bluuebunny/crossref_metadata_2025 huggingface dataset:
Assessing the translation capabilities of NCI-designated cancer websites with a focus on lung, breast, prostate and ovarian cancers.
Authors: Smith Kolton , Elmarabti Ettaib , Fried Hayley , Spaccavento Colette M.
Published: June 2023

e18514

Background: The world is becoming more and more dependent on the internet for garnering information. Medicine is no exception, with studies suggesting that 70% of patients will consult the internet to learn more about their health. Considering the diverse population served by the United States healthcare system, it is crucial that information can be accessed by Americans of Limited English Proficiency (LEP). This is especially true when it comes to cancer, a disease affecting hundreds of thousands of LEP Americans each year. National Cancer Institute (NCI)-designated cancer treatment centers represent the cutting-edge treatment facilities in oncology. Americans diagnosed with cancer often turn to the website of the nearest NCI-designated cancer center. Our study provides a snapshot of which NCI-designated cancer center websites provide translation capabilities for patient navigations including appointment scheduling, disease information and treatment for four of the most common types of cancer. Methods: Over the course of 2022, we performed a cross-sectional review of the language and translation services available to patients on each of the 71 NCI-designated cancer center websites with a focus on lung, breast, prostate and ovarian cancers. The primary outcomes included availability of translation services, method of translation (google translator vs. written text vs. telephonic) and number of languages offered. Results: Of the 71 NCI-designated cancer center websites, 15 (21.1%) provide information on prostate, lung, ovarian and breast cancer in languages other than English. Among these, 9 (60%) provide direct translation, 1 redirects the user to the NCI website for cancer information, and 5 offer only language lines. Furthermore, of the 9 cancer centers offering direct translation on their websites, only 6 had 2 or more languages. The most common translation language was Spanish (15/15) followed by Arabic and Chinese (11/15). The availability of translated cancer information on these websites did not correlate with the prevalence of LEP in each state. Analyzing previous NCI website interrogations shows that there has been no increase in the translation capabilities of NCI websites since 2019. Conclusions: One way to improve the quality of care in patients with Limited English Proficiency by improving access to care is to increase language concordant resources. NCI designated cancer center websites are sources of cancer related health knowledge. Our research exemplified that there are areas of opportunity to improve the reachability of these recourses to the LEP population. Increasing language concordant resources acknowledges and addresses one of the barriers to care that interferes with the quality of cancer care for LEP patients, promoting shared health care decision making for better health outcomes in a vulnerable population.
Racial disparities and inequity in clinical trials of chimeric antigen receptor T-cell therapy.
Authors: Thakur Rahul Kumar , Mehta Ansh , Vegivinti Charan Thej Reddy , Hammami M Bakri Bakri , Adhikari Biplov , Subedi Roshan , Adhikari Anurag , Kumar Abhishek
Published: June 2023

e18515

Background: Chimeric antigen receptor (CAR) T-cell therapy is a paradigm-shifting advancement in hematologic malignancies with therapeutic futility. There is growing evidence that there are disparities affecting race and ethnicity for malignancy treatments as well as under-representation of minorities in clinical trials. We analyzed the racial representation in clinical trials of CAR-T products in the US. Methods: We searched all clinical trials in PubMed for six FDA-approved CAR-T therapy for all indications. We included all phase 2 and above published trials that were conducted in the US and recorded demographic data. Results: Out of total 64 studies; 16 were included for final analysis. A total of 1678 patients enrolled in the CAR-T therapy trials. The table shows indication and demographic data of the patient. Only 9 (56%) articles reported race and 8 (50%) articles reported ethnicity. We found only 47 (3%) African Americans, 47 (3%) Asian races, and 53 (3%) Hispanic ethnicity patients were enrolled in the trials. Conclusions: Our study highlights inadequate reporting of race/ethnicity and continued under-representation of minorities in clinical trials. This is the largest study examining the generalizability of CAR-T cell therapy RCTs at a population level. The underrepresentation in RCTs is an alarming finding as the incidence of many of the diseases is quite high in such minority populations thus exposing a significant disparity in health equity and healthcare access. More insights through research and policymaking are necessary to overcome barriers to delivering equitable healthcare, especially to underrepresented minorities.[Table: see text]
Associations between micro-geographic social vulnerability and disparities in cancer incidence.
Authors: Aijazuddin Ismail , Alloghbi Abdurahman , Sukari Ammar
Published: June 2023

