Treatment-related Data Research Articles

Establishing a Risk Model for Diabetic Nephropathy and Addressing the Therapeutic Effect of Combined Epalrestat- Dapagliflozin Regimen.

To explore the construction of a diagnostic prediction model of diabetic nephropathy (DN) in type 2 diabetic patients for prognostic risk prediction and observe the therapeutic effect of Epalrestat combined with Dapagliflozin on DN. The study consisted of two phases, phase I: A retrospective analysis was conducted on the case information and clinical treatment related data of a total of 460 patients who underwent kidney biopsy from June 2018 to June 2021. They were randomly divided into validation queue and training queue. The predictive factors of the diagnostic prediction model were obtained through multivariate logistic regression. An interventional study of 94 patients with DN admitted between January 2022 and August 2023 was conducted, and they were randomized into a control group (n = 47) receiving Dapagliflozin and a research group (n = 47) receiving Epalrestat combined with Dapagliflozin. The glucose metabolism, renal function, and treatment safety of the two groups before and after treatment were compared. In addition, the adverse reactions during the treatment of the two groups were counted. In the phase I of the study, the DN risk model established showed a good performance in the diagnosis and risk assessment of patients with DN and could provide certain reference opinions for future clinical practice. In the phase II of the study, the research group showed better glucose metabolism and renal function than the control group after treatment (P < .05), but no statistical difference was identified between groups in the incidence of adverse reactions (P > .05). Conclusion. Epalrestat combined with Dapagliflozin is significantly effective in the treatment of DN, which can effectively improve glucose metabolism and renal function in DN patients.

Prognostic evaluation using radiomics after stereotactic body radiotherapy in early-stage lung cancer

Non-small cell lung cancer (NSCLC), the leading cause of cancer-related deaths, is the most common subtype of lung cancer with an incidence of 85%. Stereotactic body radiotherapy (SBRT) is a curative treatment option for patients with early-stage NSCLC who cannot undergo surgery due to medical reasons or who refuse surgery. Radiomics non-invasively extracts advanced imaging features invisible to the human eye from medical images. Radiomics has prognostic value in predicting oncological outcomes after lung SBRT. Although studies on this subject are available in the literature, they are quite heterogeneous. There is a need for large-scale multicenter studies in which standard imaging techniques are used to obtain radiomic features, artificial intelligence-based segmentations are used to eliminate differences between contours, and SBRT dose schemes with appropriate therapeutic indexes are applied. This review aimed to interpret the existing studies and emphasize the clinical importance of radiomics, which can contribute to personalized treatment. A comprehensive literature search was conducted through the PubMed database using a wide range of keywords, which yielded 11 peer-reviewed articles published between 2017 and 2024. Seven articles evaluated computed tomography radiomics, and four evaluated fluorodeoxyglucose positron emission tomography-computed tomography radiomics. Oncological outcomes are not always identical in patients with a similar history receiving similar treatments at the same stage and age. Clinical, demographic, or treatment-related data are insufficient to predict prognosis and determine personalized treatment. Incorporating radiomics to these data can help establish models with higher accuracy and achieve personalized treatment.

Efficacy and safety of treat-and-extend intravitreal brolucizumab in naive and switched patients with macular neovascularization: one-year follow-up study

Backgroundto analyze, at one year, the efficacy and safety of treat-and-extend (T&E) intravitreal (IV) Brolucizumab in patients affected by macular neovascularization (MNV). Both naïve and previously treated (i.e., switched) patients were included, and the data from the two groups were compared.Methodsanatomical (i.e., central subfoveal thickness, CST; presence of fluid), functional (i.e., best corrected visual acuity, BCVA) and treatment-related (i.e., number of IV injections within the study period; number of patients reaching a 12-weeks interval between treatments) data from 41 eyes of 41 subjects (20 naïve and 21 switched) were analyzed. Patients were treated with 3 monthly IV injections followed by a T&E regimen based on a disease activity assessment performed at each scheduled IV treatment.Resultssignificant CST reduction (from 412.1 ± 115.8 to 273.2 ± 61.6; p < 0.05) and BCVA (mean; p) improvement were observed in the naïve group, while in the switched cohort, both parameters were almost stable. In the naïve and switched groups, 55% and 33.5% of patients, respectively, reached a 12-week IV interval at one year, with a mean of 6.55 ± 1 and 7.43 ± 0.68 IV treatments, respectively. One patient with mild anterior uveitis without sequelae was recorded.ConclusionIn patients with MNV, IV Brolucizumab injections following a T&E regimen demonstrated great efficacy and a good safety profile, with greater anatomical and functional results in naïve patients.Trial registrationThis study was approved by the Local Ethics Committee (protocol number 155/2020, general registry number n°11486, InterHospital Ethics Committee, San Luigi Gonzaga Hospital, Orbassano, Italy).

