Retrospective Cohort Analysis Research Articles

Clinical Characteristics of "Severe" Peripheral Psoriatic Arthritis: A Retrospective Analysis of a Longitudinal Cohort.

The concept of severity in a multidomain disease such as psoriatic arthritis (PsA) is still not well defined. The aim of this study was to identify the clinical characteristics of patients with severe peripheral PsA. Retrospective analysis of a longitudinal cohort. Demographic and clinical characteristics of patients with PsA were collected at baseline and at last follow-up. We defined the severe population using the modified Composite Psoriatic Disease Activity Index (mCPDAI); which excludes ankylosing spondylitis quality of life scale). Hence, patients with a score of 3 in at least one domain were defined as having severe PsA. Clinical characteristics of patients fulfilling the definition of severe PsA were compared to those non-severe. We evaluated 177 patients with peripheral PsA (M/F: 98/76). Of these, 64 (36.1%) were identified as severe according to the mCPDAI criteria, at baseline. Eighteen patients (10.1%) at last follow-up still met the definition of severe PsA. At last follow-up visit, severe patients with PsA were only males (18/18, P < 0.01) and have worse outcomes in terms of disease activity, pain, function, and impact of disease. Male sex and the severity of skin involvement at baseline were factors associated with the presence of severe PsA. The agreement between the presence of severe PsA and the absence of minimal disease activity was slight [Cohen's k: 0.174 (0.084-0.264)]. Our study showed that severe patients with PsA had more disease activity, pain, and impact of disease than non-severe patients. Furthermore, we demonstrated that severity and disease activity are not interchangeable concepts.

Effect of finerenone on nephrotic syndrome in patients with diabetic kidney disease

IntroductionDiabetic kidney disease (DKD) is an important complication of diabetes as it results in end-stage renal disease; hence, several drugs have been developed for its treatment. However, even with treatment with renin-angiotensin system inhibitors and sodium-glucose cotransporter-2 inhibitors, the residual risk of DKD remains. While this risk is an issue, the renoprotective effects of finerenone, a novel non-steroidal mineralocorticoid receptor antagonist, are becoming evident. High proteinuria increases the risk of cardiovascular death as well as renal failure. Hence, it is especially important to address cases of urine protein to nephrotic levels in DKD, however, no previous studies have assessed the safety and efficacy of finerenone in patients with DKD and nephrotic syndrome. Therefore, this study aimed to assess whether finerenone has a renoprotective effect in advanced DKD complicated by nephrotic syndrome. MethodsNine patients with DKD and nephrotic syndrome who received 10–20 mg/day of finerenone were retrospectively analyzed. The average observation period was 9.7 ± 3.4 months. Patients with serum potassium levels greater than 5.0 mEq/L at the start of finelenone were excluded. Changes in urinary protein levels, estimated glomerular filtration rate (eGFR), and serum potassium levels were studied before and after finerenone administration. ResultsThe mean changes in the urinary protein creatinine ratio (UPCR) at baseline were 6.6 ± 2.0. After finerenone treatment, the mean UPCR decreased to −0.6 ± 3.9; however, this change was not statistically significant.The eGFR decline slope also tended to decrease with finerenone treatment (before vs. after: 3.1 ± 4.9 vs. −1.7 ± 3.2 mL/min/1.73 m2. Furthermore, finerenone did not increase serum potassium levels. ConclusionsPatients treated with finerenone showed decreased UPCR; hence, it is suggested that finerenone may be effective in treating nephrotic syndrome in patients with DKD. These findings may be applicable to real-world clinical settings. Nonetheless, it is important to note that this study was a retrospective analysis of a single-center cohort and had a limited sample size, highlighting the need for additional large-scale investigations.

Demographic and socioeconomic analysis of patients with glucagonoma: Insights from the National Cancer Database.

e16319 Background: Glucagonoma is a rare glucagon-producing alpha islet cell tumor primarily of the pancreas, and a type of pancreatic neuroendocrine tumor. These types of cancers have a 10-year survival rate of about 38%. Metastasis may be found in approximately 50% of glucagonoma cases. As a result of the low incidence of glucagonoma, analysis of the diagnostic patterns may provide more insight into the disease’s epidemiology. This study analyzed the National Cancer Database (NCDB) to examine demographic factors of individuals diagnosed with glucagonoma. Methods: ICD-8152-3 Data from the NCDB between 2004-2020 was gathered to perform a retrospective cohort analysis on patients diagnosed with glucagonoma (N = 88). Descriptive statistics were used to investigate demographic factors such as age, sex, race, Hispanic status, years of education, insurance, facility type, distance from facility, and Charlson-Deyo score. Regression analysis was utilized to evaluate incidence trends. Results: We found that patients had an average age of 61 years (SD = 13, range = 23-90), with an average tumor size of 53 mm (SD = 39, range = 12-140), and the majority were male (61%) and White (90%). The majority of patients (97%) did not receive palliative care, with surgery (57%) and chemotherapy (28%) being the primary treatments. Post-surgery, 90% had no residual tumor, and survival rates were 98% after thirty days and 96% after ninety days. Most were treated in academic/research facilities (43%) and had private insurance (59%) or Medicare (34%). The largest median household income quartile of these patients was $74,063 or more (39%).The study noted a 2-year survival rate of 74%, a 5-year rate of 54%, and a 10-year rate of 31%, with a mean survival of 89.3 months. The primary disease sites were the tail of the pancreas (32%) and pancreas, NOS (22%). The distribution across NCDB Analytic Stage Groups was 19% for Stage I, 11% for Stage II, 2% for Stage III, and 23% for Stage IV. Conclusions: This study represents the first analysis of glucagonoma patients using the National Cancer Database, filling a gap in our understanding of the disease. The findings indicate that the majority of glucagonoma patients were non-Hispanic, White, and had tumors primarily located in the tail of the pancreas, aligning with earlier case report descriptions. Socioeconomically, patients most likely had earnings above the median income quartile, resided in densely populated metropolitan areas, and received treatment in academic facilities. Further investigation is necessary to have a more thorough grasp of the impact of demographic and socioeconomic characteristics on glucagonoma patients' diagnosis, course of treatment, and overall survival rates.

