bluuebunny/crossref_metadata_2025 huggingface dataset:
A real-world longitudinal assessment of the treatment-related symptoms and associated burden among patients receiving chemotherapy.
Authors: Trask Peter , Rusli Emelly , Holt Tracy , Kramer Mordecai , Galaznik Aaron
Published: June 2024

e23158

Background: For patients (pts) with cancer, treatment with cytotoxic chemotherapy is associated with a variety of treatment-related symptoms including nausea, vomiting, diarrhea and constipation. Often the ability to manage these symptoms when they occur is the difference between completion of chemotherapy and early discontinuation. The first weeks of treatment are critical for understanding the pts’ acute experience with chemotherapy. The objective of this study is to longitudinally evaluate treatment-related symptoms and associated treatment burden among chemotherapy pts through a real-world electronic remote symptom monitoring system. Methods: Pts treated with chemotherapy in U.S. academic cancer centers were enrolled in Carevive’s Patient Reported Outcomes Mobile Platform (Carevive PROmpt®) between September 2020 and Dec 2023, with 3 month median follow-up. A total of 476 pts were enrolled, across early (81%) and late (19%) stage disease. Weekly PRO-CTCAE-derived surveys assessed severity, frequency, and interference for 16 symptoms often associated with cancer treatment: anxiety, constipation, cough, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth/throat sores, muscle pain, nausea, numbness and tingling, rash, sadness, shortness of breath, and vomiting. The GP5 assessed weekly overall bother with the side effects of treatment. Questionnaires were administered weekly starting at treatment initiation. Results: The mean age of chemotherapy pts was 67.3 (SD = 13.2) years, with 75% female, and 20% African American. At treatment initiation, 302 pts reported symptoms by PRO-CTCAE, and 100 completed the GP5. At week 1, constipation, general pain (GP), nausea, numbness/tingling (N/T), and shortness of breath were experienced by 20-25% of pts. Over the first 4 weeks of treatment, pts reported an increase in constipation, decreased appetite, diarrhea, and nausea at week 2, with a return to week 1 frequency over the remaining weeks. Diarrhea, however, remained elevated. While week 1 capture rates were lower, patterns for treatment bother were similar. At week 1, 34% of pts reported being bothered at least “Somewhat” by the side effects of treatment. This increased to 48% at week 2, but returned to near the week 1 frequency over the remaining weeks. Conclusions: For remote-monitored pts in this real-world data set treated with chemotherapy both alone and in combination, the most frequent symptoms at the start of treatment were nausea, GP, and N/T. The frequency of pts with GP and N/T did not change over the course of treatment suggesting their possible presence prior to the observed regimen. Increases in chemotherapy-related symptoms show the importance of ongoing assessment over the first 4 weeks of treatment, ideally with feedback to treating physicians and concomitant symptom management to optimize successful chemotherapy completion.
Preliminary validation of a novel patient-reported outcomes (PRO) questionnaire for patients with cutaneous T-cell lymphoma: The CTCL-PRO-18.
Authors: Akkad Neha , Jeffe Donna , Frank Anastasia , Al-Hammadi Noor , Watkins Marcus , Musiek Amy , Mehta-Shah Neha
Published: June 2024

