Real-world Retrospective Study Research Articles

Efficacy of disitamab vedotin in non-small cell lung cancer with HER2 alterations: a multicenter, retrospective real-world study

BackgroundNon-small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) alterations poses a substantial treatment challenge. Current HER2-targeted therapies offer limited efficacy. Antibody-drug conjugates (ADCs) targeting HER2 have emerged as a promising therapeutic strategy. This study aimed to evaluate the clinical response to a novel ADC drug Disitamab vedotin (RC48) in advanced NSCLC with HER2 alterations.MethodsThis study conducted a retrospective review of patients harboring HER2 alterations treated with RC48 in the real world. Clinical outcomes were evaluated in terms of objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).ResultsOut of 22 patients, 21 (95.5%) received RC48 combination therapy, while one received RC48 monotherapy. The ORR of all patients reached 45.5%, and the DCR stood at 90.9%. The median PFS (mPFS) was 7.5 months. Among patients receiving RC48 combination therapy, the ORR was 47.7%, and the mPFS of 8.1 months. The combination of RC48 with platinum+/- bevacizumab resulted in the highest ORR of 71.4% (5 out of 7 patients), with HER2 TKI following at a 50.0% ORR (4 out of 8 patients). First-line (1L) treatment with RC48 showed an ORR of 62.5% (5 out of 8 patients), second-line (2L) treatments had a 57.1% ORR (4 out of 7 patients), and beyond second-line (>2L) treatments exhibited a 14.3% ORR (1 out of 7 patients). Patients with 1L, 2L, or >2L treatment had a mPFS of 8.1 months, 7.2 months, and 7.4 months, respectively. Patients with HER2 mutations or amplifications, and those with concurrent mutations and amplifications at baseline, showed mPFS of 8.1 months, 9.4 months, and 7.4 months, respectively. The mPFS was significantly longer in patients with HER2 amplification. The most common adverse events included hand-foot syndrome (54.5%), asthenia (50.0%), decreased white blood cell count (45.5%), and liver impairment (45.5%). Grade 3 adverse events occurred in one (4.5%) patient.ConclusionRC48, particularly in combination regimens, demonstrates promising efficacy in advanced NSCLC with HER2 alterations. These findings underscore the need for further research to validate RC48’s application in clinical practice.

Efficacy of rechallenge after first-line immunotherapy for advanced gastric cancer: A retrospective real-world study

ABSTRACT We aimed to explore the efficacy of rechallenge after first-line immunotherapy in advanced gastric cancer (AGC) and to analyze the factors affecting prognosis based on clinical characteristics. Eighty-five AGC patients who underwent rechallenged after the failure of first-line treatment with immune checkpoint inhibitors (ICIs) were retrospectively collected from July 2019 to December 2022 in Jiangsu Cancer Hospital. Potential factors affecting prognosis were analyzed by univariate and multivariate Cox analysis. Survival analysis was performed by Kaplan–Meier method and Log rank test. Stratified factors included human epidermal growth factor receptor 2 (HER-2) and programmed cell death-ligand 1 combined positive score (PD-L1 CPS). The objective response rate (ORR) was 15.3%, and the disease control rate (DCR) was 74.1%. The median progression-free survival (PFS) was 4.8 months. Results showed that patients in the I + C group had the best response. The ORR was 20.0% VS 8.7% in the I + C group and I + C + AAD group. The DCR was 78.0% VS 65.2%, and the median PFS was 6.7 VS 4.7 months [hazard ratio (HR): 0.55, 95% confidence interval (CI): 0.30–1.00, p = .022]. The ORR was 20.0% VS 8.3% in the I + C group and I + C + ADC group. The DCR was 78.0% VS 75.0%, and the median PFS was 6.7 VS 4.4 months (HR: 0.59, 95%CI: 0.26–1.30, p = .112). The median PFS was 4.7 VS 4.4 months in the I + C + AAD group and I + C + ADC group (HR: 1.21, 95%CI: 0.60–2.47, p = .580). Adverse events (AEs) were found in 34 patients, mainly including leukopenia 9 (10.6%), and neutropenia 8 (9.4%). The incidence of grade 3–4 AEs was 8.2%. There were no drug-related deaths and all AEs were manageable. Rechallenge after first-line immunotherapy showed good survival benefit and acceptable safety in the therapy of AGC. Especially for patients with HER-2-positive and PD-L1 CPS ≥ 1%, rechallenge may be an effective treatment modality.

