Treatment Characteristics Research Articles

Continuous Electroencephalography in Acute Liver Failure: Findings and Prognostic Value.

Neurologic complications contribute significantly to morbidity and mortality in acute liver failure (ALF). However, clinical assessment of neurologic function in this population is often challenging. Continuous electroencephalography (cEEG) is a low-risk, noninvasive diagnostic tool that can monitor real-time cerebral function. We aimed to investigate cEEG findings and prognostic significance of specific EEG features in a cohort of strictly defined patients with ALF. This was a retrospective, single-center study of adult patients with ALF who underwent cEEG monitoring for at least 6h between 2013 and 2022. Clinical, laboratory, imaging, and treatment characteristics were evaluated. cEEG variables included background continuity, background frequency, the presence of sporadic epileptiform discharges, rhythmic or periodic patterns, and electrographic or electroclinical seizures. The primary outcome was mortality or transition to end-of-life care during the index admission. A total of 32 patients with ALF were included. 56.3% of patients had rhythmic or periodic patterns, of which the majority were generalized periodic discharges (37.5%). 12.5% of patients had sporadic epileptiform discharges, and 6.3% of patients demonstrated electrographic or clinical seizures. Eighteen (56.3%) patients died or were transitioned to end-of-life care during the index admission. Worsening background continuity or frequency over the course of the cEEG recording was significantly associated with poor outcome (p = 0.001, p = 0.007, respectively), with a 100% mortality rate in patients demonstrating these EEG trends. A worst recorded continuity of suppression, attenuation, and burst-suppression was also associated with poor outcome (p = 0.012). The presence of rhythmic or periodic patterns, sporadic epileptiform discharges, or seizures was not predictive of outcome. Worsening cEEG background continuity or frequency is associated with poor outcome in adults with ALF. cEEG may contribute useful prognostic information in these patients, in conjunction with other laboratory and clinical markers of disease severity.

Surgical Complications for Oral Cavity Cancer: Evaluating Hospital Performance.

Complications of oral cavity cancer (OCC) surgery have an impact on the quality of life. Therefore, evaluating hospital performance on complication rates can help identify best practices for improving the quality of OCC care. As patient and tumor characteristics also impact hospital results, case-mix adjustment should be considered to provide a valid hospital comparison. This study investigated hospital variation in the quality indicator "a complicated postoperative course" after OCC surgery. This population-based cohort included all first primary OCC patients diagnosed between 2018 and 2021 who were surgically treated with curative intent. A complicated postoperative course was defined as 30-day mortality, unplanned readmission, surgical complications requiring reintervention or prolonged hospital stay, or fistula formation. Hospital performance was analyzed using funnel plots with case-mix correction. A total of 2,266 OCC patients could be included. The distribution of case-mix variables varied significantly between hospital populations. Nationally, a complicated postoperative course occurred in 13.9% and uncorrected hospital rates ranged from 2.7% to 31.1%. A WHO performance score ≥2, cT3-T4 tumors, and floor-of-mouth tumors were associated with an increased risk of a complicated postoperative course, and non-squamous cell carcinoma with a decreased risk. Significant outliers remained after case-mix correction for patient, tumor, and treatment characteristics. Complications after OCC surgery are prevalent, especially regarding extensive tumors and surgery. To identify best practices in OCC surgery, hospital performance on a complicated postoperative course should be adjusted for case-mix and treatment variables. Providing feedback on hospital performance for complications can instigate improvement plans for better outcomes. 3 Laryngoscope, 2025.

Can We Accurately Predict Adult Height in Pediatric Patients Who Undergo Treatment for Sarcoma?