Real-world evidence of survival outcomes in breast cancer subtypes after neoadjuvant chemotherapy in a Brazilian reference center.

Neoadjuvant chemotherapy (NAC), traditionally used for locally advanced disease, is now applied for operable disease, particularly to treat aggressive breast cancer (BC). This study aimed to characterize the pathological complete response (pCR) and its relationship with overall survival (OS) and disease-free survival (DFS) among BC patients receiving NAC in a Brazilian public reference center, as well as the association between pCR and BC subtypes. A retrospective cohort study used a comprehensive BC database from a Brazilian women's health reference center, including patients diagnosed between 2011 and 2020 who underwent NAC. We collected demographic, cancer-specific, and treatment-related data, analyzing OS and DFS based on pCR status using the semiparametric Kaplan-Meier method, with the date of BC diagnosis as the starting point. The study included 1,601 patients, with an average age of 49 years and a majority presenting stage IIIa disease (35%). Most had invasive nonspecial type (NST) BC (94%), and a significant portion (86.7%) exhibited a Ki-67 index <14. The overall pCR rate was 22.7%, with higher frequencies observed in the triple negative and luminal B subtypes. Patients who achieved pCR had significantly higher survival rates (89% alive vs. 61%, P<0.001) and better DFS (90% vs. 66%, P<0.001), except in the luminal A subtype, where pCR did not correlate with improved OS or DFS. These updated real-world data (RWD) from BC patients who underwent NAC in Brazil revealed a pCR rate of 22.7% in all cancer subtypes and stages. pCR was not associated with better outcomes in patients with luminal A, contrasting with other subtypes.

Characteristics of lymphoedema, in particular midline lymphoedema, after treatment for prostate cancer: a retrospective study

BackgroundPatients undergoing treatment for prostate cancer may develop lymphoedema of the midline region. This has a substantial impact on a patient’s quality of life and its diagnosis is often delayed or missed. Therefore, the purpose of this study is to compare the characteristics of patients with leg and midline lymphoedema to patients with only leg lymphoedema.MethodsWe retrospectively collected patient-, cancer-, lymphoedema- and lymphoedema treatment-related data of 109 men with lymphoedema after treatment for prostate cancer. First, 42 characteristics were compared between both groups. Second, factors predicting presence of midline lymphoedema were explored by multivariable analyses.ResultsThe mean age of the patients with lymphoedema was 68 ( ±7) years and mean BMI is 28 (±4) kg/m2. Median duration of lymphoedema before the first consultation was 27 (9;55) months. Based on univariable analyses, patients with leg and midline lymphoedema had more frequently upper leg lymphoedema (89% (31/35) vs. 69% (51/74), p = 0.026), skin fibrosis (34% (12/35) vs. 16% (12/74), p = 0.034) and lymphatic reconstructive surgery (9% (3/35) vs. 0% (0/71), p = 0.020) than patients with only leg lymphoedema. Additionally, patients with leg and midline lymphoedema reported less frequently lower leg lymphoedema (77% (27/35) vs. 95% (70/74), p = 0.007). Based on the multivariable analysis, not having lower leg lymphoedema, skin fibrosis, performing self-bandaging and self-manual lymphatic drainage appear to be predictors for having midline lymphoedema.ConclusionsIf patients with lymphoedema after prostate cancer do not have lower leg lymphoedema, have skin fibrosis, perform self-bandaging or self-manual lymphatic drainage, they possibly have midline lymphoedema.

Prevalence of treatment-resistant schizophrenia among people with early psychosis and its clinical and demographic correlates.

The prevalence of treatment-resistant schizophrenia (TRS) among people with first-episode schizophrenia (FES) has been sub-optimally researched in Australia and internationally. We evaluated the prevalence of TRS among a cohort of FES patients and compared their sociodemographic and clinical characteristics to those with FES who were treatment responsive. Over 2 years, we collated demographic, clinical and treatment-related data of all patients with ICD-10 (International Classification of Diseases, Tenth revision) diagnosis of schizophrenia who were active in October 2020 at four early psychosis intervention services (EPIS) in Western Australia. We used a modified version of Suzuki et al. criteria to diagnose TRS. The data were analysed utilising descriptive statistics, the Mann-Whitney U test, Student's t-test and the False-Discovery Rate method. The prevalence of TRS among the 167 patients diagnosed with FES was 41.3%, and the rates did not differ significantly between the services (p = 0.955). Those in the TRS group were less independent (p = 0.011), had more prolonged unemployment (p = 0.014) and were more likely to be on disability pension (p = 0.011) compared to the treatment responsive group. Furthermore, they had greater severity of symptoms (p = 0.002), longer duration of psychiatric symptoms (p = 0.019), more hospitalisations (p = 0.002) and longer cumulative admission durations (p = 0.002). Our study revealed that treatment resistance to antipsychotics is prevalent among people with FES managed at EPIS. Notably, it establishes an association between TRS and heightened clinical severity and psychosocial and treatment burden. These findings highlight the imperative for early detection of treatment resistance and timely and specialised interventions for this condition in mental health services.