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 < 0.001), further sporadic UTI within 31–365 days after the index date (OR: 0.68; 95% CI: 0.58–0.78; p < 0.001), and recurrent UTI (OR: 0.63; 95% CI: 0.48–0.82; p < 0.001). This was also accompanied by reduced antibiotic prescriptions (1–30 days: OR: 0.63; 95% CI: 0.53–0.74, p < 0.001; 31–365 days: OR: 0.56; 95% CI: 0.49–0.64, p < 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.

Clinical Features, Management, and Recurrence of Acute Ischemic Stroke Occurring in Patients on Oral Anticoagulant Treatment for Nonvalvular Atrial Fibrillation: A Real-World Retrospective Study.

The optimal management of acute ischemic stroke (AIS) in patients with oral anticoagulation (OA) is challenging. Our study aimed to analyze the clinical characteristics and outcome of AIS in patients with OA for nonvalvular atrial fibrillation (NVAF). We retrospectively analyzed data on NVAF patients with AIS on direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) admitted to our Stroke Unit from 2017 to 2022. Ninety-day modified Rankin Scale (mRS), 90-day, and 12-month stroke recurrences were recorded. A total of 169 patients (53.2% female, mean age 82.8±6.7 y), 117 (69.2%) on DOAC, and 52 on VKA (30.8%), were enrolled. Mean age, in-hospital mortality, and 90-day mRS ≥4 were significantly higher in VKA patients. 63.4% of VKA patients had subtherapeutic INR, whereas 47.1% of DOAC patients were on low-dose (14.2% off-label). Large vessel occlusion and embolic etiology were more frequent in VKA patients (34.6% vs. 26.4%, P =0.358; 92.3% vs. 74.3%, P =0.007, respectively), whereas lacunar strokes were more frequent in DOAC patients (19.8% vs. 12.2%, P =0.366). Among patients on VKA before AIS 86.4% were switched to DOAC, whereas a DOAC-to-VKA and a DOAC-to-DOAC switch were done in 25.4% and 11.7%, respectively. Stroke recurrence occurred in 6.4% of patients at 90 days and 10.7% at 12 months. Anticoagulant switching was not associated with stroke recurrences. In our study, nonembolic etiology was more frequent in DOAC patients and anticoagulant switching did not reduce the risk of stroke recurrence. Prospective multicentric studies are warranted.

Disparities in SGLT2i utilization among heart failure patients with different ejection fraction in China: findings from chinese cardiovascular association database-heart failure center registry