e18523

Background: Disparities in cancer incidence and diagnosis are the result of complex physical-social-environmental interactions. Geography is one crucial lens for assessment of these disparities. The CDC’s Social Vulnerability Index (SVI) ranks micro-geographies such as Census Tracts based on social factors and can be used to identify health disparities in measures such as cancer incidence. Methods: Actual and age-adjusted expected incidence of common cancers were obtained from the New York State Cancer Registry for 2013-2017 at the Census Tract level. Data were merged with the CDC’s Overall SVI rating for 2016 at the Census Tract level. Analysis included 4,647 Census Tracts, accounting for 97.71% of New York State’s 2016 population (19,078,306 population included). For each cancer, actual and expected incidence were grouped by overall SVI percentile, then percentage deviation from expected cancer incidence was calculated. Pearson correlational test and two-tailed t-test were performed for incidence deviation of each cancer by overall SVI percentile. Results: In New York State, significant correlations between Census Tract Overall Social Vulnerability Index (SVI) percentile and percentage deviation from expected cancer incidence were found for 5 out of 6 cancers reported in the State Cancer Registry. Strong positive relationships between degree of vulnerability and deviation from expected incidence were found for Lung Cancer (R = 0.75, p < 0.001) and Colorectal Cancer (R = 0.67, p < 0.001). Strong negative relationships were found for Female Breast Cancer (R = -0.90, p < 0.001), Urinary Bladder Cancer (R = -0.76, p < 0.001), and Non-Hodgkin Lymphoma (R = -0.73, p < 0.001). A significant correlation was not found for Prostate Cancer, which demonstrated a bimodal relationship with higher excess incidence at low and high vulnerability ratings. Conclusions: There are statistically significant increases in reported incidence of Colorectal and Lung Cancers in more vulnerable Census Tracts in NY State. Paradoxically, there are significant decreases in reported incidence of Breast Cancer, Bladder Cancer, and Non-Hodgkin Lymphoma in more vulnerable Census Tracts. Further exploration of micro-geographic trends is critical to understand the extent to which these disparities are explained by true differences in cancer incidence or by variations in screening access and utilization. [Table: see text]
Validation of the Tagalog and Ilokano translations of the Functional Assessment of Cancer Therapy-General (FACT-G) scale for adult cancer center patients in a state-funded tertiary hospital.
Authors: Dela Cruz Earnest Caiser Quilang
Published: June 2023

e18524

Background: Patient reported outcomes such as the health related quality of life (HRQOL) is a significant variable that should be used in clinical decision making and health policy. The Functional Assessment of Cancer Therapy - General (FACT-G), is one of the most widely used HRQOL questionnaires and to make it more accessible globally translation to local dialects are imperative for inclusive service delivery. Prior to use, the validity and reliability of these tools should be established for the population it is intended to cater. Consistent with the mission statement of the hospital the researcher wanted this service to be more accessible and equitable by addressing language differences for our non english speaking end-users. Hence, the study aimed to document validity and reliability of translated Tagalog and Ilokano versions of the FACT-G questionnaire for use in patients catered upon by the Baguio General Hospital and Medical Center (BGHMC). Methods: Psychometric evaluation of the above tools was done involving 384 adult cancer patients of BGHMC. Data management and analysis using SPSS software was used to evaluate reliability, face validity, content validity, and construct validity. An addition of cognitive interviews was done with end-users and subsequent thematic analysis aimed to improve questionnaire quality. Results: Both the Tagalog and Ilokano questionnaires had indices above the set value for reliability measured as Chronbach’s alpha of 0.968 and 0.974, content validity indices of 0.95 and 0.95, and face validity indices of 0.98 and 0.98, respectively. Construct validity was established through an exploratory factor analysis comprised of a principal components analysis and Varimax factor rotation with Kaiser normalization. Conclusions: The Tagalog and Ilokano questionnaires are reliable and valid tools for use of approximation of HRQOL of cancer patients catered by the BGHMC. With the results of the validation study it is recommended to incorporate the use of these translated questionnaires to the day to day health service provision to approximate the health-related quality of life of cancer patients. These can also be used as measures to evaluate interventions and policies that are directed towards cancer patients catered in Northern Luzon. To better these questionnaires the revised questionnaires includes the omission of the 7th item in the scale of general social and family well-being to minimize disruptions in rapport due to nature of the question. Another is the reversion of the 2nd item in the scale of general emotional well-being so that it would have the same direction on the approximation of HRQOL with the other items in the scale.
Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration.
Authors: Yang Felice , Huang Yue , Lerro Catherine , Liu Wei , Fiero Mallorie , Feng Zhou , Kanapuru Bindu , Patel Timil , Amiri-Kordestani Laleh , Ison Gwynn , Fashoyin-Aje Lola A. , Kluetz Paul , Singh Harpreet , Rivera Donna
Published: June 2023

