Patient Population Research Articles

Development and preliminary validation of a platform for systematic, unbiased pre-screening of non-small cell lung cancer (NSCLC) across three community oncology practices.

e23230 Background: With a rapidly increasing number of candidate drugs and clinical trials in oncology, efficiency in clinical trial execution has become a primary focus area for innovation. Currently, fewer than 5% of oncology patients enroll in clinical trials, and data suggests a lack of diversity in clinical trial patient populations compared to the broader patient demographic. To address these issues, we developed a systematic unbiased pre-screening platform for all patients. This approach holds the promise of hastening clinical trials by enhancing the identification of eligible patients and concurrently promoting diversity among those invited to participate in these trials. Methods: A framework for use of EMR ingested data and standardized abstraction of select 160 variables was developed for patients with NSCLC. An algorithm based on 7 key eligibility criteria was developed to generate an automated assessment of eligibility for a presumed trial. Abstracted data was compared to a medical oncologist’s assessment (gold standard) and the automated tool was validated by comparing eligibility assessment before each visit with that of a medical oncologist. Results: Three community oncology practices in the US participated. Source data-verified values for histology, ECOG PS, treatment history, line of therapy, and current metastatic status were available for > 90% of patients in real-time. Tumor NGS testing rates for actionable alterations exceeded 75%. From Oct 23, 2023 to Jan 14, 2024, 786 NSCLC pts had MD visits. Preliminary validation of the automated tool in 79 patients revealed concordant classification in 76/79 pts (96.2%). Sensitivity, specificity, PPV and NPV were > 90%. Concordance for all variables was 98% between the abstractor and medical oncologist. Conclusions: A platform for systematic, unbiased pre-screening of patients for clinical trials in NSCLC has been developed to support and facilitate oncology sites without imposing financial or resource burdens or affecting routine clinical workflow. Preliminary validation supports high performance. Updated validation data will be presented in the meeting. The high levels of data completeness and quality, including NGS testing rates that are substantially higher than what has previously been reported in community centers, underscore their suitability as clinical trial sites.

Efficacy of Inclisiran in Patients Having Familial Hypercholesterolemia: Heterozygous Compared to Homozygous Trait, a Systematic Review and Meta-analysis.

To find out whether inclisiran sodium has different efficacy in heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) patient groups. We conducted the systematic review and meta-analysis of ORION clinical trials. PubMed, Embase, and Clinicaltrials.gov databases were searched for the relevant studies. Atheroscalerotic parameters considered for our objective were low-density lipoprotein cholesterol, total cholesterol, proprotein convertase subtilisin/kexin type 9 (PCSK9), apolipoprotein B, and nonhigh-density lipoprotein cholesterol. Primary outcomes were the percentage difference in atheroscalerotic parameters at follow-up relative to baseline values. Our study examined these primary outcomes to determine whether there is a statistically significant difference between the HeFH and HoFH groups. Risk of bias was assessed by the Cochrane risk of bias tool. Meta-analysis was performed when at least 2 studies reported on the same variable. Four ORION clinical trials provided the data related to the mean difference in the atheroscalerotic parameters at follow-up relative to baseline, of HeFH and HoFH patient populations, after administration of 300 mg inclisiran subcutaneously. We pooled together these mean differences for each group and applied a statistical test to analyze if the values were significantly different between the groups. The results of our study unveiled the significant difference in pooled mean differences in low-density lipoprotein cholesterol (HeFH: -48.62%; HoFH: -9.12%; P < 0.05), total cholesterol (HeFH: -30.31%; HoFH: -11.50%; P < 0.05), apolipoprotein (HeFH: -39.97%; HoFH: -14.68%; P < 0.05), and nonhigh-density lipoprotein (HeFH: -44.51%; HoFH: -12.22%; P < 0.05) between HeFH and HoFH groups. However, the difference in pooled mean difference in PCSK9 values (HeFH: -68.41%; HoFH: -56.25%; P = 0.2) between HeFH and HoFH groups was statistically insignificant. Studies were of high quality. There was a significant difference in the reductions in atherosclerotic lipid parameters in heterozygous and homozygous populations after the administration of inclisiran except for PCSK9 parameter. Further studies are needed to support this conclusion.

Colorectal cancer and the heart: Uncovering the beat of racial disparities in MACCE.

