Multicenter Study Research Articles

The relationship between intercultural sensitivity, ethnocentrism, socio-demographic characteristics and xenophobia in nursing students: A descriptive and multi-centric study

BackgroundXenophobia plays a pivotal role in influencing the delivery of culturally competent care. Nevertheless, the relationship between intercultural sensitivity, ethnocentrism, socio-demographic characteristics and xenophobia in nursing students remains undetermined. AimThis study aimed to determine the relationship between intercultural sensitivity, ethnocentrism, socio-demographic characteristics and xenophobia in nursing students. Methods and participantsThe study involved 1045 nursing students from six universities in Türkiye. Data were collected using the “Participant Information Form,” the “Intercultural Sensitivity Scale,” the “Ethnocentrism Scale,” and the “Xenophobia Scale.” Multiple linear regression was employed for the analysis. ResultsIntercultural sensitivity (β = −0.09; p = 0.028) emerged as a negative predictor of xenophobia levels in students, while ethnocentrism (β = 0.17; p = 0.000) was identified as a positive predictor of xenophobia levels. Additionally, socio-demographic characteristics, including age, living in an extended family, academic year, participation in intercultural nursing courses, and interaction with immigrant neighbors, were established as significant predictors of xenophobia. ConclusionThis study revealed a direct correlation between higher intercultural sensitivity and reduced xenophobia, whereas an increase in ethnocentrism was linked to elevated levels of xenophobia. These results offer valuable insights for educators and policymakers to combat xenophobia and design targeted interventions.

151P Real-world treatment with risdiplam in adults with SMA: a multicentre study

151P Real-world treatment with risdiplam in adults with SMA: a multicentre study

Adjuvant intravesical therapy in intermediate-risk non-muscle-invasive bladder cancer.

To evaluate the impact of adjuvant therapy on oncological outcomes in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC), as due to the poorly-defined and overlapping diagnostic criteria optimal decision-making remains challenging in these patients. In this multicentre study, patients treated with transurethral resection of bladder tumour for Ta disease were retrospectively analysed. All patients with low- or high-risk NMIBC were excluded from the analysis. Associations between adjuvant therapy administration with recurrence-free survival (RFS) and progression-free survival (PFS) rates were assessed in Cox regression models. A total of 2206 patients with intermediate-risk NMIBC were included in the analysis. Among them, 1427 patients underwent adjuvant therapy, such as bacille Calmette-Guérin (n = 168), or chemotherapeutic agents, such as mitomycin C or epirubicin (n = 1259), in different regimens up to 1 year. The median (interquartile range) follow-up was 73.3 (38.4-106.9) months. The RFS at 1 and 5 years in patients treated with adjuvant therapy and those without were 72.6% vs 69.5% and 50.8% vs 41.3%, respectively. Adjuvant therapy was associated with better RFS (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.70-0.89, P < 0.001), but not with PFS (P = 0.09). In the subgroup of patients aged ≤70 years with primary, single Ta Grade 2 <3 cm tumours (n = 328), adjuvant therapy was not associated with RFS (HR 0.71, 95% CI 0.50-1.02, P = 0.06). While in the subgroup of patients with at least one risk factor including patient age >70 years, tumour multiplicity, recurrent tumour and tumour size ≥3 cm (n = 1878), adjuvant intravesical therapy was associated with improved RFS (HR 0.78, 95% CI 0.68-0.88, P < 0.001). In our study, patients with intermediate-risk NMIBC benefit from adjuvant intravesical therapy in terms of RFS. However, in patients without risk factors, adjuvant intravesical therapy did not result in a clear reduction in the recurrence rate.

