Real-world Cohort Study Research Articles

Psoriatic arthritis phenotype clusters and their association with treatment response: a real-world longitudinal cohort study from the psoriatic arthritis research consortium

ObjectivesTo identify phenotype clusters and their trajectories in psoriatic arthritis (PsA) and examine the association of the clusters with treatment response in a real-world setting.MethodsIn the multicentre PsA Research Consortium...

Nephroprotective effect of SGLT2 inhibitors in elderly patients with type 2 diabetes mellitus and hypertension: a real-world population-based cohort study

ABSTRACT Objectives This study aimed to investigate the nephroprotective effect of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in elderly patients with type 2 diabetes mellitus (T2DM) and hypertension based on real-world clinical data. The study aimed to provide a theoretical basis for evidence-based pharmacological treatment of chronic kidney disease in this population. Methods The ‘Health Cloud’ platform of the Shanghai Municipal Health Commission was employed to identify and screen elderly patients with T2DM and hypertension. The propensity score matching cohort was further constructed to estimate the effect of SGLT2i on the risk of rapid decline in renal function (∆eGFR≤-5 ml/min/1.73 m2 or ∆eGFR%≤-5%). Multiple sensitivity analyses were conducted to assess the robustness of the results. Results After propensity score matching, no significant differences of covariates were identified between the SGLT2i and non-SGLT2i groups. The results of multivariate logistic models demonstrated a consistent and inverse correlation between SGLT2i use and the risk of rapid eGFR decline, whether defined as ∆eGFR≤-5 ml/min/1.73 m2 (OR = 0.60, 95% CI:0.38-0.96) or ∆eGFR%≤-5%（OR = 0.57, 95% CI:0.37-0.89). In the stratification of renin-angiotensin system inhibitor (RASi) treatment, SGLT2i was associated with a lower risk of rapid eGFR decline in the RASi group (all ORs < 1, p < 0.05), with no interaction between SGLT2i and RASi (all P for interaction > 0.05) detected. Conclusions SGLT2i significantly reduced the risk of rapid eGFR decline in elderly patients with T2DM and hypertension, but the synergistic effect with RASi remains unclear.

Effectiveness of a Combination of Nasturtium Herb and Horseradish Root (Angocin® Anti-Infekt N) Compared to Antibiotics in Managing Acute and Recurrent Urinary Tract Infections: A Retrospective Real-world Cohort Study

Background: The goal of this study was to evaluate whether the medical recommendation of Angocin® Anti-Infekt N, compared to standard antibiotic treatment shortly after the diagnosis of a urinary tract infection (UTI) or cystitis, is negatively associated with an early, sporadic, or recurrent UTI, subsequent antibiotic prescriptions, pyelonephritis as a renal complication, or UTI-associated sick leave. Methods: This retrospective cohort study was based on data from the IQVIATM Disease Analyzer database and included patients diagnosed with acute UTI or cystitis by physicians in Germany between 2005 and 2021, who were prescribed either Angocin® or standard antibiotics within 4 days after diagnosis. Patients prescribed antibiotics were matched to those prescribed Angocin® (5:1) using propensity scores. Univariable logistic and Cox regression models were used to investigate the association between Angocin® prescription and the defined study outcomes. The effects of Angocin® were adjusted for age, sex, insurance status, index diagnosis, and physician specialty. Results: A total of 2277 Angocin® patients and 11,385 antibiotic patients were available for analysis. Compared to antibiotic prescriptions, Angocin® prescription was associated with significantly lower odds of an early relapse within 1–30 days after the index date (odds ratio (OR): 0.74; 95% confidence interval (CI): 0.62–0.87; p &lt; 0.001), further sporadic UTI within 31–365 days after the index date (OR: 0.68; 95% CI: 0.58–0.78; p &lt; 0.001), and recurrent UTI (OR: 0.63; 95% CI: 0.48–0.82; p &lt; 0.001). This was also accompanied by reduced antibiotic prescriptions (1–30 days: OR: 0.63; 95% CI: 0.53–0.74, p &lt; 0.001; 31–365 days: OR: 0.56; 95% CI: 0.49–0.64, p &lt; 0.001). A strong, but due to the low incidence, not significant, negative association was observed between Angocin® prescription and the occurrence of pyelonephritis (hazard ratio (HR): 0.67; 95% CI: 0.43–1.06; p = 0.073). Conclusions: The results of this real-world data study demonstrate that Angocin® can be an effective therapeutic option for managing acute and recurrent UTIs and serves as an alternative therapy to antibiotics.