Sarcoma and its treatment has the potential to limit adult height attainment in skeletally immature patients. However, evidence on the extent of this limitation in sarcoma specifically is mixed, and existing height prediction tools such as the Paley multiplier method have proven unreliable in this setting. As such, orthopaedic surgeons are left with the challenge of counseling patients and their families on expected height deficits without an adequate understanding of the extent of these deficits. Equally important, these surgeons must also understand the amount of skeletal growth remaining during the presurgical planning process for limb reconstruction to adequately grasp a patient's risk of subsequent limb length discrepancy. (1) To what extent does pediatric sarcoma and its treatment limit adult height attainment? (2) Using retrospective data on pediatric patients with sarcoma, can we create a height prediction model that yields more accurate estimates of expected adult height than the Paley multiplier method? For this retrospective pilot study, 223 pediatric patients with sarcoma from a single pediatric sarcoma center between 1976 and June 2022 were identified using diagnostic codes. Inclusion criteria were completion of chemotherapy before skeletal maturity, survival to maturity, and complete height data (that is, height at diagnosis and at skeletal maturity). Of the 223 patients identified as potentially eligible, 56 met inclusion criteria. The remaining 167 patients were excluded on the basis of not receiving chemotherapy (9% [15 of 167]), receiving chemotherapy after skeletal maturity was reached (20% [33 of 167]), not surviving to skeletal maturity (19% [31 of 167]), not reaching skeletal maturity at the time of chart review (43% [72 of 167]), having insufficient treatment data available for analysis (7% [11 of 167]), or being lost to follow-up (that is, no further clinic visits where height at skeletal maturity was recorded) (3% [5 of 167]). Data collection encompassed cancer type; age, height, and weight at diagnosis and maturity; and treatment characteristics. A total of 43% (24 of 56) were female and 57% (32 of 56) were male. Among included patients, 70% (39 of 56) had primary bone tumors, of which 64% (25 of 39) involved lower extremity. Diagnoses of osteosarcoma (41% [23 of 56]) and Ewing sarcoma (36% [20 of 56]) predominated. Doxorubicin (82% [46 of 56]) and cyclophosphamide (61% [34 of 56]) were the most common chemotherapeutics; the mean ± SD treatment duration was 76 ± 88 weeks. Female patients were diagnosed at a mean age of 11 ± 4 years, reaching skeletal maturity at 16 ± 1 years. Male patients were diagnosed at a mean age of 14 ± 3 years, reaching skeletal maturity at 17 ± 1 years. We compared CDC z-scores, which quantify patient height relative to the population mean using SD and percentiles, at diagnosis and maturity to track growth before and after sarcoma treatment, thus quantifying our cohort's growth trajectories relative to the population mean. The Paley multiplier method is a quick and easy-to-use limb length prediction tool that utilizes validated age- and sex-specific multipliers. Its predictions based on height at diagnosis were compared with final attained heights. A novel height prediction model accounting for chemotherapy was derived via multiple regression using two-thirds of the cohort. The remaining one-third was used to test accuracy of the model. Skeletally immature patients diagnosed with and treated for sarcoma were found to achieve shorter heights at maturity than predicted by the Paley method and CDC growth curves. The Paley method overpredicted adult height by a mean ± SD of 4.3 ± 5.9 cm in female patients (95% confidence interval 1.8 to 6.8; p < 0.001) and 4.9 ± 6.1 cm in male patients (95% CI 2.6 to 7.1; p < 0.001). Median (range) CDC z-scores at maturity (0.47 [-1.7 to 3.2]) were lower than at diagnosis (0.73 [-1.7 to 2.6]) (median difference -0.26; p < 0.001). Patients diagnosed at younger ages were more likely to have larger discrepancies in both CDC z-scores at maturity and in predicted heights. Our novel height prediction model yielded predictions most similar to actual heights attained by incorporating sex, age at first chemotherapy, and height at diagnosis into the following equation (result given in centimeters): 116 + 12 (if male) + 0.6 × (height at diagnosis in cm) - 3.2 × (age at first chemotherapy in years). Our novel height prediction model more accurately accounts for growth limitations imposed by pediatric sarcoma treatment compared with the Paley method and CDC z-scores. With our model, surgeons are now better equipped to plan complex surgical reconstruction of lower extremity tumors in growing children because of a better grasp of eventual adult height and, relatedly, risk for limb length discrepancies. However, to identify any factors that may influence the model's accuracy, larger studies with more diverse cohorts are needed.Level of Evidence Level IV, therapeutic study.

Lichen Sclerosus in Cancer Patients.

To characterize the association between cancer therapies and the development of lichen sclerosus (LS) in a case series of patients. A retrospective chart review was performed to screen for patients who were diagnosed with LS while undergoing cancer therapy at Memorial Sloan Kettering Cancer Center between 2003 and 2019. Patients were excluded if they had been diagnosed with LS prior to starting cancer therapy. Clinical and treatment characteristics were analyzed. The final study sample included 29 female patients who developed LS in the setting of systemic cancer therapy. Median time to LS onset after cancer therapy initiation was 420 days. Primary tumor types included breast (10, 34.5%), gynecologic (8, 27.6%), gastrointestinal (5, 17.2%), cutaneous (2, 6.9%), lung (2, 6.9%), and hematologic (2, 6.9%). Cancer therapy regimens included hormonal therapy (10, 34.5%), chemoradiation (7, 24.1%), cytotoxic chemotherapy (7, 24.1%), PD-1/PD-L1 inhibitors (3, 10.3%), local radiation (1, 3.4%), and allogeneic stem cell transplant (1, 3.4%). Across all patients, the mean number of treatments for LS was 2.8. Twenty-three (79.3%) patients received the first-line therapy of ultrapotent topical steroids, but 16 (69.6%) required additional topical and systemic treatment. Limitations include retrospective design and referral bias. Breast cancer was the most common primary tumor among patients in this study. The most common cancer therapy regimen was hormonal therapy. Most patients required an escalation in therapy to manage their LS. For patients undergoing cancer treatment, concomitant LS management can present unique challenges due to the biological mechanism of some anticancer therapies and the pathophysiology of LS. There is limited data to guide treatment of LS for this population. Some of the patients included in this analysis had progression of LS and recurrence of cancer while undergoing management of both conditions, necessitating close follow-up.

Enhancing geriatric trauma mortality prediction: Modifying and assessing the Geriatric Trauma Outcome Score with net benefit and decision curve analysis.