Comprehensive Proteomic Profiling ofHuman Myocardium Reveals SignalingPathways Dysregulated in Hypertrophic Cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease. Signaling pathways that link genetic sequence variants to clinically overt HCM and progression to severe forms of HCM remain unknown. The purpose of this study was to identify signaling pathways that are differentially regulated in HCM, using proteomic profiling of human myocardium, confirmed with transcriptomic profiling. In this multicenter case-control study, myocardial samples were obtained from cases with HCM and control subjects with nonfailing hearts. Proteomic profiling of 7,289 proteins from myocardial samples was performed using the SomaScan assay (SomaLogic). Pathway analysis of differentially expressed proteins was performed, using a false discovery rate<0.05. Pathway analysis of proteins whose concentrations correlated with clinical indicators of severe HCM (eg, reduced left ventricular ejection fraction, atrial fibrillation, and ventricular tachyarrhythmias) was also executed. Confirmatory analysis of differentially expressed genes was performed using myocardial transcriptomic profiling. The study included 99 HCM cases and 15 control subjects. Pathway analysis of differentially expressed proteins revealed dysregulation of the Ras-mitogen-activated protein kinase, ubiquitin-mediated proteolysis, angiogenesis-related (eg, hypoxia-inducible factor-1, vascular endothelial growth factor), and Hippo pathways. Pathways known to be dysregulated in HCM, including metabolic, inflammatory, and extracellular matrix pathways, were also dysregulated. Pathway analysis of proteins associated with clinical indicators of severe HCM and of differentially expressed genes supported these findings. The present study represents the most comprehensive (>7,000 proteins) and largest-scale (n=99 HCM cases) proteomic profiling of human HCM myocardium to date. Proteomic profiling and confirmatory transcriptomic profiling elucidate dysregulation of both newly recognized (eg, Ras-mitogen-activated protein kinase) and known pathways associated with pathogenesis and progression to severe forms of HCM.

ID: 329757 Multi-Center Pilot Study to Assess Provider Experience with an Artificial Intelligence Multimedia Informed Consent Platform

ID: 329757 Multi-Center Pilot Study to Assess Provider Experience with an Artificial Intelligence Multimedia Informed Consent Platform

Adenocarcinoma of the esophagogastric junction: characteristics of female patients and young adult patients based on a 12-year retrospective and prospective multicenter clinicoepidemiological cohort study in Japan

BackgroundAdenocarcinoma of the esophagogastric junction (AEGJ) is most common in men and the elderly, but the disease is becoming more common in female and young adult persons. We have investigated the clinicoepidemiological characteristics of female and young adult patients with AEGJ and the 12-year trends in the Kurashiki area for young adult patients with AEGJ.MethodsPatients diagnosed with AEGJ in 12 hospitals between January 2008 and December 2019 were included in this study. Patients were divided into three groups by age (young adult [≤50 years], middle-aged [51 to 70 years], and elderly [>70 years]). Factors associated with AEGJ such as obesity, smoking, hiatal hernia and male, which were reported in our previous study, were identified.ResultsOne hundred and eighty-eight AEGJ patients, including 36 females and 20 young adults, were characterized. There was no significant change in the annual incidence of AEGJ among female (p=0.078) and young adult patients (p=0.89). Female patients without any associated factors, accounting for 53% (19/36) of the female patients and young adult patients, had significantly more histologically undifferentiated cancers than patients with at least one associated factor (58% [11/19] vs. 30% [50/169], p=0.025) and middle-aged and elderly patients (60% [12/20] vs. 30% [25/83] vs. 28% [24/85], p =0.026). Smoking was significantly less common in women than in men (8% [3/36] vs. 57% [87/152], p < 0.01). There were no significant differences between ages in the proportions of these associated factors.ConclusionsHistologically undifferentiated AEGJ cancers were more frequent in female patients without any associated factors and in young adult patients. Factors associated with AEGJ may differ between women and men, but they are similar in young adults and older adults. No increase in young adult patients with AEGJ was observed in the 12-year study.

Magnitude, associated factors of difficult airway, and predictive value of airway examinations among maxillofacial surgery patients at public hospitals in Southern Ethiopia: a multicentre cross-sectional study

Background: “Difficult airway” is the clinical situation in which a conventionally trained anesthesiologist experiences difficulty with mask ventilation, laryngoscopy, and difficulty with tracheal intubation, or both. Associated factors and predictive value difficult airways, maxillofacial surgery study setup is under studied. Objective: To determine the magnitude and associated factors of difficult airways and predictive value of airway examinations among adult patients who underwent maxillofacial surgery at public hospitals in Southern Ethiopia 2022. Methods and materials: An institutional-based multicenter cross-sectional study was conducted among 250 maxillofacial patients from March to 30 June 2022 at selected hospitals. The data were entered into Epi_Data software version 4.3 and analyzed by STATA software version 14. All variables that were statistically significant in bivariate analysis, at the P less than 0.25, were included in the multivariate logistic regression analysis. The predictive value or the effectiveness of airway examinations in predicting difficult airways was analyzed by receiver operating curve. Results: In the current study, the magnitude of difficult airways was 21.2% (95% CI = 16.3–26.1%) and the magnitude of difficult intubation, difficult laryngoscopy, and difficult mask ventilation was 6.4% (95% CI 3.3–9.4%), 9.6% (95% CI 6.1–13%), and 13.6% (95% CI (9.1–16.8%), respectively. History of head and neck surgery adjusted odds ratio (AOR)=6.3, 95% CI (2.85–14.34), cervical collar AOR=4.9, 95% CI (1.96–12.49), and cervical spine injury AOR=2.4, 95% CI (1.07–5.38) were independently and significantly associated with difficulty of airway. Modified Mallampati class and sternomental distance were identified as good preoperative tests to predict difficult laryngoscopy, intubation, and mask ventilation. Conclusion and recommendation: The magnitude of difficult airways was maxillofacial surgery. Among various airway assessment tests, no single test was perfectly accurate. Anaesthesia professionals are recommended to use a combination of preoperative airway assessments.