Effectiveness and Persistence of Anti-TNFα Treatment in Patients with Rheumatoid Arthritis – A 7 Years Real-World Cohort Study

Effectiveness and Persistence of Anti-TNFα Treatment in Patients with Rheumatoid Arthritis – A 7 Years Real-World Cohort Study

Long-term efficacy and safety of dupilumab for moderate-to-severe atopic dermatitis: a prospective real-world cohort study in China

Long-term efficacy and safety of dupilumab for moderate-to-severe atopic dermatitis: a prospective real-world cohort study in China

The effectiveness of sacral lateral branch radiofrequency neurotomy for posterior sacroiliac joint complex pain in patients selected by dual sacral lateral branch blocks; A real-world cohort study

BackgroundPrevious study of spinal neurotomy procedures indicates that stringent block selection improves outcomes. However, this pattern is not established for sacral lateral branch radiofrequency neurotomy (SLBRFN). Few SLBRFN studies have used stringent block selection criteria such as ≥80 % pain reduction following dual sacral lateral branch blocks (SLBB). ObjectiveEvaluate the effectiveness of SLBRFN in patients with ≥80 % pain relief following dual SLBBs. MethodsRetrospective single-arm cohort study of consecutive patients from two Canadian musculoskeletal and pain clinics who underwent first-time SLBRFN after report of ≥80 % pain relief following dual diagnostic SLBBs. Patients were identified by electronic medical record query between 2016 and 2022. The primary outcome was the proportion of individuals with a ≥50 % reduction in the numeric pain rating scale (NPRS) score three months after SLBRFN. Secondary outcomes included the proportion of responders achieving the minimal clinically important difference (MCID) on the pain disability quality-of-life questionnaire (PDQQ), and the duration and mean percentage of pain relief among those with recurrent symptoms after a successful SLBRFN. ResultsOf the 70 participants included, 32 (45.7 %; 95 % CI = 34.6–57.3) reported a ≥50 % reduction in NPRS, and 35 (50.0 %; 95 % CI = 38.6–61.4) achieved the MCID on the PDQQ at 3-months. Among the 17 patients who reported a return of symptoms, the mean duration of relief was 8.0 ± 3.5 months, and the mean percentage of pain relief was 77.9 % ± 16.4 %. Logistic regression models revealed that the use of multi-tined RF probes and lower patient BMI were associated with treatment success. Discussion/conclusionSLBRFN reduced pain and disability in approximately 50 % of patients at 3 months when selected using relatively restrictive selection criteria. Treatment success was associated with multi-tined RF probe type and lower patient BMI. Larger prospective studies assessing long-term outcomes are needed to further evaluate the impact of different selection criteria and techniques on SLBRFN effectiveness.

Lipoprotein(a) levels in acute myocardial infarction patients and their associations with prior events and coronary artery disease severity: a real-world cohort study