Long-Term Effects of Pulmonary Valve Implantation and Prosthesis Evolution in Patients with Repaired Tetralogy of Fallot.

Pulmonary valve regurgitation is a significant long-term complication in patients with tetralogy of Fallot (TOF). This study aims to investigate the effects of pulmonary valve implantation (PVI) on the anatomy and function of the right ventricle (RV) and the long-term evolution of the implanted prosthesis in the pulmonary position. A single-center retrospective cohort analysis was performed in 56 consecutive patients with TOF who underwent PVI. The study included patients of both sexes, aged ≥ 12 years, and involved assessing clinical and surgical data, pre- and post-operative cardiovascular magnetic resonance imaging, and echocardiogram data more than 1 year after PVI. After PVI, there was a significant decrease in RV end-systolic volume indexed by body surface area (BSA), from 89 mL/BSA to 69 mL/BSA (p < 0.001) and indexed RV end-diastolic volume, from 157 mL/BSA to 116 mL/BSA (p < 0.001). Moreover, there was an increase in corrected RV ejection fraction [ RVEFC = net pulmonary flow (pulmonary forward flow - regurgitant flow) / R V end-diastolic volume ] from 23% to 35% (p < 0.001) and left ventricular ejection fraction from 58% to 60% (p = 0.008). However, a progressive increase in the peak pulmonary valve gradient was observed over time, with 25% of patients experiencing a gradient exceeding 60 mmHg. Smaller prostheses (sizes 19 to 23) were associated with a 4.3-fold higher risk of a gradient > 60 mmHg compared to larger prostheses (sizes 25 to 27; p = 0.029; confidence interval: 1.18 to 17.8). As expected, PVI demonstrated improvements in RV volumes and function. Long-term follow-up and surveillance are crucial for assessing the durability of the prosthesis and detecting potential complications. Proper sizing of prostheses is essential for improved prosthesis longevity.

Implementation of a vascular acute care surgery model is associated with improved surgeon efficiency and 2-year mortality after lower extremity intervention

ObjectiveVascular surgeons work long, unpredictable hours with repeated exposure to high-stress situations. Inspired by general surgery acute care surgery models, we sought to organize the care of vascular emergencies with the implementation of a vascular acute care surgery (VACS) model. Within this model, a surgeon is in-house without elective cases and assigned for consultations and urgent operative cases on a weekly basis. This study examined the impact of a VACS model on postoperative mortality and surgeon efficiency. MethodsThis was a retrospective cohort analysis of institutional Vascular Quality Initiative data from July 2014 to July 2023. Patients undergoing lower extremity bypass, peripheral vascular intervention, or amputation were included. There was a washout period from January 2020 to January 2022 to account for COVID-19 pandemic practice abnormalities. Patients were separated into pre- or post-VACS groups. The primary clinical outcomes were 30-day and 2-year mortality. Secondary clinical outcomes included 30-day complications and 30-day and 1-year major adverse limb events (MALE). Separate analyses of operating room data from July 2017 to February 2024 and fiscal data from fiscal year 2019 to fiscal year 2024 were conducted. A washout period from January 2020 to January 2022 was applied. Efficiency outcomes included monthly relative value units (RVUs) per clinical fraction full-time equivalent (cFTE) and daytime (0730-1700, Monday-Friday) operating room minutes. Patient factors and operative efficiency were compared using appropriate statistical tests. Regression modeling was performed for the primary outcomes. ResultsThere were 972 and 257 patients in the pre- and post-VACS groups, respectively. Pre-VACS patients were younger (66.8 ± 12.0 vs 68.7 ± 12.7 years; P = .03) with higher rates of coronary artery disease (34.6% vs 14.8%; P < .01), hypertension (88.4% vs 82.2%; P = .01), and tobacco history (84.4% vs 78.2%; P = .02). Thirty-day mortality (2.4% pre-vs 0.8% post-VACS; P = .18) and Kaplan-Meier estimation of 2-year mortality remained stable after VACS (P = .07). VACS implementation was not associated with 30-day mortality but was associated with lower 2-year mortality hazard on multivariable Cox regression (hazard ratio [HR], 0.5; 95% confidence interval [CI], 0.3-0.9; P = .01). Operative efficiency improved post-VACS (median, 850.0; interquartile range [IQR], 765.7-916.3 vs median, 918.0; IQR, 881.0-951.1 RVU/cFTE-month; P = .03). Daytime operating minutes increased (469.1 ± 287.5 vs 908.2 ± 386.2 minutes; P < .01), whereas non-daytime minutes (420.0; IQR, 266.0-654.0 vs 469.5; IQR, 242.0-738.3 minutes; P = .40) and weekend minutes (129.0; IQR, 0.0-298.0 vs 113.5; IQR, 0.0-279.5 minutes; P = .59) remained stable. ConclusionsA VACS model leads to improvement in surgeon operative efficiency while maintaining patient safety. The adoption of a vascular acute care model has a positive impact on the delivery of comprehensive vascular care.

