bluuebunny/crossref_metadata_2025 huggingface dataset:
Recurrence free survival in patients with HPV+ head and neck cancer treated with TORS and neck dissection.
Authors: Melachuri Manasa , Patel Terral , Awad Daniel , Kim Seungwon , Sridharan Shaum , Duvvuri Umamaheswar
Published: June 2023

e18076

Background: Prior research has demonstrated that delays to initiation of radiation therapy (RT) in the treatment of head and neck squamous cell carcinoma (HNSCC) after surgery result in poorer survival outcomes. However, there is limited data with little long-term follow up to evaluate whether human papilloma virus (HPV) positive primaries undergoing transoral robotic surgery (TORS) and neck dissection (ND) face a similar decrement in recurrence free survival (RFS) and disease specific survival (DSS). Methods: Single center retrospective chart review of patients diagnosed with HPV positive primary nonmetastatic HNSCC who underwent TORS with ND followed by RT with or without Chemotherapy and/or Immunotherapy from 2012-2022 with data collection from December 2022 to February 2023. 248 patients met inclusion criteria and were analyzed for DSS and RFS. Kaplan-Meier survival analysis with Log-rank testing was used to assess the impact of time intervals between diagnosis, TORS, radiation initiation and radiation completion on survival. Univariable and Multivariable Cox proportional hazards regression analysis was performed to identify factors associated with RFS and DSS and adjust for potential confounding variables. Subgroup analysis was completed with high risk (lymph nodes > 4 with extracapsular extension) and low risk population. Results: Median follow-up time was 47.22 months (1452.07 days). Of 248 patients, 17 had a recurrence and 12 died due to disease. In patients who underwent radiation therapy for a time frame (TR1-R2) of 5-7 weeks compared with those who had a shortened or prolonged course of RT, RFS (140.116 months, p-value = .012) and DSS (142.641 months, p-value = .016) were improved. Although time from diagnosis to TORS did not impact RFS (p-value = .195), improved RFS persisted in patients who underwent time from diagnosis to radiation completion (TD-R2) or total treatment package time (TTPT) between 17-20 weeks (109.155 months, 95% CI: 105.276-113.034, p-value = .057) compared to patients with TTPT less than 17 or greater than 20 weeks. When the population is stratified into high risk and low risk groups, patients in the high risk group who underwent Chemotherapy had improved RFS compared to no chemotherapy (HR: 7.19, p-value = .09). On Univariate Analysis, TR1-R2 < 5 weeks and > 7 weeks, TD-R2 < 17 weeks and > 20 weeks, extracapsular extension, smoking history, and age > 70 were associated with increased risk of recurrence. Conclusions: For HPV positive patients with OPSCC undergoing TORS and Neck dissection, time to radiation initiation may not be as critical in improving OS, DSS, and RFS as other patient populations. However, the length of radiation time between 5 to 7 weeks and overall treatment time from 17-20 weeks may improve recurrence free survival and disease specific survival.
Malignant glomus tumor of the head and neck: A National Cancer Database analysis.
Authors: Anderson Quinton , Hsia Beau , Tuman Jaylin , Wu Xinxin , Sinai Erin , Silberstein Peter T. , Keirns Darby
Published: June 2023

e18078

Background: Malignant glomus tumors of the head and neck are rare malignancies originating from glomus bodies found within the skin, soft tissues, and mucosa of the head and neck. Malignant glomus tumors often arise from benign glomus tumors and rarely metastasize. In cases where metastasis had ocurred it was typically fatal. Another review of the malignant glomus tumor cases indicated that only a minority developed metastases. These findings, along with a general lack of knowledge regarding demographic and socioeconomic factors on glomus tumors warrants further investigation. The National Cancer Database (NCDB) was analyzed to identify demographic factors among patients and better understand the epidemiology of these tumors. Methods: A retrospective cohort analysis was performed using the 2004–2020 National Cancer Database including patients with a histologically confirmed malignant glomus tumor diagnosis (N = 42). Demographic factors such as race, age, sex, Hispanic status, insurance status, Charlson-Deyo score, facility type, and distance to facility were analyzed by descriptive statistics. Results: A total of 42 patients with a confirmed malignant glomus tumor diagnosis were identified in the National Cancer Database (NCDB) between 2004 – 2020. The average age of diagnosis was 60.9 years (SD = 13.7, range = 36 - 90 years). The aortic body and other paraganglia were the most common primary tumor sites (57.1%). Most patients were White (69.0%) or Black (28.6%). Most individuals (88.1%) had a Charlson-Deyo comorbidity score of 0. A higher percentage of patients were in the bottom quartile of income earners (31.4%). Fewer patients lived in metropolitan counties with populations less than 1 million compared to those that lived in counties with a population greater than 1 million (52.5%). More patients were privately insured (47.6%) relative to those who were insured by Medicare/Medicaid or uninsured. The most common treatment facility type was an academic/research program (57.5%) and patients lived an average of 40.1 miles (SD = 65.6, range = 0.6 – 265.4) from their treatment facility. Conclusions: Before this study, there had been no previous report on the socioeconomic profile of patients with malignant glomus tumors. However, our findings indicate that these patients are more prone to having a low income and that White patients are more likely to be affected. No obvious connection exists between metastases and racial minority status. Additional research is needed to grasp how socioeconomic factors, such as low income and minority status, affect the risk, diagnosis, treatment, and overall survival of individuals with malignant glomus tumors.
Correlations between overall response rate, progression-free survival and overall survival with kinase inhibitors in radioiodine-refractory differentiated thyroid cancers: A systematic review and meta-analysis.
Authors: Ilerhunmwuwa Nosakhare Paul , Wasifuddin Mustafa , Hakobyan Narek , Tahir Muhammad , Avezbakiyev Boris
Published: June 2023