Abstract Introduction Circulating lipoprotein(a) [Lp(a)] has been associated with the risk of atherosclerotic coronary artery disease (CAD) and is an emergent therapeutic target. The objective of this study is to explore the association between serum levels of Lp(a) and previous myocardial infarction (MI) and/or coronary revascularization and the extension of obstructive CAD in patients with acute MI undergoing coronary angiography. Methods All consecutive patients with MI who underwent coronary angiography and Lp(a) measurement between May and November 2023 were included. Patient data were either registered prospectively or completed retrospectively using electronic health records. Lp(a) was measured using the Immunoturbidimetric Assay method with reaction intensification by particles, employing the World Health Organization/International Federation of Clinical Chemistry and Laboratory Medicine (WHO/IFCC) International Reference Reagent (SRM2B), on the "Roche Cobas C702" chemistry analyzer. The number of major coronary arteries (left main, left anterior descending, left circumflex and right coronary arteries) with stenosis &amp;gt;50% on the coronary angiography were registered. In the primary analysis we explored the association between Lp(a) levels using tertiles and previous occurrence of MI/revascularization, as well as the extension of obstructive CAD. In the secondary analysis we compared Lp(a) levels in patients with and without previous MI/revascularization and patients with 3-4 major vessels CAD vs. 0-2 vessels. Results A total of 116 patients were enrolled, with a mean age of 62±13 years, 79% males, 29% with known coronary artery disease, 71% with dyslipidemia, 24% with diabetes, 65% with hypertension, and 58% were either active or former smokers. The median Lp(a) level was 72 (20-183) nmol/L. In the primary analysis (table 1), the number of previous MI/revascularizations was significantly higher in the third tertile of Lp(a) (T3) versus T1 (p=0.044). No significant differences were found for the remaining analyses. In the secondary analysis (figure 1) the level of Lp(a) was significantly higher in patients with 3-4 vessel CAD vs. 0-2 vessel (158.4±145.2 nmol/L vs. 103.16±104.6 p=0.044). Conclusion In this small real-world cohort population with acute MI, the number of previous MI or coronary revascularization was higher in patients with increased levels of Lp(a) and this marker of atherosclerotic disease was greater in patients with more extensive CAD.

Transferrin saturation is a superior prognostic biomarker for iron deficiency after acute decompensated heart failure: a retrospective clinical real-world cohort study

Abstract Background Iron deficiency (ID) is the most common extracardiac comorbidity in heart failure (HF) and associated with worse outcomes. While a uniform definition of ID in HF remains lacking, several biomarkers for ID, including ferritin and transferrin saturation (TSAT), are used in both clinical trials and clinical practice. However, which biomarker is a superior prognostic predictor for ID in HF remains unsettled. In addition, real-world clinical data on ID screening and intravenous (IV) iron treatment is largely missing. Purpose To determine which biomarker is a superior prognostic predictor for the composite endpoint of HF rehospitalisation (HHF) and all-cause mortality in a real-world cohort of patients with HF and coexisting ID, and to investigate frequency and predictors of ID screening and IV iron treatment. Methods In this retrospective cohort study, all patients aged 18-85 years hospitalised at a tertiary university hospital with new onset HF with reduced ejection fraction (HFrEF) in 2016-2020 were consecutively included from medical records by ICD-10 code I50.0-I50.9 and followed until 31 December 2021. Patient characteristics, comorbidities, medications, laboratory results and data on follow-up, including if ID was tested for, IV iron administration, HHF and all-cause mortality was collected. First available iron status after admission for index hospitalisation was used. Predictors for ID screening and IV iron use were identified with univariate logistic regression. The association between ID markers and the composite endpoint was analysed with Cox regression adjusted for age, sex, baseline anemia, estimated glomerular filtration rate (eGFR) &amp;lt;30 mL/min/1.73 m2 and N-terminal pro-B type natriuretic peptide (NT-proBNP) below median value with median ferritin and TSAT values set as references respectively. Results In all, 753 patients were included (66.5 ± 12.7 years, 508 (67.5%) men, ejection fraction 29.5 ± 6.9% and mean NT-proBNP 6241 ± 7183 ng/L). Of these, 484 (64.3%) were screened for ID and 235 (48.6%) fulfilled criteria for ID. Of these, 94 (40.0%) received IV iron. Of screened patients, 28.6% had ID with anemia and 20.8% ID without anemia (Table 1). Factors associated with screening for ID were follow-up at hospital, anemia, eGFR &amp;lt;30 mL/min/1.73 m2 and ischemic heart disease, and for IV iron additionally chronic kidney disease and peripheral artery disease. Median ferritin was 140 µg/L and TSAT 0.2. Both ferritin and TSAT displayed an inversely linear association with outcomes, while TSAT &amp;lt;0.2 showed a stronger association with increased risk of HHF and all-cause mortality compared to median values (Figure 1-2). Conclusions In a real-world clinical setting, TSAT was a superior prognostic biomarker for worse outcomes compared to ferritin in patients hospitalised for acute HF. While both ID screening and IV iron use remained greatly underutilised in clinical practice, identification of a reliable biomarker for ID is critical.