e23161

Background: Improving quality of life (QoL) is key to clinical decision-making for patients with cutaneous T-cell lymphoma (CTCL). Currently there is no measure of QoL that captures concerns of patients with advanced-stage CTCL. A thematic analysis of interviews with early- and late-stage patients with CTCL identified novel QoL domains. Using these data, we developed questionnaire items for a new QoL measure (CTCL-PRO-18). Methods: Consented patients completed our new survey and previously validated metrics: SF-36, MF/SS-CTCL QoL, VAS-Itch (past 24 hours), Skindex-29, CES-D, and PROMIS™ Sleep Disturbance. Principal component analysis (PCA) with varimax rotation reduced the number of items on our measure; Cronbach’s alpha evaluated the internal-consistency reliability of items that loaded on each component and the overall measure. We examined the construct and convergent validity of the CTCL-PRO-18 using Pearson correlations, and differences in QoL outcomes by patient demographics and disease status using analyses of variance (ANOVA). Results: 82 patients (47 male; 69 white, 11 Black, 2 Hispanic) completed the surveys. The PCA yielded an 18-item, 5-component solution: 6-item self-consciousness; 3-item burden of treatment; 3-item concern about sores; 3-item sleep/fatigue; and 3-item lack of available CTCL resources. The 5 subscales and overall CTCL-PRO-18 measure had acceptably high reliabilities; Cronbach’s alphas ranged from .74 to .93. Correlations between the CTCL-PRO-18 and each of the previously validated measures were statistically significant (P < .005). Correlations between CTCL-PRO-18 and SF-36 (subscales ranged r =-.320 to -.624), CESD ( r= .645), PROMIS™ Sleep Disturbance ( r= .4780), and VAS-Itch ( r= .665) were moderate. Correlations between CTCL-PRO-18 and MF/SS-CTCL QoL ( r= .720) and Skindex-29 ( r= .814) were high. Correlations between the overall CTCL-PRO-18 and each of its subscales were significant (P < .001) and ranged from .571 (Burden of Treatment) to .882 (Self-consciousness). ANOVAs showed no statistically significant gender or racial/ethnic (white vs. Black/Hispanic race/ethnicity) differences in the CTCL-PRO-18 or the 5 component scores. Burden of Treatment scores were significantly lower for patients with no active disease compared with patients with reduced symptoms and active disease (4.9 [SD 3.9], 6.4 [3.2], and 8.2 [3.8], respectively; P = .018). Conclusions: The CTCL-PRO-18 and its 5 subscales had high internal-consistency reliability. Correlations were higher between the CTCL-PRO-18 and other CTCL-relevant measures (Skindex-29, MF/SS-CTCL QoL) than they were between the CTCL-PRO-18 and less CTCL-specific measures, providing preliminary evidence of the construct and convergent validity of the CTCL-PRO-18. Examination of the discriminant validity of this metric is warranted.
Correlation of stress, depression, sleep, and pain with race and body mass index (BMI): Secondary analysis from Alliance A011502.
Authors: Gandhi Shipra , Ballman Karla V. , Holmes Michelle D. , Visvanathan Kala , Symington Banu , Carvan Margaret , Matyka Carol , Weiss Anna , Winer Eric P. , Razaq Wajeeha , Carey Lisa A. , Partridge Ann H. , Chen Wendy Y.
Published: June 2024

e23171

Background: A011502 is a phase 3 trial that randomized high-risk nonmetastatic breast cancer (BC) patients (pts) to aspirin 300 mg daily vs. placebo. Obesity and Black race have been shown to be associated with worse clinical outcomes. We studied the association of stress, depression, sleep and pain with each other, and with BMI and race. Methods: At baseline, 2735, 2610, 2720, and 2422 pts completed Perceived Stress Scale (PSS), Center for Epidemiologic Studies Depression Scale Revised (CESD-R), Brief Pain Inventory (BPI), and Pittsburgh Sleep Quality Index (PSQI) respectively. Stress was categorized with PSS scores: low (0-13), moderate (14-26) or high (27-40). Depression was categorized with CESD-R scores: no depression (0-15) or depression (≥16). Pain was categorized with BPI scores: none/mild (0-3) or moderate/severe (≥4). Sleep quality was categorized with PSQI scores: good (0-5) or poor ( > 5). Associations of measures by race and BMI were analyzed using chi-square test. Results: There was a statistically significant association among stress, depression, pain, and sleep quality (p < 0.01 for all). Compared to pts with BMI < 25, overweight and obese women reported higher stress (2.9%, 2.3% vs. 1.7%, p = 0.04), depression (13.4%, 18% vs. 9.6%, p < 0.01), moderate/severe pain (16.5%, 20.3% vs. 12%, p < 0.01), and poor sleep (64.9%, 71.5% vs. 60.4%, p < 0.01). Black women reported more moderate/severe pain compared to White women or other races (32.9% vs. 14.2% vs. 27.8%, p < 0.01). There was no association of other symptoms with race (Table 1). Conclusions: Obesity was associated with higher stress, depression, poor sleep and pain among BC pts from A011502. Black women reported higher pain compared to other races. Future studies are warranted that determine causal associations, how symptoms may relate to outcome disparities, and develop approaches to address them. U10CA180821, U10CA180882, UG1CA233196; https://acknowledgments.alliancefound.org . Clinical trial information: NCT02927249 . [Table: see text]
Trends and landscape of clinical outcome assessment use to support oncology product approvals.
Authors: Dumais Kelly , Davis-Aoki Reina
Published: June 2024