1611 Background: Due to its high prevalence, colorectal cancer (CRC) forms a considerable burden on the healthcare system. Advancements in treatment modalities like immunotherapy have led to significant improvement in the 5-year survival. This, along with the cardiotoxic therapy regimens results in a remarkable incidence of major cardiovascular and cerebrovascular events (MACCE). Thus, it becomes imperative to address the intricacies of factors including racial disparities in MACCE, as these aid with facilitating equitable management of all CRC patients. Methods: Using ICD-10 codes, patients with CRC were identified from National Inpatient Sample 2019 database. We included all-cause in-hospital mortality (ACIHM), acute myocardial infarction (AMI), atrial fibrillation (AF), cerebrovascular accident (CVA), and sudden cardiac death (SCD) as MACCE for the outcomes. Baseline characteristics including demographics, comorbidities; and MACCE outcomes were studied using chi-square for categorical or ANOVA for continuous data (statistical significance determined as p-value &lt; 0.05) and results were stratified based on patient’s races. Results: A total sample patient population of 171,695 patients with a diagnosis of CRC were identified of which 70.71% (121,410) were White, 13.85% (23,790) were Black, 9.15% (15,720) were Hispanic, 3.23% (5,555) were Asian/Pacific Islander, 0.5% (840) were Native American, and 2.55% (4380) belonged to Other races. Substantial differences in the prevalence of comorbidities were noted with hypertension (46.32%) and renal failure (24.74%) being more common in Black patients, diabetes mellitus (37.5%) in Native American patients, and dyslipidemia (37.89%) in White patients. Upon comparison with White patients, the ACIHM was higher in Black patients with adjusted odds ratio (aOR) of 1.23 (95% CI 1.057-1.432, p = 0.007) and Asian/Pacific Islander patients with aOR of 1.359 (1.014-1.823, p = 0.04). While AMI was found to be lower in all races, as compared to White patients, AF was remarkably higher in all races. CVA was higher in Black patients as compared to White patients with aOR of 1.626 (95% CI 1.401-1.886, p &lt; 0.001). SCD was substantially higher in Black patients with aOR 2.059 (95% CI 1.478-2.869, p &lt; 0.001), and in Hispanic patients with aOR 1.743 (95% CI 1.1-2.761, p = 0.018), when compared to White patients. Conclusions: The study noted higher prevalence of MACCE across the board with poorer outcomes in non-White populations, which highlights the urgent need for resource allocation to improve outcomes. This has to be done in pre and post cancer treatment patients, especially in high risk populations. Additionally, the role of cardio-oncology service at every stage of management of CRC appears to be crucial.

Associations between prognosis and primary endpoint selection in phase III oncology trials in the United States.

e23022 Background: Overall survival (OS) is commonly used as a primary endpoint in phase III oncology trials in the United States, serving as direct evidence of clinical benefit and as an objective outcome measure. Other endpoints such as progression-free survival (PFS) and objective response rate (ORR) are also utilized. Factors such as a cancer type and treatment line are considered important for primary endpoint selection, however, the fundamental factor influencing primary endpoint selection across various cancer types or treatment lines remains unclear. I hypothesize that the prognosis of the target patient population is one of the key fundamental factors across any groups in primary endpoint selection. This study aims to investigate the associations between the prognosis and the type of primary endpoint. Methods: All phase 3 clinical trials conducted in the US, focusing on drug therapies for cancer, between January 1, 2015 and Dec 31, 2022 were included. Multinomial logistic regression was utilized to assess the relationships between prognosis, indicated by the median overall survival of the control arm, and the type primary endpoint among OS, non-OS time-to-event endpoints (Other TTE), and response or remission rate (RR). Models were adjusted for cancer type, treatment line, the primary endpoint of the previous clinical study for the same target patient population, monotherapy, mechanism of action (MOA), biomarker for the drug, orphan drug designation (ODD), and accelerated approval (AA) before regulatory approval. Results: Out of 5,877 phase 3 clinical trials, 151 studies and 167 evaluation sets were included in the analysis. When the prognosis and the type of primary endpoint were tested, this factor demonstrated a statistically significant difference with a positive coefficient for Other TTE, RR, and a co-primary endpoint of OS and Other TTE compared to OS. The prognosis, the median OS of the control arm, was 10.5 months (95% CI 5.00-16.6) for OS, 18.5 months (95% CI 7.50-34.3) for Other TTE, 32.9 months for RR, and 13.6 months (95% CI 8.7-46.6) for the co-primary endpoint of OS and Other TTE respectively. No effect modification was observed for Other TTE and the co-primary endpoint of OS and Other TTE. Conclusions: A better prognosis is associated with the selection of surrogate endpoints in phase 3 oncology trials among many factors. The associations between the prognosis and the type of primary endpoint were observed for Other TTE and a co-primary endpoint of OS and Other TTE. These findings elucidate one of the fundamental factors for primary endpoint selection and emphasize the importance of prognosis in selecting a primary endpoint in phase 3 clinical trial in oncology in the US. However, further study is required to comprehensively understand the impact of RR on primary endpoint selection, as this analysis was limited by the lack of median OS data for RR.

Correlating survival outcomes in patients with advanced prostate cancer with novel hyperpolarized 13C MRI metabolic imaging biomarkers.

e15059 Background: Hyperpolarized 13C (HP 13C) MRI is a novel molecular imaging approach that detects aberrant aerobic metabolism, namely elevated rates of pyruvate-to-lactate conversion (kPL), in patients with advanced malignancies. Higher kPL has been shown to correlate with higher tumor grade among patients with localized prostate cancer (PC). This research sought to evaluate the correlation between kPL and clinical outcome measures in patients with advanced PC. Methods: Patients with metastatic or locally advanced PC (castration sensitive or resistant) were prospectively enrolled at our institution and underwent HP 13C MRI of one or more target lesions identified on prior conventional imaging. Voxelwise kPL values were computed in MATLAB using an inputless two site exchange model. kPL,median was defined as the median kPL value per-patient across all target lesions; kPL,kurtosis measured the tailedness of the kPL distribution per-patient. We retrospectively analyzed progression free survival (PFS) and overall survival (OS) in subgroups divided by metabolic activity below versus above cut-point (kPL,median &lt;0.017 s-1 and ≥ 0.017s-1, respectively). Survival statistics were calculated using the Cox PH model. Results: Sixteen patients (6 with castration-sensitive and 10 with castration-resistant PC) were accrued. With a median follow-up of 22.0 months from the date of MRI, the lower-kPL subgroup had significantly longer median PFS (11.2 vs 0.5 months; p&lt;0.01) and OS (NR vs 18.4 months; p&lt;0.05) compared to the higher-kPL subgroup. By comparison, baseline serum PSA (PFS: p=0.19, OS: p=0.41) and LDH (PFS: p=0.60, OS: p=0.34) did not demonstrate a significant association with clinical outcomes. There was a strong negative correlation between kPL,kurtosis and OS (r = -0.75), and moderate negative correlations between kPL,median and OS (r = -0.45) as well as kPL,max with both PFS (r = -0.48) and OS (r = -0.54). There was no significant kPL,median difference between castration-sensitive and resistant subgroups (0.015±0.011 vs 0.016±0.006 s-1, p&gt;0.8). Conclusions: HP 13C MRI-derived non-invasive metabolic biomarker kPL,median significantly correlated with clinical outcome measures in a retrospective analysis of patients with advanced PC, outperforming established serological prognostic markers PSA and LDH. Limitations include our small sample size, retrospective design, and heterogeneous patient population. Nevertheless, these encouraging preliminary results support further investigation of HP 13C MRI as a prognostic and/or predictive PC biomarker in multi-center prospective imaging trials. [Table: see text]