Calibration and discrimination indicators alone are insufficient for evaluating the clinical usefulness of prediction models, as they do not account for the cost of misclassification errors. This study aimed to modify the Geriatric Trauma Outcome Score (GTOS) and assess the clinical utility of the modified model using net benefit (NB) and decision curve analysis (DCA) for predicting in-hospital mortality. The Trauma Quality Improvement Program (TQIP) 2017 was used to identify geriatric trauma patients (≥ 65 years) treated at Level I trauma centers. The outcome of interest was in-hospital mortality. The GTOS was modified to include additional patient, injury, and treatment characteristics identified through machine learning methods, focusing on early risk stratification. Calibration and discrimination indicators, along with NB and DCA, were utilized for evaluation. Of the 67,222 admitted geriatric trauma patients, 5.6% died in the hospital. The modified GTOS score included the following variables with associated weights: initial airway intervention (5), Glasgow Coma Scale ≤13 (5), packed red blood cell transfusion within 24 h (3), penetrating injury (2), age ≥ 75 years (2), preexisting comorbidity (1), and torso injury (1), with a total range from 0 to 19. The modified GTOS demonstrated a significantly higher area under the curve (0.92 vs. 0.84, p < 0.0001), lower misclassification error (4.9% vs. 5.2%), and lower Brier score (0.036 vs. 0.042) compared to the original GTOS. DCA showed that using the modified GTOS for predicting in-hospital mortality resulted in higher NB than treating all, treating none, and treating based on the original GTOS across a wide range of clinician preferences. The modified GTOS model exhibited superior predictive ability and clinical utility compared to the original GTOS. NB and DCA offer valuable complementary methods to calibration and discrimination indicators, comprehensively evaluating the clinical usefulness of prediction models and decision strategies.

Lurasidone uses and dosages in Spain: RETROLUR, a real-world retrospective analysis using artificial intelligence

IntroductionLurasidone is used for schizophrenia and bipolar depression in many countries, yet there is a lack of existing literature about its use, efficacy, and safety in real life. We aimed to characterize lurasidone-treated patients by analyzing unstructured information in electronic health records (EHRs).MethodsThis was a multicenter, retrospective, observational, and descriptive study that used data extracted from EHRs of patients initiating treatment with lurasidone in four Spanish hospitals from September 2019 to March 2022. Stratification included primary diagnosis, antipsychotic therapy, and lurasidone dose. Natural language processing and machine learning were used to extract and analyze unstructured clinical data using SNOMED CT terminology. Sociodemographic, clinical, and treatment characteristics, as well as symptoms and potential adverse events as efficacy and safety outcomes, were evaluated at inclusion and during follow-up.ResultsAmong 2,374,218 patients attending the participating hospitals during the study period with 66,523,391 EHRs, 272 initiated lurasidone and were included. Median (Q1; Q3) age was 46 (37; 56) years, and 60.3% were female. Common comorbidities were hypertension (46.7%), dyslipidemia (44.5%), and diabetes (30.5%), and 87.1% had received a median of three antipsychotics before lurasidone, being olanzapine (52.9%) and quetiapine (45.2%) the most frequently used. During follow-up, 16.9% of the patients discontinued lurasidone, and few patients (&amp;lt;1.2%) reached high doses (111 and 148 mg/day). Lurasidone demonstrated effectiveness in reducing positive and negative symptoms, anxiety, depression, and suicidal ideation, with a marked reduction in most of the adverse events compared to the pre-lurasidone period.DiscussionLurasidone reduced positive and negative symptoms frequencies with a favorable safety profile, while low discontinuation rates suggest efficacy-tolerability balance, patient satisfaction, and acceptability. Our data reflect that in Spain lurasidone is used at low doses, limiting its beneficial effects according to clinical trials results.

Socio-demographic, health, treatment, and labour market characteristics of sick-listed employees diagnosed with and treated for a mental disorder in Germany

Purpose To examine the socio-demographic, health, treatment, organisation, job, and labour market characteristics of 484 German sick-listed employees diagnosed with a mental disorder (MD), along with gender differences. Methods This cross-sectional study used online baseline self-report data from sick-listed employees diagnosed with and treated for a MD, recruited as part of an evaluation trial for a return to work (RTW) intervention (DRKS00026232). Descriptives and t-tests/chi-squared tests were performed. Results Mean age was 42.6 years (range 20–60 years). Nearly 60% were female, 31% highly educated, and more than half fell into lower gross household income groups. Recurrent depression was a common diagnosis. The employees reported moderate depressive symptoms, low RTW self-efficacy, and poor work ability. Gradual RTW was rated the most common workplace accommodation need for RTW. Significant gender differences were found regarding socio-demographic, health, job, and labour market characteristics. Conclusions Despite the majority having permanent, fulltime, white-collar jobs, the results highlight the vulnerability of persons with a diagnosed MD in the labour market, suggesting an urgent need for more clinical and work-directed aftercare. Women seem more disadvantaged than men but not regarding treatment and organisation characteristics, emphasising the importance of addressing gender differences in mental health and practice.

Determinants of first-line clinical trial enrollment among Black and White gynecologic cancer patients.

Disparities in gynecologic cancer clinical trial enrollment exist between Black and White patients; however, few examine racial differences in clinical trial enrollment predictors. We examined whether first-lineclinical trial enrollment determinants differed between Black and White gynecologic cancer patients. We used the National Cancer Database to identify Black and White gynecologic cancer (cervix, ovarian, uterine) patients diagnosed in 2014-2020. Multivariable logistic regression was used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between clinical trial enrollment (yes vs no) and sociodemographic, facility, tumor, and treatment characteristics stratified by race. We included a multiplicative interaction term between each assessed predictor and race to test whether associations differed by race. We included 703,022 gynecologic cancer patients (mean [SD] age at diagnosis, 60.9 [13.1] years). Clinical trial enrollment was lower among Black (49/86,058, 0.06%) vs. White patients (710/616,964, 0.11%). Only cancer site differed by race: among Black patients, a cervical vs. uterine cancer diagnosis (OR = 4.63, 95% CI = 1.67-12.88) was associated with higher clinical trial enrollment odds, while among White patients, both cervical (OR = 2.21, 95% CI = 1.48-3.29) and ovarian (OR = 3.40, 95% CI = 2.58-4.47) cancer diagnoses (vs. uterine cancer) were associated with higher enrollment odds. Most predictors were associated with clinical trial enrollment odds among White but not Black patients. Few differences in first-lineclinical trial enrollment predictors exist between Black and White gynecologic cancer patients. Although small numbers of Black patients and low clinical trial prevalence are limitations, this descriptive analysis is important in understanding racially disparate clinical trial enrollment.