e18087

Background: Differentiated thyroid cancer (DTC) has a good prognosis; however, about 30% of patients will experience a recurrence after treatment and become refractory to radioiodine therapy. Some studies, including randomized controlled trials (RCTs), have shown the efficacy of kinase inhibitors in these patients, but whether overall response rate (ORR) can predict progression-free survival (PFS) and/or overall survival (OS) has not been well established in the literature. We examined the correlations between ORR and PFS/OS with kinase inhibitors in radioiodine (RAI)-refractory DTC. Methods: PubMed, SCOPUS, Embase, and ClinicalTrials.gov were queried for studies that used kinase inhibitors in RAI-refractory DTC. Eligibility included a clinical diagnosis of RAI-refractory DTC, the use of kinase inhibitors, and articles published in English. ORR, PFS, and OS data were manually retrieved from the studies, and correlative analyses using Spearman's rank correlation coefficient ( rs) were conducted to determine their relationships. Results: Two hundred ninety articles were identified from the literature search; after removing duplicates and screening for relevance and eligibility, 24 studies (6 RCTs and 18 observational), consisting of 1,791 participants, were included for analysis. The kinase inhibitors used were: sorafenib, lenvatinib, donafenib, apatinib, sunitinib, cabozantinib, and vemurafenib. There was no significant correlation between ORR and PFS or OS, and between PFS and OS. However, a sub-analysis of the 6 RCTs (n = 410) alone showed a significantly strong positive correlation between ORR and PFS ( rs = 0.92, p = 0.003) with a 20% increase in ORR corresponding to a prolonged PFS by about five months. No significant correlation was found between any two endpoints in the observational studies. Conclusions: Overall response rate is a predictor of PFS and can be used as a surrogate endpoint for the latter (PFS) in RCTs with kinase inhibitors in RAI-refractory DTC, especially when the time to reach PFS data may be protracted, costly, and delayed treatment. The lack of correlations between ORR and PFS or OS in the observational studies may be due to different populations with varying responses, less controlled settings, time to reach OS data, and probably smaller sample sizes.
The influence of grade on mortality risk in salivary gland malignancy.
Authors: Bastien Amanda J , Luu Michael , Balzer Bonnie , Aro Katri , Jang Julie , Mita Alain C. , Scher Kevin , Mallen-St. Clair Jon , Vasquez Missael , Epstein Joel , Lin De-Chen J , Chen Michelle , Zumsteg Zachary Stephan , Ho Allen S.
Published: June 2023

e18100

Background: Salivary malignancies are amongst one of the most difficult malignancies to classify.Currently, the impact of histologic variants has not been well described. The objective of this study was to evaluate histologic subtype and grade in salivary cancer staging. Methods: Salivary cancer histologies were collected from the National Cancer Database (NCDB) and the Surveillance, Epidemiology, and End Results (SEER) database. Multivariable models were used to adjust for clinicopathologic covariates and assess for relationships between histologic subtype, grade, and survival. Results: Histologic variants have a wide range of mortality risk (e.g., acinic cell carcinoma has a favorable 5-year survival, in opposition to salivary duct carcinoma) on univariate analysis(p < 0.001). Using multivariable analysis, the survival differences disappeared. However, worsening grade corresponded signficantly with deteriorating survival (5-year OS of 89% [95% CI 88-90%] (low-grade), 81% [95% CI 79-82%] (intermediate-grade), 45% [95% CI 44-47%] (high-grade) (p < 0.001)), on both multivariable analysis and propensity score matching. Recursive partitioning analysis incorporating grade into current staging generated a TNM+G schema (c-index 0.75, 95% CI 0.745-0.755) superior to the existing system (c-index 0.73, 95% CI 0.723-0.736). Conclusions: Grade is a significant factor in determining mortality risk in salivary cancers. Including grade into staging will improve current staging systems.
Demographic and socioeconomic factors of patients with nonencapsulated sclerosing carcinoma: An NCDB analysis.
Authors: Stewart Laura , Wu Xinxin , Keirns Darby , Silberstein Peter T. , Hsia Beau
Published: June 2023