Examining knowledge of cancer-related family history in an urban underserved patient population.

e22550 Background: An accurate assessment of family history of cancer is essential in assigning cancer risk, and in decision making regarding the timing and method of cancer screening. However, obtaining a complete and accurate cancer-related family history, including first- and second-degree relatives, is often challenging in underserved communities. Familial dynamics such as single parent households, kinship care, and estrangement may act as barriers to an individual’s knowledge of their family health history. Presently, Electronic Medical Record systems constrain users to a binary documentation of cancer history as either ‘yes’ or ‘no’. However, patients may be unaware or uncertain of their family’s cancer history. These unknowns are not captured, resulting in poor understanding of patient knowledge regarding their family history of cancer. Objective: To assess knowledge of cancer-related family history for first- and second-degree relatives among an urban underserved patient population. Funding source: The American Cancer Society. Methods: University of Illinois Health patients aged 45-75 years without a history of colorectal cancer, who received an order for colorectal cancer screening through fecal immunochemical testing or screening colonoscopy were eligible to participate. A total of 88 respondents completed a 23-item telephone survey assessing knowledge of their family cancer health history using a 5-point Likert scale. Surveys were administered in both English and Spanish languages. Results: Of the 88 survey participants, 50 (57%) were female, 54 (61%) were of black or African American race, and 31 (36%) were of Hispanic or Latino ethnicity. On a single-item question assessing overall knowledge of their cancer-related family history, 35 (39.7%) responded they know it well or very well, versus 13 (14.8%) with little or no knowledge. On knowledge of maternal cancer related history, 8 participants (9.1%) reported little or no knowledge of their mother’s cancer history, and 29 participants (33%) reported little or no knowledge of their maternal relatives’ cancer history. On knowledge of their father’s cancer history, 35 (39.8%) reported little or no knowledge of their father’s cancer history, and 48 participants (54.5%) reported little or no knowledge of their paternal relatives’ cancer history. Conclusions: This original research study addresses the current gap in understanding patient knowledge regarding familial cancer health history. Survey results demonstrate a striking discrepancy between respondent reported overall knowledge of cancer-related family history, and knowledge of their maternal and paternal cancer histories. Moreover, respondents reported increased knowledge of their mother’s versus father’s cancer history p &lt; 0.0001. Improved recognition of unknown family history in first- and second-degree family members may improve cancer-risk assessment.

Factors associated with delays in care of suspicious lung nodules at an academic medical center.

e13705 Background: Shorter time to lung cancer diagnosis and treatment are associated with improved outcomes. Here, we assessed factors contributing to delays in each phase of care to identify targets for improving the timeliness of suspicious lung nodule care in a diverse patient population. Methods: We conducted a retrospective study of patients evaluated for suspicious lung nodules at an academic medical center from 2020 to 2022. Patients with presumed or proven stage I/II lung cancer were included. Patients with stage III/IV and non-primary lung cancers were excluded. Multivariable Cox regressions were performed. Results: Of 157 patients, mean age was 70±8.6 years, 59% were female, and 53% were Black. Most lung nodules were biopsied bronchoscopically (61%) or surgically (26%). Most (83%) nodules were stage I/II non-small cell lung cancer, 10.2% were benign and 4.4% were other. Treatment was surgery in 48% and stereotactic body radiotherapy (SBRT) in 41%. Median intervals were 4 (IQR 0-18) days from nodule identification to referral, 7 (IQR 3-14) days from referral to consultation, 20 (IQR 12-34) days from consultation to biopsy, 4 (IQR 2-6) days from biopsy to diagnosis, and 28 (IQR 8-43) days from diagnosis to treatment initiation. Multivariable Cox regression showed that longer time from referral to diagnosis (TTD) was associated with Black race, widowed status, and referral &gt; 1 year from the start of the COVID-19 pandemic. Longer time from referral to treatment (TTT) was associated with female gender, widowed status, 4th Area Deprivation Index (ADI) quartile, frailty, BMI &gt; 18.5, ECOG performance status &lt; 2, bronchoscopic biopsy, and initial treatment with SBRT. Longer time from consultation to biopsy was associated with female gender, widowed status, frailty, no cardiovascular disease, and living &gt;12.5 miles from the hospital. Longer time from diagnosis to treatment was associated with Medicaid, referral &gt; 1 year from the start of the pandemic, cardiovascular disease, and SBRT. Conclusions: The longest delays in lung nodule care are associated with time from consultation to biopsy and from diagnosis to treatment. Efforts to address disparities and modifiable factors could improve the timeliness of care for patients with suspicious lung nodules. [Table: see text]