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended for heart failure (HF) patients regardless of left ventricular ejection fraction (LVEF). Although Chinese HF guidelines still recommend traditional renin–angiotensin–aldosterone system inhibitors, beta blockers, mineralocorticoid receptor antagonists, the Chinese Cardiovascular Association (CCA) HF Center Registry has launched a project to promote the guideline-directed medical therapy (GDMT) for HF patients in China. However, data on the utilization of GDMT in Chinese HF patients is scarce, especially SGLT2i. Purpose We aimed to investigate the usage status of SGLT2i in HF patients with different LVEFs and explore associated factors with SGLT2i adoption in hospitalized HF Chinese patients. Methods This is a retrospective real world study using data from the CCA Database-HF Center Registry. The study included HF patients hospitalized in 52 secondary or tertiary hospitals, including 26 accredited heart failure centers (HFC) and 26 non-accredited heart failure centers (NHFC). Centers that meet the 25 quality control standards established by CCA can be accredited as HFC. We evaluated the use rate of SGLT2i overall and by HF type, as well as the change of SGLT2i usage rate at discharge during the study period from 1st July 2022 to 31st March 2023. LASSO and multivariable logistic regression were also used to explore associated factors of SGLT2i adoption at discharge. Result We included 8,843 hospitalized HF patients: 5,326 (60.2%) were male, 2,980 (33.7%) HFrEF, 1,624 (18.4%) HFmrEF, 3,653 (41.3%) HFpEF and 586 (6.6%) lacked EF data. Overall, SGLT2i were adopted in 3,666 (41.5%) HF patients at discharge (58.1% in HFrEF, 45.3% in HFmrEF, 28.8% in HFpEF). Overall, the usage rate of SGLT2i at discharge rose from 35.2% to 50.2%. Specifically, for HFrEF patients, there was a rise from 56.2% to 64.4%. For HFmrEF and HFpEF patients, the usage rate increased from 37.5% to 54.4% and from 22.2% to 35.7%, respectively (Figure 1). The usage rate of SGLT2i was higher in HFC compared with NHFC (47.1% vs. 35.8%, p<0.001). In multivariable logistic regression, older age, new-onset heart failure, hospital location, etc. were associated with a lower usage rate of SGLT2i at discharge. In contrast, HFC, dilated cardiomyopathy, obesity, etc. were associated with a higher utilization rate of SGLT2i (Figure 2). HF classification by LVEF was also an independent influencing factor even after adjusting other factors; when HFrEF was used as a reference, the use rate of SGLT2i was lower in HFmrEF (OR 0.79, 95% CI 0.69 - 0.91) and HFpEF (OR 0.44, 95% CI 0.39 - 0.49). Conclusion In clinical practice in China, the usage rate of SGLT2i for HF treatment is increasing but needs to be further improved. Disparities exist in usage rates among HF patients with different LVEFs. Addressing this disparity necessitates a targeted approach, emphasizing increased utilization in HF patients regardless of LVEF.SGLT2i usage rate in HFFactors affecting SGLT2i adoption in HF

Effects of Concurrent Administration of Spironolactone in Veterans with Metastatic Prostate Cancer Receiving Abiraterone: A Real-World Retrospective Study.

Prostate cancer is the most common cancer in men in the United States with low survival rates once metastasized. Abiraterone is approved for use in castrate-sensitive and castrate-resistant prostate cancer and is used extensively in the Veterans Affairs (VA) healthcare system. Spironolactone, a diuretic used to treat heart failure, edema, ascites, and hypertension, may increase androgen levels and reduce effectiveness of abiraterone when used concurrently to treat prostate cancer patients. While previous case studies support this, no large epidemiology studies have been conducted. The current study utilizes the large, VA prostate cancer data core and evaluates the effect of concomitant spironolactone on efficacy of abiraterone treatment in metastatic prostate cancer patients. The study selected 18,943 veterans with metastatic prostate cancer on abiraterone treatment. Of these, 581 patients (3.1%) were also on concomitant spironolactone. The concomitant treatment group, abiraterone + spironolactone, significantly differed from the abiraterone-only group in body mass index, prevalence rates of heart failure and liver disease, and being previously treated with docetaxel. A 1:1 propensity score matching method was used to balance sample sizes and baseline traits between the two treatment groups, abiraterone versus abiraterone + spironolactone. Kaplan-Meier curves and Cox proportional hazard model were used to compare 5-year overall survival and all-cause mortality outcomes, respectively, between the two groups. After propensity score matched, the abiraterone + spironolactone group was treated with abiraterone significantly longer than the abiraterone-only group (mean ± standard deviation days 549.0 ± 552.3 vs. 435.5 ± 474.1; p = 0.0002) and had a higher 5-year overall survival rate (44% vs. 37%; p = 0.0116). Veterans with metastatic prostate cancer treated with abiraterone + spironolactone also had a lower 5-year all-cause mortality compared to those only on abiraterone (hazard ratio 0.80, 95% confidence intervals 0.61-0.96; p = 0.012). This large VA observational study suggests that concomitant use of spironolactone does not compromise cancer control or survival of metastatic prostate cancer patients treated with abiraterone.

