tbuckley/cabot-search huggingface dataset:
Improving ethnic and racial diversity within clinical trial populations through community recruitment and inclusion initiatives: Experience from MyTACTIC.
Authors: Richard Michael Zuniga, David R. Spigel, Lee S. Schwartzberg, Jason Hong, Luke Passler, Walter C. Darbonne, Tania Szado, Ari VanderWalde, Davey Daniel
Journal: Journal of Clinical Oncology (2024)

e13679 Background: Clinical trial populations are not typically ethnically diverse, restricting healthcare equity and the generalizability of clinical trial data to real-world populations. Moreover, mostpatients (pts) with cancer in the US receive treatment in the more diverse community setting, where minority groups are usually better represented but with lower trial enrollment rates than academic centers. MyTACTIC (NCT04632992) is a phase II, non-randomized basket trial evaluating targeted therapies in pts with advanced solid tumors with specific biomarkers. Inclusive research practices, including mostly community recruitment, were implemented in MyTACTIC to improve access for patients who may otherwise not have been able to enroll. This retrospective analysis presents their impact on the diversity of the trial population. Methods: Adult pts with advanced solid tumors were enrolled from community cancer clinics (private practices and community hospitals) or large academic centers, into 1 of 15 arms based on biomarker alterations. Inclusive research practices implemented to diversify pt recruitment included: revision of eligibility requirements to be more inclusive for minorities; language simplification and streamlining of study protocol; training activities; free transportation. We compared race and ethnicity data between the study population and trial sites’ catchment area (geographical area of pts around the clinical site). Results: Forty pts, all of White race, were initially enrolled across 14 sites, which prompted additional focus on diversity efforts. The trial was expanded to 45 sites across 21 states: 252 pts were enrolled (83% of White race) (Table). Most (96%) selected sites (n=249 pts) were community clinics. The proportion of pts from racial minorities was generally higher in study centers from ethnically diverse catchment areas. Protocol streamlining and staff training were also beneficial to pt recruitment. Free-ride transportation removed the barrier of access to clinical trial sites. The impact of other initiatives will be presented. Conclusions: Running clinical trials at community oncology sites does not, in itself, equal increased diversity of study populations: other efforts, including but not limited to free transportation and community site selection, are also needed. Here we share some learnings from the MyTACTIC study, based on outcomes from the various inclusive research practices implemented in this trial. Clinical trial information: NCT04632992 . [Table: see text]
Optimizing colorectal cancer screening outreach: A probability-based strategy by Temple University Hospital.
Authors: Christopher Grivas, Manasa Vallabhaneni, Abraham Ifrah, Gabrielle Gillow, Brianna Graham, Nikita Dahake, Shelby McNeilly, Rishabh Khatri, Claire Raab
Journal: Journal of Clinical Oncology (2024)

e13502 Background: Temple University Hospital has created an initiative to increase colorectal cancer (CRC) screening to a historically underserved population in Northern Philadelphia through the administration of Fecal Immunochemical Tests (FIT). FIT testing possesses the advantage of being inexpensive and easy to use. Moreover, FIT testing serves as an additional opportunity for underserved patients to be integrated into a health network to receive lifesaving care when utilized by a large health system such as Temple Health. This study demonstrates how healthcare institutions, such as Temple Health, can employ probability-based modeling created from empiric data to navigate uncertainty and establish goals for the number of colonoscopies they aim to perform per a specific quantity of FIT tests distributed within the community. By doing so, they can significantly enhance the overall screening efforts in Northern Philadelphia and provide an essential service to those who need it most. Methods: FIT tests were distributed to the participants at community engagement events. FIT response rates, positivity rates, and progression to colonoscopy rates were determined and fit to a binomial distribution in Palisades @Risk software and underwent a Monte Carlo simulation of 10,000 iterations to determine the different probabilities of response rates, positivity rate, and colonoscopies performed per 1000 FIT tests distributed. Results: A total of 292 tests were distributed with a response rate of 56.5% (165 patients) and a positivity rate of 8.9% (26 patients). Out of 292 patients, 2.4% (7 patients) have had a colonoscopy or are scheduled to have a colonoscopy at Temple University Hospital. Probability curves were created to demonstrate the probability of number of responses, number of positive tests, and number of colonoscopies performed per 1000 FIT tests administered to the community. Lastly, we modeled the number of FIT tests that need to be administered to the community to perform at least 100 colonoscopies with different levels of certainty (Table). Conclusions: Here we show how hospital systems, like Temple Health, can use probability distributions based on empiric data to set tangible goals regarding their community engagement efforts to increase access to CRC screening. Through the utilization of probability distributions, healthcare organizations can gain deeper insights into resource allocation needs and strategically direct their initiatives, ultimately fostering a more inclusive and equitable approach to population-based CRC screening. [Table: see text]
Why cancer survivors who are parents are not getting support for their children.