e18527

Background: Ovarian cancer is the fifth leading cause of cancer mortality among U.S. women. Because clinical trials have historically not been demographically representative of real-world patients, an understanding of the extent of disparities is an important step in addressing them. We aimed to evaluate the representation of older adults and racial and ethnic minorities in trials for ovarian cancer drugs. Methods: We conducted a pooled analysis of all trials that were submitted to the U.S. Food and Drug Administration (FDA) from January 1, 2010 to December 31, 2020 in support of marketing applications for epithelial ovarian, fallopian tube, or primary peritoneal indications. Demographic data (age, race, and ethnicity) for adult participants were analyzed alongside incident ovarian cancer case data (diagnosis between 2010 and 2019) from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. Enrollment to Incidence Ratio (EIR) is reported and defined as the percentage of participants divided by percentage of U.S. incident ovarian cancer cases. An EIR between 0.80-1.20 indicates adequate representation; <0.80 or >1.20 indicates underrepresentation or overrepresentation, respectively. Participants with race or ethnicity categories reported as unknown or missing, or insufficient for calculation were not included in this analysis. A sensitivity analysis was conducted to evaluate the exclusion of trials enrolling only BRCA+ participants. Results: The analysis included 8,211 participants enrolled across 15 clinical trials. Age was available for all participants; race/ethnicity was not reported for 16.3% of participants. With increasing age, EIR decreased (Table). Non-Hispanic (NH) White participants had the highest EIR of all racial/ethnic groups, while NH Black and Hispanic participants had the lowest EIR. Results were similar when excluding trials enrolling only BRCA+ participants. Conclusions: Adults aged ≥75, NH Black, and Hispanic participants were underrepresented in registrational trials for new ovarian cancer therapies. To enhance understanding of the correlation between age, race, and ethnicity, further analyses are necessary. Prospective measures are essential, as discussed in recent FDA guidances, to enroll an adequately representative population in ovarian cancer clinical trials.[Table: see text]
The UC san diego health suspicion of cancer clinic.
Authors: Vaidya Poorva , Cutting Elena R. , Kato Shumei , Mitchell William M. , Heyman Benjamin Michael , Gold Kathryn A.
Published: June 2023

e18528

Background: Physicians at UC San Diego Moores Cancer Center (MCC), like at many major cancer centers in the United States, are subspecialized by tumor type. Patients with symptoms concerning for cancer, but without a diagnosis, often face challenges in establishing care with an oncologist, which can potentially lead to delays in diagnosis and treatment. Methods: At our institution, we created a Suspicion of Cancer (SOC) clinic for referral of patients who have symptoms concerning for cancer, but without a definitive diagnosis of malignancy. The purpose of the clinic is to facilitate establishment of a diagnosis and access to an oncologist in a timely manner. We created an order for referral in our electronic medical record system that enables any provider to refer to patients to the SOC clinic. Once a referral is placed, a hematologist-oncologist or medical oncologist reviews the case and approves the patient for an appointment with the SOC clinic. Results: Between January 2022 and November 2022, we received 107 unique referrals to the SOC clinic. The average age of referred patients was 64 years, with 50 (46.7%) females and 57 (53.3%) males. Thirty-four (31.2%) referrals were from primary care doctors, 23 (21.5%) from hospital medicine, 22 (20.6%) from emergency medicine, 15 (14.0%) from medical subspecialties or neurology, 11 (10.3%) from surgery or surgical subspecialties, and 1 (0.93%) that was self-referred. Thirty (28.0%) patients already had definitive diagnosis of malignancy from either our institution or an outside institution, while 77 (72.0%) did not have a diagnosis at time of referral. Of the 107 referrals, 21 (19.6%) did not follow up with a medical oncologist or hematologist-oncologist within our health system. Reasons for not following up included insurance status, establishing care elsewhere, failed attempts to contact patients, or no shows to established clinic appointments. One patient was already established with a hematologist-oncologist within the MCC prior to referral. Eighty-six (80.4%) patients were seen in new consultation by a medical oncologist or hematologist-oncologist at our institution. After referral, the average time to consultation with a medical oncologist or a hematologist-oncologist was 15.3 days. In the 77 cases without diagnosis at time of referral, 39 (50.6%) underwent biopsy, while 38 (49.4%) were deemed to not require biopsy or declined biopsy. Twenty-five (32.5%) patients were diagnosed with cancer and 52 (67.5%) either did not have biopsy or had a negative biopsy. Ninety-two (86.0%) of the 107 referred patients were alive at time of analysis, while 15 (14.0%) were deceased. Conclusions: The MCC SOC clinic offers a referral pathway to expedite diagnosis and access to care for new oncology patients. In continuing to collect data related to the above outcomes, we hope to identify barriers to the delivery of oncologic care and improve patient outcomes.
Diversity, equity, and inclusion (DEI) champions: Lessons learned and implications for future programming to support cancer clinical trials.
Authors: Figueroa-Moseley Colmar , Gansauer Lucy , McDermott Jessica Dreger , Espinoza Gutarra Manuel Ricardo , Nagaraj Gayathri , Robinson Patricia A. , Bangs Rick , Caban-Holt Allison
Published: June 2023