Influence on surgical approach in hepatocholangiocarcinoma: A demographic and socioeconomic analysis.

e16280 Background: Hepatocholangiocarcinoma (HCC-CC) is a rare and aggressive malignancy of the liver that contains histopathological features of both hepatocellular carcinoma and cholangiocarcinoma. Surgery is the mainstay of treatment, and the surgical approaches used include radical hepatic resection, laparoscopic, and robotic surgery. There has yet to be a study that explores the impact of demographic features on the choice of surgical modality in patients with HCC-CC. The National Cancer Database (NCDB) was analyzed to determine the effects of demographic features on surgical modality and overall survival. Methods: A retrospective cohort analysis utilizing the NCDB included 2,449 patients diagnosed with HCC-CC (ICD-8180/3) between 2004-2020. Surgical modality was categorized into either open or minimally invasive by the preliminary treatment. Minimally invasive techniques included robotic-assisted and minimally invasive. Race, sex, age at diagnosis, income level, insurance used, distance from the facility, and the status of the facility as an academic center on the surgical modality were compared using Pearson Chi-squared tests or independent samples t-test as pertinent. Multivariate analysis with binary logistic regression was used to analyze the following categorical variables in relation to choice of surgical modality: race, sex, income, insurance, sex, and facility type. Surgical treatment modality on overall survival was analyzed by the Kaplan-Meier method. Exclusion criteria included missing data. Results: Most cases analyzed were White (75.8%), male (67.5%), and had government insurance as the primary payor at diagnosis (60.6%). Of the cases analyzed, 625 underwent surgery (25.5%). Patients who underwent minimally invasive surgery were more likely to be government-insured than patients who underwent open surgery (69.8% vs. 55.6%, P &lt; 0.05). Patients who underwent open surgery were younger on average (61.4 vs. 66.0 years, P &lt; 0.05). There was no significant difference in distance from residence to the treatment facility between the two surgical approaches. Multivariate analysis showed that patients treated at academic centers were less likely to receive minimally invasive surgery (28.1%) over open surgery (71.9%; P = 0.041, 95% CI 0.469-0.985) without statistical significance for race, sex, income, or insurance. The average survival time was significantly longer in open vs minimally invasive surgery (67.9 vs. 55.3 months, P &lt; 0.05). Conclusions: We identified that patients who underwent open surgery had significantly better overall survival with an average difference of 12.6 months. Even after accounting for other factors, the choice of surgical modality was significantly influenced by treatment at an academic institution. Patients receiving care at an academic facility are more likely to receive open surgery leading to overall increased survival.

Malignant blue nevus: Epidemiology, socioeconomic factors, and disease presentation.

e21565 Background: Malignant blue nevus (MBN) is a rare and aggressive melanoma that arises in a blue nevus and tends to metastasize to the lymph nodes. Metastasis has been described in up to 55% of cases, and the 10-year survival rate is 51%. Current literature on MBN is limited. Data from the National Cancer Database (NCDB) on the demographic and socioeconomic characteristics of patients with MBN could provide insightful information regarding the epidemiology of this rare disease. Methods: The 2004-2020 NCDB was used to perform a retrospective cohort analysis of patients diagnosed with malignant blue nevus (N = 118) using ICD-O-3 code 8780/3. This study used descriptive statistics to analyze factors such as age, sex, income status, insurance status, Charlson-Deyo score, treatments, and survival rates. Results: A total of 118 patients diagnosed with MBN were recorded in the NCDB with an average age at diagnosis of 56.7 ± 17.2 years with a female preponderance (59%). Nearly all patients were insured (99%), mostly by private insurance (59%) or Medicare (27%). Over half of patients (54%) were enrolled in research programs, and 62% of patients comprised the top two income quartiles based on median household income. The vast majority of patients (81%) had no major comorbidities (Charlson-Deyo = 0). The top primary sites were the skin of the scalp and neck (36%) and the trunk (21%). The average tumor size was 21.2 ± 30.3 mm ranging from 2 mm-120 mm. The most frequent treatment performed was surgery, with 92% of patients undergoing surgical procedures of the primary site. Among these, the most common procedures were wide excision or re-excision (52%), excisional biopsy (14%), and shave biopsy followed by gross excision (10%). After resection, 77% of patients showed no residual tumor. In place of surgery, a smaller number of patients received alternate treatments as their main therapy, such as radiation therapy (11%), chemotherapy (6%), or immunotherapy (12%). The 2-year and 5-year survival rates were 88% and 68% respectively. Conclusions: Based on our literature review, this study is the first NCDB analysis on MBN and presents data from the largest cohort of patients to date. Patients with MBN are more likely to be female, and most lack major comorbidities. The most common sites are the scalp, neck, or trunk, in line with current literature. Review of socioeconomic factors revealed that an overwhelming majority of patients are likely to be insured and in the top two income quartiles. These findings could implicate that those who are more socioeconomically advantaged may have more resources for recognition of disease and proper diagnosis, especially considering the challenges of diagnosing MBN due to poorly defined histological criteria. Further research efforts should investigate the impacts of socioeconomic factors on diagnosis, treatments, and prognosis.

Robotic distal ureterectomy for high-risk distal ureteral urothelial carcinoma: a retrospective multicenter comparative analysis (ROBUUST 2.0 collaborative group).