e23186

Background: The regulatory landscape in oncology trials has evolved with growing emphasis on patient-focused drug development. Further to tumor and survival outcomes, measuring how patients feel and function via clinical outcome assessments (COAs) provides critical information on symptoms and treatment burden and may help to inform risk/benefit evaluation for new treatments. This study aimed to examine trends in the use of COAs to support efficacy or safety in oncology product labeling. Methods: Product labeling information was obtained from PROLABELS (Mapi Research Trust), a database containing COA-related data sourced from the efficacy or safety sections of FDA Product labels and EMA SmPC where at least one COA is mentioned. Oncology product labels were screened based on therapeutic indications and study information. The clinical study details published in the label/SPC between 1990 and 2022 were used for further analysis. Results: A total of 180 EMA and FDA approved drugs and devices for oncology indications where COAs were mentioned in the product label were identified. 288 studies with COAs supported these drug approvals. These studies were in 52 different indications, with most in multiple myeloma (31), followed by non-small-cell lung cancer (24), prostate cancer (22), and breast cancer (22). Of the COAs that were used, 47% were patient-reported outcomes, 18% were clinician-reported outcomes, 30% were composites, and 5% were unspecified. The number of studies conducted with COAs supporting a product label increased over time, with 3x more studies in the past 10 years (189 from 2013-2022) compared to the previous 10 years (60 from 2003-2012). For studies listing specific COA names, 63 unique COAs were used. Excluding response criteria assessments, the most common COAs were the EORTC-QLQ-C30 (57 studies), EORTC-QLQ-LC13 (18 studies), and EQ-5D-3L (17 studies). The two indications with the largest variety of COAs used were prostate cancer (10 unique COAs) and non-small-cell lung cancer (9 unique COAs). Conclusions: In line with regulators highlighting the utility of COAs in evaluating clinical benefit, results show an increase in studies using COAs to support efficacy and safety in oncology product approvals. With COAs providing critical information on symptoms, side effect impact, and quality of life, including this information on labels may help patients and providers make more informed healthcare decisions, and for market differentiation.
Longitudinal race/ethnicity (R/E) specific trends in patient-reported outcomes (PRO) in elderly women with breast cancer (BC) in the SEER-MHOS database.
Authors: Dookeran Keith A. , Meyer Nicolette A. , Landeta Vidal Jennifer , Champion Kristen E.
Published: June 2024