Timing of inopressor initiation in patients with acute myocardial infarction complicated by cardiogenic shock

Abstract Introduction Inotropes and vasopressors (inopressors) are commonly used in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS). The characteristics of patients subjected to early or late initiation of inopressors are not yet described, and the impact of timing on outcomes remains uncertain. Purpose This retrospective real-world data study aims to identify patient-, treatment-, and outcome characteristics of AMICS patients treated with early- or late initiated inopressors. Methods The Netherlands Heart Registration (NHR) prospectively records baseline, procedural, and outcome data for PCI patients. Between 2017-2021, additional retrospective data on CS patients were collected by fourteen Dutch hospitals. Patients were categorized based on the timing of inopressor initiation, either early (pre PCI) or solely late (at the cathlab or within 24 hours after PCI). Patients presenting with an out of hospital cardiac arrest were excluded. Missing data were imputed through multiple imputation (30x). Multivariable logistic regression analysis was performed to evaluate the association between the timing of inopressor initiation and 30-day mortality, adjusting for univariate significant confounders among variables known at admission. Results A total of 956 consecutive CS patients were included of whom 418 (43.7%) and 538 (57.3%) patients were subjected to early and late initiation of inopressors respectively. The most frequently used drug in both groups was noradrenaline. At baseline, patients in the early initiation group were younger (67.4 vs. 70.0 years, p <0.001), presented with a lower mean arterial pressure (MAP) (72.5 vs. 76.3, p = 0.048) and higher lactate (4.2 vs. 3.6, p = 0.012), and presented with a NSTEMI more often (36.0% vs. 14.2%, p <0.001). They also had a higher prevalence of previous myocardial infarction (33.9% vs. 22.9%, p <0.001) and previous CABG (14.3% vs. 6.2%, p <0.001). Moreover, 30-day mortality rates were higher in the early initiated group (48.6% vs. 37.6%, pLogrank <0.001). After multivariate adjustment for age, admission MAP and lactate, early inopressor initiation remained independently associated with 30-day mortality (OR 1.44, 95%-CI 1.08-1.98) compared to late initiation. Conclusion In this Dutch cohort of CS patients undergoing PCI, baseline- treatment- and outcome characteristics differed between patient categories receiving either early or late initiated inopressors. Patients who were subjected to early initiated inopressors were younger, presented with worse hemodynamics, had a more extensive cardiovascular medical history and higher 30-day mortality rates. The results of this study reemphasize the importance of identifying patients who benefit from inopressors.30-day mortality late vs. earlyTable patient characteristics

One-year outcomes of a digital twin intervention for type 2 diabetes: a retrospective real-world study

This retrospective observational study, building on prior research that demonstrated the efficacy of the Digital Twin (DT) Precision Treatment Program over shorter follow-up periods​​, aimed to examine glycemic control and reduced anti-diabetic medication use after one-year in a DT commercial program. T2D patients enrolled had adequate hepatic and renal function and no recent cardiovascular events. DT intervention powered by artificial intelligence utilizes precision nutrition, activity, sleep, and deep breathing exercises. Outcome measures included HbA1c change, medication reduction, anthropometrics, insulin markers, and continuous glucose monitoring (CGM) metrics. Of 1985 enrollees, 132 (6.6%) were lost to follow-up, leaving 1853 participants who completed one-year. At one-year, participants exhibited significant reductions in HbA1c [mean change: -1.8% (SD 1.7%), p < 0.001], with 1650 (89.0%) achieving HbA1c below 7%. At baseline, participants were on mean 1.9 (SD 1.4) anti-diabetic medications, which decreased to 0.5 (SD 0.7) at one-year [change: -1.5 (SD 1.3), p < 0.001]. Significant reductions in weight [mean change: -4.8 kg (SD 6.0 kg), p < 0.001], insulin resistance [HOMA2-IR: -0.1 (SD 1.2), p < 0.001], and improvements in β-cell function [HOMA2-B: +21.6 (SD 47.7), p < 0.001] were observed, along with better CGM metrics. These findings suggest that DT intervention could play a vital role in the future of T2D care.