Real-world implementation of an EHR-integrated, SMS text remote patient monitoring platform at an academic cancer center.

e13669 Background: Remote monitoring studies in oncology have shown improved quality of life, decreased healthcare utilization, and even improved overall survival in an oncologic population, however applications in a real-world setting have been limited. Barriers to successful deployment include low patient engagement rates with smartphone apps, lack of integration with the EHR and burdensome clinical workflows for staff. Methods: We sought to assess the feasibility of an EHR-integrated, SMS text conversational AI agent to automate the collection of ePRO data as well as the assessment and triage of common patient symptoms for patients with GI and GU tumors receiving anti-cancer therapy. This program was developed collaboratively by a health system digital health team, nursing informatics, IT support resources, oncology nurses, medical oncologists, and representatives from Memora Health. Core components included 1) weekly ePRO collection based on the NIH’s CTCAE, 2) NLP activated symptom triage for 16 common symptoms and toxicities 3) weekly symptom check-in 4) weekly medication adherence assessment for patients on oral therapy. Patients received all messages through SMS on their phones, and all data collected were routed into the EHR. In-EHR visualizations allowed nurse coordinators to track ePRO symptoms over time and symptoms that met pre-specified criteria triggered EHR-based alerts. Results: Of 99 patients ordered into this SMS program, 83 enrolled (84% enrollment rate), with 55 Uro Onc patients; 44 GI Onc patients. A total of 2,583 surveys were sent to patients. 98% of patients completed at least 1 survey. Overall patient survey completion rate was 62%. Medication adherence surveys had the highest completion rate at 81%. ePRO completion rates were higher for GU (65%) vs GI (39%) patients (p&lt;0.01). 71% of ePRO surveys generated a symptom alert to the nursing staff. Patient satisfaction was high with 93% rating this SMS program as “excellent” or “good” (n=78). Care team surveys found that 3 of the 6 Oncologists believe ePRO collection is valuable and 3 of 6 used ePRO data to adjust a care plan. Nurse coordinators had a mixed view of the program with a majority reporting that there were too many symptom alerts. Conclusions: We successfully deployed an EHR-integrated SMS program to collect ePRO data, track patient symptoms, and monitor adherence to oral therapy. We believe having a physician champion influenced patient engagement in the GU patient population. Patients had a favorable impression of this program and survey completion rates demonstrated ease of use for patients. Clinical staff, particularly nurses, felt that there were too many alerts. Additional workflow changes may reduce alert burden and better incorporate ePRO learnings into clinical practice.

Efficacy of trifluridine/tipiracil in 3rd or 4th line of treatment in patients with advanced or metastatic colorectal cancer: A real-world data analysis with subgroups exploration.

e15576 Background: Patients with unresectable mCRC can achieve long-term overall survival (OS) thanks to modern systemic treatment and subsequent lines of therapy. With effective 1st, 2nd and next lines of therapy, their condition often allows further lines of treatment. Since publication of RECOURSE study, one of the most frequently used drugs in the 3rd or 4th line is trifluridine/tipiracyl (FTD/TPI). There is limited data on optimal selection of patients in order to obtain the greatest therapeutic gain with the least toxicity. The aim of this study was to find and define groups of patients who would benefit most from this treatment in a real-world mCRC patient population. Methods: Consecutive patients with unresectable or metastatic colorectal cancer (mCRC) started treatment with FTD/TPI between 1/Sep/2019 and 31/Dec/2023. Clinical factors including age, gender, primary location of colorectal cancer, BRAF, RAS and MSI-H status, ECOG performance status, baseline CEA level, location of metastases, response to treatment and AEs occurrence were analyzed. Survival analyses were performed using the Kaplan-Meier method, Log-rank and chi-square tests were used for comparison between groups. Data cut-off was 31/Jan/2024. Results: 822 medical records of patients with mCRC were analyzed. In total 261 patients treated with FTD/TPI were enrolled. 204 (78%) patients were treated with FTD/TPI in 3rd line (L3) and 57 (22%) in the 4th line (L4). Patients with RASmt were statistically more numerous in the L3 group; no other statistically significant differences in baseline characteristics was found between L3 and L4 groups. Estimated median OS (mOS) was 10.2 and 14.4 months in L3 and L4 group, respectively; no statistical significance was found between them (p = 0.0866; HR = 1.34, Cl 95% 0.9-1.9). Estimated median PFS (mPFS) was 7.4 and 4.6 months in L3 and L4 group, respectively, and statistically significant differences in mPFS was found in the L3 group in comparison to L4 (p = 0.0079; HR = 0.65, Cl 95% 0.5-0.9). Disease progression (PD) was found in 187 (92%) and 50 (88%) patients in the L3 and L4 group, respectively. PD was most common reason for discontinuing therapy. Most frequent serious AEs of grade 3 or higher were diarrhea, neutropenia and weakness. There were no grade 5 AEs and toxicity rarely led to discontinuation of FTD/TPI therapy. 102 (39%) patients were qualified for next line sequential systemic treatment after L3 or L4. Conclusions: Patients with mCRC who were treated with FTD/TPI in the 3rd line had better PFS than patients treated in 4th line, but mOS was statistically non-significantly better in L4 than L3, which requires further analysis. FTD/TPI is an effective therapy in subsequent lines of treatment for mCRC patients with acceptable toxicity.

Patterns of screening and access to care in women diagnosed with breast cancer in a safety-net system.