e23189

Background: PRO can be used to characterize health-related quality of life in cancer survivors; however, few studies have reported on longitudinal trends. Hence, we examined R/E specific (White/Black/Hispanic) longitudinal trends in physical and mental PRO for elderly women with BC. Methods: Data is from the Surveillance, Epidemiology, and End Results- Medicare Health Outcomes Survey (SEER-MHOS). The analytic sample (n = 33,386) included 25,267 White, 4,553 Black, and 3,566 Hispanic women newly diagnosed between 2010-2017 with 10 years of follow-up survey data. Generalized linear models with age/time-stratified predictive margins [means with 95% confidence intervals (CI)] were used to examine age/body mass index-adjusted physical and mental health PRO by R/E as physical and mental component summary t-scores [PCS/MCS: are linear transformation of the 0-100 possible range scoring for 8 Veterans RAND 12 Item Health Survey (VR-12) sub-scales, with mean of 50 and standard deviation (SD) of 10, normed to the US population]. Results: Overall PRO trends for all R/E groups were observed to decrease (i.e., worsen) over the 10 year period, however, trends remained highest for Whites and lowest for Hispanics [average Black/White Risk Difference (RD) (PCS: -3.2; -3.7, -2.8), (MCS: -3.4; -3.8, -2.9); average Hispanic/White RD: (PCS -3.3; -3.8, -2.8), (MCS: -5.4; -5.8, -4.9)]. Compared with White, Black and Hispanic women aged 45 years at diagnosis had significantly worse PRO at 10 years of follow-up [PCS: (White: 39.7; 38.2, 41.2), (Black: 33.7; 29.6, 37.9), (Hispanic: 31.4; 26.7, 36.1); MCS: (White: 47.1; 45.6, 48.5), (Black: 41.2; 37.2, 45.2), (Hispanic: 35.4; 30.8, 38.9)]. Similar disparity in R/E trends was also observed at older age strata (i.e., 55, 65, 75 and 85). For PCS the R/E disparity was no longer significant after 8 years follow-up for age strata 55, 65, and 75, and after 4 years for age strata 85. But for MCS the R/E disparity remained significant up to 8 years follow-up for age strata 55, 65, 75, and 85. With regards to VR-12 sub-scale examination, most of the PCS R/E disparity was likely due to differences in the general-health score; whereas for MCS disparity, it was likely due to differences in social-functioning, role-limitation, and emotional-well-being. Conclusions: Our findings show durable R/E specific disparities in longitudinal physical and mental PRO trends in elderly women with BC; this should inform strategies to optimize healthy aging for BC survivors.
Acupuncture for cancer symptoms: Clinical application and longitudinal impact.
Authors: Lasheen Wael , Walsh Declan , Yaguda Susan , Polsky Jonathan
Published: June 2024

e23191

Background: Evidence for acupuncture (ACUP) in cancer care is inconsistent. ACUP is variously used for multiple symptoms, e.g. anxiety, chemotherapy-related peripheral neuropathy, dyspnea, hot flashes, insomnia, and pain. Approximately 500 unique patients are treated for ACUP annually in our Section of Integrative Oncology. Our objective was to evaluate ACUP’s clinical application and longitudinal impact on symptoms severity. Methods: This was a retrospective analysis of those treated in a group ACUP session. Symptoms were rated before each session on a severity numeric rating scale (0-10). Clinical improvement was defined as a 2-point decrease from baseline (T1). We report symptoms from baseline to the fourth sessions (T1-T4). Counts are presented as percentages and numbers summarized by mean (standard deviation; SD) or median (interquartile range; IQR). Groups were compared statistically as appropriate. Results: 2239 consecutive patients were treated between 2015-2022. Mean (SD) age was 57 (±12); 83% were female; 57% breast primary site, 9% hematologic, 9% gastrointestinal, 8% gynecologic, 4% lung, 3% prostate, and 9% other malignancies. Symptoms treated were pain (61%), insomnia (48%), fatigue (44%), neuropathy (41%), anxiety (37%), hot flashes (37%), and other symptoms (17%). 68% presented with multiple symptoms. They received a median (IQR) of 4 (2-6) sessions and 7 (7-14) days apart. At T1 symptom severity scores, median (IQR), were anxiety 5(2-7), fatigue 5(3-7), hot flashes 6(4-8), insomnia 6(4-8), neuropathy 5(3-8), and pain 5(3-7); Table1. By T2, improvement was observed in patients, N (%), with hot flashes 476 (66%), anxiety 434 (62%), fatigue 464 (56%), insomnia 407 (55%), neuropathy 441 (55%), and pain 563 (50%). Symptom severity improvement was statistically significant by T2 and by T3 clinically relevant; Table 1. By T4, about 60% were still on ACUP treatment. Multiple ACUP sessions ( > 1) were associated with older age and higher symptom burden, and fewer sessions with more severe T1 anxiety and fatigue. Fewer males were treated, yet symptoms improved like in females. Conclusions: Symptoms were of moderate severity at referral. In this large consecutive sample (N = 2239) of mostly younger breast cancer women, group ACUP was associated with broad based symptom benefit. Repeated ACUP treatments were important for clinical improvement. Males and females benefited equally however fewer males were referred. Several confounders need to be considered interpreting these results. [Table: see text]
Characterization of remote symptom alerts generated from patient-reported outcome (PRO) symptom monitoring in a real-world breast cancer population.
Authors: Hurtado Castillo Marisabel , Rusli Emelly , Wujcik Debra , Galaznik Aaron , Kaufmann Tara L.
Published: June 2024

