding hypointensity on apparent diffusion coefficient maps (66.3%, 67/101). As for selection of neoadjuvant regimen and assessment of cCR, 57.4% (58/101) of physicians preferred a long course of radiotherapy with or without induction and/or consolidation capecitabine + oxaliplatin, whereas 25.7% (26/101) preferred immunotherapy in combination with chemotherapy and concurrent radiotherapy. Most (96.0%, 97/101) physicians believed that the primary lesion should be assessed ≤12 weeks after completion of radiotherapy. Patients were frequently informed about the possibility of achieving cCR after neoadjuvant therapy and the strategy of watch-and-wait by 43.6% (44/101) of the responding physicians and 38.6% (39/101) preferred watch-and-wait for patients who achieved cCR or near cCR after neoadjuvant therapy for rectal cancer. Capability for multiple follow-up evaluations (70.3%, 71/101) was a crucial factor influencing physicians' choice of watch-and-wait after cCR. The proportion who patients who did not achieve cCR and underwent surgical treatment was lower in provincial tertiary hospitals (74.2%, 23/31) than in provincial general hospitals (94.5%, 52/55) and municipal hospitals (12/15); these differences are statistically significant (χ2=7.43, P=0.020). The difference between local recurrence and local regrowth was understood by 88.1% (89/101) of respondents and 87.2% (88/101) agreed with monitoring every 3 months for 5 years. An increase in local excision or puncture rates to reduce organ resections in patients with pCR was proposed by 64.4% (65/101) of respondents. Conclusion: Compared with the results of a previous survey, Chinese surgeons' awareness of the watch-and-wait concept has improved significantly. Oncologists in oncology hospitals are more aware of the concept of watch-and-wait.

Long-Term Taste and Smell Outcomes After COVID-19

Self-report surveys suggest that long-lasting taste deficits may occur after SARS-CoV-2 infection, influencing nutrition, safety, and quality of life. However, self-reports of taste dysfunction are inaccurate, commonly reflecting deficits due to olfactory not taste system pathology; hence, quantitative testing is needed to verify the association of post-COVID-19 condition with taste function. To use well-validated self-administered psychophysical tests to investigate the association of COVID-19 with long-term outcomes in taste and smell function. This nationwide cross-sectional study included individuals with and without a prior history of COVID-19 recruited from February 2020 to August 2023 from a social media website (Reddit) and bulletin board advertisements. In the COVID-19 cohort, there was a mean of 395 days (95% CI, 363-425 days) between diagnosis and testing. History of COVID-19. The 53-item Waterless Empirical Taste Test (WETT) and 40-item University of Pennsylvania Smell Identification Test (UPSIT) were used to assess taste and smell function. Total WETT and UPSIT scores and WETT subtest scores of sucrose, citric acid, sodium chloride, caffeine, and monosodium glutamate were assessed for groups with and without a COVID-19 history. The association of COVID-19 with taste and smell outcomes was assessed using analysis of covariance, χ2, and Fisher exact probability tests. Tests were completed by 340 individuals with prior COVID-19 (128 males [37.6%] and 212 females [62.4%]; mean [SD] age, 39.04 [14.35] years) and 434 individuals with no such history (154 males [35.5%] and 280 females [64.5%]; mean (SD) age, 39.99 [15.61] years). Taste scores did not differ between individuals with and without previous COVID-19 (total WETT age- and sex-adjusted mean score, 33.41 [95% CI, 32.37-34.45] vs 33.46 [95% CI, 32.54-34.38]; P = .94). In contrast, UPSIT scores were lower in the group with previous COVID-19 than the group without previous COVID-19 (mean score, 34.39 [95% CI, 33.86-34.92] vs 35.86 [95% CI, 35.39-36.33]; P < .001]); 103 individuals with prior COVID-19 (30.3%) and 91 individuals without prior COVID-19 (21.0%) had some degree of dysfunction (odds ratio, 1.64 [95% CI, 1.18-2.27]). The SARS-CoV-2 variant present at the time of infection was associated with smell outcomes; individuals with original untyped and Alpha variant infections exhibited more loss than those with other variant infections; for example, total to severe loss occurred in 10 of 42 individuals with Alpha variant infections (23.8%) and 7 of 52 individuals with original variant infections (13.5%) compared with 12 of 434 individuals with no COVID-19 history (2.8%) (P < .001 for all). In this study, taste dysfunction as measured objectively was absent 1 year after exposure to COVID-19 while some smell loss remained in nearly one-third of individuals with this exposure, likely explaining taste complaints of many individuals with post-COVID-19 condition. Infection with earlier untyped and Alpha variants was associated with the greatest degree of smell loss.