Authors: Alicia Kabir
Journal: Journal of Clinical Oncology (2024)

e13747 Background: Previous research indicates there are approximately two million cancer survivors in the United States who have children under the age of 18, impacting between three and five million youth. These children are often caregivers and face mental health issues, including fear and depression. Kesem is the largest nonprofit dedicated to supporting children impacted by a parent’s cancer, and we completed research to understand why so few cancer patients seek and receive support for their children. Methods: Kesem’s methods included three weeks of ethnographic research in mostly underrepresented communities in rural Mississippi, the Pacific Northwest, and southern Nevada. We completed 124 interviews in 18 cities. We also surveyed 147 survivors and reviewed over 30 databases. Results: There are two primary reasons why cancer survivors do not seek support for their children. First, many families lack awareness of support options. Second, even if support was presented, there are many barriers keeping a family from participating. There is a lack of awareness about parental cancer. The majority of the research participants had not heard of Kesem or any other program offering support for their children. Focus group data indicated that most survivors were given only information for themselves and for an adult caregiver. Most had never been asked whether they had children. Even if support were presented, survey data (n=147) showed that many families would not participate. Notably, survivors had low trust in the healthcare system. Only 63% of the patients surveyed (n=147) would have approached their oncologist’s or physician’s office for advice on how to support their children, had they known to ask. Per above, 49% assumed they could not trust the service provider offering support for their children, without even seeing information on the provider or the program. Conclusions: There are at least three million children in the United States alone navigating a parent’s cancer journey without the mental health support they need. During a cancer diagnosis, continued focus on the social determinants of health, including a review of the core family structure, is critical. We must be asking if youth are in need of support. In order to have higher participation in programming, we must build trust in underrepresented communities, which can be partially addressed by providing services at no cost to families and by being flexible to address scheduling concerns. [Table: see text]
Racial disparities in presentation and survival for lobular breast cancer.
Authors: Simran Sandhu, David Wai Lim, Vasily Giannakeas
Journal: Journal of Clinical Oncology (2024)

1596 Background: We characterized differences in presentation and survival, and identified predictors of survival, among women of varying race with lobular breast cancer. We also assessed if these trends were unique to ILC by comparing with invasive ductal carcinoma (IDC) and mixed invasive ductal-lobular carcinoma (IDLC). Methods: Using the SEER database, we performed a population-based retrospective cohort study of women diagnosed with ILC, IDC, and IDLC between 1998 and 2019. We collected race, age, marital status, and income. Clinical data included grade, size, laterality, clinical stage, receptor status, surgery type, chemotherapy, radiation, and breast-cancer-specific survival (BCSS). Differences between racial groups were assessed using Chi-square tests or one-way ANOVA. To identify predictors of survival, Cox-proportional hazard models were constructed. Statistical analyses were performed using SAS and P values &lt; 0.05 were considered significant. Results: 38,769 women with ILC were identified, including 32,857 White, 2398 Black, 2352 Asian, and 1162 women of other race. Black women presented with higher-grade, advanced clinical stage, ER+ disease, N2-3 stage, and lower rates of unilateral/bilateral mastectomy than White women. Black women were more likely to not undergo surgery (7.13%), compared with White (4.25%) and Asian (4.04%) women ( P = .0001). Asian women were younger, had more ER-/PR- ILC, and received more chemotherapy. The five-year BCSS rates in Black, White, Asian, and women of other race were 91.5%, 94.2%, 93.7%, and 95.7%, respectively ( P&lt; .0001). Predictors of worse survival include Black race (HR 1.32, P &lt; .0001), ER-/PR- (HR 2.18, P&lt; .0001), ER+/PR- (HR 