e23193

Background: Women with breast cancer experience debilitating symptoms, yet the patient-reported symptom burden among patients on treatment remains largely uncharacterized. This study characterized electronic PRO (ePRO) symptom monitoring data of patients with breast cancer in real-world settings to assess differences in remote symptom alerts by clinical characteristics. Methods: We conducted a retrospective descriptive study of complete case ePRO data reported by patients at twelve US sites using Carevive PROmPT, a remote symptom monitoring platform. Participants consent to share de-identified, aggregate ePRO symptom data and sociodemographic and clinical characteristics from the electronic health record. We characterized PRO-CTCAE symptom data reported by breast cancer patients on active cancer treatment enrolled between 9/2020 and 11/2023. The PRO platform generates an algorithm-based alert if the combination of symptom severity, frequency, and interference is moderate or severe. We used descriptive statistics to characterize symptom severity and number of alerts by baseline patient-report ECOG status, age, cancer stage (Stage I-III vs. IV), and breast cancer subtype. Results: Of 646 patients, 519 (80%) generated alerts during treatment. Population characteristics were: median age 56 years-old (range 26-84), 72% White, 20% Black/African American, 62% Stage I-III, 15% HER2 positive, 47% ER and/or PR positive, HER2 negative,18% triple negative. Patients reported a total of 19,425 symptoms over a median of 12 weeks with 80% compliance rate, of which 39% resulted in alerts. Participants generated a median of 1 alert per week. About 50% of alerts occurred in the first 12 weeks of ePRO completion, with a higher proportion in Week 1-4 across all subgroups (range, 15-38%). On average, ECOG 2 or greater patients generated more alerts per week than ECOG 0-1, (mean 2.1, (SD 1.3) vs. 1.7 (SD 1.0). Younger patients ( < 50 years) generated more alerts compared to those older than 50 years (87% vs. 77%). Patients with early-stage disease reported more alerts than the Stage IV group (81% vs. 78%). In the metastatic setting, triple negative patients reported a median of 3 (range 1-8) moderate/severe symptoms per week; the other subtypes reported a median of 1 (range 1-8). Conclusions: Women on breast cancer treatment reported their symptom experience with high compliance rates in the real-world setting. Nearly 40% of symptom reports generated an alert, with a higher proportion in the first month of treatment. Younger, early-stage, and metastatic triple negative patients with breast cancer reported a higher symptom burden compared to other groups. Future work will investigate symptom experience by sociodemographic and clinical characteristics to further identify patients who may benefit from more intensive symptom reporting and management.
Screening oncology articles in a qualitative literature review using large language models: A comparison of GPT4 versus fine-tuned open source models using expert-annotated data.
Authors: Thorlund Kristian , Lloyd-Price Lucy , Jafar Reza , Nourizade Milad , Burbridge Claire , Hudgens Stacie
Published: June 2024