1531 Background: Screening mammography reduces breast cancer specific mortality by allowing diagnosis at an earlier stage. Inconsistent guidelines and limitations in access to primary care are among factors that affect screening uptake. In this study, we reviewed patient characteristics, access to care, and uptake of screening mammogram (SMMG) prior to a breast cancer diagnosis at a safety-net system. Methods: Parkland Health (PH) is the safety-net system for Dallas County and is affiliated with the University of Texas Southwestern Simmons Comprehensive Cancer Center. Electronic medical records of patients with a new invasive breast cancer diagnosis between 2018 and 2019 at PH were reviewed and data on demographics and clinical presentation were collected. Patients were categorized based on SMMG uptake prior to their cancer diagnosis: never-screened, ever-screened (SMMG &gt; 2 years prior to diagnosis) and recent-screened (SMMG within 2 years of diagnosis). Results: A total of 468 new breast cancer cases were identified (48.7% Hispanic; 32.9% Black). Of these, 12.2% were younger than 40 and 27.8% were 40-49. Payer mix included 64.7% uninsured and 34.8% Medicare/Medicaid. Half of the patients (50.6%) never had SMMG. Never-screened rate was higher among younger patients (98.2% in &lt; 40; 53.8% in 40-49; and 39.4% in &gt;50; p &lt; 0.0001). Only 25.2% (118/468) of the patients had a SMMG within 2 years prior to their diagnosis. Among patients aged &gt;40, 44.0% (181/411) were never-screened and 28.7% (118/411) were recent-screened. Screen-detection rate among patients &gt;40 was 40.1% (165/411), of whom 22 (13.3% of screen-detects) were diagnosed with cancer on their first ever SMMG. Race/ethnicity, insurance status, and positive family history of cancer were not significantly different between never, ever, and recent-screened patients. Screening uptake correlated with nodal status, tumor size and stage at diagnosis. Patients who had a prior encounter at Parkland were more likely to have a SMMG. Patients established with Parkland primary care at diagnosis were more likely to have early-stage disease. In patients &lt; 40, 24.6% presented with stage IV disease at diagnosis and 57.9% did not have a primary care provider. A positive family history of breast/ovarian cancer or any cancer was noted in 38.6% and 57.9% of patients &lt; 40, respectively. Conclusions: In the cohort presented here, 27.8% of patients were between age 40-49, reflecting the impact of a gap in the guideline, which is now addressed in the most recent iteration of USPSTF guidelines. Connecting ED users to primary care, identifying higher risk individuals through family history, and increasing SMMG rate in the primary care setting are among strategies to reduce the rate of late-stage diagnosis of breast cancer, particularly among vulnerable patient populations.

Interstitial Lung Disease as an emerging contributor to mortality in patients with Inflammatory Bowel Disease: A population-based epidemiological study.

We aim to investigate the contribution of Interstitial Lung Disease (ILD) to mortality in patients with Inflammatory Bowel Disease (IBD). We carried out a comprehensive retrospective, population-based epidemiological study across the United States from 2001 to 2020, using the Wide-ranging Online Data for Epidemiologic Research (WONDER) database. Mortality data were classified according to the International Classification of Diseases, Tenth Revision, with the codes J84 for ILD, K50 for Crohn's Disease (CD), and K51 for Ulcerative Colitis (UC). To discern patterns, Age-adjusted Mortality Rates (AMR) were computed, stratified by gender, geographic census region, and racial/ethnic demographics. From 2001 to 2020, there were 57,967 reported deaths among IBD patients with an AMR per million significantly rising from 10.989 in 2001-2005 to 11.443 in 2016-2020 (p<0.0001). ILD was a contributor to death in 1.19% (692/57,967) of these cases, with AMR rising from 0.092 to 0.143 per million (p=0.010). The percentage of ILD-related deaths in the IBD population increased from 1.02% to 1.30% over two decades. ILD was a more common cause of death in patients with CD than with UC (54.6% vs. 45.4%), with a significant increase for both conditions from 2001 to 2020 (p<0.05). An upward trend in ILD-related mortality was observed in both sexes (p<0.05), and within the White population (p=0.010). The observed increase in mortality rates due to ILD among patients with IBD is concerning and highlights a critical need for systematic ILD screening protocols within the IBD patient population to facilitate early detection and management.

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.

Overall survival in soft tissue sarcomas (STS) in Hispanic vs non-Hispanic White patients: Single center experience.

e23526 Background: Racial, ethnic, and socioeconomic factors have been implicated in the variability of survival rates among soft tissue sarcoma (STS). These disparities are multifactorial and may reflect differences in disease biology, access to care, treatment responses, and others. In situations where different racial groups have equitable access to healthcare, healthcare disparities can decrease, and survival gaps can narrow. Differences in survival in STS in racial minorities have been poorly studied. Recognizing the potential impact of such disparities, our study thereby contributes to the ongoing discourse on healthcare equity in STS outcomes. Methods: We conducted a retrospective analysis of 30 STS patients, stratifying them into Hispanic (H) and non-Hispanic white (NHW) groups at Dignity Health Cancer Institute in Phoenix, Arizona. The Mann-Whitney U test was chosen to compare survival distributions, given the non-normal distribution of our sample. Survival analysis was performed using the Kaplan-Meier method, and the log-rank test was applied to determine statistical significance. All analyses were executed in GraphPad Prism software. Results: Our cohort comprised 13 (43%) NHW and 17 (57%) H patients. The mean ages were 57.2 years for NHW and 48.9 years for H, with a balanced gender distribution across groups. The most common subtypes of STS in NHW were liposarcoma (n = 3, 23.1%), and spindle cell carcinoma (n = 2,15.4%). Comparatively, the most common subtypes of STS in H were liposarcoma (n = 5, 29.4%) and leiomyosarcoma (n = 3, 17.6%). All patients were diagnosed with Stage 4 STS. Treatment modalities differed marginally, with NHW patients undergoing more surgical interventions, while H patients were more frequently administered chemotherapy. Median overall survival from the start of first-line therapy was 412 days for NHW and 500 days for H patients. Despite the longer median overall survival observed in Hispanics, the intergroup difference did not reach statistical significance (P = 0.68). Conclusions: The similar survival times between H and NHW STS patients at our institution may hint at an equitable provision of care across racial demographics in a relatively controlled single-center experience. However, the trend of extended survival in the Hispanic group, while not statistically confirmed, raises questions that merit further inquiry. This study serves as a preliminary exploration into racial disparities in STS, advocating for larger-scale research with more diverse patient populations. Further studies are essential to understand these findings and identify and optimize factors contributing to narrowing the survival gap in minorities, with the goal of enhancing STS prognosis for all racial groups.