e18529

Background: Improving diversity and representativeness in SWOG Cancer Research Network (SWOG) clinical trials is critical for addressing disparities in prevention, detection, treatment, supportive care, and mortality among patients with cancer diagnosis. Understanding the needs of underrepresented groups (URGs) and building relationships and trust between these populations and researchers can help overcome barriers to study recruitment. SWOG developed a formal organization structure to provide evidence-based guidance for increasing diverse representation in SWOG research. Methods: Funded through a grant from Genentech and the Hope Foundation, SWOG developed a methodology and field guide to improve representativeness in clinical trials. This methodology includes analyzing the current clinical trial portfolio, reviewing study sites and inclusion/exclusion criteria, refining protocol and accrual plans to be more inclusive, implementing changes, and sharing findings with study teams and communities. Five DEI Champions were selected to work with 5 research committees including Gastrointestinal, Lung, Breast, and Genitourinary Cancers and Multiple Myeloma to identify action plans. The Champions provided tools, evidence, and strategies to implement SWOG’s DEI methodology, provided countermeasures for studies not meeting prespecified enrollment benchmarks, and analyzed and reported participation across the SWOG clinical trial portfolio. Champions, study teams, and committees all implemented strategies and structure for research program modifications and policies. Results: Four of the 5 research committees showed significant improvements in infrastructure and implementation of DEI. Factors that improved DEI within SWOG research committees included a willingness of the committee to engage in DEI work; the infrastructure in place to support the implementation of DEI; the tumor sites being studied, and cross-committee collaborations on research protocols (Veterans, Patient Advocacy, Recruitment & Retention, and Palliative & Support Care). Conclusions: The DEI Champion role is an important strategy that engages cancer researchers and staff in DEI improvement activities and improves infrastructure and recruitment of URGs to clinical trials. Further research is needed to determine the impact of DEI champions on cancer clinical trial participation.
Point-of-care isoenzyme type M2 pyruvate kinase quick stool test for the detection of gastric cancer in Rwanda: A pilot study.
Authors: Riano Ivy , Shikama Felicien , Mukanumviye Marie Solange , Ingabire Zainab , Nyampinga Dyna , Forbes Victoria , Chamberlin Mary D. , Aberra Hanna
Published: June 2023

e18530

Background: Isoenzyme type M2 pyruvate kinase (M2-PK) can only be detected in gastrointestinal (GI) tumors. Detection of M2-PK on a small, portable platform with minimal training required, could offer a streamlined approach for the diagnosis of GI cancers especially in low-income countries (LIC's). We evaluated the feasibility of M2-PK stool test to detect gastric cancer in Rwanda. Methods: Participants with GI symptoms were screened and scheduled for upper endoscopy during the 5th Annual Rwanda Endoscopy Week. Participants who underwent gastric biopsy and provided a stool sample were enrolled. Three Rwandan medical centers participated. ScheBo M2-PK Quick test (Biotech AG, Giessen, Germany) was used to test fecal tumor M2-PK. Study approval was obtained from Dartmouth Health, UConn Health, and University of Rwanda IRB's. Descriptive statistics were estimated. Study is currently enrolling patients to reach the desired sample size (N = 110). Results: A total of 35 patients were consented; 26 patients did not have a biopsy, 1 did not provide a stool sample, 1 was lost to follow-up, and 7 were analyzable. 57.1% were male (n = 4) and 42.9% females (n = 3) with ages ranging from 50 to 71 years old. Males accounted for 66.6% of the cases of gastric cancer (n = 2). The most predominant symptoms reported were dyspepsia (66.7%), and weight loss (33.3%). Among those with hemoglobin levels available the mean was 8.63 g/dL (SD ± 0.71). Only one patient completed staging imaging with CT scans. Two patients with positive M2-PK stool tests had a proven diagnosis of gastric cancer (100%). One of them had a diagnosis of GIST. There was only 1 confirmed gastric adenocarcinoma in 5 patients with a negative M2-PK stool test, yet two patients were told to repeat the endoscopy procedure. Conclusions: A point-of-care (POC) quick stool test to screen gastric cancer is feasible in Rwanda. Study participation interest was high among Rwandan patients. Due to a lack of flexible endoscopes in LIC's, screening is restricted to patients living near regional or urban endoscopy centers, which contributes to the growing prevalence of gastric cancer and health disparities. Cancer control programs in LIC's can be implemented and maintained iteratively with realistic expectations and interventions tailored to the local population, its cultural values, and economic infrastructure. Thus, an emerging POC M2-PK stool test can triage patients to early medical attention when suspected gastric cancer.
Readability and understandability of instruments for collecting patient-generated data (PGD).
Authors: Chiodi Camila Kelly , Arvis Johanna , Martin Elise , Barbier Aude , Di Meglio Antonio , Jacob Guillemette , Menvielle Gwenn , Everhard Sibille , Guillemin Francis , Luis Ines Maria Vaz Duarte , Franzoi Maria Alice B
Published: June 2023