Gastric volvulus in children: diagnosis and treatment approaches

Gastric volvulus is a sporadic disease in the pediatric age group and is very complex in terms of etiology and management. In this study, we aimed to discuss two late-diagnosed gastric volvulus cases, review the diagnosis and treatment methods of gastric volvulus cases in the pediatric age group encountered in the literature, and reduce concerns about the correct diagnostic approach to these cases. The first case was an 8-year-old girl who was followed up due to developmental delay and metabolic disease and was admitted due to recurrent vomiting attacks. The endoscopic reduction was first performed on the patient whose upper gastrointestinal tract imaging was compatible with organoaxial gastric volvulus. Since vomiting attacks continued, laparoscopic gastropexy was performed. In the postoperative follow-up, there was weight gain and vomiting complaints wholly regressed. The second case was a 1-year-old girl who was treated for gastroesophageal reflux at an external center due to vomiting and developmental delay, but she did not receive any response. The endoscopic reduction was performed because the patient's upper gastrointestinal imaging was compatible with the organoaxial gastric volvulus. Laparoscopic gastropexy was performed on the patient whose vomiting recurred. The stomach was expected to be seen in the upper passage imaging in the postoperative period. In the systematic search made in the MEDLINE/Pubmed database using the keywords "gastric volvulus and pediatric," 41 literature articles presenting 47 cases between 2013 and 2023 were included. The patient's age, gender, complaints at admission, type of gastric volvulus, and treatment-related data were collected. The most common symptoms in the patients were vomiting, and abdominal pain and the most common comorbidities were diaphragmatic pathologies and wandering spleen. The most preferred treatment was anterior gastropexy. Gastric volvulus is characterized by vomiting, abdominal pain, and developmental delay. It is tough to diagnose, especially in chronic cases. In addition to the conservative approach in chronic cases, anterior gastropexy should be preferred to prevent recurrent volvulus attacks.

Clinical outcomes and risk stratification in unresectable biliary tract cancers undergoing radiation therapy

BackgroundBiliary tract cancers (BTC) are rare and aggressive malignancies originating from intrahepatic and extrahepatic bile ducts and the gallbladder. Surgery is the only curative option, but due to late-stage diagnosis, is frequently not feasible, leaving chemotherapy as the primary treatment. Radiotherapy (RT) can be an effective alternative for patients with unresectable, non-metastatic BTC despite the generally poor prognosis and significant variability. To help manage patients with unresectable BTC who receive RT, we aimed to identify prognostic markers that could aid in predicting overall survival (OS).MethodsA retrospective cohort study was conducted at the University of Pennsylvania, involving seventy-eight patients with unresectable BTC treated with definitive intent RT. Comprehensive demographic, clinical, and treatment-related data were extracted from the electronic medical records. Univariate and multivariate Cox regressions were employed to identify predictors of OS after RT. A biomarker model was developed for refined survival prediction.ResultsThe cohort primarily comprised patients with good performance status without significant hepatic dysfunction at presentation. The predominant treatment approach involved hypofractionated RT or concurrent 5FU-based chemoRT. Median OS after RT was 12.3 months, and 20 patients (15.6%) experienced local progression with a median time of 30.1 months. Univariate and multivariate analyses identified CA19-9 (above median) and higher albumin-bilirubin (ALBI) grades at presentation as significant predictors of poor OS. Median OS after RT was 24 months for patients with no risk factors and 6.3 months for those with both.ConclusionsOur study demonstrates generally poor but significantly heterogeneous OS in patients with unresectable BTC treated with RT. We have developed a biomarker model based on CA19-9 and ALBI grade at presentation that can distinguish sub-populations with markedly diverse prognoses. This model can aid the clinical management of this challenging disease.

Impact of primary tumor resection in the management of metastatic well-differentiated neuroendocrine tumors of the small bowel and pancreas.