e18103

Background: Nonencapsulated sclerosing carcinoma (NSC) is a rare and aggressive variant of papillary thyroid carcinoma (PTC) that accounts for 0.7-6.6% of its cases. It is associated with greater rates of vascular invasion, metastasis, and relapse compared to classic PTC. With prompt initiation of aggressive treatment including radical surgery, lymph node resection, and possible radioiodine treatment, NSC has a 10-year survival rate of 93%. Given the importance of proper diagnosis and selection of aggressive treatments, data regarding its epidemiology could further improve patient outcomes. The demographics of NSC patients were analyzed using the National Cancer Database (NCBD). Methods: Data from NCDB was queried and patients with a confirmed diagnosis of NSC between 2004 and 2020 were identified for a retrospective cohort analysis (N = 1,130). Yearly diagnosis rates were analyzed using regression analysis. Factors including patient age, sex, race, insurance status, urban/rural residence, surgical treatment approach, treatment facility type, and 90-day mortality were identified and evaluated via descriptive statistics. Results: The NCDB contained a total of 1,130 patients with a confirmed diagnosis of NSC from 2004 – 2020. The incidence rate of new diagnoses remained stable over this time (R2 = 0.0). Women were much more likely to be diagnosed (78.5%) compared to men (21.5%) with an average age at diagnosis of 44.0 years (SD = 18.7, range = 6 – 90 years). Most patients were White (86.0%), lived in metropolitan areas with a greater than 1 million population (56.5%), and were privately insured (68.9%). The vast majority of patients were treated surgically (99.9%). A complete thyroidectomy was the most common surgical approach (89.3%), more so than subtotal thyroidectomy or lobectomy. For the patients with valid data, the most common treatment facility type was an academic/research program (42.6%) followed by comprehensive community cancer programs (33.8%). Most patients survived at least ninety days after their primary surgery (98.2%) and were still alive at the date of last contact (88.4%). Conclusions: NSC is an aggressive subtype of PTC, but it generally has a good prognosis with initiation of aggressive treatment. The findings of this research corroborated previous studies showing that NSC is much more common in females than males, is most commonly treated with complete thyroidectomy, and has high 90-day survival rates. In examining the demographic features of this patient population, it was found that the majority of patients were White, lived in large metropolitan areas, and were privately insured. This may suggest that a relative ease of access to healthcare aided in their diagnosis. Future research should focus on understanding how demographic and socioeconomic factors may contribute to the timing of diagnosis, chosen treatments, and overall mortality rates of patients with NSC.
An audit of neoadjuvant chemotherapy in sinonasal teratocarcinosarcoma from an academic tertiary care centre in India.
Authors: Peelay Zoya Ravish , Patil Vijay Maruti , Noronha Vanita , Singh Ajaykumar Chandrabhan , Prabhash Kumar , Shah Minit Jalan , Menon Nandini Sharrel
Published: June 2023

e18109

Background: Sinonasal teratocarcinosarcoma (SNTCS) are rare types of sinonasal malignancies, incidence is approximately 3% of all head and neck cancers and less than 1% of all tumors. There is very limited literature available on SNTCS and most of the literature available is in the form of case reports and small case series. The management of these tumors is complicated because of the location and paucity of data available in such scenarios where resection becomes difficult in extensive disease and the role of neoadjuvant chemotherapy (NACT) becomes significant. This audit was performed to study the tolerance and outcomes with NACT followed by surgery(Sx) in these treatment protocols. Methods: A retrospective analysis of a prospectively maintained database approved by the IEC of TMH. The baseline characteristics, extent of tumor, type of NACT, adverse events was curated from the EMR and patients' hospital files. Patients with clinically or radiologically extensive/inoperable disease at presentation were planned for NACT for a duration of 6-8 weeks. Post NACT these patients underwent axial imaging for response assessment.(RECIST v1.1). The adverse events due to NACT were noted as per CTCAE v5.0. Results: There were 27 patients of SNTCS. The median age of the whole cohort was 42 years (IQR 30-56) and 85.2% (n=23) were male. The ECOG PS was 0-1 in 24 (88.8%) patients and only 3 (11.1%) patients had ECOG PS 2. 17 patients (63%) had a history of addiction. 7 patients had clinical palpable regional nodes (25.9%) and 1 patient (3.7%) had lung metastasis at presentation. All 27 patients received NACT in view of extensive disease .15 patients (55.6%) had intracranial extension of disease with intradural extension. Only 10 patients (37%) had intraparenchymal disease. 22 patients (81.5%) had Kadish stage C-D disease and the remaining 5 patients (18.5%) had Kadish stage B at baseline. 20 patients (74.1%) received Cisplatin & Etoposide as NACT and remaining 7 received other chemotherapy. Median number of chemotherapy cycles was 2 (Q1 is 2 - Q3 is 3). 1 patient (3.7%) did not complete the planned NACT due to toxicity. The incidence of grade 3-5 toxicity in accordance with CTCAE version 5.0 was 37.03%. There was 1 death (3.7%) due to chemotherapy toxicity. Details of response to NACT are given in the table. 18 patients (77.8%) underwent Sx, 5 patients (18.5%) received CTRT and 2 patients (7.4%) received definitive RT and 2 patients (7.4%) did not receive any local therapy .Post Sx in local node was found in 3 patients (11.11%).The 2 years progression free survival was 53.2%(95%CI 31.3 - 70.9) and 2 years overall survival was 60.9%(95%CI 37.6 - 77.8). Conclusions: NACT improves survival in locally advanced SNTC with significant response rates. [Table: see text]
Tick tock on the stomach clock: Factors affecting time to diagnosis of gastric adenocarcinoma at an urban cancer center with a large East Asian patient population.
Authors: Choi April , Chadha Bhawneet , Doshi Hiten , Edmiston Charly , Gurinovich Anastasia , Elkon Jacob Matt
Published: June 2023