Improving ethnic and racial diversity in biomarker-driven clinical trials: A proof of concept with the BASECAMP-1 master prescreening study of patients with high-risk solid tumors with human leukocyte antigen-A*02 (HLA-A*02) loss of heterozygosity (LOH).

1604 Background: Diversity in clinical studies is essential to address health disparities, but racial and ethnic minorities are often underrepresented in clinical studies, especially in precision medicine studies using genetic data (1). BASECAMP-1 (NCT04981119) is an ongoing prescreening study to identify patients with unresectable advanced or metastatic solid tumors and tumor-associated HLA-A*02 LOH for the EVEREST-1 and -2 Tmod chimeric antigen receptor T-cell therapy trials. When enrollment began in 2021, eligibility for Part 1 was restricted to patients with germline HLA-A*02:01 based on preclinical data. Additional analysis revealed the blocker in the Tmod construct had activity across HLA-A*02 subtypes (Mock, et al. Mol Ther Oncolytics.2022). Eligibility for Part 1 was then expanded to all HLA-A*02 subtypes, allowing enrollment of more diverse patient populations. HLA-A*02 allele subtypes vary by ethnicity and race; the frequency of HLA-A*02:01 is 96% in non-Hispanic Whites, but ranges from 53% to 73% in other ethnicities and races. The frequency of all other HLA-A*02 allele subtypes (HLA-A*02:XX) is &lt;5% in non-Hispanic Whites but up to 66% in other ethnicities and races (2,3). Methods: Patients eligible for BASECAMP-1 were identified at United States study sites. All patients screened before January 16, 2024, for Part 1 were included for demographic and central lab HLA-A typing. The % increase in eligibility and % of heterozygous HLA-A*02 patients with HLA-A*02:XX were calculated by ethnicity and race. Results: A total of 1124 patients were screened for germline HLA-A*02 typing; 431 patients were HLA-A*02:01 heterozygous, of whom 37 (9%) were Hispanic, 14 (3%) African American (AA), 2 (&lt;1%) American Indian or Alaska Native, 17 (4%) Asian or Pacific Islander (API), and 324 (75%) non-Hispanic White (Table). The eligibility expansion identified 62 patients with HLA-A*02:XX heterozygosity, of whom 6 (10%) were Hispanic, 6 (10%) AA, 19 (31%) API, and 25 (40%) non-Hispanic White. Conclusions: By expanding enrollment to include HLA-A*02:XX, 16% more Hispanic, 43% more AA, and 112% more API patients were identified, improving the diversity in this trial compared with that of initial enrollment. 1. Aldrighetti, et al. JAMA Netw Open 2021. 2. Ellis, et al. Human Immunol. 2000. 3. Gragert, et al. Human Immunol.2013. Clinical trial information: NCT04981119 . [Table: see text]

Demographics and survival outcomes of stage IV male breast cancer: A retrospective analysis of SEER database.

11142 Background: Male Breast Cancer (MBC) is a rare malignancy accounting for &lt;1% of all breast cancer cases in the United States. It is often lately diagnosed due to lack of awareness leading to substantial morbidity and mortality. Previous studies revealed higher risk of death among males compared to females across all stages, but little known about the impact of Hormone Receptor (HR) and Human Epidermal growth factor Receptor 2(HER 2) statuses on prognosis and survival among MBC patients. So, we aim to study the survival outcomes of stage IV MBC patients using SEER (Surveillance, Epidemiology, and End Results) data. Methods: A retrospective analysis was conducted using a SEER database and identified stage IV MBC cases (Any T, Any N, M1) diagnosed between 2010-2015. The selection of these years is based on the reporting of HER2 status on SEER database starting from 2010 and to ensure a current period and a minimum of 5 years of follow-up. Patient demographics, tumor HR/HER 2 status and survival data were extracted and analyzed. Subgroup analyses were performed to show the correlation between HR/HER 2 status and survival. Results: The study included 144 patients. 59.7%(86/144) were above 60 years of age. Majority were Caucasians up to 68.1%(98/144) followed by African Americans 18.7% (27/144), Hispanics 6.9%(10/144) and Asians/Pacific Islanders 6.2%(9/144). Among the subtypes, the most common was HR+/HER2- consisting of 69.4%(100/144) followed by HR+/HER2+ 19.4%(28/144), HR-/HER2- 9.7%(14/144), HR-/HER2+ 1.4%(2/144). The median overall survival varied among different subtypes of breast cancer and was noted to be 31.5 months, 25 months, 4.5 months and 10 months among HR+/HER2-, HR+/HER2+, HR-/HER2- and HR-/HER2+ respectively (Table). In the comparison between HR+/HER2+ and HR-/HER2-, the risk of death differed significantly, as indicated by a hazard ratio of 0.26 (95% CI 0.12-0.56, p = 0.001), highlighting a poor survival of HR-/HER2-. Conclusions: This retrospective analysis provides valuable insights into the demographics and survival outcomes of stage IV MBC patients. Triple negative (HR-/HER2-) subtype continues to have poor outcomes in males as well, emphasizing the need to explore novel treatment strategies to improve outcomes for this unique patient population. Although, treatment regimens for MBC are extrapolated from women, the disparity in survival across all subtypes requires the need to get more men on breast cancer clinical trials when feasible. [Table: see text]