Effects of immunosuppressive therapy on renal prognosis in primary membranous nephropathy

BackgroundImmunosuppressive therapy plays a crucial role in treating membranous nephropathy, with previous studies highlighting its benefits for patients with primary membranous nephropathy (PMN). Guidelines suggest that the management of membranous nephropathy should be tailored to individual risk levels. However, there is a lack of real-world studies examining the effects of immunosuppressive therapy on renal outcomes in PMN patients. This study aimed to investigate the relationship between immunosuppressive therapy and renal prognosis in PMN patients.MethodsThis was a real-world retrospective study including patients diagnosed with PMN in Shenzhen Second People’s Hospital and Hechi People’s Hospital. Univariate and multivariate Cox regression analysis and Kaplan-Meier survival analysis were used.ResultsAfter propensity score-matching, 464 PMN patients were included and they were assigned to conservative and immunosuppressive group in a 1:1 ratio. Immunosuppressive therapy was the protective factor of renal composite outcome (HR = 0.65, p < 0.01). Separately, the effect was significant in moderate- and high-risk but not in low-risk patients. Key influencing factors including age, blood pressure, albumin and total cholesterol levels, with slight differences among patients at different risk.ConclusionsThis study demonstrates the efficacy of immunosuppressive therapy in non-low-risk PMN patients. The key factors affecting renal prognosis in patients with different risk levels are emphasized to help provide individualized treatment.

Risk of Surgical Site Infections after Tooth Extraction in Chronic Kidney Disease: A Retrospective Real-World Study in Japan.

Risk of Surgical Site Infections after Tooth Extraction in Chronic Kidney Disease: A Retrospective Real-World Study in Japan.

Effects of SGLT2i and Pioglitazone on FIB-4 Index in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease—A Real World Retrospective Study from India

Aims: Several studies support type 2 diabetes mellitus (T2DM) as one of the risk factors of metabolic dysfunction associated steatotic liver disease (MASLD). Recently, the use of pioglitazone and sodium-glucose co-transporter 2 inhibitors (SGLT2i) has been on the rise considering its beneficial effects in reducing liver dysfunction. We aim to determine the clinical effectiveness of these drugs in improving MASLD and T2DM. Materials and methods: We conducted a retrospective study of 279 T2DM patients with MASLD who were prescribed pioglitazone and/or SGLT2i from two clinics in India. The primary endpoint was change in fibrosis (FIB-4) index and the aspartate aminotransferase to platelet ratio index (APRI) score at one year follow-up. Appropriate statistical tests were applied to assess the significance of the outcomes. Results: Of the total (276) patients, 46% of patients were at low risk of advanced fibrosis, 11% were at high risk for advanced fibrosis, and the majority (50%) were on SGLT2i treatment. At follow-up, there is a statistically significant reduction in the mean (SD) FIB-4 index (1.92 [1.22] vs. 1.68 [0.99]) and APRI score (0.42 [0.34] vs. 0.33 [0.21]); p &lt; .001. Among treatment groups, there is a significant difference in the mean FIB-4 index both at baseline (F: 4.23; p &lt; .05) and follow-up (F: 3.45; p &lt; .05). These scores were highly significant in the combination treatment with SGLT2i and pioglitazone ( p &lt; .05). Conclusions: Our results indicate a combination therapy with SGLT2i and pioglitazone might be beneficial in managing MASLD, especially in reducing the FIB-4 index and APRI score in Indian T2DM patients with MASLD.