The role of kidney-sparing surgery in patients with high-risk upper urinary tract urothelial carcinoma is controversial. The present study aimed to assess oncological and functional outcomes of robot-assisted distal ureterectomy in patients with high-risk distal ureteral tumors. The ROBUUST 2.0 multicenter international (2015-2022) dataset was used for this retrospective cohort analysis. High-risk patients with distal ureteral tumors were divided based on type of surgery: robot-assisted distal ureterectomy or robot-assisted nephroureterectomy. A survival analysis was performed for local recurrence-free survival, distant metastasis-free survival, and overall survival. After adjusting for clinical features of the high-risk prognostic group, Cox proportional hazard model was plotted to evaluate significant predictors of time-to-event outcomes. Overall, 477 patients were retrieved, of which 58 received robot-assisted distal ureterectomy and 419 robot-assisted nephroureterectomy, respectively, with a mean (±SD) follow-up of 29.6 months (±2.6). The two groups were comparable in terms of baseline features. At survival analysis, no significant difference was observed in terms of recurrence-free survival (P=0.6), metastasis-free survival (P=0.5) and overall survival (P=0.7) between robot-assisted distal ureterectomy and robot-assisted nephroureterectomy. At Cox regression analysis, type of surgery was never a significant predictor of worse oncological outcomes. At last follow-up patients undergoing robot-assisted distal ureterectomy had significantly better postoperative renal function. Comparable outcomes in terms of recurrence-free survival, metastasis-free survival, and overall survival between robot-assisted distal ureterectomy and robot-assisted nephroureterectomy patients, and better postoperative renal function preservation in the former group were observed. Kidney-sparing surgery should be considered as a potential option for selected patients with high-risk distal ureteral UTUC.

Demographic and socioeconomic factors of enterochromaffin cell carcinoid.

e16288 Background: Gastric carcinoid tumors, previously known as neuroendocrine neoplasms, are derived from enterochromaffin cells and show an increasing incidence globally. Neuroendocrine tumors often result in hormonal syndromes due to the production of exogenous hormonal peptides by the tumor. Current treatment options include surgical resection and somatostatin pharmacotherapy to blunt tumor growth. A gastric carcinoid malignancy that requires more investigation is enterochromaffin cell carcinoid (ECC). Considering the increasing incidence of gastric carcinoids, a retrospective investigation of demographic data involving enterochromaffin cell carcinoids was performed using the National Cancer Database (NCDB). Methods: The 2004-2019 NCDB was explored to perform a retrospective cohort analysis of patients diagnosed with ECC. 200 patients with a histologically confirmed diagnosis (ICD-O-3 code 8241/3) were identified. Descriptive statistics were used to analyze the following demographic data of patients in this study: race, sex, age, income quartile, facility type, Hispanic status, and Chales/Deyo score. Regression analysis was used to interpret incidence trends. Results: The NCDB identified 200 patients diagnosed with ECC from 2004-2019 with incidence rates varying over this time (R² = 0.0001). The mean age at diagnosis was 55 years (SD = 19.7, range = 14-90). Women (62%) were more likely to be diagnosed than men. The majority of patients were White (86%) and non-Hispanic (80%). Most patients (99.9%) received treatment for the remission of the cancer, predominantly through surgical means (86.5%). More patients were treated in an Comprehensive Community Cancer program (34.5%) than in an academic/research program (26.0%). The majority of individuals lived in metropolitan counties with a population greater than 1 million (54%) than in other metropolitan counties (22%). Most patients were in the fourth quartile of income earners (32.1%). The top primary site was the appendix (40.5%), and most individuals (79.5%) had Charles/Deyo comorbidity scores of 0. Conclusions: To the best of our understanding, this is the first NCDB investigation of Enterochromaffin Cell Carcinoid (ECC) and therefore addresses a meaningful educational disparity on the topic. Most ECC patients tend to be White, non-Hispanic individuals with a primary diagnosis site of the appendix, consistent with previous studies. Upon analyzing the socioeconomic factors of ECC patients, it was found that they often fall into the top income quartile, live in densely populated metropolitan counties, and receive treatment from a comprehensive community cancer program. Due to the significance of these demographic and socioeconomic factors, more research is needed to understand their impact on the diagnosis and treatment of ECC.

Survival analysis and life expectancy of pediatric patients with spinal muscular atrophy in Thailand

BackgroundSurvival data for Thai patients with 5q spinal muscular atrophy (SMA), the leading cause of infant mortality worldwide, are lacking. ObjectiveThis study aimed to determine the survival rates and life expectancies of pediatric patients with SMA types 1, 2, and 3. MethodsWe conducted a retrospective cohort analysis of genetically confirmed 5q SMA patients aged 0–18 years who were treated between 1999 and 2021 at the pediatric neuromuscular clinic of Siriraj Hospital, Bangkok, Thailand. Mortality data were sourced from the Civil Registration Office. ResultsThe study included 113 patients: 37 with SMA type 1, 53 with type 2, and 23 with type 3. Life expectancy varied significantly by SMA type: 2.2 years for type 1, 11 years for type 2, and 16.5 years for type 3. The median survival times for SMA type 1 and 2 were 1.9 and 19 years, respectively. In SMA type 2, early onset (<1 year) correlated with a shorter median survival than later onset (≥1 year) (log-rank test P = 0.009). Early onset SMA type 2 had a median survival time of 15.9 years, while 75 % of those with later onset SMA type 2 survived until the age of 19 years. Cox proportional hazards analysis revealed that each month's delay in disease onset reduced the annual mortality risk by 17 % for type 1 patients and by 20 % for type 2 patients. Compared with female patients, male patients with type 2 disease had a 12-fold increased mortality risk. ConclusionsAge at onset is a significant predictor of survival and life expectancy in patients with SMA types 1 and 2. These insights are crucial for genetic counseling and prognostic discussions in clinical settings.