467P A multicenter retrospective study in Turkish children with myotonic dystrophy type 1

467P A multicenter retrospective study in Turkish children with myotonic dystrophy type 1

Real-world antithrombotic strategies in patients with atrial fibrillation and recently developed acute coronary syndrome

BackgroundThe antithrombotic strategy for patients with atrial fibrillation (AF) and coronary artery disease following percutaneous coronary intervention is shifting towards less intensive. Nevertheless, for patients with AF and acute coronary syndrome (ACS), an optimal antithrombotic strategy is yet to be established. Methods and resultsWe conducted a multi-center cohort study involving 146 Japanese centers that had prospectively registered 460 patients with AF and ACS followed for 2 years. Primary endpoint was the composite of thrombotic and bleeding events, and secondary endpoints included heart failure hospitalization. At the time of study registration, 86% of participants had received direct oral anticoagulants (DOACs) and 75% had received aspirin-based triple antithrombotic therapy (TAT) between March 2017 and August 2019. Apixaban was the most frequently used DOAC (29%). While the proportion of anticoagulants did not change according to the time course, the intensity of antiplatelets significantly attenuated over time (dual antiplatelet at baseline: 75%, and at 2-years: 7%). The cumulative incidence of the primary outcome measure was similar in patients with warfarin and DOACs. However, the risk of heart failure hospitalization was significantly higher in those with warfarin compared to DOACs (Hazard ratio: 2.8, 95% confidence interval: 1.1-5.8, p=0.022). ConclusionsThe present findings suggest the appropriate optimization of antithrombotic medication balancing in patients with AF and ACS in Japan by reducing the intensity of antiplatelets during the study period.

Association between health communication on integrated healthcare and primary healthcare visits among rehabilitation outpatients: a multicenter cross-sectional study in China

ObjectiveThis study examines the relationship between health communication on integrated healthcare and primary healthcare visits among rehabilitation outpatients in China. MethodsA multi-stage sampling scheme was used to select the rehabilitation outpatients as study participants. A total of 3415 participants from 21 medical institutions in seven cities in China were included in the final analysis. The measurement included primary healthcare visits, health communication on integrated healthcare, and basic characteristics (age, sex, educational level, marital status, household income, and diagnoses). The association between health communication on integrated healthcare and primary healthcare visits was modeled using logistic regression controlling the general characteristics and disease status. ResultsAmong 3415 rehabilitation outpatients, the mean age of participants was 45.3 years (SD:24.9), and more than half (54.0%) were male. The majority (56.3%) were diagnosed with orthopaedic disorders. Patients who had a higher level of knowledge on integrated healthcare, received information of integrated healthcare from organizational communication (β = 1.79; 95% CI = 1.40, 2.28) and interpersonal communication (β = 6.95; 95% CI = 2.87, 16.84), the interaction terms of ‘organizational communication * knowledge’(β = 0.99; 95% CI = 0.97, 1.00), and ‘interpersonal communication * knowledge’(β = 0.92; 95% CI = 0.87, 0.97) were associated with visiting primary healthcare initially when had an illness the last two weeks. ConclusionThis study indicated that rehabilitation outpatients display a low level of primary healthcare visits, calling for interpersonal-based health communication interventions to be implemented to improve their integrated healthcare knowledge and promote better primary healthcare visits practices in China.

Association of Soy Foods With Gastric Cancer Considering Helicobacter pylori: A Multi-Center Case-Control Study.