A real-world retrospective study to assess efficacy and safety of alectinib as adjuvant therapy in IB-IIIB NSCLC patients harboring ALK rearrangement.

Alectinib has demonstrated promising disease-free survival (DFS) benefit for early-stage non-small cell lung cancer (NSCLC) patients with ALK rearrangement positive in phase 3 ALINA trial. However, real-world evidence for the efficacy and safety of alectinib in early-stage ALK-positive NSCLC is limited. We retrospectively reviewed 68 patients with stage IB-IIIB ALK-positive NSCLC who underwent complete pulmonary resections from April 2010 to July 2023 at a single institution. 38 (55.9%) enrolled patients had N2 lymph node metastasis, and 17 (24.9%) patients had multi-station N2 metastasis. Patients were stratified into two groups according to the adjuvant treatment regimen, with 19 patients in the alectinib group and 49 patients in the chemotherapy group. There were no significant differences in clinicopathological characteristics between the two groups. After curative resection surgery, patients in alectinib group received oral alectinib at a dose of 600 mg twice daily and patients in chemotherapy group received platinum-based doublet chemotherapy regimen every 3 weeks for 4 cycles. The primary endpoint was 3-year DFS. The Kaplan-Meier method was used to estimate DFS and overall survival (OS). Safety analyses were conducted by comparing the incidence of adverse events between the two groups. At the last follow-up date (January 22th, 2024), A total of 1 (5.3%) and 28 (57.1%) DFS events were observed in alectinib group and chemotherapy group respectively. The 3-year DFS showed significant improvement in the alectinib group compared with chemotherapy group (91.7% vs 60.7%, P=0.051). In the IIIAN2 subgroup, the 3-year DFS rate in the alectinib group reached a satisfactory 87.5%. In both groups, the majority of AEs were graded as level 1 or 2, No grade 3-4 AEs were observed in alectinib group. Alectinib, as adjuvant therapy, demonstrated favorable efficacy and manageable safety in patients with completely resected ALK-positive stage I B-IIIB non-small cell lung cancer. A limitation of this study is the small sample size, and a larger-scale real-world sample study is needed to further evaluate the efficacy and safety of alectinib as adjuvant therapy.

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.

Androgen deprivation therapy, neoadjuvant androgen deprivation therapy, and adjuvant androgen deprivation therapy in patients with locally advanced prostate cancer: a multi-center real-world retrospective study.

Determining the potential benefit of neoadjuvant androgen deprivation therapy (ADT) and adjuvant ADT in patients with locally advanced prostate cancer (LAPC) undergoing complete resection. 139 patients diagnosed with cT3-4, or cN+ LAPC in Xiangya Hospital and The First Affiliated Hospital of University of South China from 2010 to 2021 were collected. Cancer-specific survival (CSS) and overall survival (OS) of patients were assessed using Kaplan-Meier and Cox proportional risk analysis. We also analyzed the functional outcomes of two subgroups of patients who underwent radical prostatectomy (RP). Of the 182 patients with cT3-4, or cN+ LAPC, 139 patients (76.4%) were enrolled in the study with a 5-year survival rate of 82.3%. 45 patients (32.4%) received ADT alone, 46 patients (33.1%) received neoadjuvant ADT before surgery, and the remaining 48 patients (34.5%) received surgery with adjuvant ADT. Neoadjuvant ADT before surgery and surgery with adjuvant ADT were associated with significantly improved survival compared with ADT alone. Multivariate Cox models showed that neoadjuvant ADT before surgery (hazard ratio [HR], 0.29; 95% CI 0.13-0.92) or surgery with adjuvant ADT (HR, 0.26; 95% CI 0.16-0.78) was associated with improved CSS compared with ADT alone. Regional lymph node metastasis, positive lymphovascular invasion, and Gleason score 9 + were independent predictors of LAPC CSS and OS. More patients in the neoadjuvant ADT before surgery group achieved final continence status within 12 months after surgery (93.48% v 77.08%). CSS and OS were significantly prolonged in cT3-4, or cN+ LAPC patients who received neoadjuvant ADT before surgery and surgery with adjuvant ADT compared to ADT alone.