e18508

Background: Gastric cancer is the fifth most common cancer in the world and disproportionately affects the East Asian population. Various factors contribute to this disparity such as genetics and environmental exposure. Given that language barriers can contribute to reduced quality of healthcare delivery, screening rates, and patient safety, it is important to assess the impact of language on the diagnosis of gastric cancer. Tufts Medical Center’s proximity to Boston’s Chinatown make our patient population unique for analysis of these factors. Here we present a single-institution experience of the factors affecting gastric adenocarcinoma time to diagnosis. Methods: We used ICD-10 codes to retrospectively identify patients at Tufts Medical Center with a diagnosis of gastric cancer between January 2011 and December 2021. We excluded patients that did not have a diagnosis of gastric adenocarcinoma or lacked adequate clinical documentation. We recorded demographic, clinical, and treatment characteristics including race (White, Asian, or other), primary language (English, Asian or other), presenting symptoms, enrollment in hospice, and interpreter status (certified, non-certified, none, or not applicable). Certified interpreters included professional medical services for in-person, video, or phone interpreters. Non-certified interpreters included family members, physicians fluent in the language, or others. We assessed the impact of these on the time between initial presentation to the healthcare system and eventual diagnosis of gastric cancer. Results: 80 patients were included in the analysis. Mean days to diagnosis by race were as follows: White (40), Asian (43), other (25), p = 0.20. Mean days to diagnosis based on language were as follows: English (40), Asian (43), other (6), p = 0.07. Mean days to diagnosis based on interpreter status were as follows: certified (19), non-certified (13), none (73), NA (40) (p = 0.05). When pairwise comparison was done, there was no difference between certified and non-certified interpreter (p = 0.40). There was no difference between certified interpreter and no interpreter (p = 0.06). There was a statistically significant difference between non-certified interpreter and no interpreter (p = 0.04). Presenting symptoms and eventual enrollment in hospice did not significantly impact time to diagnosis. Conclusions: We saw a shorter time from initial presentation to diagnosis of gastric adenocarcinoma in non-English speaking patients who used an interpreter at the initial visit compared to those who did not. One should always consider interpreter availability as an important part of reducing health disparities.
Medication acquisition program: Successful access to innovative treatment options.
Authors: Doctor Vicki , Schink Julian C. , Moran Amber , Gandra Neha , Markman Maurie
Published: June 2023

e18521

Background: Targeted treatments are often not available due to clinical, financial, and administrative barriers. Our medication acquisition program (MAP) serves our national network of cancer centers, helping patients gain access to off-label and scientifically appropriate targeted therapy and immunotherapy when access was unavailable due to the following barriers: clinical trial not available, patients with government insurance unable to afford copay, or insurance policy exclusion or denial for an off-label or on-label indication. The use of genomic testing is used increasingly to identify candidates for clinical trials. While our patients are always offered a clinical trial when available, they don’t always qualify. The goal of this study was to examine our success rate in acquiring medications and the clinical outcomes of those therapies. Methods: An IRB approved retrospective review was completed on patients who accessed targeted treatments that had an existing standard of care (SOC) indication in another tumor type or were being denied access for their on-label indication. For purposes of this study, we defined clinical benefit as treatment duration of 4 months or greater. Results: 1,041 referrals were received by our program between 10/1/2015 and 12/31/2021. While not all therapies referred and accessed were started, we have maintained a 99% success rate for access to these therapies with one dedicated oncology nurse. All therapies started were accessed through appeals to payers or through patient assistance programs. Of the 769 patients who started treatment, 507 (66%) were on therapy for 3 months or less, 120 (16%) were on therapy for 4 to 6 months, 64 (8%) were on therapy for 7 to 10 months, and 78 (10%) were on therapy for 11 months or more. 342 of patients starting therapy through MAP went on to progress and of those, 231 (68%) were able to receive another treatment for their cancer and continue treating at our center. Overall, this process has demonstrated a clinical benefit for 262 (34%) patients who were able to stay on therapy for four months or longer. Conclusions: A process for medication access overseen by one oncology certified nurse highly skilled and knowledgeable of access process as well as a lean methodology for execution has made innovative options for precision care accessible to 769 patients with advanced cancer. The number of patients who access and start treatment combined with the overall clinical benefit for these patients demonstrate how this efficient process, facilitated by nominal FTEs, can enable successful alternate access for patients seeking options. Our medication acquisition program has provided our patients access to targeted treatments that would have otherwise not been available while enhancing our center’s ability to offer innovative options to patients who have exhausted SOC options.
Time to colonoscopy and insurance status at an FQHC.
Authors: Dand Hardik , Ranasinghe Ushan , Hart Miranda
Published: June 2023