Association between completeness of revascularization and cardiovascular outcomes in patients with diabetes and non-ST elevation myocardial infarction: a population-based registry analysis

Abstract Introduction Approximately one-third of the patients presenting with non-ST elevation myocardial infarction (NSTEMI) have diabetes. From these, two-thirds have multivessel coronary disease. The impact of completeness of revascularization in this population remains unclear. Purpose To evaluate the contemporary patterns of coronary revascularization among patients with diabetes and NSTEMI, and the clinical outcomes stratified by anatomic completeness of revascularization. Methods All patients with diabetes and multivessel disease admitted for NSTEMI between April 2009 and March 2020 in Ontario, Canada were included. Patients with previous coronary artery bypass graft surgery (CABG) at any time, percutaneous coronary intervention (PCI) in the previous 90 days, or shock were excluded. Patients were classified in four groups, from the most to the least complete revascularization strategy: CABG, complete revascularization with PCI, incomplete revascularization with PCI, or no revascularization. Outcomes included all-cause death and the composite of all-cause death, myocardial infarction, and stroke. Multivariable Cox regression was used to account for confounding (demographics, comorbidities, left ventricular function, coronary anatomy, laboratory tests, and diabetes treatment). Results We included 14,511 patients (mean age: 68.7±11.5y; 69.6% males). A total of 4,525 (31.2%) patients were treated with CABG, 3,008 (20.7%) with complete PCI, 3,624 (25.0%) with incomplete PCI and 3,354 (23.1%) were not revascularized. Patients with more complex coronary disease were more frequently treated with CABG, while PCI was more common in those with less complex disease (p&amp;lt;0.001; Fig 1). The mean number of grafts in the CABG group was 3.4±1.0. The mean number of stents in the complete and incomplete PCI groups was 2.4±1.3 and 1.7±0.9, respectively. Adjusted 5-y risks of all-cause death following CABG, complete PCI, incomplete PCI and no revascularization were, respectively, 25.9%, 29.8%, 32.2%, and 39.4%. Over a median follow-up of 5.8ys, CABG was associated with reduced all-cause death compared with complete PCI (HR 0.82; 95%CI 0.75 - 0.90), incomplete PCI (HR 0.73; 95%CI 0.67 - 0.80), or no revascularization (HR 0.54; 95%CI 0.50 - 0.58); p&amp;lt;0.001 for all (Fig 2). Adjusted 5-y risks of the composite endpoint following CABG, complete PCI, incomplete PCI and no revascularization were, respectively, 34.0%, 41.5%, 44.6%, and 52.9%. CABG was associated with reduced rates of the composite endpoint compared with complete PCI (HR 0.75; 95%CI 0.69 - 0.81), incomplete PCI (HR 0.67; 95%CI 0.62 - 0.72), or no revascularization (HR 0.50; 95%CI 0.47 - 0.54); p&amp;lt;0.001 for all. Conclusion In this contemporary real-world cohort study, almost a quarter of the patients with diabetes and NSTEMI did not receive any revascularization procedure. Cardiovascular outcomes were incrementally improved with CABG or complete revascularization with PCI, compared to no revascularization.Figure 1Figure 2

Remdesivir for Patients Hospitalized with COVID-19: Evidence of Effectiveness from Cohort Studies in the Omicron Era.

Remdesivir is the only antiviral approved for treatment of persons hospitalized for COVID-19. This supplement presents new information from real-world cohort studies reporting reduced mortality in at-risk populations and reductions in re-admission for COVID-19 in the Omicron era.