e18534

Background: PGD are crucial to inform and optimize cancer care. These may include patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMS), or patient preferences information (PPI). The increasing use of PGD has led to the need for the adaptation of instruments to different languages and cultures. Recent data has brought attention to the additional need to consider patients’ ability to understand written information included in PROMs. Low health literacy is associated with higher risk for quality-of-life deterioration and generates disparities, including underrepresentation in cancer research. Aiming at improving equity and representation, we evaluated readability and understandability of nine French-language PROMs that are currently used in a contemporary cohort of breast cancer survivors. Methods: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning’s Fog Index (FOG), and the FRY graphics (yielding a mean score representing the n. of school years required to understand the respective text). Readability was considered ideal if mean score ≤6th grade level and acceptable if between 6-8th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool (PEMAT, range 0-100%, higher scores corresponding to easier understandability) and defined as ideal if PEMAT ≥ 80%. Plain-language best practice was met if both readability and understandability were ideal. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Two native French speakers, including a patient representative, independently evaluated each PROM. An additional independent assessment was requested if discordance. Results: None of the 9 PROMs evaluated had ideal readability scores, and only 1 had an acceptable score. Understandability ranged from 55-91%, and only 3 PROMs had ideal scores. None of the instruments met the definition of plain-language best practice. ELF-Q identified points for improvement in several dimensions of the PROMs (Table). Conclusions: The use of comprehensive linguistic and cultural frameworks during the development and translation of self-reported PGD instruments may improve experience and engagement of patients with lower literacy and foster equity and representation in cancer cohort studies. [Table: see text]
A funder-based comparison of global oncology research led by NCI-designated cancer centers: Results from the 2021 global oncology survey.
Authors: Garton Elise M. , Eldridge Linsey , Cira Mishka K. , Frank Allison , Loehrer Patrick J. , Duncan Kalina
Published: June 2023

e18535

Background: Equitable global cancer research partnerships are key to reducing the global burden of cancer, which disproportionately affects low-and middle-income countries (LMICs). One indicator of equitable partnerships is the inclusion of LMIC investigators in global cancer research. In 2021 the National Cancer Institute (NCI) conducted a survey of the 71 NCI-Designated Cancer Centers about their global oncology activity. The survey results highlight cancer centers' non-NIH funded global cancer research, training, and capacity-building projects and complement data about global cancer research funded by the National Institutes of Health (NIH). This analysis presents NIH and non-NIH funded global oncology research led by cancer centers stratified by collaborator income class. Methods: NCI designed and fielded an online survey to cancer center global oncology contacts and principal investigators of research projects from July 2021 through January 2022. Data about NIH grants were sourced from internal NIH systems. Income classes are defined by the World Bank and analysis was conducted in Microsoft Excel and Python. A two proportion Z test was used to test for differences in collaborator income class between NIH grants and non-NIH funded projects. Results: Ninety-four percent (67/71) of cancer centers responded to the survey. Forty-seven cancer centers reported 257 global oncology projects with named international collaborating institutions in 2021. Comparatively, 69 cancer centers held 688 NIH cancer research grants with international collaborating institutions in 2021. These projects and grants had collaborators in 111 countries, including 72 LMICs. Projects and grants were stratified by whether they had collaborators only in high-income countries (HICs), only in LMICs, or in both HICs and LMICs, as shown in Table 1. Non-NIH funded global oncology projects were significantly more likely than NIH grants to have only LMIC collaborators (p = 0.0006) or both HIC and LMIC collaborators (p < 0.0001). Conclusions: While the inclusion of LMIC collaborators in research does not guarantee an equitable partnership nor effective research, it is one indicator of these efforts. The results of the global oncology survey demonstrate that cancer centers are committed to conducting research in LMICs and with LMIC institutions, and they are more likely to collaborate with LMIC institutions when supported by a non-NIH funder or by institutional funds. Further analysis is recommended to understand the extent to which research collaboration indicates equitable partnership, and the barriers and facilitators to collaboration posed by different funding sources. [Table: see text]
Treatment adherence and clinical outcomes of osimertinib (Osi) among ethnic-minority patients (pts) with EGFR-mutated NSCLC.
Authors: Lee Matthew , Miao Emily , Zhang Chenxin , Xue Xiaonan , Tuckman Steven , Halmos Balazs , Cheng Haiying
Published: June 2023

e18536

Background: Osimertinib (Osi) is widely used in the management of patients with EGFR-mutated NSCLC but there is limited data on the treatment adherence and clinical outcome of Osi in ethnic minorities. This study aims to evaluate race/ethnicity, adherence and other demographic, socioeconomic and clinical factors of patients with NSCLC treated with Osi. Methods: A retrospective cohort study of a total of 102 patients with EGFR mutated NSCLC that were prescribed Osi from 1/1/16-12/31/22 with 46 patients within Montefiore’s own specialty pharmacy system with updated claims data. Adherence was measured using two methods with medication possession ratio (MPR) and proportion of days covered (PDC). Primary endpoint was overall survival (OS) along with secondary endpoints of progression-free survival (PFS) and treatment duration from the start of Osi, compared minority vs non-minority using log-rank testing and survival analysis with cox proportional models. Results: A median follow-up time of 10.5 months (mons), median age of 69 years old and 34.8% self-reported as Non-Hispanic Black (NHB), 45.6% as Hispanic (H), 10.9% as non-Hispanic White (NHW) and 8.7% non-Hispanic Asian. Treatment adherence did not differ between Blacks vs non-Blacks or Hispanics vs non-Hispanics using both MPR or PDC. The median out of pocket cost for our pts after financial assistance and insurance was around $80 (USD). Compared to non-Hispanics, Hispanics had similar OS, PFS and treatment duration. However, compared with Non-Blacks, Blacks had inferior PFS (p=0.021) and borderline significance of worse OS (p=0.052) and shorter duration of Osi (p=0.068). Further results are summarized in the table. Conclusions: Our study demonstrates that treatment adherence did not differ among minority vs. non-minority patients. However, unlike Hispanics who had similar survival to non-Hispanics, Blacks had inferior PFS, OS and shorter duration of Osi compared to Non-Blacks. This warrants further research on the underlying mechanisms to help improve patient care and outcome while undergoing Osi treatment especially in Black pts. [Table: see text]
Impact of ethnicity and insurance on adverse effects and treatment outcomes related to immune checkpoint inhibitors at a safety net hospital.
Authors: Mahadevia Himil , Eidenschink Benjamin , Harry Stephanie Sarita , Kujtan Lara Ann
Published: June 2023