This study aims to explore the relationship between soy food consumption and gastric cancer (GC) risk, accounting for Helicobacter pylori infection status. We analyzed data from patients with GC and healthy individuals prospectively enrolled by 6 hospitals between 2016 and 2018. Dietary intake was evaluated using questionnaires that categorized seven dietary habits and 19 food groups. Multivariate logistic regression models were applied to examine associations. Model I adjusted for various epidemiological factors, while Model II included further adjustments for H. pylori infection. Primary exposures examined were consumption frequencies of nonfermented, unsalted soy foods (soybean/tofu) and fermented, salty soy foods (soybean paste stew). A total of 5,535 participants were included, with 1,629 diagnosed with GC. In Model I, the frequency of soybean/tofu consumption was inversely related to GC risk; adjusted odd ratios (aORs) were 0.62 (95% confidence interval [CI], 0.48-0.8), 0.38 (95% CI, 0.3-0.49), 0.42 (95% CI, 0.33-0.53), and 0.33 (95% CI, 0.27-0.42) for 1 time/week, 2 times/week, 3 times/week, and ≥4 times/week. Consumption of 2 servings/week of soybean paste stew showed the lowest GC association, forming a V-shaped curve. Both low (aOR, 4.03; 95% CI, 3.09-5.26) and high serving frequencies of soybean paste stew (aOR, 2.23; 95% CI, 1.76-2.82) were associated with GC. The association between soy foods and GC in Model II was similar to that in Model I. The soy food-GC associations were consistent across sexes in Model I. Nonetheless, the positive correlation between frequent consumption of soybean paste stew (≥5 times/week) and GC was more pronounced in women (aOR, 7.58; 95% CI, 3.20-17.99) compared to men (aOR, 3.03; 95% CI, 1.61-5.88) in Model II. Subgroup analyses by H. pylori status and salty diet revealed a consistent inverse relationship between soybean/tofu and GC risk. In contrast, soybean paste stew showed a V-shaped relationship in H. pylori-positive or salty diet groups and no significant association in the H. pylori-negative group. Soybean/tofu intake is consistently associated with a decreased risk of GC. However, the relationship between soybean paste stew consumption and GC risk varies, depending on H. pylori infection status and dietary salt intake. ClinicalTrials.gov Identifier: NCT03046745.

Red cell distribution width and mean platelet volume detection in patients with endometrial cancer and endometrial hyperplasia.

Endometrial cancer is the most common malignancy in women in developed countries, and its incidence is increasing annually. Due to the availability and cost-effectiveness of serum markers of red cell distribution width (RDW), and mean platelet volume (MPV), we decided to investigate these two important markers in patients with endometrial cancer and assess their role in diagnosing the tumor and differentiate it from endometrial hyperplasia and other causes of bleeding. This is a case-control study that examined the data of patients who were referred to Al-Zahra Hospital during 2022-2023 with complaints of abnormal bleeding and underwent diagnostic curettage. Based on the pathology findings, the patients were divided into 3 groups, including endometrial cancer, endometrial hyperplasia, and control. The clinical characteristics and results of MPV and RDW were compared in these three groups. The IBM SPSS Statistics for Windows, Version 21.0. was used for data analysis. In this study, 87 women were examined in three groups endometrial cancer, endometrial hyperplasia, and control with a mean age of 52.70 ± 11.63 years. The results showed that the endometrial cancer group, had higher gravida, underlying disease, history of radiation therapy, anticoagulant therapy, blood transfusion, surgery, and family history of cancer (p < 0.05). Meanwhile, the endometrial cancer group had lower menstrual age and history of using contraceptives than other groups (p < 0.05). In addition, in this study, the results indicated that the levels of MPV and RDW in the endometrial cancer group were significantly higher than in the endometrial hyperplasia and control groups (p < 0.05). Since MPV and RDW are cheap and accessible and can be easily obtained from complete blood count panels, they can be used as suitable diagnostic markers for endometrial cancer. However, conducting comprehensive multicenter prospective studies with a larger sample size can be helpful.

Predictive Value of CCQ and its Subdomains for Hospitalized Exacerbations in Chronic Obstructive Pulmonary Disease: A 3-Year Observational Prospective Study.