e23196

Background: Clinical Outcome Assessment (COA) conceptual gap analyses for oncology are complex and time consuming. Artificial Intelligence may efficiently reduce time to completion of such analyses. We aimed to assess two AI models’ performance for literature screening to identify relevant qualitative oncology research. We also compared accuracy and run-time for both AI models. Methods: We manually curated a dataset of title/abstract screening (n = 1,700 study references) across 17 landscape reviews. Among these, 11 landscape reviews (n = 951 study references) spanning over were in oncology, including 8 solid cancers (breast, lung, urothelial, colorectal, esophageal, head and neck, pancreatic, and stomach) and 3 non-solid cancers (lymphoma, acute myeloid leukemia, and multiple myeloma). Each citation was annotated for eligibility (Y/N) by population, study design (qualitative), and reporting of concepts (how patients feel or function). We then compared the accuracy of two AI models at predicting the screening decisions of expert researchers. The two AI models were Generative Pre-trained Transformers 4 (GPT4, OpenAI) prompts and a fine-tuned SciFive biomedical large language model (LLM). We used 70% of the data for training and 30% for test. Accuracy estimates were obtained only for the models’ ability to label eligibility within the 11 oncology datasets. Results: Both LLMs performed well for assessing relevance by oncology population, with F1-scores for the GPT4 and SciFive models being 0.92 and 0.83 respectively (precision was 0.92 and 0.93 respectively). For concept reporting the fine-tuned SciFive model outperformed GPT4 with an F1-score and precision 0.88 and 0.92 versus 0.81 and 0.79. The same was true but less pronounced for eligibility by study design, with an F1-score and precision 0.81 and 0.90 versus 0.86 and 0.76. For overall eligibility, the customized SciFive model outperformed the GPT4 model with an F1-score and precision of 0.84 and 0.92 versus 0.85 and 0.82. Lastly, it took the GPT4 prompts between 10-30 minutes to screen 100 abstracts. By contrast, the customized SciFive model took 1-2 minutes on a computer with a Quadro RTX 8000 GPU. Conclusions: In conclusion, both AI models are promising. The fine-tuned SciFive model appears slightly more accurate and performs substantially faster than the GPT4 model.
EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 assessing discrepancy in clinician-patient importance of sexuality over 2 years post-cancer diagnosis.
Authors: Rao Shivani , Lee Ju-Whei , Hashim Sinan , Zaren Howard A. , Radeke Erika K. , Cella David , Fisch Michael Jordan , Wagner Lynne I. ,   EROS ECOG ACRIN E1Q11 Trial Group
Published: June 2024

e23197

Background: Cancer diagnosis and therapeutic interventions are associated with altered reproductive health including sexuality. Despite pertinence to quality of life, cancer management frequently precludes periodic assessments of sexual health. Methods: The EROS trial is a clustered randomized trial performed at 17 NCI Community Oncology Research Program (NCORP) sites (including 8 NCORP sites and 9 Minority/Underserved NCORP sites) from 2016-2023. Eligible subjects included reproductively capable women aged 15-55 with new cancer diagnosis. We report on an embedded observational study pertaining to oncosexuality. Perceived importance of patient’s sexuality maintenance was assessed for clinicians and patients on a 10-point Likert scale (1 = Not important; 10 = Extremely important). Mean and standard deviation were computed for value discrepancy (pairwise clinician-patient differential) by arm assignment and timepoint (baseline, 3-, 6-, 12- and 24-months). One-sample t-test was conducted with Bonferroni’s adjustment to evaluate cell mean of the value discrepancy against zero (α = 0.02). A mixed effect model analyzed intervention effect on value discrepancy over time, adjusting for baseline covariates (α = 0.05). Results: Mean patient importance rating within the intervention arm ranged from 8.39 (SD = 2.39) at baseline to 7.84 (SD = 2.86) at 24-month assessment; paired clinician value varied from 8.17 (SD = 2.57) to 7.77 (SD = 2.92), respectively. Within non-intervention arm, mean patient importance rating varied from 8.23 (SD = 1.95) at baseline to 8.68 (SD = 1.67) at 24-month assessment; paired clinician value ranged from 7.93 (SD = 1.86) to 8.15 (SD = 1.70). Mean clinician-patient value differentials with respect to arm assignment and timepoint were not significantly different from zero. A significant arm-by-timepoint interaction effect was noted (p = 0.0417). Post-hoc simple main effect analysis exhibited no intervention effect at any assessment timepoint. Conclusions: Data indicate high concordance of sexuality importance within oncologic clinicians and patients over the 2 years. Findings necessitate investigation to ensure management of sexual health matches level of importance to the cancer survivor. Clinical trial information: NCT01806129 .
Developing a manual clinical trials screening process in a diverse southern gynecologic oncology practice in the Deep South.
Authors: Klein Margaret , Pirzadah Humza , Magharehabed Yasmeen , Chapple Andrew G. , Castellano Tara , Jernigan Amelia
Published: June 2024