Overall survival after CDK4/6 inhibitor dose reduction in women with metastatic breast cancer

BackgroundBreast cancer is the most common cancer in women, and the first-line treatment for patients with hormone-receptor positive/HER2-negative metastatic breast cancer is CDK4/6 inhibitor plus endocrine therapy. Understanding the impact of CDK4/6 inhibitor dose reduction, which occurs in about half of the patients, is important.MethodsThis real-world cohort study is based on electronic health records from Capital Region of Denmark. All women with metastatic breast cancer initiating first-line treatment with CDK4/6 inhibitor between May 2017 and October 2022 were included.ResultsA total of 546 patients were eligible for inclusion in the 12-week landmark analysis and 192 (35%) experienced dose reduction. These patients were older, had worse ECOG PS, more received prior adjuvant endocrine treatment, and more received fulvestrant as the endocrine backbone. Dose reduction was associated with reduced overall survival (39.9 vs. 54.3 months) and shorter treatment duration (18.0 vs. 26.9 months). Adjusted hazard ratio for death was 1.38 (95% CI: 1.01–1.89).ConclusionsDose reduction of CDK4/6 inhibitors within the first 12 weeks of treatment was associated with significantly higher mortality and shorter treatment duration. These findings contrast with previous analyses showing no effect of dose reduction, likely due to considering immortal time bias in this study.

Investigation into the Effectiveness of an Herbal Combination (Angocin®Anti-Infekt N) in the Therapy of Acute Bronchitis: A Retrospective Real-World Cohort Study.

The goal of this study was to evaluate whether the medical recommendation of Angocin®Anti-Infekt N (heretofore referenced as Angocin®) on the day of diagnosis of acute bronchitis is negatively associated with the recurrence of acute bronchitis diagnosis, antibiotic prescriptions, incidence of chronic bronchitis, and duration of sick leave. This study included patients in general practices in Germany with a first documented diagnosis of acute bronchitis between 2005 and 2022 (index date) and a prescription of Angocin®, thyme products, essential oils, mucolytics or antibiotics on the index date. The association between Angocin® prescription and the risks of a relapse of acute bronchitis, development of chronic bronchitis, or subsequent antibiotic prescription were evaluated using Cox regression models. Univariable conditional logistic regression models were used to investigate the association between Angocin® prescription and duration of sick leave. After a 1:5 propensity score matching, 598 Angocin® patients and 2990 patients in each of the four comparison cohorts were available for analysis. Angocin® prescription was associated with significantly lower incidence of a renewed confirmed diagnosis of acute bronchitis as compared to essential oils (Hazard ratio (HR): 0.61; 95% Confidence Interval (CI): 0.46-0.80), thyme products (HR: 0.70; 95% CI: 0.53-0.91), mucolytics (HR: 0.65; 95% CI: 0.49-0.85) or antibiotics (HR: 0.64; 95% CI: 0.49-0.84). Also, there were significantly lower incidences of subsequent re-prescriptions of antibiotics when compared to mucolytics (HR: 0.73; 95% CI: 0.53-0.99) or antibiotics (HR: 0.53; 95% CI: 0.39-0.72) and a significantly lower risk of chronic bronchitis as compared to essential oils (HR: 0.60; 95% CI: 0.46-0.78), thyme products (HR: 0.53; 95% CI: 0.41-0.69), mucolytics (HR: 0.49; 95% CI: 0.38-0.63) or antibiotics (HR: 0.59; 95% CI: 0.45-0.76). Considering the limitations of the study, the results shed light on the sustaining effectiveness of Angocin® prescription in the management of acute bronchitis and the associated outcomes when compared to several other treatments commonly used for this condition.

Safety and Efficacy of Metformin for Idiopathic Intracranial Hypertension. A U.S-Based Real-World Data Retrospective Multicenter Cohort Study.