Malignant chondroblastoma: NCDB analysis of demographic and socioeconomic factors.

e23500 Background: Malignant chondroblastomas are atypical forms of the rare benign chondroid-producing neoplasm known as a chondroblastoma. Chondroblastomas account for less than 1% of all bone tumors and arise in the epiphyses of long bones in young adults. Unlike conventional chondroblastoma, the majority of patients diagnosed with malignant chondroblastomas tend to be older and tumors present at atypical body sites. Therefore investigating trends in diagnosis may yield important insight into its epidemiology. The National Cancer Database (NCDB) was explored to analyze the demographic factors in patients diagnosed with malignant chondroblastoma. Methods: A retrospective cohort analysis utilizing the 2004–2020 National Cancer Database (NCDB) included 67 patients with a histologically-confirmed diagnosis of malignant chondroblastoma (ICD-O-3 Code 9230). Demographic factors (age, sex, race, Hispanic status, insurance status, facility type, distance from facility, and Charlson-Deyo score) were analyzed by descriptive statistics, and incidence trends were interpreted using regression analysis. Results: Between 2004 – 2020, the NCDB identified 67 patients with a confirmed malignant chondroblastoma diagnosis. There was a slightly increasing incidence of patients diagnosed per year (R² = 0.471). The most common primary site was the frontal lobe (60%). Males and females were affected equally (49% and 51%, respectively) with a mean age at diagnosis of 46.5 years (SD = 15.3, Range = 21 – 74 years). The majority of patients were White (90%), non-Hispanic (87%), lived in metropolitan areas (82%), and were privately insured (63%). Treatment facilities primarily consisted of academic programs (48%). Patients lived an average of 27 miles away from the facility (SD = 49, Range = 356.3 miles). Most individuals (76%) had Charlson-Deyo comorbidity scores of 0. Primary treatment methods involved administering radiation therapy (52%). 60 patients (90%) underwent surgical intervention. For valid data, post-surgery survival rates were 100% after 30 days and 93% after 90 days. About half of the patients (57%) survived 5 years after their initial diagnosis. Conclusions: Malignant chondroblastoma is locally aggressive and has metastatic potential. Surgical intervention was the most common treatment (90%), which is consistent with the previous literature. In this study, AJCC staging was not applicable to almost all of the patients (99%). To the best of our knowledge, this is the first NCDB analysis of malignant chondroblastoma patient demographic and socioeconomic factors which addresses a significant gap in knowledge. Most patients were White, non-Hispanic, lived in metropolitan areas and were privately insured. Additional investigation is required to enhance our understanding of how demographic and socioeconomic factors influence the diagnosis, staging, and treatment of individuals with malignant chondroblastoma.

Analysis of demographic and socioeconomic factors in mixed type rhabdomyosarcoma using NCDB.

e23538 Background: Mixed type rhabdomyosarcoma is a rare soft tissue tumor characterized by the presence of two histologically different subtypes of rhabdomyosarcoma, commonly found in the testis. Despite a majority of the patients undergoing aggressive treatment, the prognosis is poor. Analysis of its diagnostic trends could prove valuable in understanding mixed type rhabdomyosarcoma’s epidemiology. The 2004-2020 National Cancer Database (NCDB) was analyzed to determine the demographic factors of patients with mixed type rhabdomyosarcoma. Methods: A retrospective cohort analysis of the 2004–2020 NCDB, using ICD-O-3 code 8902/3, included patients diagnosed with mixed type rhabdomyosarcoma (N = 94). Descriptive statistics were used to analyze various demographic factors such as sex, age, race, Hispanic status, educational background, insurance status, facility type and location, distance from facility, and Charlson-Deyo score. Incidence trends were examined through regression analysis. Results: The NCDB identified a total of 94 patients with a confirmed diagnosis of mixed type rhabdomyosarcoma from 2004-2020, with a slight decline in incidences diagnosed per year (R² = 0.0903). Females had a slightly higher likelihood of being diagnosed (55%) compared to males (45%), with average age at diagnosis being 40.06 years (SD = 2.8, Range = 1-90). The majority of patients were White (72%) and of non-Hispanic descent (82%). The top primary site was the testis (23%), with endometrium being another major site (15%). Most (83%) patients had a Charles/Deyo comorbidity score of 0. All patients received immunotherapy as primary treatment. Most (46%) patients were privately insured. A majority (26%) of patients received treatment at an academic/research program. A greater number (53%) of patients resided in metropolitan counties with a population larger than 1 million. Most (40%) patients belonged to the highest quartile of income earners of $74,063 or greater. Conclusions: Our research on mixed type rhabdomyosarcoma, the first NCDB analysis of its kind, aims to address a notable knowledge gap on the topic. Similar to information presented in earlier studies, our analysis revealed mixed type rhabdomyosarcoma has a relatively poor prognosis and is mostly observed in White, Non-Hispanic individuals. Analysis on the demographics of this patient population revealed most patients were top quartile income earners, resided in a metropolitan location, and were more likely to be treated at an academic/research program. Further research should aim to better understand the impact of such demographic and socioeconomic features on the diagnosis, treatment plans, and overall mortality rates of patients with mixed type rhabdomyosarcoma.

Contemporary Role of Open Left Thoracoabdominal Approach in Esophageal Malignancy Treatment.