e23209

Background: At this time, there is no standard clinical trial screening process or definition that has been adopted within Gynecologic Oncology. In our low resource, highly diverse Gynecologic Oncology patient population, we sought to create an equitable, adaptable, manual screening process that better reflected our patient population. Our objective is to describe our clinical trial screening process and our success in improving trial enrollment and a matched trial portfolio. Methods: An IRB-approved, QI project was implemented in July 2022 to evaluate trial access for Gyn Onc patients. First, screenable events were defined as: the start of one’s first scheduled visit, bi-monthly tumor boards, weekly pre-op meetings, and by keeping track of on a shared Epic list. Potential patients were those with a screenable event: new patients or diagnoses, regimen changes, progressions, and recurrences. Events were categorized into screen positive or screened no trial available. Screen positives were further categorized as screen fail, screen positive, enrollment failure, or enrolled. Data about patients was collected via weekly research team meetings. Monthly meetings occurred to review progress. This data was compared to trials available, number of patients with trail available, and those that enrolled. Reasons for enrollment fails were tracked to improve access and anticipate barriers. Results: Overall demographic data of patients was collected. The average age of participants was 60.67 years (SD = 13.45), and the average distance to a treatment center was 59.27 miles (SD = 137.43). Other demographics are presented in Table 1. For each month, the percentages of “screen no trial available (SNTA)” events and patients who screened positive and did enroll on trial were recorded. Over time, SNTA rates stayed stable, but enrollment increased. Patient preference accounted for 32.8% of enrollment fails (n = 42), pre-existing symptoms/conditions accounted for 23.4% (n = 30), and distance/location accounted for 21.1% (n = 27). During a time of high employee turnover in the summer months of 2023, there was a rise in enrollment fails due to staffing (n = 6, 4.7%). Conclusions: Through a collaborative quality initiative, we describe an effective process of clearly defining and tracking our patient population and ‘screenable events’ for which all patients are screened and offered trial participation if eligible. We show that we improved understanding of the patient population, built a clinical trial portfolio better matched to population served, exceeded national averages for enrolling patients on trials, and are moving toward improved number eligible over time. [Table: see text]
Creating and establishing a sustainable culture of clinical and translational research at an academic cancer center.
Authors: Kumar Parvesh , Cross Chad L. , Baker Ken , Hildebrandt Gerhard
Published: June 2024

e23220

Background / Objectives: At the Ellis Fischel Cancer Center (EFCC) at the Univ. of Missouri (MU) School of Medicine (SOM), our recent (2016 - 2020) accurals to interventional oncology clinical trials (CT) have been suboptimal. Hence, the EFCC research leadership undertook a number of initiatives since 2021 to improve the function and productivity of the oncology CT enterprise. The objective of our retrospective review was to determine the impact of our initiatives including improving enrollments to clinical trials. Methods: These major programmatic initiatives have included the following: (1) CT portfolio analysis; (2) faculty survey to assess concerns/ needs related to enrollment; (3) Development of a "One-Pager" list of open CT; (4) Working with faculty leader "champions"; (5) Increasing the number of clinical research staff; (6) Initiation of a monthly "Clinical Trials Working Group (CTWG)" to monitor enrollment to clinical trials, troubleshooting obstacles to accruals and on-going CT portfolio analysis and adjustments; (7) Development of multi-disciplinary "Disease Working Groups" (DWGs) in Breast, GU, GYN-Onc., Lung, GI and CNS cancers to establish a Protocol Review & Monitoring System (PRMS) with the objective of aligning our clinical trials with our patient population; (9) Initiation of a monthly “Investigator Education Workshop” (IEW) to educate our faculty on the conduct of investigator initiated CT and pharma sponsored CT; (10) Initiation of a "Top Enrolling Ceremony" to honor the top enrollers to clinical trials. Results: The analysis of our CT portfolio revealed that in both December 2020 and May 2021, more than half [i.e., 52% (n = 17/33 and n = 13/25, respectively] of our CT had never enrolled a patient in the lifetime of the protocol. Since the implementation of the PRMS in late 2021, we have observed a continual decrease in the status of those clinical trials with “never” any enrollments from a historical average of 52% to 34% in January 2022, to 32% in January 2023 and to 28% in October 2023, p = 0.0173. In addition, implementation of the PRMS also had an immediate significant impact such that only 53% of all of the protocols reviewed by the Protocol Review and Monitoring Committee were approved in 2021 vs. a historical average of 75% from 2018 - 2020. Moreover, between 2021 and 2023, an average total of 82 patients were enrolled to interventional oncology clinical trials vs. the historical average of 42 patients per year from 2016- 2020, representing an overall increase of 95% p = 0.0004. Conclusions: The development and establishment of the PRMS within the last 3 years has had a very positive impact on our clinical trial enterprise at the EFCC by reducing active clinical trials that are not suitable for our patient population and significantly increasing our enrollment to interventional oncology clinical trials. For 2024, we will continue our implementation of the PRMS at the EFCC.
Development and preliminary validation of a platform for systematic, unbiased pre-screening of non-small cell lung cancer (NSCLC) across three community oncology practices.
Authors: Campbell Fontaine Annette , McAneny Barbara L. , Tucker Valerie , Koontz Michael Zach , Trotter Chardria , Paulson Joseph , Svedman Christer , Pan Alexander , Peguero Julio Antonio , Campos Luis T.
Published: June 2024