Genomic profiling of matched tumor samples in patients with rectal cancer undergoing total neoadjuvant therapy.

213 Background: Total neoadjuvant therapy (TNT) is increasingly used for locally advanced rectal cancer. However, which patients benefit most from TNT remains to be elucidated. In this study we sequenced a TNT cohort with long-term follow-up to identify genomic correlates of TNT efficacy. Methods: Patients with locally advanced rectal cancer who underwent TNT followed by surgery (Oct 2016-June 2020) were identified at our institution. MSS patients with paired tissues (normal, biopsy, and surgery) with successful DNA extraction and sequencing were analyzed. Retrospective chart review collected patient demographics and clinical outcomes. Genomic analyses were performed with the R maftools package. Descriptive statistics were calculated with Fisher’s exact, Wilcoxon rank sum, and Wilcoxon rank sum exact tests. Univariate survival analyses (UVA) were calculated with Cox proportional hazards regressions. All statistical analyses were performed using R (v4.3.2). Results: 53 patients met inclusion criteria and 32 patients with paired tissues (64 samples) were obtained and successfully sequenced. All patients received chemotherapy, most commonly FOLFOX (81.3%) as part of TNT and a 5-FU based chemoradiation therapy (RT) regimen. Almost all patients received 50.4 Gy (93.8%). Median followup was 57 months (IQR: 47-68). There were 24 pathological responders (R) [complete/partial] and 8 nonresponders (NR) [stable disease/progression]. R vs NR were not statistically different across demographic or treatment characteristics. Local recurrences were infrequent (9.4% 3/32). No covariates were prognostic on UVA survival analyses. However, NR was associated with worse distant metastases free survival (DMFS) (HR = 4.11, CI 1.01-16.8, p = 0.048) on UVA. 5-year DMFS was 83% for R and 50% for NR, and the median DMFS was not reached for R, 41 mo for NR. Tumor mutation burden (TMB) did not change with treatment (pre = 4.5 vs post = 6.2 mutations/Mb; r, 1.7-10.3, p=0.59) and was not different on biopsy between R and NR (4.1 vs 5.9, p=0.09). Pre-treatment, the most mutated gene was APC (81%), [majority nonsense/frameshift (88%)], followed by TP53 (69%), [missense (59%)]. When comparing frequent mutations (n ≥ 5), PIEZO1 was more mutated in NR (63%, 5/8) than R (4% 1/24 patients) (p = 0.023 [multiple testing corrected]). Putative radioresistant KRAS-TP53 co-mutations were uncommon with similar representation in both groups (R 12.5%, 3/24, NR 12.5%, 1/8). Conclusions: Pathologic response positively correlated with DMFS in this cohort with long-term followup. PIEZO1 mutations were negatively prognostic for pathologic NR to TNT. This uncovers a potential new role in chemoRT resistance in addition to a previously reported association with metastatic spread. Further evaluation of PIEZO1 as a prognostic biomarker may help personalize appropriate treatment for patients with locally advanced rectal cancer.

Clinical outcomes of stereotactic body radiation therapy to the liver.

565 Background: Stereotactic body radiation therapy (SBRT) can accurately and effectively target liver lesions with an ablative dose. However, prior studies suggest that SBRT directed at tumors near the central hepatobiliary tract may lead to downstream toxicity including biliary stricture and impaired liver function. This study aims to evaluate clinical outcomes and hepatobiliary toxicities associated with SBRT to the liver. Methods: This retrospective study reviews 177 patients who received CT- or MR-guided SBRT to the liver at Dana-Farber Cancer Institute and Brigham and Women’s Hospital from 2010 to 2024. Patient demographics, treatment characteristics, and clinical outcomes were extracted from electronic medical records. Local control, regional control, and overall survival were assessed using Kaplan-Meier methods. Toxicity was evaluated by tracking the incidence of biliary stricture requiring intervention and Child-Pugh (CP) scores pre- and post-SBRT. Results: Of the 177 patients, 47 (26.6%) had primary disease and 130 (73.4%) had metastatic disease, with a median follow-up of 58.7 months. Among those with primary disease, 9 (19.1%) had post-SBRT local progression (median time to progression not reached, 95% CI: 47.3, NA) and 26 (55.3%) had regional progression (median time to progression of 20.5 months, 95% CI: 6.5, 58.1). Of patients with metastatic disease, 44 (33.8%) had local progression (median time to progression of 40.2 months, 95% CI: 23.0, NA) and 96 (73.8%) had regional progression (median time to progression of 5.9 months, 95% CI: 4.8, 9.3). Median overall survival post-SBRT was 34.6 months for primary disease (95% CI: 20.2, 57.7) and 23.6 months for metastatic disease (95% CI: 19.0, 28.8). 18 patients (10.1%) later developed biliary stricture requiring intervention (12.8% of primary disease and 9.2% of metastatic disease). Of the 119 patients with CP scores available, 59 patients (49.6%) had a maximum post-SBRT CP score increase of 2 or more (55.0% of primary disease, 46.8% of metastatic disease). Conclusions: This study demonstrates that SBRT is an effective treatment option for local control in the liver, with better survival and progression outcomes for primary disease compared to metastatic disease. Among potential post-SBRT toxicities, initial analysis indicates frequent increase in CP score and low incidence of biliary stricture requiring intervention. An ongoing analysis will explore whether the dose to central bile ducts correlates with late strictures and toxicities.