Despite the widespread use of minimally invasive techniques, open left thoracoabdominal esophagectomy (LTE) can offer excellent visualization and adaptability. The current study aimed to present and evaluate the outcomes related to an open LTE in esophageal malignancy treatment. A retrospective cohort analysis of data collected from two institutions was performed, including patients with distal esophageal or junctional tumors who underwent open LTE between November 2018 and December 2023. Twenty-two patients were included (16 males; mean age 62.8 years). Postoperative complications occurred in eight patients (36%), with pulmonary complications being the most prevalent (seven patients; 32%). One patient experienced a clinical anastomotic leak. No reoperations or escalation to a higher level of care were required. In-hospital and 30-day mortality were zero. Tumor cells were found at the surgical margins in six patients (27%). The mean lymph node yield was 27. During the follow-up period, there were nine deaths and 11 cases of disease recurrence. Isolated locoregional recurrence was seen in five patients (23%). The one-year and two-year overall survival rates were 79% and 47%, respectively. In selected cases, open LTE remains a valid and safe operation with acceptable morbidity and oncological efficacy.

Analysis of demographic and socioeconomic factors in biphasic synovial sarcoma using data from the National Cancer Database.

e23524 Background: Synovial sarcoma, a rare type of soft tissue sarcoma, can be classified into two subtypes - biphasic and spindle cell. Of the two, biphasic synovial sarcoma (BSS) has a better 5-year survivorship; however, 35% of patients diagnosed with BSS die within 5 years. Despite past controversy, adjuvant chemotherapy has been found to improve overall survival for patients with stage III BSS. The National Cancer Database (NCDB) was examined to discover the demographics of individuals diagnosed with BSS. Methods: The 2004-2020 NCDB was analyzed to conduct a retrospective cohort analysis. Patients with a histologically confirmed diagnosis of BSS (ICD-O-3 code 9043) were included (N = 92). Demographic factors like age, sex, race, Hispanic origin, insurance status, educational attainment, distance from facility, facility type, and Charles/Deyo score were evaluated using descriptive statistics and incidence trends were interpreted with regression analysis. Results: Ninety-two biphasic synovial sarcoma cases sampled between 2004 and 2020 revealed an average age at diagnosis of 47.3 years (SD = 19.9, range = 5–87), with males being more likely to be diagnosed (58%). The patients reside at an average of 42 miles from treatment facilities (SD = 108.56, range = 0.3–800.6). Primary disease sites varied, including the lower lobe of the bronchus or lung (12%), upper lobe (11%), and long bones (11%). Diagnosis frequency (2004–2020) showed minimal variation (R^2 = 0.007). Palliative care was not received in 95% of cases, and 41% of patients did not undergo a surgical procedure at the primary site. In patients who received surgery, residual tumor absence post-resection was noted in 56% of patients. Primary treatments included chemotherapy (48%) and radiation therapy (42%), with an average tumor size of 65.2 mm (SD = 42.8, range = 9–195 mm). Notably, 74% survived beyond 90 days post-surgery, with a thirty-day mortality rate of 2%. Patients survived an average of 8.5 years post-diagnosis. Facility-wise, 37% were in academic/research programs. Privately insured patients constituted 60%, with 51% of all patients residing in metropolitan areas of 1 million or more. Conclusions: This analysis addresses a critical knowledge gap, offering insights into the demographics and socioeconomic factors affecting the diagnosis and treatment of Biphasic Synovial Sarcoma (BSS). The average age of BSS diagnosis is 47.3 years with males being predominantly affected, consistent with earlier case reports. BSS patients showed diverse geographic distribution. Survival beyond 90 days post-surgery was high. Chemotherapy and radiation therapy were common treatments. Unique findings include a majority residing in metropolitan areas, and non-academic program treatments. This study underscores the necessity for further research to grasp the impact of these factors on BSS diagnosis, treatment, and overall survival.

Incidence and demographics of bile duct cystadenocarcinoma from the National Cancer Database.

e16231 Background: Bile duct cystadenocarcinoma, a rare tumor of the biliary tree, manifests itself within both multilocular and unilocular cysts composed of mucous-secreting, cytologically malignant epithelial cell populations. While similar in presentation to other biliary tree malignancies, bile duct cystadenocarcinoma has unique morphological variations between sexes. This contrast in disease manifestation based on sex could potentially impact diagnostic imaging, testing approaches, and treatment strategies for both female and male patients. The potential impact of demographics on the prognosis of bile duct cystadenocarcinoma, along with limited literature on the subject, make it a compelling subject for hypothesis generating epidemiological inquiry. The National Cancer Database will be used to illuminate the demographic intricacies. In this pursuit, we aim to provide a demographic and incidence background to prompt future research dedicated to the understanding of bile duct cystadenocarcinoma. Methods: The National Cancer Database (NCDB) was used to complete a retrospective cohort analysis of all patients diagnosed with histologically confirmed bile duct cystadenocarcinoma from the years 2004 to 2020. Demographic factors were subjected to descriptive statistical techniques, while a comprehensive regression analysis was employed to analyze the patterns in disease incidence. Results: Between 2004 and 2020, 64 patients were diagnosed with bile duct cystadenocarcinoma in the NCDB. There was a decline of incidence per year (R2 = 0.0392). The majority of those diagnosed with this disease were female (70%). Most of the patients were from Caucasian ethnicity (73%). The average age of diagnosis was 65 years old ( SD = 12.5, range = 33-88). The highest percentage of patients were on Medicare (55%). The primary site of the cancer was in the intrahepatic bile duct (63%). 70% of patients had a Charlson-Deyo Score of 0. Stage 1 was the most detected stage (42%). The average size of the tumor when detected was 65 mm (SD = 35.5, range = 9-144 mm). Most patients (72%) received surgical treatment and the remainder received radiation or chemotherapy alone. Regarding margins post-surgery, most of the patients (56%) had no residual tumor. Almost all patients (92%) received treatment designed for cure/remission. Mean survival after diagnosis was 8 years. Conclusions: Consistent with a vast majority of case reports, our results demonstrated that the majority of cases of bile duct cystadenocarcinoma were found in women (70%). Moreover, given that a significant proportion of patients affected by this disease are covered by Medicare (55%), we contend that investigating the precise influence of demographic factors and social determinants of health in this context presents a compelling avenue for future research.