Patients with gastroenteropancreatic (GEP) neuroendocrine tumors (NET) often present with advanced disease. Primary tumor resection (PTR) in the setting of unresectable metastatic disease is controversial. Most studies evaluating the impact of PTR on overall survival (OS) have been performed using large population-based databases, with limited treatment related data. This study aims to determine whether PTR improves OS and progression-free survival (PFS) in patients with metastatic well-differentiated GEP-NET. This is a retrospective single-institution study of patients with metastatic well-differentiated GEP-NET between 1978 and 2021. The primary outcome was OS. The secondary outcome was PFS. Chi-squared tests and Cox regression were used to perform univariate and multivariate analyses (MVA). OS and PFS were estimated using the Kaplan-Meier method and log-rank test. Between 1978 and 2021, 505 patients presented with metastatic NET, 151 of whom had well-differentiated GEP-NET. PTR was performed in 31 PNET and 77 SBNET patients. PTR was associated with improved median OS for PNET (136 vs. 61 months, p = .003) and SBNET (not reached vs. 79 months, p<.001). On MVA, only higher grade (HR 3.70, 95%CI 1.49-9.17) and PTR (HR 0.21, 95%CI 0.08-0.53) influenced OS. PTR resulted in longer median PFS for patients with SBNET (46 vs. 28 months, p = .03) and a trend toward longer median PFS for patients with PNET (20 vs. 13 months, p = .07). In patients with metastatic well-differentiated GEP-NET, PTR is associated with improved OS and may be associated with improved PFS and should be considered in a multidisciplinary setting. Future prospective studies are needed to validate these findings.

The National Swedish Lymphoma Register - a systematic validation of data quality.

The Swedish Lymphoma Register (SLR) was initiated in the year 2000 with the aim to monitor quality of care in diagnostics, treatment and outcome of all lymphomas diagnosed nationally among adults. Here, we present the first systematic validation of SLR records as a basis for improved register quality and patient care. We evaluated timeliness and completeness of register records among patients diagnosed with lymphoma in the SLR (n = 16,905) compared with the National Cancer Register for the period 2013-2020. Comparability was assessed through evaluation of coding routines against national and international guidelines. Accuracy of 42 variables was evaluated through re-abstraction of data from medical records among 600 randomly selected patients diagnosed in 2016-2017 and treated across all six Swedish healthcare regions. Results: Completeness was high, >95% per year for the period 2013-2018, and >89% for 2019-2020 compared to the National Cancer Register. One in four patients was registered within 3 months, and 89.9% within 2 years of diagnosis. Registration instructions and coding procedures followed the prespecified guidelines. Missingness was generally low (<5%), but high for occasional variables, for example, those describing maintenance and consolidative treatment. Exact agreement of categorical variables was high overall (>80% for 24/34 variables), especially for treatment-related data (>80% for 17/19 variables). Completeness and accuracy are high in the SLR, while timeliness could be improved. Finetuning of variable registration guided by this validation can further improve reliability of register reports and advance service to lymphoma patients and health care in the future.

Intravenous Iron Versus Oral Iron Administration for the Treatment of Iron Deficiency Anemia: A Patient-Preference Study.

Intravenous iron supplementation has been reported to provide a superior safety profile and effectiveness in the treatment of iron deficiency anemia(IDA) compared to traditional oral iron supplements. To assess preference for intravenous iron versus oral iron among patients with IDA at King Abdulaziz University Hospital,Jeddah, Saudi Arabia. This observational cross-sectional study included 267 adults diagnosed with IDA or on treatment for IDA at King Abdulaziz University Hospital between February 2023 and March 2024. A specially modified questionnaire was used for the collection of data, which included demographic and treatment-related data. The values of the variables are presented as mean and standard deviation or median and interquartile range. Differences with an asymptotic two-tailed P-value of less than 0.05 were considered to be statistically significant. The majority of the included patients were women (95.5%), Saudi nationals (90.6%), and from the Western region (98.1%). About half of the included patients were receiving intravenous iron supplementation (51.7%), and the other half were receiving oral iron supplements (48.3%). However, the majority of the patients (74.9%) reported that they preferred intravenous iron treatment. With regard to factors that affected their preference, education level (P = 0.044), employment status (P = 0.009), and income level (P = 0.007) were identified as significant predictors. Among the patients who preferred oral iron therapy, the reason cited by the majority, that is, 79.1%, was that tablets were easier to adhere to than needles, while 50.7% stated that tablets had fewer side effects than needles and 64.2% reported a fear of needles. Among the patients who preferred intravenous iron therapy, the majority, that is, 82.4%, stated that intravenous administration was easier for them. Further, 73.5% were of the opinion that intravenous iron therapy had fewer side effects (73.5%), 27.7% reported that they were unable to swallow iron tablets, and 52.5% reported that they had difficulty remembering to take iron tablets. About a third of patients discontinued oral iron therapy due to changes in bowel habits (35%). Although 18.7% of the patients reported feeling pain with intravenous iron therapy, the majority were satisfied (79.4%) and recommended intravenous iron treatment for anemia to friends and family members (84.6%). In contrast, more than half of the patients on oral therapy were uncomfortable (56.2%) with the treatment. Further, 37.1% were not satisfied with their iron tablets, and 25.1% of patients stated that they would not recommend iron tablets for anemia treatment to their friends or family members. The majority of the patients preferred intravenous iron therapy to correct IDA because oral therapy was associated with difficulties related to swallowing iron tablets and remembering to take the tablets. Although the results indicate that both therapies have similar effectiveness, patients receiving intravenous treatment appeared to be more satisfied with the treatment and recommended it to friends and family.