Effects of traditional Chinese medicine on outcomes and costs of dementia care: results from a retrospective real-world study

ObjectivesThis study aims to assess the impact of Traditional Chinese Medicine (TCM) on dementia patients, utilizing real-world data. Specifically, it seeks to evaluate how TCM influences clinical outcomes by examining changes in the Clinical Dementia Rating (CDR) and Mini-Mental State Examination (MMSE) scores, as well as its effect on medical expenses over a two-year period. Data from a multi-center research database spanning from 2004 to 2021 will be used to achieve these objectives, addressing the current gap in empirical data concerning intuitive outcomes and cognitive function assessments.MethodsPropensity score matching was adopted to improve comparability among the intervention and control groups. Due to repeated dependent variable measurements, the generalized estimating equation was used to control for socio-demographic characteristics, regional characteristics, and Western medicine treatments for dementia.ResultsAfter propensity score matching, a total of 441 research subjects were included: 90 in the TCM intervention group and 351 in the non-TCM intervention group. The results of multivariate regression analysis showed that compared with the non-TCM intervention group, the MMSE scores in the TCM intervention group increased by 0.608 points each year. The annual change in CDR scores in the TCM intervention group was 0.702 times that of the non-TCM utilization group. After TCM intervention, annual outpatient expenses increased by US$492.2, hospitalization expenses increased by US$324.3, and total medical expenses increased by US$815.9, compared with the non-intervention group.ConclusionsTCM interventions significantly decelerate cognitive decline in dementia patients, evidenced by slower reductions in MMSE scores and mitigated increases in CDR scores. However, these benefits are accompanied by increased medical expenses, particularly for outpatient care. Future healthcare strategies should balance the cognitive benefits of TCM with its economic impact, advocating for its inclusion in dementia care protocols.

Lenvatinib versus Sorafenib Second-Line Therapy in Patients with Hepatocellular Carcinoma Progressed to Atezolizumab plus Bevacizumab: A Retrospective Real-World Study

Introduction: The most frequently used first-line treatment in patients with advanced hepatocellular carcinoma (HCC) is atezolizumab plus bevacizumab. Upon progression after this treatment, the standard of care in many countries is sorafenib, due to the lack of reimbursement for other drugs. Several randomized trials are currently underway to clarify the best second-line therapy in patients with HCC. This real-world study aimed to compare outcomes reached by lenvatinib and sorafenib second-line therapy in this setting. Methods: The overall cohort included 891 patients with HCC from 5 countries treated with atezolizumab plus bevacizumab in first-line setting between October 2018 and April 2022. At the data cut-off (May 2022), 41.5% of patients were continuing a first-line treatment, 5.5% were lost at follow-up, and 53.0% of patients had progressive disease after first-line therapy. 51.5% of patients with progressive disease received a second-line treatment, while 48.5% did not receive any subsequent therapy. Between patients receiving second-line treatment, 11.1% of patients underwent transarterial chemoembolization, 21.0% received sorafenib, 35.4% underwent lenvatinib, and 32.5% were treated with other drugs. Results: Lenvatinib second-line subgroup achieved a median overall survival (mOS) of 18.9 months, significative longer (p = 0.01; hazard ratio [HR]: 2.24) compared to sorafenib subgroup that reached a mOS of 14.3 months. The multivariate analysis highlighted albumin-bilirubin 1 grade (p < 0.01; HR: 5.23) and lenvatinib second-line therapy (p = 0.01; HR: 2.18) as positive prognostic factors for OS. The forest plot highlighted a positive trend in terms of OS in favor of patients treated with lenvatinib second-line regardless of baseline characteristics before first-line therapy. Conclusion: These results suggest that, in patients with HCC progressed to first-line atezolizumab plus bevacizumab, lenvatinib second-line therapy is associated to an improved survival compared to sorafenib.