Racial differences in therapies received by patients with cutaneous T cell lymphoma (CTCL): A single center retrospective cohort analysis.

e23141 Background: Black patients with cutaneous T-cell lymphoma (CTCL) have increased risk of mortality and higher rates of treatment complications compared to other racial groups, however, drivers of these disparities are poorly understood. Recent advances in novel targeted therapies, such as mogamulizumab and brentuximab vedotin (BV), have demonstrated improved survival compared to standard therapies. We aimed to identify treatment patterns and clinical outcomes in patients with mycosis fungoides and Sezary syndrome (MF/SS) to better understand potential drivers underlying these racial disparities. Methods: We performed a retrospective review of 282 patients with a histopathologic diagnosis of advanced stage MF/SS seen at the Winship Cancer Institute of Emory University from 2000-2023. Clinical data was collected from the electronic medical record and included demographics, histopathologic findings, therapies received, highest disease stage reached, and survival. Differences in baseline characteristics and treatments were assessed using univariate analysis. The association between race, insurance status, disease stage, and category of treatment was assessed using multivariable analysis of overall survival (OS). Results: The cohort was comprised of an even distribution of patients identifying as Black (50%) and white (47.5%). Median age at diagnosis was 61 years (range, 12-91), and Black patients had an earlier age of diagnosis compared to white (median 52 vs. 65.5 years, p &lt; 0.001). The majority of patients had a pathological diagnosis of MF (79.1%). Large cell transformation was seen in 24.8%. Most common stage was stage 2b (36.2%); other stages included 3a (18.1%), 3b (4.3%), 4a1 (19.1%), 4a2 (13.1%), and 4b (9.2%). Systemic therapies were divided into three groups: standard chemotherapy, biologics (interferon, retinoids, extracorporeal photopheresis, and methotrexate), and novel agents (mogamulizumab, BV, and clinical trials). Median OS was 47.5 months (range, 2-246 months), and was greater in patients who received treatment with novel agents (hazard ratio 0.46, 95%, CI 0.29-0.73, p &lt; 0.001). Black patients were less likely to receive photopheresis and local radiation compared to white patients (36.73% vs. 63.27% and 39.53% vs. 60.47%, p &lt; 0.05, respectively), however, there were no differences in the receipt of novel agents by race. There were no differences in OS between Black and white patients. Conclusions: While we did find some differences in treatment patterns by race, these did not translate to a difference in outcomes. Importantly, in this cohort of patients who received similar rates of novel targeted therapies across racial groups, there were no differences in survival by race. These findings suggest that factors such as access to novel targeted therapies may play a role in the well-documented racial disparities in treatment outcomes.

Spindle cell rhabdomyosarcoma: A study of demographics and socioeconomic factors using NCDB.

e23539 Background: Spindle cell rhabdomyosarcoma (SC-RMS) is a rare malignancy characterized by elongated spindle cells displaying eosinophilic and fibrillar cytoplasm, resembling smooth muscle fibers. SC-RMS is primarily diagnosed in children with particular involvement of the nasopharynx, parotid gland, nasal cavity, and paratesticular regions. Though surgical resection and chemotherapy are the current recommendations, definitive treatment guidelines remain unestablished. Because SC-RMS is a novel cancer type, evaluating the diagnostic trend of the disease has the potential to provide valuable insights into its epidemiology. An analysis of the National Cancer Database (NCDB) was conducted to identify the demographic factors associated with patients who have been diagnosed with SC-RMS. Methods: A retrospective cohort analysis of the 2004–2020 NCDB, using ICD-O-3 code 8912/3, included patients with a histologically-confirmed diagnosis of SC-RMS (N = 132). Demographic factors (age, sex, race, Hispanic status, educational attainment, insurance status, facility type, distance from facility, and Charles/Deyo score) were analyzed by descriptive statistics and incidence trends were interpreted in regression analysis. Results: A total of 132 patients with a confirmed diagnosis of SC-RMS were identified, with a declining incidence of diagnoses per year (R² = 0.4507). The average age of diagnosis was 33.9 years (SD = 27.2, Range = 1-90). SC-RMS was more commonly observed among males (63%), with a majority of patients being non-Hispanic (87%) and White (74.2%). The top primary site was the testis (20%). Most patients (83%) had a Charlson/Deyo comorbidity score of 0. The majority (69%) of patients received surgery as their primary treatment. Most patients were privately insured (49%) and resided in metropolitan areas with a population greater than 1 million (48%). More (29%) patients were in the highest quartile of income earners of $74,063 or greater. Patients were treated most often at an academic/research program (19%) or comprehensive community care program (12%). Patients lived an average of 68.2 miles (SD = 267.9, Range = 0.6 - 2403.1) from the treatment facility. Conclusions: To the best of our knowledge, this is the first NCDB analysis on SC-RMS. Our analysis revealed that the majority of SC-RMS patients were young males with primary involvement of the testis, supporting previous studies. Analysis of the socioeconomic factors of SC-RMS patients revealed that more patients were privately insured, resided in densely populated metropolitan areas, and were part of the top quartile of income earners. Further research is supported to better understand the impact of socioeconomic factors on diagnosis, treatment options, and overall mortality rates associated with SC-RMS.