Characteristics of children and adolescents with multidrug-resistant and rifampicin-resistant tuberculosis and their association with treatment outcomes: a systematic review and individual participant data meta-analysis.

There are few data on the treatment of children and adolescents with multidrug-resistant (MDR) or rifampicin-resistant (RR) tuberculosis, especially with more recently available drugs and regimens. We aimed to describe the clinical and treatment characteristics and their associations with treatment outcomes in this susceptible population. We conducted a systematic review and individual participant data meta-analysis. Databases were searched from Oct 1, 2014, to March 30, 2020. To be eligible, studies must have included more than five children or adolescents (0-19 years of age) treated for microbiologically confirmed or clinically diagnosed MDR or RR tuberculosis within a defined treatment cohort, and reported on regimen composition and treatment outcomes. Abstracts were screened independently by two authors to identify potentially eligible records. Full texts were reviewed by two authors independently to identify studies meeting the eligiblity criteria. For studies meeting eligiblity criteria, anonymised individual patient data was requested and individiual level data included for analysis. The main outcome assessed was treatment outcome defined as treatment success (cure or treatment completed) versus unfavourable outcome (treatment failure or death). Multivariable logistic regression models were used to identify associations between clinical and treatment factors and treatment outcomes. This study is registered with Prospero (CRD42020187230). 1417 studies were identified through database searching. After removing duplicates and screening for eligibility, the search identified 23 369 individual participants from 42 studies, mostly from India and South Africa. Overall, 16 825 (72·0%) were successfully treated (treatment completed or cured), 2848 died (12·2%), 722 (3·1%) had treatment failure, and 2974 (12·7%) were lost to follow-up. In primary analyses, the median age was 16 (IQR 13-18) years. Of the 17 764 (87·1%) participants with reported HIV status, 2448 (13·8%) were living with HIV. 17 707 (89·6%) had microbiologically confirmed tuberculosis. After adjusting for significant factors associated with treatment outcome, the use of two (adjusted odds ratio [OR] 1·41 [95% CI 1·09-1·82]; p=0·008) or three (2·12 [1·61-2·79]; p<0·0001) WHO-classified group A drugs (bedaquiline, moxifloxacin, levofloxacin, and linezolid) compared with the use of no group A drugs at all was positively associated with treatment success. Younger and clinically diagnosed children are underrepresented among those treated for MDR and RR tuberculosis and should be a focus for case-finding efforts. Overall treatment outcomes in our analysis were better than in adults but lower than the international targets of 90% or more individuals successfully treated. Treatment with more group A drugs was associated with better treatment outcomes in children and adolescents, highlighting the need for more rapid access to these drugs and improved regimens. Unitaid.

Impact of Lauren’s subtype in locally-advanced gastric cancer (LAGC) prognosis: A call for change.

497 Background: Patients with LAGC should undergo perioperative chemotherapy and surgery. Lauren’s diffuse subtype and signet-ring cell carcinoma have been linked to worse outcomes and chemoresistance in this setting. This study aimed to assess the impact of Lauren’s classification on response to neoadjuvant chemotherapy and prognosis in LAGC. Methods: This analysis involved adult patients from a prospectively collected gastric cancer database who had histologically confirmed LAGC and received curative-intent perioperative chemotherapy and surgery. Patients were classified into two groups according to Lauren’s classification: intestinal and non-intestinal subtypes (including diffuse, signet-ring cell carcinoma and mixed histologies). Clinicopathological and treatment characteristics (age, gender, primary site, HER-2 status, staging laparoscopy, neoadjuvant chemotherapy, surgery and pathological complete response) of the two groups were compared using chi-square tests. Survival curves were obtained using Kaplan-Meier, and log-rank and Cox proportional models used to compare survival between groups. Results: Between 2015 and 2022, 174 patients met the inclusion criteria, with a median follow-up of 62.2 months (95% CI: 57.9-66.9). The intestinal subtype comprised 72 patients (41.4%) and the non-intestinal subtype included 102 (58.6%). The median age of diagnosis was significantly higher for the intestinal subtype (63 years) compared to the non-intestinal subtype (56 years; p&lt;0.001). Female patients represented 26.4% of the intestinal subtype and 46.1% of the non-intestinal subtype (p=0.013). The primary gastric site was more prevalent in the non-intestinal subtype (78.4%) compared to the intestinal subtype (51.4%; p&lt;0.001). HER-2 positivity was observed in 12.5% of intestinal and 4.5% of non-intestinal subtypes (p=0.14). Staging laparoscopy was conducted in 67 out of 72 (93%) patients with the intestinal subtype and in 96 out of 102 (94.1%) patients with the non-intestinal subtype, p=1. FLOT and FOLFOX/CAPOX protocols were administered in 50% and 40.2% of intestinal subtype cases, and in 53.9% and 36.2% of non-intestinal subtype cases, respectively (p=0.14). Pathological complete response rates were 8.5% for intestinal and 11.5% for non-intestinal subtypes (p=0.46). Three-year recurrence-free survival rates were 67.1% for intestinal and 64.6% for non-intestinal subtypes (HR=0.99, 95% CI: 0.61-1.61, p=0.96), while five-year overall survival rates were 73.3% and 67.2%, respectively (HR=1.12, 95% CI: 0.63-1.97, p=0.70). Conclusions: Our findings demonstrate that the non-intestinal subtype is more common in younger, female patients with primary gastric sites. However, Lauren’s subtype did not significantly correlate with pathological staging post-neoadjuvant chemotherapy or prognosis in LAGC. Lauren’s subtype should not influence treatment decisions in LAGC.