First-line pembrolizumab for lung cancer in a Spanish real-world study.

e23268 Background: KEYNOTE (KN) 024 trial showed that pembrolizumab significantly improves progression free survival (PFS) and overall survival (OS) in patients with previously untreated advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression ≥ 50% without EGFR/ALK alterations. The main aim of this study is to report the outcomes (PFS and OS) of pembrolizumab in a real life setting. Methods: Multicenter retrospective study in 42 Spanish hospitals. Inclusion period: 01/2016 – 07/2020; cut-off date: 31/12/2021. Demographic, clinical and treatment-related data were retrospectively obtained from patients’ medical files. Statistical analysis was carried out using descriptive metrics and survival analysis techniques (Kaplan-Meier, log-rank test, Cox regression). Results: In our cohort of 1005 patients, 74.5% were males, mean age was 66.4 ± 9.7 and mean BMI 25.6 ± 4.6. The majority were current (35.6%) or former smokers (56.6%), with 11 % of patients with ECOG ≥ 2. Patients with a non squamous histology were 79.5% and 95.2% were classified as IV stage (30.3% had hepatic and/or brain metastases, 49.3% had ≥ 2 metastatic sites). Pembrolizumab dose was mainly fixed (83.1% of patients), while the number of treatment cycles was highly variable. 31.8% received concurrent radiotherapy, while previous corticoid (PCE), antibiotic and proton pump inhibitors (PPI) exposure were 18.2%, 7.7% and 40.7% respectively. With a median follow-up of 6.3 months, median OS and PFSwere 19 (95%CI: 16.2 – 21.3) and 8.7 (95%CI: 7.2 – 10.1) months. Several variables were associated with PFS and OS after univariate survival analysis. Age and previous antibiotic exposure were associated to worse OS but not to PFS. Multivariate analysis showed that ECOG ≥2 (HR 2.7 95%CI 2-3.5) and previous PPI exposure (HR 1.3 95%CI 1.1-1.6) were predictors of poor outcome. Conclusions: In our cohort, pembrolizumab showed lower OS and similar PFS than KN 024. Our results confirm that poor PS (ECOG) is a negative predictive factor for effectiveness. [Table: see text]

Analysis of factors affecting complete pathological remission after neoadjuvant immunocombination chemotherapy treatment for locally advanced esophageal squamous carcinoma.

e16061 Background: Chemotherapy combined with immunotherapy for locally advanced esophageal squamous carcinoma has achieved a high rate of complete pathological remission, which is conducive to a better prognosis for patients; however, not all ESCC patients benefit from ICI therapy, so finding validated prognostic markers of efficacy will help us to screen for populations that are superior to neoadjuvant immunotherapy. Methods: Patients with locally advanced esophageal squamous carcinoma treated with neoadjuvant immune-combination chemotherapy followed by radical surgery from January 2019 to June 2023 at our institution were collected. The grouping was based on whether pathologic complete remission (pCR) was achieved after neoadjuvant therapy. Clinical and treatment-related data as well as hematologic, inflammatory, and nutritional indices within 1 week before neoadjuvant therapy and within 1 week after 2 cycles of neoadjuvant immune-combination chemotherapy treatment were collected from all patients, and univariate and multivariate analyses were performed to assess independent predictors of pCR. Results: Patients in both pCR and Non-pCR groups were more likely to obtain pCR if they had pre-treatment BMI &gt; 21Kg/m2 vs BMI ≤21Kg/m2, number of neoadjuvant therapy cycles ≥3 cycles vs number of neoadjuvant therapy cycles = 2 cycles, and CYFRA21-1ng/ml &lt; 3.28 vs ≥3.28 before neoadjuvant therapy (p &lt; 0.05). Patients with albumin ≥40.10g/L vs albumin &lt; 40.10g/L, NLR &lt; 2.50 vs NLR ≥2.50, and NRI ≥98.06 vs NRI &lt; 98.06 were more likely to achieve pCR before treatment in both groups (p &lt; 0.05). SII ≥521.75 VS SII &lt; 521.75 was more likely to achieve pCR after 2 cycles of treatment (p &lt; 0.05). Univariate analysis of the comparison of dynamic changes in nutritional inflammatory indexes during treatment between the two groups of patients showed that pCR was more likely to be achieved in patients with persistently elevated eosinophil counts and NLR after 2 cycles of neoadjuvant immune-combination chemotherapy treatment (p &lt; 0.05). The results of multifactorial analysis showed that pre-treatment BMI, SII after 2 cycles of treatment, and dynamic changes in eosinophils during neoadjuvant therapy were independent influences on complete pathological remission after neoadjuvant immune-combination chemotherapy treatment (p &lt; 0.05). Conclusions: Complete pathological remission after neoadjuvant immune-combination chemotherapy treatment for esophageal squamous carcinoma was significantly correlated with the patient's pre-treatment BMI, Post-treatment SII, and eosinophil dynamics during treatment.