Bevacizumab combination therapy versus standard chemotherapy for ovarian cancer in shorter and longer followup duration: A systematic review and meta-analysis of randomized controlled trials.

e23296 Background: Bevacizumab is an anti-angiogenesis drug commonly added to standard chemotherapy regimens in the treatment of ovarian cancer. However, its comparative efficacy and safety in shorter and longer followup duration leaves a research gap that needs to be addressed. This systematic review and meta-analysis aims to evaluate the efficacy and safety of bevacizumab in patients with ovarian cancer in shorter and longer follow up duration. Methods: We searched Medline, Cochrane CENTRAL, Scopus, and Google Scholar for all phase 3 randomized controlled trials (RCTs) that administered bevacizumab to women with ovarian cancer. Review Manager 5.4 was used to calculate risk ratios (RR) and hazard ratios (HR) with 95% confidence intervals (95% CIs). We assessed the quality of included studies using version 2 of the Cochrane Risk of Bias tool (RoB 2). Results: After screening the titles, abstracts, and full texts, we included nine RCTs in our systematic review and meta-analysis. Four RCTs had low risk of bias while five had some concerns. Bevacizumab was associated with a progression free survival benefit for &lt; 36 months (HR 0.59, 95% CI 0.45 to 0.76, p &lt; 0.0001, I2= 90%) and &gt; 36 months (HR 0.66, 95% CI 0.55 to 0.80, p &lt; 0.0001, I2= 80%), and an overall survival benefit for &lt; 36 months (HR 0.87, 95% CI 0.78 to 0.98, p = 0.02, I2= 0%) but not for &gt; 36 months (HR 0.98, 95% CI 0.89 to 1.09, p = 0.77, I2= 30%). There was no difference in deaths between intervention and control groups &lt; 36 months (RR = 0.95, 95% CI 0.86 to 1.04, p = 0.26, I2= 10%) or &gt; 36 months (RR 1.02, 95% CI 0.97 to 1.06, p = 0.50, I2= 0%). Bevacizumab reduced disease progression &lt; 36 months (RR 0.82, 95% CI 0.72 to 0.92, p = 0.0008, I2= 82%) but not at &gt; 36 months (RR 0.83, 95% CI 0.58 to 1.19, p = 0.30, I2= 94%). The adverse events reported with Bevacizumab use included thrombocytopenia, neutropenia, leukocytopenia, anemia, hypertension, bleeding or hemorrhage, and gastrointestinal, cardiac, and dermatological adverse events. Conclusions: Bevacizumab may improve progression free survival within and after 36 months, overall survival within 36 months, and reduce disease progression within 36 months. Future studies should explore the long-term effectiveness of bevacizumab in diverse patient populations and focus on individual patient-tailored treatment approaches to optimize outcomes.

Clinical outcomes of patients receiving venetoclax and hypomethylating agents for AML in academic and academic-community partnerships.

e23235 Background: Prior studies have reported improved outcomes for acute myeloid leukemia (AML) in academic over nonacademic settings potentially due to the availability of multidisciplinary teams, clinical trials and increased resources (1,2). Our institution has partnered with community practices to further evaluate this disparity. In this study, we analyzed treatment outcomes when nonacademic centers partnered with academic centers to treat AML using a regimen of venetoclax and a hypomethylating agent. Methods: We reviewed 92 patients with newly diagnosed AML treated with venetoclax and either decitabine or azacitidine at an academic center (n = 57) or community practice with academic center support (n = 35). When partnering with the community, patients received the first cycle of therapy at an academic center. Before discharge, our team completed financial screening, scheduled follow up appointments and provided prescriptions. The primary objective was to evaluate the overall response rate (ORR) with a secondary evaluation of differences in chemotherapy management and complications. Results: Patients in the academic setting tended to have more adverse risk disease (80.7% vs. 74.3%, p = 0.36) according to the European LeukemiaNet (ELN) (table). The overall survival (OS) of all patients was 10.7 months (95% CI 9.4-15.7) with no significant difference between the groups. The ORR was similar between the community and academic settings (40.0% vs. 36.8%, p = 0.46). The complete remission (CR) rate was 11.4% in the community versus 19.3% in the academic setting (p = 0.67), and the CR rates were improved in the academic group versus the community after cycle 2 (12.9% vs. 0%, p = 0.72) and cycle 3 (25.0% vs. 0%, p = 0.46). Adverse events were comparable, except for increased rates of fatigue (80.7 vs. 54.3%, p = 0.01) and diarrhea (33.3 vs. 11.4%, p = 0.04) in the academic setting. Conclusions: Contrary to prior studies, our evaluation and ongoing partnerships support the transition of AML treatment to a community setting with academic consultation. Although there were some differences in adverse events, the OS and ORR were similar. Furthermore, this study did not identify any significant safety concerns that could prevent patients from receiving this regimen in either setting. Our goal is to continue evaluating this partnership, as we design prospective studies to improve the care of this patient population. 1. Giri S et al. OS of AML Treated at Academic Center Vs Nonacademic Center. Blood 2015. 2. Halpern AB et al. Practice patterns &amp; outcomes for adults with AML. Hematol Am Soc 2020.[Table: see text]