The prediction capacity of the Clinical COPD Questionnaire (CCQ) and its functional, symptom, and mental subdomain for COPD hospitalized exacerbation were rarely studied. To examine the prognostic capacity of the total CCQ and its three subdomains for 3-year COPD hospitalized exacerbations. We analyzed the predictive ability of total CCQ score and its subdomains for hospitalized exacerbations in an observational cohort of 987 subjects with stable COPD from the RealDTC, an ongoing multicenter prospective study. Hospitalized exacerbations were prospectively collected every 6month for a maximum of 3years. The total CCQ and its functional and symptom domain, but not the mental domain, were significantly associated with 3-year hospitalized exacerbations by multivariate Cox regression analysis. The predictive capacity of functional domain was similar to that of the total CCQ, but significantly stronger than the symptom and mental domain by ROC analysis (P < 0.05). ROC curves also showed that the AUC of exacerbation history combined with CCQ functional domain was larger than that of exacerbation history alone (P < 0.0001). Additionally, the predictive value of multivariable models that contains CCQ functional domain was significantly better than the corresponding model without CCQ functional domain (P < 0.05). The total CCQ and its functional and symptom domain were independent risk factors of 3-year hospitalized exacerbations. The prognostic capacity of the functional domain was similar to that of total CCQ, and was significantly stronger than the symptom and mental domain. The CCQ functional domain was able to increase the predictive power of exacerbation history and other multivariable prediction models, indicating it may have an important role in the multivariable prediction tool for hospitalized exacerbation, and its combination with other clinical variables might be used as a low-cost approach for assessments of the disease severity and severe exacerbation in COPD patients in the future.

The Prognostic Impact of Minimally Invasive Esophagectomy on Survival After Esophagectomy Following a Delayed Interval After Chemoradiotherapy: A Secondary Analysis of the DICE Study.

To evaluate prognostic differences between minimally invasive esophagectomy (MIE) and open esophagectomy (OE) in patients with surgery after a prolonged interval (>12wk) following chemoradiotherapy (CRT). Previously, we established that a prolonged interval after CRT before esophagectomy was associated with poorer long-term survival. This was an international multicenter cohort study involving 17 tertiary centers, including patients who received CRT followed by surgery between 2010 and 2020. Patients undergoing MIE were defined as thoracoscopic and laparoscopic approaches. A total of 428 patients (145 MIE and 283 OE) had surgery between 12 weeks and 2 years after CRT. Significant differences were observed in American Society of Anesthesiologists grade, radiation dose, clinical T stage, and histologic subtype. There were no significant differences between the groups in age, sex, body mass index, pathologic T or N stage, resection margin status, tumor location, surgical technique, or 90-day mortality. Survival analysis showed MIE was associated with improved survival in univariate ( P =0.014), multivariate analysis after adjustment for smoking, T and N stage, and histology (HR=1.69; 95% CI: 1.14-2.5) and propensity-matched analysis ( P =0.02). Further subgroup analyses by radiation dose and interval after CRT showed survival advantage for MIE in 40 to 50Gy dose groups (HR=1.9; 95% CI: 1.2-3.0) and in patients having surgery within 6 months of CRT (HR=1.6; 95% CI: 1.1-2.2). MIE was associated with improved overall survival compared with OE in patients with a prolonged interval from CRT to surgery. The mechanism for this observed improvement in survival remains unknown, with potential hypotheses including a reduction in complications and improved functional recovery after MIE.

Non-interventional, multicenter retrospective study of the effectiveness and safety of teduglutide in short bowel syndrome adult patients in Spain. The T-REX study

Non-interventional, multicenter retrospective study of the effectiveness and safety of teduglutide in short bowel syndrome adult patients in Spain. The T-REX study

The short-term outcomes and risk factors of post-myocardial infarction ventricular septal rupture: a multi-center retrospective Study

ObjectivesPost-myocardial infarction ventricular septal rupture (PIVSR) is one of the most severe types of mechanical complications after acute myocardial infarction (AMI) with high mortality and poor prognosis. The risk factors for short-term mortality of patients with PIVSR may be not widely recognized. We aimed to assess the prevalence and short-term mortality risk predictors of PIVSR.MethodsA total of 62 patients with a diagnosis of PIVSR were admitted to three top general public hospitals in Chongqing, China. Clinical characteristics and short-term outcomes of patients with PIVSR were compared. Predictors of PIVSR were assessed using logistic regression analysis.ResultsMean age was 70.7 ± 10.7 years (38.7% female). The overall in-hospital mortality of PIVSR remained high (71%). Most (47/62) of the patients were in Killip class III or IV at the time of rupture diagnosis. Logistic regression analysis revealed that white blood cell count (WBC, OR 1.619, 95% CI 1.172–2.237, P = 0.005), cardiogenic shock (OR 47.706, 95%CI 2.859-795.945, P = 0.007) and left ventricular ejection fraction (LVEF, OR 0.803, 95%CI 0.689–0.936, P = 0.009) were independent risk factors of in-hospital early mortality. The nomogram developed for predicting the risk of short-term mortality showed a robust discrimination, with an area under the receiver operating characteristic curve (AUC) of 0.956 (95%CI 0.912-1.000).ConclusionThe short-term mortality of PIVSR remained high. WBC, cardiogenic shock, and LVEF were the independent predictive factors of short-term mortality. Our nomogram might be used to predict early mortality of patients with PIVSR.