Prognostic risk factors for apical root resorption in orthodontic patients – Are the Kjær’s morphologic characteristics of clinical relevance?

BackgroundPatients undergoing orthodontic treatment (OT) face an increased risk of developing external apical root resorption (EARR). A prognostic risk assessment prior to OT can potentially be conducted through anatomical features in panoramic radiography. This retrospective study aimed to assess the significance of Kjær's morphological characteristics in analyzing the risk of EARR. MethodsPanoramic radiographs of 1,156 patients (624 females, 532 males) were retrospectively analyzed. Anamnestic and treatment-related data were extracted from patient records. The mean age at the start of OT was 12.8 ± 2.2 years (min. 6.4 years, max. 22.3 years) and at the end of OT 15.9 years (min. 8.5 years, max. 24.1 years). The mean treatment duration was 3.1 ± 1.6 years. Panoramic radiographs with a minimum of two per patient were examined for the presence of Kjær’s characteristics. The degree of EARR was registered defining resorption in four degrees of severity. Bivariate analysis and multivariate Poisson regression were performed to assess the association between Kjær’s characteristics and EARR patient- and tooth- related (α = 0.05). ResultsIn total, 72.8% of the patients showed EARR at the end of OT with lateral maxillary incisors most frequently affected. Short roots (p < 0.001) were significantly associated with EARR in patients. Tooth-related microdontia (#12, #22, lower second premolars), narrow crowns (#11, #21, lower incisors), short roots (upper incisors, lower first molars) and ectopia (#11, #21, #13), such as shorter distal roots of the mandibular first molar showed a significant association with EARR depending on severity degree. The type of orthodontic appliance (fixed: p < 0.001, fixed and removeable: p = 0.008), as well as treatment duration (p < 0.001) were also identified as risk factors for EARR. ConclusionsAlthough the risk assessment for EARR development through panoramic radiography analysis is limited, predisposition appears to be present in specific dental characteristics and treatment-related factors.

A dosiomics model for prediction of radiation-induced acute skin toxicity in breast cancer patients: machine learning-based study for a closed bore linac

BackgroundRadiation induced acute skin toxicity (AST) is considered as a common side effect of breast radiation therapy. The goal of this study was to design dosiomics-based machine learning (ML) models for prediction of AST, to enable creating optimized treatment plans for high-risk individuals.MethodsDosiomics features extracted using Pyradiomics tool (v3.0.1), along with treatment plan-derived dose volume histograms (DVHs), and patient-specific treatment-related (PTR) data of breast cancer patients were used for modeling. Clinical scoring was done using the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 criteria for skin-specific symptoms. The 52 breast cancer patients were grouped into AST 2 + (CTCAE ≥ 2) and AST 2 − (CTCAE < 2) toxicity grades to facilitate AST modeling. They were randomly divided into training (70%) and testing (30%) cohorts. Multiple prediction models were assessed through multivariate analysis, incorporating different combinations of feature groups (dosiomics, DVH, and PTR) individually and collectively. In total, seven unique combinations, along with seven classification algorithms, were considered after feature selection. The performance of each model was evaluated on the test group using the area under the receiver operating characteristic curve (AUC) and f1-score. Accuracy, precision, and recall of each model were also studied. Statistical analysis involved features differences between AST 2 − and AST 2 + groups and cutoff value calculations.ResultsResults showed that 44% of the patients developed AST 2 + after Tomotherapy. The dosiomics (DOS) model, developed using dosiomics features, exhibited a noteworthy improvement in AUC (up to 0.78), when spatial information is preserved in the dose distribution, compared to DVH features (up to 0.71). Furthermore, a baseline ML model created using only PTR features for comparison with DOS models showed the significance of dosiomics in early AST prediction. By employing the Extra Tree (ET) classifiers, the DOS + DVH + PTR model achieved a statistically significant improved performance in terms of AUC (0.83; 95% CI 0.71–0.90), accuracy (0.70), precision (0.74) and sensitivity (0.72) compared to other models.ConclusionsThis study confirmed the benefit of dosiomics-based ML in the prediction of AST. However, the combination of dosiomics, DVH, and PTR yields significant improvement in AST prediction. The results of this study provide the opportunity for timely interventions to prevent the occurrence of radiation induced AST.