Real-world treatment patterns and outcomes for patients with neoadjuvant treatment between 2019-2022 for gastric or gastroesophageal junction cancer (GC/GEJC) in the US community setting.

345 Background: Treatment options for patients with early-stage GC/GEJC are still limited and the prognosis remains poor, despite recent therapy approvals. With the latest adoption of FLOT use in the US, it is important to understand patients’ characteristics, treatment patterns and outcomes in the US community oncology setting. Methods: This retrospective observational cohort study used electronic health records data from 278 adult patients with stage II-IVA GC/GEJC adenocarcinoma initiating neoadjuvant treatment (index) within The US Oncology Network between 1/1/2019 and 12/31/2022, based on Food and Drug Administration approval of FLOT in 2019. Patients were followed through 9/30/2023, last patient record or death, whichever occurred first. Descriptive analyses were conducted to evaluate patient and treatment characteristics. Kaplan-Meier was used to assess overall survival (OS) and event-free survival (EFS) from index. Adjusted Cox proportional hazard models were used to analyze the association of surgery as a time-dependent variable with OS and EFS. Results: Median (interquartile range [IQR]) age at index was 67.5 (58.2, 74.2) years; most patients were male (68.0%), and half were Caucasian (51.1%). Stage III was the most common initial stage (50.0%), followed by IIB (29.1%), and II (not otherwise specified)/IIA (19.8%). Most patients had an ECOG (0-1) 65.5%. Median (IQR) follow-up from index was 15.6 (8.6, 27.8) months. The most common neoadjuvant regimens were FLOT (51.1%), doublet (28.4%), and CROSS (18.0%). Median OS (months) (95% confidence interval [CI]) for patients with surgery was not reached (NR) (47.7, NR) and those without was 16.1 (8.6, 35.1). Patients with surgery had a longer median EFS (95% CI) (months) than those without 38.3 (25.0, NR) vs 5.6 (4.5, 6.5) (log rank p-value &lt;0.0001). Adjusted hazard ratios (95% CI) for OS and EFS indicated that patients who received surgery were less likely to experience an event than those without, 0.252 (0.139, 0.456) and 0.268 (0.169, 0.426), respectively (p&lt;0.0001). Conclusions: Study findings showed a high proportion of patients receiving FLOT since its approval in US, with a directional OS benefit similar to the FLOT4 trial. Also, receipt of surgery was a strong predictor for OS and EFS. While the results are promising, most patients who did not receive surgery progressed within 6 months and died a little over a year from index. However, given the small portion of patients who did not receive surgery, further research is needed to understand if there is an unmet need for this group. Variable Doublet CROSS FLOT N 79 50 142 Surgery Rate (%) 60.8% 62.0% 71.8% GC Rate (%) 79.8% &lt;20% 85.9% OS, median (95% CI), months 26.0 (20.9, NR) 37.7 (27.8, NR) 52.1 (47.7, NR) EFS, median (95% CI), months 10.8 (8.4, 23.2) 20.9 (11.3, 26.3) 37.7 (18.0, NR)

Change and predictors of body composition after gastrectomy for gastric cancer during first postoperative year.

After gastrectomy for gastric cancer, patients often lose significant body weight because of decreased caloric intake and nutrient absorption. Body weight typically requires approximately 1 year to stabilize. This study aimed to examine the changes and predictors of body composition during the first postoperative year. A total of 230 patients underwent radical gastrectomy for stage I to III gastric cancers. Body composition was measured using bioelectrical impedance analysis, and changes were analyzed over 1 year. Multiple regression analysis was used to identify predictors of body composition changes. Body composition changes and significant body weight and body fat mass reductions occurred primarily within the first 6 months postoperatively. Skeletal muscle mass initially decreased but improved after 6 months without significant changes related to adjuvant chemotherapy. Increased edema was observed at 6 and 12 months postoperatively in patients after total gastrectomy and adjuvant chemotherapy. Gastrectomy type and body mass index significantly affected postoperative body weight changes. In addition, gastrectomy type was associated with changes in skeletal muscle mass and bone mineral content. Adjuvant chemotherapy significantly affected the whole-body phase angle at 6 and 12 months. Our findings emphasized the initial significant reductions postoperatively and subsequent adjustments over time and elucidated the complex interplay between surgical techniques, adjuvant treatment, and patient characteristics and midterm changes in body composition.

Imaging Findings, Complications, and Mimics after Common and Advanced Dental Procedures.