Idiopathic intracranial hypertension (IIH) remains a challenging condition to manage, with limited therapeutic options. This study investigated the potential of metformin as a novel treatment for IIH, exploring its effects on disease outcomes and safety profile. We conducted a retrospective cohort study using the TriNetX database, analyzing data from 2009 to August 2024. Patients diagnosed with IIH were included, with exclusions for other causes of elevated intracranial pressure and pre-existing diabetes. Propensity score matching was employed to balance cohorts according to age, sex, race, ethnicity, Hemoglobin A1C, and baseline body mass index (BMI) at the time of metformin initiation. Outcomes were assessed at various follow-up points up to 24 months. Our study initially comprised 1,268 patients in the metformin group and 49,262 in the control group, with notable disparities in several parameters. Post-matching, both cohorts were refined to 1,267 patients each after matching with metformin group. Metformin-treated patients showed significantly lower risks of papilledema, headache, and refractory IIH status at all follow-up points (p<0.0001). The metformin group also had reduced rates of therapeutic spinal punctures and acetazolamide continuation. BMI reductions were more pronounced in the metformin group, with significant differences observed from 6 months onward (p<0.0001). Notably, metformin's beneficial effects persisted independently of BMI changes. The safety profile of metformin was favorable, with no significant differences in adverse events compared to the control group which did not receive metformin during the study timeframe. Our study provides evidence for metformin's potential as a disease-modifying therapeutic approach in IIH, demonstrating improvements across multiple outcomes. The benefits appear to extend beyond weight loss, suggesting complex mechanisms of action. These findings warrant further investigation through prospective clinical trials to establish metformin's role in IIH management and explore its underlying therapeutic mechanisms.

Global Leadership Initiative in Sarcopenia (GLIS)–defined sarcopenia increases the mortality of esophageal cancer patients after esophagectomy: A Chinese real-world cohort study

ObjectivesTo assess the impact of the definition of the Global Leadership Initiative in Sarcopenia (GLIS) on mortality in esophageal cancer (EC) patients, postesophagectomy, within a Chinese cohort and to validate the effectiveness of a new GLIS framework in oncology. MethodsWe performed an observational real-world cohort study in a single center at Daping Hospital of the Army Medical University in China, spanning from December 2014 to July 2022. We used the combined definition of muscle mass and muscle strength in a new GLIS framework for the diagnosis of sarcopenia. Potential covariates were identified through univariate and multivariate analyses. The association between GLIS-defined sarcopenia and mortality was estimated using Kaplan–Meier curves and Cox models. We also conducted stratified analyses to assess the stability of multivariable Cox models. ResultsA total of 520 EC patients were included in the study, with a median follow-up of 48.7 months. A total of 229 EC patients (44.0%) were identified with GLIS-defined sarcopenia. Patients with GLIS-defined sarcopenia had significantly worse overall survival in Kaplan–Meier curves (log-rank P = 0.015). Age; sex; tumor, node, metastasis stage; blood glucose; bleeding volume in operation; and operating time were introduced as covariates in a fully adjusted Cox model. Multivariable-adjusted Cox models revealed that GLIS-defined sarcopenia was an independent prognostic factor for EC patients postesophagectomy (hazard ratio, 1.87, 95% confidence interval, 1.28–2.74, P = 0.001). Stratified analyses confirmed the stability of the relationship between GLIS-defined sarcopenia and mortality in EC patients. ConclusionsGLIS-defined sarcopenia is prevalent among Chinese EC patients and is linked to increased mortality risk postesophagectomy. This finding offers compelling evidence and serves as a valuable reference for the establishment of an operational definition of GLIS sarcopenia.

Intensive Uric Acid-Lowering Improved Outcomes in Type 2 Diabetes with CKD: A Multicenter, Retrospective, Real-World Cohort Study

Intensive Uric Acid-Lowering Improved Outcomes in Type 2 Diabetes with CKD: A Multicenter, Retrospective, Real-World Cohort Study

The association of diabetes mellitus and routinely collected patient-reported outcomes in patients with cancer. A real-world cohort study.