e18543

Background: In 2021, Federally Qualified Health Centers (FQHCs) cared for over 30 million patients, 68.7% of whom had Medicaid or were uninsured. FQHCs face challenges to obtain colonoscopies for patients, as many specialists are outside of network coverage or do not accept uninsured patients. As such, many FQHCs use fecal immunochemical testing (FIT) as an initial colon cancer screen. A positive FIT requires a follow-up colonoscopy. Follow-up colonoscopy rates range from 18% to 57% at FQHCs nationally. This study investigates a possible relationship between insurance status and time to colonoscopy after a positive FIT at an FQHC in Chicago. Methods: We performed a retrospective chart analysis. Charts were obtained from the electronic health record by an informatics team. Patients aged 45 years or older with a positive diagnostic FIT between 12/2020 and 12/2021 were selected. We evaluated insurance status, date of positive FIT, date of colonoscopy when applicable, and colonoscopy results. Results: A total of 314 patients were identified of which, 169 (53.8%) were insured and 145 (46.2%) were uninsured. From the 44 (13.7%) patients that completed colonoscopies, 25 (58.1%) were insured and 18 (41.9%) were uninsured. A Chi-square test revealed no significant relationship between patients who did or did not have a colonoscopy and insurance status. The mean number of days between positive FIT and colonoscopy was 124.7 (SD 64.7) and ranged from 38 to 309 days. A two-sample t-test found no significant difference in the mean time to colonoscopy between insured and uninsured patients. Colonoscopy results revealed the majority of patients (N = 23, 53.5%) had benign tumors with only one patient having cancer. Conclusions: In this study, insurance status did not impact time to obtain a colonoscopy. Only 13.7% of patients had a colonoscopy, lower than national rates. Several factors likely contributed to low follow-up rates, including the COVID-19 pandemic, insurance type, language barriers, and colonoscopy scheduling wait times. Establishing strong hospital partners, use of reminder calls, education and encouragement from providers, and emphasizing follow-up could improve colonoscopy rates. [Table: see text]
Clinical trial enrollment in a Hispanic-majority NCI-designated cancer center: The Mays Cancer Center experience over 10 years.
Authors: Garza Morales Rodolfo , Karnad Anand B. , Kaklamani Virginia G. , Diaz Duque Adolfo Enrique
Published: June 2023

e18551

Background: There is a perpetual lack of representation in clinical trial enrollment among minorities. In 2013, the former Cancer Therapy and Research Center (CTRC) at the University of Texas Health Science Center at San Antonio implemented the Minority Accrual Plan (MAP) to address the challenge of deliberately enrolling minority subjects in clinical trials (CT). The objective of the present study was to describe the racial and ethnic minority representation in CT conducted, at the now Mays Cancer Center (MCC), from years 2012-2021. The MCC is an NCI designated cancer center, that serves a Hispanic (HI) enriched catchment area of 5.1 million people of South Texas. Methods: This is a descriptive analysis of patients enrolled in CT at the MCC from years (y) 2012 to 2021. Patients were enrolled in either interventional treatment (IT), interventional non-treatment (INT), or non-interventional/observational (NI) CT. Variables analyzed included ethnicity, payment class, disease site, and county of origin. Results: We identified a total of 14661 patients with various tumor types who were enrolled in CT at the MCC. A total of 7019 patients (48%) were HI, 6590 patients (45%) were Non-Hispanics (NH), and 1062 (7%) patients did not report ethnicity data. The majority of patients were enrolled on NI (67%), followed by INT (18%) and IT (15%) CT. Overall, the highest enrolled disease sites were genitourinary (40%), breast (11%) and pediatric (7%) cancers. Most patients were self-pay (27%) or had Medicare (27%), whereas 19% of patients had commercial insurance and 7% had CareLink. Enrollment of HI has fluctuated over the years; 4333 HI patients were enrolled from 2012-2016, this decreased to 2686 in the following 2017-2021 period. Overall, 26% of patients were from rural locations, while 74% were from urban locations. The number of rural CT participants was greater in Val Verde (298), Kerr (272), Uvalde (163), and Frio (103) counties. Conclusions: HI continue to be disproportionately enrolled in CT. In 2012, and prior to the implementation of the MAP, 45% of the patients enrolled in clinical trials were HI. In the past 10 years, over 7000 HI patients have participated in CT, even though there have been some fluctuations in accruals rates over the past years, such as in the 2017-2021 period where the COVID-19 pandemic affected enrollment rates. This study validates the notion that better, and perhaps different approaches are needed to improve minority enrollment in CT. Finally, we conclude that the uniqueness of our geographic location did not positively impact HI enrollments. [Table: see text]
The implementation of a diverse clinical trial program at a rural community cancer center over a 10-year period.
Authors: Hrom John Stewart , Sentell Christopher , Simmons Gloria , Hinton Juliet
Published: June 2023