Various new dental treatment methods have been introduced in dental clinics, and many new materials have been used in recent years for dental treatments. Dentistry is divided into several specialties, each offering unique treatments, such as endodontics, implantology, oral surgery, and orthodontics. CT and MR images after dental treatment reveal a variety of hard- and soft-tissue changes and dental materials, which often cause image artifacts. Familiarity with posttreatment changes and dental materials is crucial to avoid misinterpretation of image artifacts as true pathologic features, identify complications, and evaluate for recurrent disease. It also is necessary to be aware of conditions that mimic posttreatment changes and know how to differentiate them at imaging. The authors focus on the imaging of expected and unexpected post-dental treatment changes and characteristics of dental materials on CT and MR images in the head and neck region. The article is divided into five sections: (a) imaging after dental implant treatment, (b) imaging after oral surgery, (c) imaging after endodontic treatment, (d) imaging after orthodontic treatment, and (e) imaging effects of dental treatments. Strategies are provided for distinguishing true pathologic features from posttreatment changes, and the importance of understanding dental procedures, the materials used, and their appearances at radiologic imaging is highlighted. Ultimately, this knowledge can enhance radiologists' ability to interpret complex posttreatment imaging findings, improve diagnostic accuracy, and facilitate effective treatment planning for patients with a history of dental procedures. ©RSNA, 2025 Supplemental material is available for this article.

Financial toxicity in patients with newly diagnosed hepatocellular carcinoma.

538 Background: Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related deaths and has been associated with significant patient (pt) financial liability, however no study has yet examined pt-reported measures of financial toxicity (FT) in this population. We sought to assess pt-reported FT in newly diagnosed HCC and to identify pt-, disease-, and treatment-related factors associated with FT. Methods: Pts with HCC were recruited prior to treatment initiation during their initial visit at a multidisciplinary liver cancer clinic at a tertiary care center between January 2023-May 2024. The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT), a validated survey for assessing financial distress in pts with cancer (range, 0-44; lower scores reflect worse financial wellness), was completed by participants during their initial visit. Sociodemographic (age, sex, race, ethnicity, primary language, insurance status, employment status, marital status, highest education completed, household income, living arrangement, home zip code), clinical (Barcelona Clinic Liver Cancer stage, performance status, age-adjusted Charlson comorbidity index, albumin-bilirubin score, presence and etiology of chronic liver disease, Child-Pugh grade, MELD-Na score), and planned treatment (surgery, liver-directed therapy, systemic therapy, clinical trial enrollment) characteristics were evaluated by questionnaires or medical record review. The EORTC QLQ-HCC18 was used to assess pt-reported quality of life (QOL). Area Deprivation Indices were calculated using pts’ home zip codes. Mean COST-FACIT scores were compared using two-sided t test for binary variables and one-way ANOVA for non-binary variables. Results: Among 47 pts enrolled, 35 (74%) completed the COST-FACIT survey. Younger age (&lt;65 vs ≥65 yrs; mean, 20.3 vs 27.8; p=0.05), non-English primary language (non-English vs English; mean, 16.2 vs 26.7; p=0.04), less completed education (high school or earlier vs college or beyond; mean, 23.3 vs 32.0; p=0.02), and worse self-reported QOL (EORTC QLQ-HCC18 score ≥cohort median vs &lt;cohort median; mean, 21.4 vs 29.2; p=0.02) were significantly associated with worse FT. Although not statistically significant, Hispanic ethnicity (Hispanic vs not Hispanic; mean, 16.1 vs 26.4; p=0.07), lack of employment (not employed vs retired vs employed; mean, 15.5 vs 29.4 vs 24.3; p=0.07), and no plan for liver-directed therapy (no vs yes; mean, 17.9 vs 26.7; p=0.07) trended towards worse pt-reported FT. Conclusions: Among pts with newly diagnosed HCC, significantly higher pt-reported FT is associated with younger age, non-English primary language, less completed education, and worse QOL. Efforts are underway to longitudinally follow our study cohort to assess the course of self-reported FT over 1-year follow-up as well as its associations with treatment response and survival.

Clinical outcomes among COVID-19 patients initiated on molnupiravir in Denmark - A national registry study.

Molnupiravir (MOV) is an orally bioavailable ribonucleoside with antiviral activity against all tested SARS-CoV-2 variants. We describe the demographic, clinical, and treatment characteristics of non-hospitalized Danish patients treated with MOV and their clinical outcomes following MOV initiation. Among all adults (>18years) who received MOV between 16 December 2021 and 30 April 2022 in an outpatient setting in Denmark, we summarized their demographic and clinical characteristics at baseline and post-MOV outcomes using descriptive statistics. Outcomes were emergent hospitalization and all-cause mortality during the 28 days after MOV initiation. We estimated the odds ratios (OR) of outcomes by time from positive test to treatment using logistic regression. We identified 3691 MOV-treated patients, of whom 45.8% were male and mean age was 70.1 years. Most patients (76.2%) initiated MOV within 0-2 days after a positive SARS-CoV-2 test and 16.8% within 3-5 days. Over a 28-day period, rates for all-cause, respiratory- or COVID-19-related, and COVID-19-related hospitalization were 4.8%, 2.6% and 1.5%, respectively. All-cause mortality was 1.6%. Initiation of MOV 3-5 days after a positive SARS-CoV-2 test compared to 1-2 days was associated with an increased risk of all-cause (OR 1.85, 95% CI 1.29-2.67) and respiratory or COVID-19-related (OR 1.78, 95% CI 1.07-2.94) hospitalization, and all-cause mortality (OR 2.90, 95% CI 1.64-5.15). MOV was primarily prescribed to vaccinated elderly persons with multiple comorbidities. The all-cause hospitalization and mortality rates in this population were low. Early initiation of MOV reduced the risk of hospitalization and death compared with late initiation.