Current studies have indicated that diabetes mellitus (DM) is highly prevalent in patients with cancer, but there is little research on consequences on the well-being of patients during cancer treatment. This analysis evaluates the relationship between DM and patient-reported outcomes (PRO) in patients with cancer, using a large and well-characterized cohort. This study utilized the Total Cancer Care protocol at the University of Utah Huntsman Cancer Institute. For this analysis, we integrated data from electronic health records, the Huntsman Cancer Registry, and routinely collected PRO questionnaires. We assessed the association between DM in patients with cancer and PRO scores for anxiety, depression, fatigue, pain interference, and physical function using multiple linear regression and t-tests. The final cohort comprised 3512 patients with cancer, with a mean age of 57.8 years at cancer diagnosis. Of all patients, 49.1% (n = 1724) were female, with 82.0% (n = 2879) patients reporting PROs at least at one time point. Compared with patients who responded, nonresponders were more often female (p = 0.0035), less frequently non-Hispanic White (p = 0.0058), and had a higher BMI (p = 0.0759). Patients with cancer and diabetes had worse PRO scores for anxiety (p = 0.0003), depression (p < 0.0001), fatigue (p < 0.0001), pain interference (p < 0.0001), and physical function (p < 0.0001) compared to patients with cancer without diabetes. Significant associations between diabetes and PRO scores were observed for anxiety (β ± SE: 1.27 ± 0.48; p = 0.0076), depression (β ± SE: 1.46 ± 0.45; p = 0.0011), fatigue (β ± SE: 2.11 ± 0.52; p < 0.0001), pain interference (β ± SE: 1.42 ± 0.50; p = 0.0046), and physical function (β ± SE: -2.74 ± 0.48; p < 0.0001). The results of this study suggest that patients with cancer and diabetes may be at greater risk for anxiety, depression, fatigue, higher pain interference, and reduced physical function. Strengthening diabetes management is imperative to address the negative impact of diabetes on PROs. In particular, this may be true for patients with skin, breast, prostate, and kidney cancer.

Comparative analysis of GLP-1 receptor agonists versus metformin on cancer outcomes in patients with polycystic ovarian syndrome: A real-world multi-center cohort study in the United States.

402 Background: To compare the effects of GLP-1 receptor agonists (GLP1RA) versus metformin on incident cancer outcomes in the female polycystic ovarian syndrome (PCOS) population. Methods: This retrospective cohort study utilized electronic health records from over 50 U.S. healthcare organizations (TriNetX). The baseline cohort comprised females aged ≥ 18 with ≥ two prescriptions for GLP1 RAor metformin following a diagnosis of PCOS, between May 1, 2005 (first GLP1 RA approval date), and December 31, 2021. All cancer types were identified using ICD-10 codes. The index date was the initiation of GLP1RA or metformin. We performed a 1:1 propensity score matched based on demographics, comorbidities, socioeconomic factors, healthcare utilization, and biomarkers (HbA1c, LDL, HDL, triglycerides, and cholesterol), insulin use and PCOS medications before index date. Analysis was performed with intention-to-treat approach. Hazard ratios (HRs) and 95% confidence intervals (CIs) for the comparison groups were calculated by the Cox regression model. Patients were followed and censored upon meeting any of the following criteria: development of an outcome, the study end date of May 19, 2024, or loss to follow-up, whichever occurred first. Results: A total of 8,223 pairs of GLP1RA initiators and metformin initiators were included. Compared to metformin, GLP1RA was associated with a lower risk of incident colorectal cancer (HR 0.35, 95% CI 0.22-0.57) and breast cancer (HR 0.55, 95% CI 0.39-0.78). There were no significant differences in risk between the GLP1RA group and metformin group for endometrial (HR 0.82, 95% CI 0.49-1.37), cervical (HR 1.17, 95% CI 0.64-2.12), ovarian (HR 1.09, 95% CI 0.56-2.11), respiratory (HR 0.32, 95% CI 0.17-0.60), skin (HR 0.51, 95% CI 0.37-0.69), kidney cancer(HR 0.99, 95% CI 0.33-3.06), thyroid cancer (HR 1.37, 95% CI 0.88-2.13), other endocrine (HR 0.81, 95% CI 0.15- 0.44), leukemia and lymphoma (HR 1.03, 95% CI 0.91-1.16), brain (HR 0.97, 95% CI 0.24-3.96), pancreatic cancer(HR 0.50, 95% CI 0.16-1.55), esophageal cancer (HR 1.99, 95% CI 0.24-16.18), stomach cancer (HR 0.33, 95% CI 0.07-1.47), and intrahepatic cancer (HR 0.89, 95% CI 0.40-1.99). Conclusions: GLP-1 receptor agonists were associated with a lower risk of colorectal and breast cancer compared to metformin in females with PCOS, with no significant differences in risk for other cancer types.Further investigation is necessary to verify the underlying therapeutic mechanisms.