e18559

Background: The state of Mississippi ranks last or close to last in the majority of health outcomes including cancer outcomes due to health disparities. Health disparities are worse for patients who face obstacles due to race, socio-economic status, or geographical exclusion. Improving minority enrollment in clinical trials allows for improved cancer care. We report the implementation of an inclusive and diverse clinical trial program at a community cancer center in rural Mississippi over a 10-year period of time. Forrest General Cancer Center cares for patients in a 19 county area with a diverse patient population consisting of 72.8% White, 25.8% Black, and 1.4% Other. Methods: We reviewed the patient database of our clinical trial program over a 10-year period of time from January 1, 2013, through December 31, 2022. All patients enrolled on clinical trials during this period were included in our analysis. We collected data regarding types of clinical trials, racial demographics, patient age, and primary sight of malignancy. A two proportion Z-test was utilized to analyze any differences between race in the study group and cancer population as a whole. A 2 tailed P value was then calculated. Results: During the 10-year period, 242 patients successfully enrolled onto clinical trials. 227 (93.80%) patients were enrolled on interventional treatment studies, and 15 (6.19%) patients were enrolled on registration studies. 233 (96.28%) patients were enrolled on pharmaceutical sponsored trials as opposed to 9 (3.72%) patients enrolled on cooperative group trials. 180 (74.4%) patients were White, 62 (25.6%) patients were identified as minority patients including 60 (24.8%) Black patients, and 2 (0.8%) Asian patients. There was no statistical difference between the racial diversity of study patients compared to baseline patient demographics (P = 0.608318). The average age of enrollment was 61.85 years (range 24-89). The average age for White patients was 63.06 years, and the average age for Black patients was 57.77 years. The most common malignancies included Breast 91 (37.6%), Lung 63 (26.0%), Hematolymphoid 41 (16.9%), Colon 16 (6.6%), Head and Neck 10 (4.1%), and Melanoma 5 (2.1%). Conclusions: We have demonstrated the successful implementation of an Oncology clinical trial program in rural Mississippi leading to advanced patient care with increased availability to high-quality clinical trials. During this time period, we have successfully enrolled a diverse population accurately representing our patients under our care. We feel that our model can successfully be implemented at cancer centers caring for underserved and minority patients throughout the United States leading to improved patient care in these populations. We have shown that it is possible to have a successful clinical trial program with primarily industry sponsored clinical trials in a community cancer center.
Next generation sequencing (NGS) testing for cancer patients at a safety NET hospital.
Authors: Azimzade Rizvan , Avenido Maria Louise , Knopf Kevin B. , Uche An
Published: June 2023

e18563

Background: Next Generation Sequencing (NGS) testing is gradually becoming an essential aspect of cancer care. However, numerous studies have shown that non-White patients are under-represented in both precision oncology clinical trials and molecular testing. Highland General Hospital (HGH) is a community safety-net hospital in Oakland, California serving primarily Black, Hispanic and Asian patients. In an effort to increase health equity, in August 2020 we began to offer NGS testing with Tempus Labs, Inc. for our cancer patients. The purpose of this study is to document this experience and highlight the genomic profile of our patient population. Methods: This is a retrospective chart review study. Patients were included if their tumor biopsy was sent for NGS testing from August 2020 to December 2022. A total of 165 patients had their samples sent for NGS, of which 148 were included in this study and 17 were excluded due to lack of sufficient tissue. Patient demographic data and predictive biomarkers were collected. For the purposes of this study, we defined predictive biomarkers as those that predict likelihood of response or lack of response to therapy as recommended by National Comprehensive Cancer Network guidelines. Results: The racial distribution of our patient sample is shown in the table below. Consistent with the patient population of HGH, our sample included mostly Black (32.4%), Hispanic (26.4%), and Asian (21.6%) patients. Non-Small Cell Lung Cancer (NSCLC) and colorectal cancer (CRC) were the two most common malignancies sequenced at 34.5% and 25.7%, respectively. For NSCLC patients, 54.9% had predictive biomarkers, with EGFR and KRAS being the most common driver mutations. For CRC patients, 60.5% had predictive biomarkers, with 73.9% of those being NRAS/KRAS and 13.0% being high tumor mutational burden. Full results to be presented. Conclusions: Based on our experience, it is feasible and informative to provide NGS testing for patients at safety-net hospitals. NGS testing allows for the most appropriate treatment selection for each patient, which can translate into better outcomes. Moreover, due to the unique demographics of patients from these hospitals, NGS tests can provide valuable information about the tumor genomic profiles of these underrepresented patients. This data can help improve drug development research and close the health equity gap. [Table: see text]
Racial disparities and clinical outcomes among cancer patients admitted with SARS-CoV-2 infection: A nationwide analysis.
Authors: Deenadayalan Vaishali , Swarna Siri Chandana , Vakil Jay , Kim Junglee , Turk Ekrem , Gupta Shweta
Published: June 2023