Breast cancer disparities among Hispanics in the US: Insights into healthcare access.

e13734 Background: Breast cancer (BC) is the most prevalent cancer and the second leading cause of cancer-related death in women in the US. Hispanics account for 19.1% of the US population, ranking as the second-largest racial/ethnic group, following the Non-Hispanics White (NHW) population. We aimed to assess the current BC characteristics and treatment patterns among Hispanics in the US. Methods: We conducted a retrospective cohort analysis utilizing the Surveillance, Epidemiology, and End Results Registry (SEER). Women newly diagnosed with breast cancer stages 1-3 between 2018 and 2020 were included. Bivariable analyses were conducted using two-sample Wilcoxon rank-sum and Chi2 square to evaluate delay in treatment, defined as a lapse of 3+ months between diagnosis and the initiation of treatment. Treatment encompassed neoadjuvant chemotherapy, radiation, or upfront surgery. Results: The study included 135,690 participants, among whom 16.5% (22,346) were Hispanic. Hispanic women were notably younger than their NHW counterparts (58 vs 65 years old). Most Hispanic and NHW patients resided in metropolitan areas and counties with an MHI exceeding $75,000. While both groups were predominantly diagnosed with Stage 1 IDC, it is noteworthy that a higher proportion of Hispanics tended to be diagnosed at more advanced stages (25.3% vs 17.9%). Additionally, Hispanic and NHW women were mostly diagnosed with HR+/HER2- BC (70.1% vs. 77.7%). Moreover, Hispanics had a higher percentage of HER2+ (15.2% vs. 11.5%) and TNBC (11.4% vs. 8.5%). Hispanics and NHW patients received mostly upfront surgery (74.3% vs. 83.1%), although a larger percentage of Hispanics were treated with NACT (20.8% vs 12.4%). Hispanic patients had a median time to treatment of 1.5 ± 1.34 months, while NHW patients had a shorter time of 1.22 ± 1.07 months, p-value &lt;0.001. After adjusting for all variables, Hispanic women had 2.47 times the odds of experiencing a treatment delay compared to NHW women. Conclusions: This study reveals healthcare access disparities for Hispanic BC patients, emphasizing the need for targeted interventions. Personalized strategies in clinical practice and health policy are crucial for ensuring equitable outcomes for all. [Table: see text]

Comment on "Impact of the Surgical Approach for Neoadjuvantly Treated Gastroesophageal Junction Type II Tumors: A Multinational, High-Volume Center Retrospective Cohort Analysis".

Comment on "Impact of the Surgical Approach for Neoadjuvantly Treated Gastroesophageal Junction Type II Tumors: A Multinational, High-Volume Center Retrospective Cohort Analysis".

Adverse events of patients treated with antibody-drug conjugates in phase 1 clinical trials at the Royal Marsden Drug Development Unit from 2014 to 2024.

e15020 Background: Antibody-drug conjugates (ADCs) are designed to improve therapeutic indices of cytotoxic agents. Nevertheless, they may induce unexpected toxicities not observed with parent payloads. This study aimed to characterize the adverse events (AEs) seen in patients treated with ADCs in Phase 1 trials at The Royal Marsden Drug Development Unit (DDU). Methods: This is a retrospective cohort analysis of consecutive patients who received at least one dose of an ADC in a phase I trial from January 2014 to January 2024 at The Royal Marsden DDU. Descriptive statistics of patient characteristics, ADCs, and treatment-related AEs were performed. Univariate and multivariate logistic regression will be utilized to assess correlations among patient and ADC characteristics and adverse events. P values of &lt; 0.05 will be considered significant. Results: A total of 131 patients who participated in twelve ADC trials were included. The median age of participants was 63 years (range: 31-84) and 61% were females. Patients received a median of three prior lines of systemic treatment. The most common type of ADC target, antibody, linker and payload were receptor tyrosine kinase (51%), humanized IgG monoclonal antibody (69%), valine-citrulline (VC) cleavable linker (85%), and a tubulin-binding payload (59%), respectively. Most patients received an ADC dose of 1-3 mg/kg (76%) with each cycle given once every 3 weeks (64%). The median number of cycles was 3 with an average treatment duration of 63 days. Within the cohort, 89% of patients developed any grade AE and 17% experienced grade 3 or higher AEs. The major treatment-related AEs were fatigue (48%), nausea/vomiting (27%), ocular toxicity (26%), neuropathy (26%), skin rash (20%) and pneumonitis (8%). The median time to first onset of treatment-related adverse events were 37 days for ocular toxicity, 46 days for pneumonitis, and 54 days for neuropathy. ADC-related AEs led to treatment interruptions (51%), dose reductions (13%), and treatment discontinuations (28%). Two treatment-related grade 5 events occurred. The objective response rate was 18%, with 1 complete response and 22 partial responses. Conclusions: Despite being designed to minimize side effects, ADCs were associated with significant toxicities, including unexpected adverse events unrelated to target, antibodies or the payloads, limiting their therapeutic indices. Further analysis of the relationship between different components of the wide range of ADCs and AEs are warranted to better understand the potential mechanisms of ADC toxicity.