Predictors of Failed Outcomes in Ureteral Reconstruction: A Real-World Retrospective Study

Background and Objectives: Ureteral reconstruction is aimed at maintaining ureteral patency without the need for long-term catheters like ureteral stents or percutaneous nephrostomies. Different surgical strategies are adopted based on the etiology, the location of the injury, and the severity of the injury. We aimed to analyze the parameters that can predict which patients might not be free from further catheterization after reconstruction. Materials and Methods: This study included patients who underwent ureteral reconstruction from January 2007 to December 2021. The success of ureteral reconstruction was defined as being free from further catheterization after the operation. Results: A total of 184 patients underwent ureteral reconstruction. Malignant disease with ureteral invasion and iatrogenic injuries accounted for 79.9% of the cases. The majority (79.3%) did not have to undergo subsequent interventions. Predictors for a failed result of ureteral reconstruction included a history of radiotherapy (OR = 2.75, p = 0.01), chronic kidney disease (CKD) (OR = 3.42, p &lt; 0.001), and an upper ureteric location of the injury (OR = 5.68, p = 0.042). Conclusions: A history of radiation therapy, an upper third ureteric location of the injury, and CKD were identified as predictors of a failed ureteral reconstruction. Malignant diseases, surgical methods, and repair techniques did not significantly affect the outcome of the operation.

Effective use of actifuse shape in spinal fusion: A retrospective chart review

Introduction: This study aimed to assess the safety and clinical performance of Actifuse Shape for spine surgery. Method: A retrospective real-world data study was conducted in two research sites in the U.S. Patient medical records had to show evidence of implantation with Actifuse Shape in 1-2 levels or 2 or more levels cervical (C2 or lower), in either posterolateral thoraco-lumbar or lumbar spine fusion procedures, among other eligibility criteria. All fusion assessments were completed using the Glassman 5 grade fusion scale. Results: Fifty-five (55) medical records were included in the full analysis set, and of these, 42 were eligible, achieving 97.6% bone fusion with a 95% CI (87.4%, 99.9%). Fusion success rates (Grade 4 or 5): 6 mo 72.7% (n=8/11), 12 mo 97.6% (n=41/42) and 24 mo 100% (n=49/49). No device-related adverse events were reported for Actifuse Shape. A “worst-case” imputation post hoc analysis was performed to take into account five patients who did not show evidence of fusion at 6 mo and were lost to follow up and were assumed to continue showing no evidence of fusion throughout the remaining study period. Forty-one out of 47 (87.2%) patients (95% CI: 74.3, 95.2) achieved successful fusion at 12 mo (±60 days) and 49/55 (89.1%) patients (95% CI: 77.8, 95.9) achieved successful fusion at 24 mo (+60 days). Conclusions: Actifuse Shape is safe and is associated with high rate of bony fusion when implanted as the primary bone graft substitute in spinal fusion surgeries.

EP.08F.14 Outcomes of Durvalumab Consolidation Treatment in Stage III Unresectable NSCLC: A Retrospective Real-World Study

EP.08F.14 Outcomes of Durvalumab Consolidation Treatment in Stage III Unresectable NSCLC: A Retrospective Real-World Study

Pathological responses of primary tumor and lymph nodes in non-small cell lung cancer after neoadjuvant chemoimmunotherapy: a retrospective real-world study

Pathological responses of primary tumor and lymph nodes in non-small cell lung cancer after neoadjuvant chemoimmunotherapy: a retrospective real-world study