Feasibility and safety of single-fraction sub-ablative radiotherapy with systemic therapy in colorectal cancer patients with ≤ 10 metastases: A multicenter pilot study (NCT05375708)

Colorectal cancer patients with ≤10 unresectable metastases were treated with single-fraction sub-ablative radiotherapy in addition to standard of care systemic therapy in a single-arm, open-label, multicenter, pilot study (SIRIUS) to assess feasibility and safety. Results indicate that radiotherapy combined with systemic therapy is feasible and safe in this population.

Therapeutic and prognosis of Cushing's syndrome: A multicenter retrospective study

Therapeutic and prognosis of Cushing's syndrome: A multicenter retrospective study

Calf circumference-albumin index significantly predicts the prognosis of older patients with cancer cachexia: A multicentre cohort study

PurposeThe aim of this study was to evaluate the combined prognostic value of calf circumference (CC) and serum albumin on mortality in patients with cancer cachexia aged ≥65 years. MethodsThis multicenter cohort study involved 5322 older patients with cancer cachexia from hospitals. The combined indicator of CC and albumin was defined as the calf circumference-albumin index (CCA). Harrell's C index, a time-dependent receiver operating characteristic (ROC) curve analysis, was used to assess the prognostic performance of the CCA and other indices. Optimal threshold was used to determine the cutoff values of CC and albumin, and the association between the CCA and all-cause mortality was assessed using Kaplan-Meier analysis and COX proportional hazard regression models. ResultsThere were 3875 men and 1447 women with a mean age of 72.0 (68.0, 78.0) years and a mean follow-up time of 55.0 (25.0, 85.0) months. A total of 1269 patients were classified into the low CCA group (0 score) by the optimal thresholds method. In the overall population, the CCA showed better differentiating power in predicting mortality in older patients with cancer cachexia compared to CC or albumin alone (C-index = 0.639, 95%CI = 0.612-0.666, P<0.05). The time-dependent ROC showed that the CCA had the highest prognostic value of all the measures studied (P<0.05). In the overall population, male and female patients with the high CCA (2 score) had better performance than those with the low CCA (0 score, 1 score). ConclusionsThe CCA index, combined CC and albumin together, could significantly predict the mortality of older patients with cancer cachexia, which might provide new help for future clinical management.

Dexamethasone is non-inferior to antihistamine plus dexamethasone premedication in preventing ramucirumab plus nab-paclitaxel infusion-related reactions in gastric cancer: a multicenter retrospective study

PurposeRamucirumab (RAM) is recommended as premedication with H1-receptor antagonists (H1RA) to prevent infusion-related reactions (IRRs). However, RAM is a human antibody with a low incidence of IRRs. We evaluated the noninferiority of non-H1RA (dexamethasone [DEX] alone) premedication to H1RA (plus DEX) premedication in terms of IRRs in patients with gastric cancer receiving RAM plus nanoparticle albumin-bound paclitaxel (nab-PTX).MethodsThis was a noninferiority, multicenter, retrospective trial conducted in three Japanese centers to assess the incidence of IRRs in patients receiving RAM plus nab-PTX for gastric cancer between 2018 and 2023. Patients with gastric cancer receiving RAM plus nab-PTX were divided into groups with and without H1RA premedication. The incidence of IRRs was compared between the two groups.ResultsNinety patients were evaluated, with non-H1RA and H1RA premedications in 43 and 47 cases, respectively. After the first dose of RAM, IRRs were not observed in either group. IRRs during the overall doses were 0% for non-H1RA premedication and 2.1% for H1RA premedication (90% confidence interval (CI): –5.6%–1.3% for each comparison). The upper limit of the 90% CI (1.3%) did not exceed the noninferiority margin (Δ) of + 10% and therefore met the noninferiority criteria.ConclusionRAM plus nab-PTX for gastric cancer with DEX premedication may be possible without H1RA premedication.