e18538

Background: Clinical trials have shown efficacy and safety of immune checkpoint inhibitors (ICI) in the treatment of various malignancies. However, trial populations often do not adequately represent patient populations in the real-world. We report immune related adverse effects (IRAEs) among patients with various malignancies, diverse ethnicities, and government sponsored insurance or uninsured, as well as treatment outcomes of ICIs in metastatic non-small cell lung cancer (mNSCLC). Methods: A retrospective study of adult patients with malignancy, who received ICI or ICI plus chemotherapy from January 1, 2015 to January 1, 2020 was conducted at a safety net hospital. Data was collected from electronic medical records with IRB approval. IRAEs were identified and categorized according to CTCAE v5.0. 1-year overall survival (OS) and median duration of ICI therapy (mDT) were calculated for mNSCLC patients. Results: We reviewed 121 patients: 49% were African American (AA), 40% were white and 11% were other ethnicities. Medicaid/Medicare (M/M) was the primary insurance for 83% of patients, 6% had commercial insurance and 11% were uninsured. The median duration of follow-up was two years. IRAEs occurred in 37% of patients; hypothyroidism was the most common (7.5%), and none led to death. The incidence of grade 2 or higher IRAEs was lower in AA (25.4%) compared to in whites (32.6%), with treatment discontinuation rates of 5% in AA versus 16% in whites. Among mNSCLC patients, AA and other ethnicities had a decreased 1-year OS of 37% and 22% respectively, compared to 48% in whites. The mDT was 8.3 months for AA and 3 months for other ethnicities, compared to 13.2 months for whites. 40% of M/M patients with mNSCLC were alive at 1 year; none of the uninsured patients were alive at 1 year. The mDT was higher in M/M patients (6 months) than uninsured patients (3.5 months). Conclusions: Ethnicity and insurance coverage may influence the incidence of IRAEs and treatment outcomes with ICI. AA had a lower incidence of IRAEs compared to whites. However, minority populations with mNSCLC had decreased survival compared to whites. mNSCLC patients with M/M had better OS than uninsured patients. Minorities and uninsured patients spent less time on ICI compared to other patients. IRAEs are a significant burden and further study of the use of ICIs in diverse populations is warranted.[Table: see text]
Is physician-patient language discordance a barrier for clinical trial enrollment in patients with cancer? A real-life study.
Authors: Urueta Portillo Daniela , Mendoza Sanchez Ana Maria , Mazo- Canola Marcela , Urueta Portillo Lisa Maria , Quilantan Nitzia Esmeralda , Gelfond Jonathan , Peguero Julio Antonio
Published: June 2023

e18539

Background: Clinical trials are essential for enhancing cancer care. Participation is concerning in racial and ethnic minority groups historically under-represented in research. So, it is crucial to note that, despite Hispanics and African-Americans being 18.9% and 13.6% of the US population, each only represents 4% of the patients enrolled in clinical trials. We address effective doctor-patient communication as a fundamental clinical function in establishing an effective doctor-patient relationship, and is vital in delivering high-quality care. In this study, we question whether physician-patient language concordance affects clinical trial enrollment. Methods: The study evaluated 982 patients diagnosed with cancer who consented to experimental clinical trials in a private practice in Houston, Texas, from 2008-2022. All trials had approved language translations for English and Spanish. We used logistic regression to model the probability of treatment, while adjusting for the effects of cancer type, gender, race, ethnicity, and language (same or different as provider). Results: 982 patients with multiple cancer types (hematological, breast, thoracic/respiratory, genitourinary, gastrointestinal, head and neck and CNS) were included in the study. The most represented tumor types were GI (32%), Breast (24%) and Thoracic (23%). 66% of patients were successfully enrolled in an experimental clinical trial and started treatment, and 95% spoke the same language as their providers. 14% of patients spoke a different language than English, Spanish being the most commonly spoken language other than English spoken by the patient and provider. The study has adequate minority representation (Caucasian 45%, Hispanic 30%, African-American 18% and Asian 5%), and equal gender distribution (52% were female). After evaluating the results, it was found that there was no statistically significant association between physician-patient language and enrollment rates (p = 0.3). It was also found that there was no impact when the assessment was divided by tumor type, gender (p = 0.8) or ethnicity. It also evaluated the rate of consent withdrawal, with only 4% of patients withdrawing consent, showing no statistically significant association with language concordance. Conclusions: In conclusion, our study confirms no significant difference in cancer patients’ enrollment rate in clinical trials if there is language concordance between physician and patient. The efforts of the medical workforce to use translators and translated versions of informed consents, surveys or outcome assessments, when available, seem enough for our patients to collect all the information required to agree to continue enrollment. It is required to further evaluate more variables that impact enrollment in minorities to stop this disparity in cancer care.
Racial disparity in cancer clinical trials: An analysis of clinicaltrials.gov protocols for race-related language and description.
Authors: Raghupathy Gayathri , Bowers Haley , Seth Roshan
Published: June 2023

