Treatment with antiangiogenic tyrosine kinase inhibitors (TKIs) has shown longer overall survival (OS) and progression-free survival (PFS) than with placebo in patients with advanced hepatocellular carcinoma (HCC) who have previously received systemic therapy. Unfortunately, TKIs are associated with some rare adverse events such as tracheoesophageal fistula formation (TEF). The common risk factors for TEF formation include radiation therapy, prior instrumentation of the esophagus/airway, surgery, and esophagitis. We present a case of a 64-year-old man with a history of HCC who developed TEF after three months of treatment with cabozantinib. Patients experiencing these events require prompt termination of the antiangiogenic TKI. Urgent intervention should be pursued to prevent respiratory failure. Clinicians should be aware of the potential adverse effects of antiangiogenic TKIs, especially in high-risk patients.

e17122 Background: Prostate cancer is the second leading cause of cancer related deaths in men. In 2023, about 288,300 new cases of prostate cancer are expected . Delays in cancer treatment can impact patients’ outcomes. In our study, we sought to describe socioeconomic and demographic factors influencing time to treatment in prostate cancer. We also studied the trend in time to treatment through the years. Methods: Using the National Cancer Database, we identified 1,605,396 patients diagnosed with prostate cancer between 2004 and 2019. Variables used for assessment include age at diagnosis, race, Charlson-Deyo score, stage at diagnosis, insurance status, median household income in patient’s zip code and year of treatment. We separated patients into two groups: those who started treatment < 60 days and patients who started treatment > 60 days using statistical analyses. We used Chi-square test to assess for differences within these groups and multivariable analysis to determine relationships between time to treatment and the socioeconomic and demographic variables. All tests were performed with a significance level of a = 0.05. Results: Out of 1,605,396 patients included in this study, 806,576 patients began treatment 60 days or less after diagnosis and 798,820 began treatment over 60 days after diagnosis. Older patients (age > 71) were less likely to be treated later than younger patients aged < 60 years (OR 0.530). Black and Hispanic patients were significantly more likely to start treatment later than white patients (OR 1.231; OR 1.086 p < 0.001). Compared to uninsured patients, those with private and other government coverage were more significantly likely to begin treatment later (OR 1.144; OR 1.469 p < 0.001). Patients with advanced stage prostate cancer were at lower risk for delayed treatment compared to those with localized disease (OR 0.218 P < 0.001). Compared to community programs, patients at academic/research programs were significantly more likely to begin treatment later (OR 2.097 p < 0.0001). In 2004, 40.5% patients began treatment over 60 days from diagnosis compared to 55.1% in 2019 (p < 0.001). We found that patients diagnosed between 2016 and 2019 were more likely to be treated later than those diagnosed between 2004-2007 (OR 1.717 p < 0.001). Conclusions: Increased rate of later time to treatment were seen in younger patients, minority groups, staging at diagnosis less than stage IV, patients treated at academic or research programs, and patients diagnosed between 2016-2019. This is likely due to the rise of active surveillance rather than immediate treatment as a management strategy in prostate cancer. Black men are at increased risk for advanced disease, hence, treatment delays should be avoided in these patients. Institution-level studies should be done to determine the pattern of treatment and address treatment delays.

Purpose: This study aims to describe the global landscape of clinical research into interventions for gastroesophageal (GE) cancers, which are a leading cause of cancer morbidity and mortality worldwide. We examine trial characteristics, focusing on geographic distribution of trial sites, participation of low-and-middle-income countries (LMICs), and factors associated with premature trial termination. Methods: We queried ClinicalTrials.gov database to identify all completed or terminated Phase III interventional studies investigating GE cancers (esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastroesophageal junctional (GEJ) and gastric adenocarcinoma). All reported characteristics were extracted. Pearson’s chi-square and Fisher’s exact test were used to compare differences in completed and terminated trials. Multivariate logistic regression was used to determine predictors of termination. Results: A total of 179 trials were identified; 90% were therapeutic. Most included sites in Asia (61%), Europe (32%), and North America (23%); few included sites in South America (9%), Africa (4%), and Oceania (9%). 63% of trials included high-income countries (HICs) sites alone; only 7% included sites in lower-middle or low-income countries. Most (70%) focused exclusively on gastric or GEJ adenocarcinoma, 13% on EAC and ESCC, and 9% ESCC alone. 16% (n=29) of trials terminated, most due to accrual difficulties (n=13, 44%). In multivariate analysis, study site number, location, and eligible patient population emerged as predictors of termination. Trials conducted exclusively in the US were more likely to terminate (OR 7.22 [95% CI 1.59-32.69]). Conversely, trials conducted exclusively in LMICs were less likely to terminate (OR 0.04 [95% CI 0.01-0.59] v conducted in HIC alone). Studies on ESCC were more likely to terminate (OR 17.74 [95%CI 1.49-210.69]). Trial design characteristics, intervention characteristics, and funding sources were not associated with termination. Conclusion: Although 80% of GE malignancies occur in LMICs, trial activity disproportionately occurs in HICs. Few trials focus on EAC/ESCC despite being highly fatal, highlighting an unmet need. Geographic location of trial sites emerged as a predictor of trial termination, with studies involving LMICs sites less likely to terminate prematurely. This finding highlights the potential benefit of including LMICs in future clinical trials to advance research for these diseases. Citation Format: Ayo Falade, Oluwatayo Adeoye, Geoffrey Buckle. Clinical Trials in Gastroesophageal Cancers: An Analysis of the Global Landscape of Interventional Trials From ClinicalTrials.gov [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 21.

No abstract