The current clinical landscape of neonatal respiratory failure in Jiangsu Province of China: patient demographics, NICU treatment interventions, and patient outcomes

IntroductionNeonatal respiratory failure (NRF) is a serious condition that often has high mortality and morbidity, effective interventions can be delivered in the future by identifying the risk factors associated with morbidity and mortality. However, recent advances in respiratory support have improved neonatal intensive care units (NICUs) care in China. We aimed to provide an updated review of the clinical profile and outcomes of NRF in the Jiangsu province.MethodsInfants treated for NRF in the NICUs of 28 hospitals between March 2019 and March 2022 were retrospectively reviewed. Data collected included baseline perinatal and neonatal parameters, NICU admission- and treatment-related data, and patient outcomes in terms of mortality, major morbidity, and survival without major morbidities.ResultsA total of 5548 infants with NRF were included in the study. The most common primary respiratory disorder was respiratory distress syndrome (78.5%). NRF was managed with non-invasive and invasive respiratory support in 59.8% and 14.5% of patients, respectively. The application rate of surfactant therapy was 38.5%, while that of neonatal extracorporeal membrane oxygenation therapy was 0.2%. Mortality and major morbidity rates of 8.5% and 23.2% were observed, respectively. Congenital anomalies, hypoxic-ischemic encephalopathy, invasive respiratory support only and inhaled nitric oxide therapy were found to be significantly associated with the risk of death. Among surviving infants born at < 32 weeks of gestation or with a birth weight < 1500 g, caffeine therapy and repeat mechanical ventilation were demonstrated to significantly associate with increased major morbidity risk.ConclusionOur study demonstrates the current clinical landscape of infants with NRF treated in the NICU, and, by proxy, highlights the ongoing advancements in the field of perinatal and neonatal intensive care in China.

Quality of life in children and adolescents after treatment for acute lymphoblastic leukemia according to the NOPHO ALL2008 protocol.

The improved outcome of childhood acute lymphoblastic leukemia (ALL) over the last decades has increased the importance of assessing late effects and health-related quality of life (HRQoL), particularly when evaluating and comparing outcomes in clinical trials. This study aimed to assess HRQoL in children treated for ALL according to the NOPHO ALL2008 protocol. Children, aged 1 to less than 18years at diagnosis, alive in first remission, and their parents, were asked to complete PedsQL 4.0 Generic Core Scales (self- and proxy-report) at ≥6months after end of therapy. Data on socioeconomic factors and parent-reported toxicity were collected through a study-specific questionnaire, and the NOPHO ALL2008 database was used to identify eligible families and add additional disease- and treatment-related data. HRQoL data were collected during 2013-2019 in Sweden, Finland, and Denmark. A total of 299 children were included. The older children (8years and older) reported similar HRQoL scores compared to Finnish reference data, except lower scores for School Functioning in high-risk patients. Scores from the parent-proxy and self-reports from 5-7-year olds were notably lower than reference. Parent-reported toxicity was associated with lower total and physical HRQoL scores in adjusted models for younger as well as older children in the self-report and parent-proxy versions, and also with lower psychosocial score in the parent-proxy. Self-reported HRQoL was similar to reference population. The most important determinant for HRQoL after end of ALL treatment was parent-reported toxicity during treatment. Thus, minimizing complications is an obvious focus for future treatment protocols.

Abstract 922: Comparison of adverse effects of different combination therapies of immune checkpoint inhibitors and radiotherapy: A systematic review and meta-analysis