e18568

Background: The novel SARS COV2 pandemic highlighted existing racial disparities in US healthcare. The impact was further amplified in the cancer community. We studied the racial disparities in the clinical outcomes of cancer patients who were hospitalised with COVID-19 infection. Methods: Healthcare Cost and Utilization Project National Inpatient Sample (HCUP-NIS) 2020 was queried to identify adult patients (Age > 18 years) admitted for COVID with underlying cancer using the ICD-10 codes. Study population was stratified based on race (White vs African Americans vs Hispanics). Primary outcomes included mortality, length of stay (LOS), and total hospitalization charges (THC). Secondary outcomes included prevalence of pulmonary embolism (PE), ICU admission, acute respiratory failure (ARF), blood transfusion, and sepsis. Statistics were performed using multivariate linear and logistic regression using STATA v17. Results: There were 53,465 adult admissions for COVID in cancer patients. Among them 30,605 (58.8%) were White (WH), 9580 (18.4%) were African Americans (AA), 8225 (15.8%) were Hispanics (HISP). HISP and AA were significantly younger compared to WH (61.7 vs 65.8 vs 72.4, p < 0.001). HISP had lowest Charlson comorbidity index (CCI) compared to whites (50.4% vs 67.7%, p < 0.001). AA had highest rates of all medical comorbidities except dyslipidemia and COPD which was higher in WH. Of the 8135 (15.2%) patients that died during the admission, 60% (N = 4880) were WH, 17.1% (N = 1390) were AA whereas 13.5% (N = 1100) were HISP. Compared to WH, HISP had a higher odds of mortality (aOR 1.24, 95% CI 1.03-1.48; p = 0.022), there was no difference in the odds of mortality between WH and AA. The LOS was increased for AA and HISP compared to WH (9.1 vs 9.44 vs 7.78 days, p < 0.001). The total hospitalization charges was also higher for AA and HISP compared to WH ($90,680 vs $123,894 vs $74,126, p < 0.001). HISP patients had higher odds of requiring intubation, blood transfusion, shock and sepsis than WH. Conclusions: Despite being significantly younger with lower comorbidity burden, HISP, had an increased odds of mortality compared to WH patients. Contrary to reported literature (PMID: 35344045), there was no significant difference in the odds of mortality between WH and AA. Further studies are needed to explore the reasons for high mortality in HISP patients. [Table: see text]
Crossing the US-Mexico border for cancer care: Which treatments are more sought-after?
Authors: Verduzco-Aguirre Haydee Cristina , Diaz Fernando Cristobal , LaPelusa Michael Brian , Aldaco Fernando , Soto Pérez de Celis Enrique
Published: June 2023

e18576

Background: Crossing the US-Mexico border to seek healthcare is common, but limited data is available regarding cross-border cancer care. Since access and availability differs between Mexico and the US, we investigated which therapies were sought by Mexico and US-based patients crossing the border to receive cancer care. Methods: An online survey was sent to oncologists in Mexican border states (Baja California, Chihuahua, Coahuila, Nuevo León, Sonora, and Tamaulipas) using the Mexican Society of Oncology’s member directory. The survey was administered via REDCap in October-November 2022. Responses were analyzed using descriptive statistics. The study was approved by the IRB of Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Results: Sixty-six respondents completed the survey (response rate 29.3%). Most were medical (n = 24, 36.4%) or surgical (n = 24, 36.4%) oncologists practicing in both public and private settings (71.2%), with almost a third practicing in Baja California (31.8%). Sixty respondents (90.9%) reported treating US patients seeking a second opinion in Mexico. Respondents reported patients traveled to receive various treatment modalities with curative surgery (64.4%) being the most common. Seven respondents (11.9%) had interacted with patients who traveled to Mexico seeking non-FDA approved therapies, including homeopathic/alternative treatments. Thirty-one respondents (47.0%) reported treating patients traveling to buy medications with oral chemotherapy (CT) (76.7%) being the most common. Fifty respondents (75.8%) reported treating Mexican patients who traveled to the US seeking a second opinion. Respondents reported patients traveled to receive immunotherapy (59.2%). Five respondents (10.2%) treated patients who traveled to the US to receive CAR-T cell therapy, not currently available in Mexico. Twenty respondents (30.8%) reported treating patients who traveled to buy medications, with oral CT (60%) being the most common. Conclusions: Mexican oncologists often treat patients seeking cross-border cancer care. Therapies sought by patients from both sides of the border differ, mostly due to local availability. Factors associated with these differences require further study to address disparities on health outcomes across the US-Mexico border. [Table: see text]
CAR-T therapy access with Louisiana Medicaid: A single institution retrospective analysis.
Authors: Chennapragada Suma Sri , Amankwah Millicent , Lerner Jaren Lobato , Shi Runhua , Ramadas Poornima
Published: June 2023

e18580

Background: Chimeric antigen receptor (CAR)-T therapy has revolutionized the treatment of hematologic malignancies over the past few years. Axicabtagene-ciloleucel was initially approved by the food and drug administration in October 2017 for relapsed/refractory diffuse large B cell lymphoma (DLBCL) after 2 or more lines of systemic therapy. In April 2022, it was approved as second-line therapy for DLBCL that is refractory to first-line or relapses within 12 months of chemoimmunotherapy. Studies have reported complete responses in 50-60% and prolongation of overall survival by 12-18 months. However, CAR-T remains an expensive therapy that can cost up to 1 million USD. Accessibility to CAR-T is governed by various socioeconomic factors including insurance status. The state of Louisiana currently does not have any institution which offers CAR-T therapy. Our Medicaid population is further disadvantaged by the fact that their insurance does not cover out-of-state services. Hence, we conducted this institutional study to evaluate the accessibility to CAR-T and the factors associated with it. Methods: Our retrospective study included adult patients with a diagnosis of DLBCL treated at LSU Shreveport between January 2018 to December 2022. We excluded all other types of B-cell lymphomas, prisoners, and pregnant women. Our primary objective was to evaluate whether the lack of access to CAR-T due to insurance status affected mortality. Our secondary objective was to examine the various demographic factors associated. Analysis was conducted using SAS. Descriptive statistics, Chi-square tests were used to report the results. Results: Our study included a total of 84 patients with a mean age of 59 years. 58% were Caucasian and 38% were African American. 65% were male. 33% had Medicaid coverage and 31% had Medicare. 60% had advanced-stage DLBCL, and 40% had early-stage (Stages I and II). 6% had either double-hit or triple-hit lymphomas. 17% of patients were considered eligible for CAR-T at relapse as per clinician discretion. 33% of patients who were eligible could not get a referral for CAR-T due to factors like insurance status and costs associated with out-of-state living. This led to an increased mortality of 60% in that cohort vs 0% in those who got referrals (p-value of 0.02). Medicaid was the predominant insurance (67%) among those who were unable to get referrals for CAR-T, thus strengthening our hypothesis. Conclusions: Through our study, we aim to bring to light the disparity faced by Louisiana Medicaid patients wherein they don’t have access to a potentially curative therapy for DLBCL. While we do recognize the expenses associated with CAR-T, we wish to highlight that not all states have direct access to this therapy. Seeing how our patients must already uproot their lives temporarily to get CAR-T, their decision could be made easier if insurance can cover the cost at least on a case-to-case basis.
Barriers and facilitators to discussion of cancer clinical trials: A qualitative study.
Authors: Castillo Brenda Sofia , Boehmer Leigh , Oyer Randall A. , Pierce Lori J. , Barrett Nadine , Guerra Carmen
Published: June 2023