EP.08E.03 Clinical Characteristics and Outcomes in Resectable Stage III ALK-Positive Non-Small Cell Lung Cancer: A Multicenter Real-World Cohort Study

EP.08E.03 Clinical Characteristics and Outcomes in Resectable Stage III ALK-Positive Non-Small Cell Lung Cancer: A Multicenter Real-World Cohort Study

Eribulin plus carboplatin combination for HER2-negative metastatic breast cancer: a multicenter, real-world cohort study

BackgroundPre-clinical data suggests a potential synergistic effect of eribulin and platinum. However, clinical data on the combination for metastatic breast cancer (mBC) is lacking. We evaluated the efficacy and safety of eribulin plus carboplatin (ErCb) in patients with mBC.Patients and methodsThis multicenter, real-world cohort study included patients with pre-treated metastatic triple negative breast cancer (TNBC) or endocrine-refractory hormone receptor (HR) positive, HER2-negative mBC who received ErCb. Eribulin (1.4 mg/m2) and carboplatin (target AUC = 2) were administered intravenously on day 1 and 8 of 21-day cycle. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated.ResultsFrom March 2022 to December 2023, a cohort of 37 patients were recruited to the study. Among them, 22 patients have TNBC and 15 have HR + HER2 − mBC. Of the 22 patients with TNBC, 8 had an initial diagnosis of the HR + HER2 − subtype. The median treatment was 6 cycles (range, 2 − 8 cycles). In the full cohort, TNBC, and HR + HER2 − subgroup, the ORR were 51.4%, 54.5% and 46.7%, the DCR were 81.1%, 81.8% and 80%, and the median PFS were 5 months, 5 months, and 5.2 months, respectively. The median OS was 12.7 months in the entire cohort and 12.8 months in TNBC subgroup. The most common grade 3/4 hematological AEs were neutropenia (37.8%), leukopenia (35.1%), febrile neutropenia (10.8%), thrombocytopenia (5.4%), and anemia (2.7%). No grade 3/4 non-hematological AEs were observed.ConclusionErCb demonstrated favorable efficacy and tolerability in patients with heavily pre-treated mBC, especially TNBC. The findings of the current study warrant further investigation of the application of this combination in earlier lines of mBC treatment.

Real-world effectiveness of inactivated vaccine on COVID-19 patients with comorbidities.

Patients with underlying diseases do not respond adequately to vaccines. Thus, continued research on the effects of vaccination in patients with comorbidities is crucial to evaluate the necessity of vaccination in this population. This study assessed the protective effects of inactivated vaccines on the severity and prognosis of COVID-19 in patients with comorbidities. A real-world retrospective cohort study was conducted from April 7, 2022, to June 6, 2022, at the Fudan University Pudong Medical Center. The collected data included demographic characteristics, symptoms, clinical severity, and outcomes of the COVID-19 patients. A total of 3,996 indigenous confirmed cases and asymptomatic infections with the Omicron variant were enrolled. Of these, 1322 (33.1%) patients had chronic comorbidities. Compared to others, COVID-19 patients with comorbidities were older, had lower vaccination rates, longer days of nucleic acid conversion and hospitalization, and a higher incidence of severe-critical illness and composite endpoint. Multivariable analyses suggested that in the comorbidity group, two-dose- (odds ratio [OR] 0.38, 95% CI 0.24-0.60; OR 0.20, 95% CI 0.08-0.51) and three-dose vaccinated patients (OR 0.26, 95% CI 0.14-0.47; OR 0.21, 95% CI 0.08-0.58) had a lower risk of aggravation and the composite endpoint; similar results were observed in the non-comorbidity group. Two or more doses of inactivated vaccines could prevent deterioration and poor prognosis in Omicron-infected patients, regardless of the presence of an underlying disease. Our findings support maximizing coverage with inactivated vaccines in highly vaccinated populations, such as those in China.