e18545

Background: Despite high cancer mortality rates in Black and Hispanic patients, they remain underrepresented in clinical trials. We analyze clinicaltrials.gov trial protocols to understand how sponsors discuss race, ethnicity, or diversity-related keywords, and map the distribution of cancer trials in the USA in relation to cancer incidence rates among Black and Hispanic Americans. Our study highlights the potential of enhanced sponsor information and data-driven site selection to reduce racial disparities in clinical trials. Methods: The US oncology trials from NIH’s clinicaltrials.gov were searched for racial disparity-related keywords using Kognitic© NLP algorithms. Keywords such as "racial," "ethnicity," "minority," "African American,”, "Hispanic” etc. were included. Only Hispanic and African American races were considered. Data were verified, classified based on keywords found. Zip codes of recruiting clinical trial sites were mapped to high-cancer-incidence counties among Hispanics and Black Americans (sources: statecancerprofiles.cancer.gov and unitedstateszipcodes.org). Results: We found 8338 (21% of all US cancer trials) clinical trials addressing racial disparity in cancer, with 4.3% being industry-sponsored, 8.3% academic-industry collaborations, and 87.3% non-industry-sponsored. 50% of the trials were interventional and the other 50% were observational, with biopharma as the primary industry represented. In industry-sponsored trials, only 10.3% directly explore race-based outcome differences, with the remainder collecting demographic data or having patients self-report their race. After comparing the locations of cancer clinical trials currently underway in the United States to counties with the highest cancer incidence rates among Black and Hispanic Americans, we discovered that only a limited number of clinical trial sites are in those high-incidence counties. Only four out of the top ten counties with the highest cancer incidence rates for Blacks and one out of the top ten for Hispanics have clinical trials actively recruiting patients, with most trials in both populations being conducted by non-industry sponsors. Conclusions: Our findings indicate that a limited number of cancer clinical trials mention race and ethnicity in publicly available trial protocols, and even fewer industry trials include race-related information. Our site analysis shows that a major gap in access to trials in areas with high cancer incidence rates, particularly for populations with low socioeconomic status. More analysis is needed to understand the relationship between trials and demographic conditions in America. Providing details on plans to address racial disparities in recruitment, trial design, and site selection will promote inclusive trial design that are accurate assessment of how drugs work in various types of patients.
Demographic factors associated with time to treatment initiation in hepatocellular carcinoma.
Authors: Bettag Joseph , Seraphin Michael , Kroes Weston , Silberstein Peter T.
Published: June 2023

e18546

Background: Hepatocellular carcinoma (HCC) accounts for 75% of all liver cancer diagnosis in the United States, with incidence rising in recent years. One aspect of treatment is time to treatment initiation (TTI). TTI is associated with better outcomes and lower patient anxiety. We hypothesize that demographic factors play a role in how fast a patient with HCC receives treatment. Methods: This study looked at 112,615 patients diagnosed with HCC from 2004-2019 in the National Cancer Database (NCDB). Demographic factors analyzed were biological sex, race, age, cancer stage, year of diagnosis, insurance status, household income, Charleson-Deyo score, and type of facility for treatment. Histology was determined using ICD-O-3 coding. Cross tabulation analysis was performed using ANOVA. Results: Patients with delayed TTI were more often male, black, stage III, 61-70 years old, on government insurance, diagnosed between 2016-2019, made less than $40,227, and treated at integrated cancer network programs. Patients with no insurance received a TTI 4 days faster than government insurance (p < .001). Patients with lower incomes also experienced greater than 2-day delays in TTI (p < .001) compared to higher incomes. Treatment at an integrated cancer network was associated with a 3-day delay compared to treatment at a community cancer center (p < .001). Males began treatment a half day after female patients (p < .017). Conclusions: Discrepancies exist in TTI for HCC patients, most notably for insurance status, race, year of diagnosis, income, and facility type. This data can be used when determining which patients may experience delays in TTI due to demographic factors.
Use of molecular NGS vs single gene testing differs by clinical setting and physician’s specialty in mNSCLC management.
Authors: Keating Katherine Elizabeth , Hewitt Rachael Victoria , Ramos Cirillo Priscila Daniele Daniele , Smart Dave , Abrunhosa Amaral Inês , Sandberg Tessa Paulien , Slifko Bethany Michelle , Alarcon Ruiz Jose Luis , Keeling Derry Mae , Kennedy Chloe Laura , Moore Wendy , Clark Jordan , Munksted Susanne , McLeod Howard L.
Published: June 2023