ITS 100 - Reducing Multi-drug Resistant Organism Infection Status Burden in a Pediatric Urologic Patient Population

ITS 100 - Reducing Multi-drug Resistant Organism Infection Status Burden in a Pediatric Urologic Patient Population

Progress Tracker Breast Cancer Registry: A Breast Cancer Canada initiative.

e23018 Background: Significant gaps exist in the collection of real-world evidence and validated patient-reported outcome measures (PROMs) data from individuals with breast cancer. Variations in treatment and surveillance care across regional jurisdictions present knowledge gaps across diverse populations which remain difficult to study. The PROgress Tracker Breast Cancer Registry, a large, prospective Canadian PROMs cohort study aims to identify care gaps through the lived patient experience to inform patient-centered care and new research directions. Methods: PROgress Tracker is a real-world, longitudinal, non-interventional PROMs registry directed by Breast Cancer Canada, a registered non-profit patient-led organization, and data managed by University of Calgary’s POET program. Launched in October 2023, this registry aims to enroll up to 50,000 adult Canadian participants with a histologic diagnosis of in-situ or invasive breast cancer (stage 0 through IV) within 10 years. A volunteer-led peer-to-peer support model, based in regional and provincial hubs across Canada, facilitates participant recruitment, engagement, and retention. Individuals who self-identify for study inclusion provide informed consent, demographic and socioeconomic profile, and clinical information on their breast cancer diagnosis. Every three months (and up to 10 years) a bilingual digital platform to reduce barriers to access is used to provide all PROgress Tracker participants 8 validated PROMs to capture evolving measures of self-efficacy for wellbeing, symptoms and overall global functioning. Based on treatment, up to 10 additional PROMs to assess the immediate adverse effects and long-term impacts of treatment are collected. PROgress Tracker has the additional capacity to link to external ethics-approved studies to investigate clinical outcome and healthcare utilization metrics for participants consenting to additional studies. Results: In progress. Conclusions: PROgress Tracker represents Canada’s first national PROMs breast cancer registry. Its unique design and implementation by a patient-led research organization helps fill gaps in current knowledge through longitudinal follow up of patients prior to, during, and after cancer care, and from the time from diagnosis through active treatment, long-term survivorship, and/or palliative care. The PROgress Tracker Registry will comprehensively gather the validated real-world data information rarely collected in in the traditional clinical or trial-based research setting using a novel self-enroll design and digital process. Such information is crucial to support evidence-based decision making to inform patient-centered healthcare change. This allows comparison across Canadian jurisdictions, is scalable to other jurisdictions around the world and further explores the utility of electronic PROMs data capture within a diverse patient population.

Trainee-led quality improvement (QI) project examining PCP prophylaxis in patients on chronic, high-dose corticosteroids.

e23211 Background: Patients with cancer who develop Pneumocystis pneumonia (PCP) have 30-day mortality rates estimated to be &gt; 50%. Despite consensus guidelines from the American Society of Clinical Oncology (ASCO) and Infectious Diseases Society of America (IDSA), appropriate PCP prophylaxis is reported as low as 3.9% for patients with solid malignancies on chronic, high-dose corticosteroids. In this trainee-led QI initiative, we investigated rates of appropriate PCP prophylaxis at a tertiary care cancer center and surveyed clinicians regarding barriers to prescribing prophylaxis. Methods: An interprofessional, multidisciplinary team consisting of hematology-oncology fellows and cancer-center level QI staff was established. This analysis combined a retrospective chart review and survey at a tertiary care center. Retrospective chart review examined PCP prophylaxis rates among patients with solid malignancies prescribed high dose/duration corticosteroids per ASCO/IDSA guidelines (≥20mg prednisone equivalents daily for ≥1 month) between May 1, 2022 and May 31, 2023. The survey, conducted between December 2022 and May 2023, assessed prescriber knowledge of, and attitudes towards, appropriate PCP prophylaxis prescription. The survey was open to clinicians across oncology specialties. Results: Over the study period, 297 patients met inclusion criteria for PCP prophylaxis (median age 62, 178 (60%) were male, 212 (71%) were White, and 55 (18%) were Black). Fewer than half of eligible patients were prescribed prophylactic antibiotics (n = 140, 47%). There were no sociodemographic differences between patients prescribed prophylaxis and those not prescribed prophylaxis. Survey responses (n = 71) included 33 (46%) attending physicians, 21 (30%) advanced practice providers, 8 (11%) residents/fellows, and 9 (13%) unknown. Thirty participants (42%) had cared for a patient who developed PCP while on corticosteroids. While 62 participants (87%) had experience prescribing PCP prophylaxis, only 18 (25%) accurately identified the dose and duration of corticosteroids at which prophylaxis is needed. Lack of guideline knowledge/education was the most commonly cited barrier to prophylaxis (Table). Conclusions: Our study shows strikingly fewer than half of eligible patients on chronic, high-dose steroids were prescribed PCP prophylaxis. Lack of provider knowledge and systems-related obstacles were noted as primary barriers. Based on these findings, an urgent QI intervention is underway to address each barrier, increase rates of PCP prophylaxis, and reduce rates of PCP incidence towards the broader goal of improving outcomes in this at-risk patient population. [Table: see text]