Abstract Background: Numerous ongoing trials are investigating cancer treatment combinations based on the combination of radiotherapy and immune checkpoint inhibitors. Understanding the toxicity profile of treatment-related adverse events is crucial. The purpose of this study is to comprehensively investigate the incidence and overview of treatment-related adverse events in different combination therapies involving radiotherapy and immune checkpoint inhibitors. Methods: We conducted a systematic review and meta-analysis of different combination therapies involving radiotherapy and immune checkpoint inhibitors. We searched English-language articles published between January 1, 2000, and May 31, 2023, in Pubmed, Embase, and the Cochrane database, investigating globally approved therapies based on PD-1, PD-L1 inhibitors, or CTA-4. Only prospective trials reporting overall incidence rates or lists of treatment-related adverse events data were included, and studies recruiting fewer than 10 patients were excluded. Retrospective studies were also excluded to minimize the risk of bias. The primary outcomes were the overall incidence and overview of treatment-related adverse events of all grades and grade 3 or higher. Heterogeneity among studies was assessed using the I2 statistic. The summary measure for primary outcomes was incidence rate (95% CI). This protocol is registered in PROSPERO (CRD42023390147). Results: We identified 1300 records, of which 50 studies (1655 patients) met the inclusion criteria. The incidence of treatment-related adverse reactions in the concurrent group was 76.0% (95% CI 73.5-78.4), and the incidence of grade 3 or higher adverse events was 23.5% (21.1-25.9). In the sequential group, the incidence of treatment-related adverse reactions was 75.9% (70.8-80.6), and the incidence of grade 3 or higher adverse events was 22.5% (18.0-27.5). In the induction group, the incidence of treatment-related adverse reactions was 72.8% (65.0-79.8), and the incidence of grade 3 or higher adverse events was 37.1% (29.4-45.3). The most common specific adverse event in the concurrent group was Fatigue (27.8% [25.2-30.6]); in the sequential group, it was Fatigue (43.3% [33.3-53.7]); in the induction group, it was Fatigue (71.4% [56.7-83.4]). Grade 3 or higher adverse events in the concurrent group was Lymphocyte Count Decreased (7.2% [5.4-9.4]); in the sequential group, it was Pneumonitis (11.1% [5.7-19.0]); in the induction group, it was Fatigue (10.5% [5.6-17.7]). Conclusion: Our study provides comprehensive data on treatment-related adverse events in different combination therapies involving radiotherapy and immune checkpoint inhibitors. Our results provide an essential reference of toxicity profiles of radiotherapy combined with immune checkpoint inhibitors for clinicians in routine practice of cancer care. Citation Format: Haiyu Zhou, Zefeng Guo, Ting Wang, Liyu Cai, Peimeng You. Comparison of adverse effects of different combination therapies of immune checkpoint inhibitors and radiotherapy: A systematic review and meta-analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 922.

Treatment outcome and survival status among adult patients treated for lupus nephritis in selected tertiary hospitals of Ethiopia

Lupus nephritis (LN) is kidney involvement of systematic lupus erythematous that ranges from mild to severe and occurs in 60% of adult patients. Despite advances in therapy, LN morbidity and mortality remains high. There is a paucity of data regarding adult LN patient's treatment outcome, survival status, and associated factors in developing countries, particularly in Ethiopia. This study aimed to assess the treatment outcome, survival status, and associated factors of adult patients treated for LN in two selected tertiary hospitals [Tikur Anbessa Specialized Hospital (TASH) and St. Paul’s Hospital Millennium Medical College (SPHMMC)] of Addis Ababa, Ethiopia. A hospital-based retrospective cross-sectional multicenter study was conducted from January 1, 2016 to January 1, 2021. Socio-demographic, clinical, and treatment-related data were collected from patient’s medical records by using a structured abstraction checklist. Descriptive statistics were used to summarize the quantitative data as appropriate. The modified Aspreva Lupus Management Study (mALMS) criteria was applied to categorize LN treatment outcomes into complete, partial, and non-response. Multinomial logistic regression analysis was performed to identify predictors of LN treatment outcome. Patients’ survival was estimated by using Kaplan–Meier and Cox proportion regression analysis. P value < 0.05 was considered to declare statistical significance. A total of 200 LN patients were included in the final analysis. Amongst these, the majority of them (91.5%) were females. The median age of the patients was 28 (15–60) years. The mean duration of treatment follow-up was 28 months. The commonly prescribed immunosuppressive drugs during both the induction (49.5%) and maintenance (60%) phases were a combination of mycophenolate mofetil with prednisolone. Complete, partial, and non-responses at the last follow-up visit accounted for 66.5%, 18.0%, and 15.5%, respectively. Patient survival at the last follow-up visit was more than 90% for patients with complete response to the induction therapy. Non-response at the last follow-up visit was significantly associated with severe disease activity index (adjusted odds ratio [AOR] = 6.25, 95% confidence interval [CI] 1.49–26.10), presence of comorbidity (AOR = 0.21, 95% CI 0.05–0.92), baseline leucopenia (AOR = 14.2, 95% CI 1.04–201.3), partial response at the end of induction therapy (AOR = 32.63, 95% CI 1.4–736.0), and duration of induction therapy of greater than 6 months (AOR = 19.47, 95% CI 1.5–258.8). This study unveiled that lower numbers of LN patients were presented with non-response at the last follow-up visit and non-response to induction therapy was associated with lower patients’ survival rates compared with complete or partial response.

Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis.

The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation. Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher' or Mann Whitney' test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain). We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III-IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05). The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.