e18547

Background: Genomic profiling is an important entrée to Precision Medicine (PM) therapies for treating metastatic non-small cell lung cancer (mNSCLC) with 16 new PM therapies approved since 2018, and 10 advancing from second (2L) to the first (1L) line. However, absent or suboptimal predictive biomarker testing leads to patients not benefiting from appropriate PM treatments (64% inappropriate; Sadik et al., 2022). Disparities in testing practices and perceptions remain when considering Next Generation Sequencing (NGS) versus Single Gene (SG) testing. We hypothesized that testing rates are associated with physician’s specialty/clinical setting, and assessed this in real-world data for USA mNSCLC patients. Methods: The DXRX database contains real-world claims and laboratory data covering 60% of USA mNSCLC population (Surveillance, Epidemiology, and Results program - SEER comparison). NGS and SG testing rates for newly diagnosed (1L) and 2L mNSCLC patients (~186K patients from 2018 to 2021) were evaluated by physician specialty and affiliation (self-populated on National Plan and Provider Enumeration System - NPPES). Oncologists and Pathologists referred 63% and 15% of the patients respectively. Results: Oncologists (ONCs) had higher NGS testing rates than pathologists (PATHs), with double the testing rates in 2L. NGS testing rates were higher in academic vs community settings, regardless of specialty. Conversely PATHs had higher SG testing rates than ONCs, particularly in community settings (Table). NGS testing rates were generally higher in 2L and SG testing higher in 1L. Conclusions: NGS is the optimal molecular testing modality for mNSCLC patients, however, there is a disparity of testing rates across physician specialties and treatment settings in decreasing order: academic ONCs > community ONCs > academic PATHs > community PATHs, who favor SG testing. This could be influenced by turnaround time needs, reimbursement challenges, and/or technology diffusion rate. As most mNSCLC patients are treated in the community setting, efforts are needed to tackle disparities in appropriate testing. [Table: see text]
Unmasking ethnic disparities in Asian representation in U.S. oncology training programs.
Authors: Santos Patricia Mae Garcia , Chino Fumiko , Torres Mylin Ann , Suneja Gita , Deville Curtiland , Vapiwala Neha
Published: June 2023

e18548

Background: Asian Americans are not traditionally considered underrepresented in oncology; however, prior analyses of oncology workforce representation have not disaggregated Asian race by ethnicity. This study assessed Asian representation in U.S. oncology training programs by country of origin. Methods: All trainees with self-reported race/ethnicity data in U.S. Radiation (Rad Onc), Medical (Med Onc), Pediatric (Peds Onc), and Surgical Oncology (Surg Onc) programs were identified using 2013-2022 data from the Association of American Medical Colleges. Complex Surgical, Gynecologic, and Orthopedic Oncology programs were included within the Surg Onc category. Asian race was disaggregated by available subgroups (i.e., Bangladeshi, Cambodian, Chinese, Filipino, Indian, Indonesian, Japanese, Korean, Pakistani, Taiwanese, and Vietnamese). Asians with > 1 or no subgroup classification were excluded. Representation quotients (RQ) were used to measure representation relative to the U.S. census population adjusted by age and year, whereby RQ = 1 denoted proportional representation; RQ > 1 and RQ < 1 denoted representation greater or less than expected; RQ = 0 denoted no representation. Linear regression assessed trends in RQ over time for each subgroup. Results: Overall, 27% of oncology trainees identified as Asian (31% Rad Onc, 30% Med Onc, 30% Peds Onc, 19% Peds Onc, 16% Surg Onc). Apart from Indonesians in Rad Onc (median [IQR] RQ, 1.21 [0-3.54]), RQ = 0 for all Indonesians, Cambodians, and Laotians, while median RQ was < 1 for all Filipinos, regardless of program type. In contrast, all other Asian ethnic subgroups had median RQ values > 1, except for Taiwanese and Vietnamese fellows in Surg Onc (0.84 [0.45-0.96]) and Peds Onc (0.43 [0.30-0.63]), respectively. Among Filipinos, median RQ values for Med Onc (0.39 [0.31-0.48]) and Peds Onc (0.51 [0.45-0.58]) were approximately half that of their respective primary residencies (Internal Medicine, 0.75 [0.75-0.73]; Pediatrics: 0.97 [0.99-91]). From 2013-2021, representation remained largely stable for all ethnic groups, with the exception of increased representation among Taiwanese Med Onc (RQ slope [95%CI], 2.96 [1.81, 4.11]; p< 0.001) and Indonesian Rad Onc (0.94 [0.53 to 1.35]; p= 0.001) trainees; and decreased representation among Indian Med Onc (-0.44 [-0.65, -0.23]; p= 0.002) and Korean Surg Onc (-0.04 [-0.61, -0.20], p= 0.003) trainees. No changes in Filipino representation were observed. Conclusions: In this first workforce analysis of oncology trainees to disaggregate Asian race by ethnicity, Cambodians, Filipinos, Indonesians, and Laotians were consistently underrepresented in oncology training programs. Further investigation is needed to understand these differences to ensure that efforts to promote diversity in oncology avoid overlooking ongoing imbalances in representation and inclusion in the U.S. physician workforce.