1.52, P&lt; .0001), and no surgery (HR 4.19, P &lt; .0001). Radiotherapy was associated with improved survival (HR 0.82, P &lt; .0001), while chemotherapy did not affect survival (HR 1.1, P= 0.0504). In comparing across breast cancer subtypes, Black women similarly present with higher grade tumors, advanced clinical stage, ER+ disease, and had higher rates of surgery omission in IDC and IDLC. However, ER-/PR- subtype was notably higher in ILC among Asian women compared with IDC, whereas Black women have higher rates of ER+/PR+ and ER-/PR- ILC. Black women had the lowest five-year BCSS rates across all breast cancer subtypes. Predictors of worse survival in IDC and IDLC include Black race and negative hormone receptor status, while radiation therapy was associated with improved survival. Conclusions: There are differences in clinical presentation of invasive lobular breast cancer according to race.Black women had more advanced disease, while Asian women were younger. Across all subtypes, overall survival for Black women at 5 years was worse compared to other racial groups. Our data provides insight into the complex interactions of race, clinical characteristics, and survival outcomes in lobular breast cancer, with implications for screening considerations.
Novel approach to implementing natural language processing for clinical staging of non-small-cell lung cancer.
Authors: Manan P Shah, Laura Prichard, John A Glaspy, Vu Vu, Jason Wang, Alex V Gelvezon, Amy Lauren Cummings
Journal: Journal of Clinical Oncology (2024)

e13624 Background: Cancer staging is instrumental in driving clinical management and trial enrollment, but staging data are generally unreliable and unstructured in the electronic health record (EHR). Advances in natural language processing (NLP) may facilitate clinical staging and documentation [1], but challenges to real-world implementation include (1) automatically identifying appropriate patients and reports from the EHR and (2) developing an unbiased dataset for training and validation [2]. We describe our institution’s novel approach to overcome these barriers while building an in-house NLP pipeline for clinical tumor staging of non-small-cell lung cancer (NSCLC). Methods: We identified patients by searching our EHR (Epic) for a molecular analysis test ordered specifically for pathological diagnoses of NSCLC at our institution. We used the test order date as the diagnosis proxy date (DPD). For each patient, we extracted imaging reports up to 16 weeks before and 6 weeks after the DPD. To derive primary tumor size, we analyzed the CT Chest or PET/CT report closest to the DPD using an oncology-trained NLP text extraction and labeling tool (John Snow Labs). We cleaned all extracted tumor size entities and identified the largest measurement linked to the lungs. We compared primary tumor measurements from the NLP pipeline to those in a preexisting, manually compiled cancer registry (CNEXT). We manually analyzed discrepancies through chart review. Results: 542 patients with a DPD between 11/2016 - 9/2023 were processed through the NLP pipeline. Of 443 patients with valid values in both the pipeline and CNEXT, 53% (234) were exact matches, and 20% (90) had a close match (within 0-5mm), yielding a 73% accuracy rate for values within 5mm. When mismatched values were manually reviewed, several cases in CNEXT were found to have a DPD differing by more than 3 months and tumor sizes derived from external reports. When these cases were excluded, 320 of the remaining 349 patients had valid values in both the pipeline and the updated manual review. In this refined population, 66% (213) were exact matches, and 15% (48) had a close match, yielding an 82% accuracy rate for values within 5mm. Conclusions: To our knowledge, this is the first report of a pathology-based method to automatically and reliably identify patients with NSCLC and their relevant imaging reports directly from the EHR. We used a prebuilt NLP tool to derive primary tumor sizes with relatively high accuracy and found that adding flags for timeline discrepancies and external reports can further improve validity. As we near completion of analogous pipelines for node and metastasis staging, we will develop methodology to identify subgroups of patients that can be clinically staged with near-perfect accuracy, ultimately aiming to substantially limit manual staging of uncomplicated cases. 1. Puts 2023. 2. Wang 2022.