e18588

Background: NCCN guidelines indicate that cancer clinical trials (CCTs) are the best management for patients with cancer. However, only 5% of patients enroll in CCTs. Few studies have examined oncology providers’ perceptions of the barriers and facilitators to discussing CCTs. Methods: This qualitative study was part of the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. A convenience sample of 10 U.S oncology providers participated in this sub-study. Their perceived barriers and facilitators to discussion of CCTs at the provider, patient, system, and CCTs levels were examined. To achieve triangulation, each provider reviewed 5 recent patient encounters to identify actual barriers and facilitators using chart-stimulated recall (CSR). Results: Nine participants were oncologists and 1 was a clinical research coordinator; 5 were female; 4 were White; 3 were Asian and 3 were Black. The table shows the most cited barriers and facilitators to discussion of CCTs, and the number of interviews in which those barriers or facilitators was mentioned. Barriers were patients’ negative attitudes and lack of knowledge of CCTs, provider assumptions about patients, lack of time to discuss CCTs and restrictive CCT eligibility criteria. Facilitators were having a CCT workforce, systematically discussing CCTs with all patients, patients requiring new treatment options or were aware of CCTs, and electronic medical record (EMR) strategies. CSR validated the most cited barriers and facilitators except patient negative attitudes and system barriers and facilitators. Conclusions: Many of the barriers to discussing CCTs are addressable with the cited facilitators (e.g. assumptions can be addressed by systematically discussing CCTs with all patients; lack of time to discuss CCTs can be addressed by a robust CCT workforce; restrictive CCT criteria can be broadened). A larger study is needed to further generalize and validate the findings. [Table: see text]
Disparities in rectal cancer initial staging evaluation for distant metastasis.
Authors: Le Brittany , Lo Angelina , Zell Jason A. , Lee Sonia
Published: June 2023

e18589

Background: About a quarter of rectal cancer patients will present with metastasis. Since metastasis dictates prognosis and treatment, detection is crucial. NCCN guidelines recommend CT of the chest, abdomen and pelvis (CT CAP) over PET/CT. Systemic race/ethnic disparities and poor access to health care have been associated with lower utilization of radiologic imaging. Here, we set out to assess disparity in initial radiology work up for rectal cancer metastasis. Methods: We reviewed consecutive rectal cancer cases at our academic institution from 2015 to 2020. Patients with inadequate history, workup performed in foreign country, or those who may not benefit from completion of imaging evaluation were excluded. Sociodemographic data, payer information and clinical history were collected from EMR. Zip code was used to assess SES and to assess for rural-urban community area (RUCA) code. Descriptive analysis, unadjusted odds ratios, and t-tests were used for analysis. Results: Among the 421 subjects, 339 met inclusion criteria. 133 were female (39.2%) and the mean age of the group was 58.6+/-13.5 years. 214 patients (63.1%) had CT CAP performed. Subjects aged 65+ were 41% less likely to have CT CAP completed compared to patients aged 24-64 (95% CI 0.37, 0.97). Subjects with Medicare coverage are 48% less likely to have CT CAP than those with private insurance coverage (CI 0.29, 0.92). Subjects who live in zip codes with median family income below the 50th percentile were 55% less likely to have CT CAP than those who live in zip codes with higher income (CI 0.27, 0.74). Subjects who live in urbanized areas were 3.87 times more likely to have CT CAP completed than those from non-urbanized areas (CI 1.53, 10.6). Subjects who were diagnosed in 2019-2020 were 1.81 times more likely to have CT CAP imaging completed compared to patients diagnosed before 2017. Race and ethnicity and BMI were also assessed, but no disparities were observed. Conclusions: Young age, private insurance, higher SES, urban neighborhood, and more recent diagnosis are associated with receipt of NCCN recommended radiologic evaluation of metastasis in rectal cancer. [Table: see text]