A review of symptom, pathogenesis and treatment characteristics of the elderly with chronic insomnia.

One third of a person's life is in a state of sleep, and good sleep quality is one of the indicators of health. Long-term insomnia has a great impact on patients' quality of life, physical and mental state. Especially in the elderly, long-term insomnia will induce a variety of chronic diseases, seriously affecting the quality of life. Because of the characteristics of the physiological structure of the elderly, insomnia in the elderly has its unique characteristics different from that of the young. This article reviews the characteristics of chronic insomnia in the elderly in terms of symptom, pathogenesis and treatment. By elaborating the characteristics of senile chronic insomnia, we hope to provide ideas for clinical treatment of senile chronic insomnia.

Extended-release pharmacotherapies for substance use disorders in incarcerated populations: A systematic review.

Substance use (SU) is prevalent among individuals in the criminal justice system (CJS). However, there is often poor access to treatment. We aimed to assess the effectiveness of two medications, extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) for the prison population. We searched Scopus, OVID/Embase, PubMed/Medline, ProQuest, EBSCO, Cochrane Library and Australian Criminology Database for original articles published from 1 January 2002 to 31 December 2022. 18+, substance use disorder; XR treatment; recent incarceration. We extracted study, participants, treatment characteristics and outcome variables. We conducted risk of bias assessments using the RoB-2, ROBINS-I, JBI tools and Evers et al. RESULTS: We identified 25 papers (16 studies) examining 3403 participants. Sixteen papers (9 studies) focused on XR-NTX, eight (7 studies) on XR-BUP and one on both. Eighteen papers (11 studies) were from the US, with the remainder from Norway, Australia, UK, Canada and Germany. There were eight RCTs (10 papers), four secondary observational analyses, four cohort studies, four economic analyses, two case series and one qualitative paper. Most studies had small-moderate samples, with varying retention and follow-up periods. Among RCTs, two XR-NTX studies for opioid use found no difference in retention vs treatment as usual and placebo, while one reported improved retention for XR-NTX implant vs methadone. One RCT showed mixed retention results for XR-NTX vs placebo in alcohol use. One XR-BUP study showed improved or equivalent treatment retention (depending on measures) vs sublingual buprenorphine. There was no difference in overdoses. SU for XR-NTX was challenging to assess due to differing definitions, measures and comparators. XR-BUP yielded mixed SU results, with one indicating a greater effect and another no difference from comparators. There is no clear evidence for the effectiveness of extended release naltrexone and buprenorphine among individuals in the criminal justice system compared with shorter acting formulations. But there is growing evidence for the effectiveness of extended release buprenorphine in reducing opioid use and improving treatment retention in that population, with potential cost offsets from initial medication expenses.

P-1558. Short vs. Long Durations of Antibiotic Therapy for Pyelonephritis in Kidney Transplant Recipients

Abstract Background Emerging data suggests shorter durations of antibiotic therapy are as effective and safe as longer durations in general populations. The objective of this study is to compare outcomes of short (7-9 days) vs long (10-15 days) durations of antibiotic therapy for acute graft pyelonephritis in kidney transplant recipients (KTRs). Summary of patient, infection and treatment characteristics. Methods IRB-approved retrospective cohort comparing short (7-9 days) to long courses (10-15 days) of antibiotics. Inclusion: Adult patients, hospitalized from 1/1/14 - 12/31/23, history of kidney transplant, acute pyelonephritis, and receipt of at least 7 days of in vitro active antibiotic therapy. Exclusion: renal or perinephric abscess, prostatitis, ≤ 2 months post-transplant. Primary outcome: clinical success, defined as resolution of infection signs and symptoms and confirmed or presumed microbiologic success at end of therapy (EOT). Secondary outcomes: length of stay from pyelonephritis onset, continued resolution of signs and symptoms at 30 days, C. difficile infection within 30 days of EOT, acute rejection, and adverse effects. Summary of primary and secondary outcomes. Results 107 patients were included: 19 (17.8%) short-course and 88 (82.2%) long-course. Table 1 describes patient, infection, transplant, and treatment characteristics. There was 1 (5.3%) failure in the short-course group compared to8 (9.1%) failures in the long-course group at EOT (p=0.456). At 30 days, there were 4 (21.1%) failures in the short-course group and 15 (17.0%) in the long-course group (p=0.742). 30-day retreatment was required in 0 short-course and 8 (9.1%) long-course patients, p=0.346. No significant differences were detected for adverse effects: 0 vs. 3 (3.4%); C. diff: 0 vs. 1 (1.1%); or treated rejection: 1 (5.3%) vs. 0 in the short-course vs long-course groups, respectively. Conclusion We did not detect differences in outcomes for pyelonephritis treatment in KTRs between those who received short compared to longer courses of antibiotic therapy. Further research is needed to solidify the place of short courses of antibiotic therapy in transplant recipients. Disclosures Rachel M. Kenney, PharmD, BCIDP, Medtronic Inc: Spouse is an employee, stockholder