Expansion of outreach to native Hawaii and Pacific Islander communities to increase breast cancer screening and clinical trial awareness in underserved and rural Oahu.
Authors: Kirsten Chun, Mai-Phi Tran-Dang, Patricia Cornett, Christa M Braun-Inglis, Jami Aya Fukui
Journal: Journal of Clinical Oncology (2024)

e13725 Background: Multiple barriers exist in the enrollment of racial and ethnic minority groups into breast cancer screening and clinical trials. Such barriers include the lack of knowledge, mistrust, and access. To increase participation of rural-dwelling Native Hawaiian/Pacific Islanders (NHPI) and other underserved minority groups in breast cancer screening and clinical trials, a pilot project was developed to augment community engagement, provide education, and gain insights into the cancer screening/clinical trial process. Our objective was to engage rural Oahu's underserved communities in breast cancer screening and facilitate enrollment into the Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients of Breast Cancer Trial (TMIST) utilizing a team comprising of a cultural congruent and gender concordant Community Health Educator (CHE) and medical oncology health care provider. Methods: We reviewed the community activities over the course of a year. The CHE facilitated outreach by speaking at numerous church events and other community gatherings. Results: Participants did not respond favorably to surveys on social determinants of health. Common reasons for their reluctance included lack of perceived importance and medical mistrust. When discussing verbiage that was intimidating or confusing such as clinical trial protocol consent language, TMIST study participants conveyed a strong sense of dehumanization. Conclusions: A total of 93 women were screened for the TMIST clinical trial. Of those, 13 were enrolled in TMIST and 31 participants received mammograms. Participant insight highlighted the importance of education using culturally sensitive language and community engagement to combat the lack of knowledge and mistrust. Continued development of education materials centered around community involvement will improve the accrual of NHPI participation in breast cancer screening/clinical trials. We hope this project established a basis for equity in communities with low breast cancer screening and clinical trial participation rates. We intend to build upon the community partnerships forged during this pilot project.
Updated safety and efficacy analysis comparing elderly vs nonelderly patients treated with consolidation nivolumab or nivolumab plus ipilimumab after chemoradiation for unresectable stage III NSCLC from the BTCRC LUN 16-081 clinical trial.
Authors: Shobha Shahani, Sandra K. Althouse, Nasser H. Hanna, Greg Andrew Durm
Journal: Journal of Clinical Oncology (2024)

e13770 Background: Lung cancer is the leading cause of cancer related deaths. The median age of those diagnosed with lung cancer continues to increase as the overall population ages. Consolidation immunotherapy after chemoradiation has become the standard treatment for patients with unresectable stage III NSCLC. However, little has been reported regarding the safety and efficacy of this strategy in an elderly patient population. Methods: Data was analyzed from a randomized phase II clinical trial in patients with unresectable stage III non-small cell lung cancer (NSCLC) who were randomized to Nivolumab (N) or Nivolumab/Ipilimumab (NI) after concurrent chemoradiation. We performed an ad-hoc analysis comparing the efficacy and toxicity based on age groups &lt;65 and ≥ 65. A total of 54 patients received N (480mg IV every 4 weeks for up to 6 cycles) and 51 patients received N (240mg IV every 2 weeks) + I (1mg/kg IV every 6 weeks for up to 4 cycles). Results: From 9/2017 to 4/2021, 105 patients were enrolled. Fifty-five were age &lt;65 (26 in N and 29 in NI) and 50 were ≥65 (28 in N and 22 in NI). Patients were matched for baseline characteristics (Table). In the N alone group, pneumonitis was noted in 14 patients: 9 (34.6%) &lt;65 and 5 (17.9%) age ≥ 65 (p=0.16). In the NI group, 19 patients experienced pneumonitis: 9 (31%) were&lt;65 and 10 (45.5%) were ≥ 65 (p=0.29). Hospitalization was noted in 9 patients in the N group: 6 (23.1%) &lt; 65 and 3 (10.7%) ≥ 65 (p=0.28). In the NI group, 20 patients were hospitalized: 9 (31%) were &lt;65 and 11(50%) were ≥ 65 (p=0.16). At 24 months, the PS for all patients &lt;65 was 61.3% and 60.5% for patients ≥65(p=0.62). PFS was 46.8% for &lt;65 and 73.8% for ≥65 (p=0.15) in the N group and 75.4% for &lt;65 and 45.4% for ≥65 in the NI group(p=0.02). OS for patients &lt;65 was 84% at 24 months and 73% for ≥65 for both groups (p=0.466). For individual groups, OS was 72.5% in &lt;65 and 81.4% for ≥65 (p=0.27) in the N group and 92.8% for &lt;65 and 68.2% for ≥65 in the NI group (p=0.029). Conclusions: Adverse events in both age groups were comparable but overall higher in NI arm in both younger and elderly patients. OS estimates were similar for both age groups in N while higher in younger patients compared to older adults in NI. [Table: see text]
Characterization of cancer clinical trials in the community setting.
Authors: Ivy Altomare, Yichen Lu, Sumanta Kumar Pal, Leigh Boehmer, Latha Shivakumar, Lyndsey Griffin, Kimberly Demirhan, Molly Kisiel, Randall A. Oyer
Journal: Journal of Clinical Oncology (2024)

e13506 Background: Extending clinical trials to community oncology sites is an imperative to meet accrual goals, ensure generalizable results, and facilitate optimal and equitable clinical care. The types of trials attractive to and successful in the community, however, are likely different from those run primarily at academic centers. We analyzed the characteristics of clinical trials open at a network of community oncology practices across the United States in the last 2 years, in order to inform both sponsors and sites about the studies most well-suited for a community setting. Methods: We analyzed characteristics from every clinical trial entered in OncoTrials, a clinical trial screening and tracking tool utilized exclusively by US community oncology practices, between 9/1/2021 through 10/09/2023 via knowledge of the trial NCT number and data available through API from clinicaltrials.gov. Descriptive statistics, including median and range for continuous variables and percentages for categorical variables are reported. Results: 1,310 clinical trials were open across 64 community oncology practices. Sponsors were classified as 80% industry (n=1,054), 15% NIH (n=195), 1% network (n=13) and 5% other (n=48). 93% of studies were interventional, 5% observational, 1% registry and 1% expanded access. Types of interventional studies (n=1,215) and the number of sites that ran them are shown (Table). The median target enrollment across all studies was 235 patients. Individual trials were open at a median of 2 community practices in our cohort (range 1-22 practices); 521 clinical trials (40%) were open at only one practice and 34 trials (2.6%) were open at more than 10 practices. The mean number of unique trials open at a practice during our 2 year observation period was 54 (median 35, range 1-264). Among these trials, the most commonly associated tumor types were lung (15%), pan-solid tumors (14%), breast (11%), lymphoma (6%), colorectal (6%), prostate (5%), gynecologic (4%), bladder (4%), head and neck (4%) and melanoma (4%). Conclusions: Community oncology practices supported a robust portfolio of clinical trials, most commonly focused on treatment of solid tumors. The vast majority were interventional (phase 2-3) and industry-sponsored. Half of sites ran Phase I trials, and Phase IV trials were uncommon but had broad participation across sites. Notably, a large proportion of studies were only open at one single site in a cohort of 64 community oncology practices. This highlights the opportunity for sponsors to leverage networks, consortia, and further research to ensure that appropriate studies are accessible among a broader range of community research sites. [Table: see text]