e23230

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

e23235

Background: Prior studies have reported improved outcomes for acute myeloid leukemia (AML) in academic over nonacademic settings potentially due to the availability of multidisciplinary teams, clinical trials and increased resources (1,2). Our institution has partnered with community practices to further evaluate this disparity. In this study, we analyzed treatment outcomes when nonacademic centers partnered with academic centers to treat AML using a regimen of venetoclax and a hypomethylating agent. Methods: We reviewed 92 patients with newly diagnosed AML treated with venetoclax and either decitabine or azacitidine at an academic center (n = 57) or community practice with academic center support (n = 35). When partnering with the community, patients received the first cycle of therapy at an academic center. Before discharge, our team completed financial screening, scheduled follow up appointments and provided prescriptions. The primary objective was to evaluate the overall response rate (ORR) with a secondary evaluation of differences in chemotherapy management and complications. Results: Patients in the academic setting tended to have more adverse risk disease (80.7% vs. 74.3%, p = 0.36) according to the European LeukemiaNet (ELN) (table). The overall survival (OS) of all patients was 10.7 months (95% CI 9.4-15.7) with no significant difference between the groups. The ORR was similar between the community and academic settings (40.0% vs. 36.8%, p = 0.46). The complete remission (CR) rate was 11.4% in the community versus 19.3% in the academic setting (p = 0.67), and the CR rates were improved in the academic group versus the community after cycle 2 (12.9% vs. 0%, p = 0.72) and cycle 3 (25.0% vs. 0%, p = 0.46). Adverse events were comparable, except for increased rates of fatigue (80.7 vs. 54.3%, p = 0.01) and diarrhea (33.3 vs. 11.4%, p = 0.04) in the academic setting. Conclusions: Contrary to prior studies, our evaluation and ongoing partnerships support the transition of AML treatment to a community setting with academic consultation. Although there were some differences in adverse events, the OS and ORR were similar. Furthermore, this study did not identify any significant safety concerns that could prevent patients from receiving this regimen in either setting. Our goal is to continue evaluating this partnership, as we design prospective studies to improve the care of this patient population. 1. Giri S et al. OS of AML Treated at Academic Center Vs Nonacademic Center. Blood 2015. 2. Halpern AB et al. Practice patterns & outcomes for adults with AML. Hematol Am Soc 2020.[Table: see text]
Results of a quality improvement program to increase complete lung cancer biomarker testing rates by focusing on system, physician, and other factors associated with adverse health outcomes.
Authors: Heron Dwight Earl , Blair Jean , Francis Jawad Elias , Stoeppler-Biege Kristina , Simpson Lijo , Stapp Jeremy , Kim Joseph
Published: June 2024

e23249

Background: Complete biomarker testing (CBT) is an underutilized standard of care for patients with advanced lung adenocarcinoma, but limited tissue samples may lead to incomplete testing. Especially if quantity is not sufficient (QNS) requiring additional samples, a prolonged time-to-initiation of treatment (TTT) has been shown to negatively impact clinical outcomes. Bon Secours Mercy Health (BSMH) Youngstown, Ohio reviewed biomarker testing data and found: 1) only 41% of patients received CBT, and 2) in the case of QNS when liquid biopsies were utilized, the time from diagnosis to results took an average of 42 days. BSMH worked in collaboration with OncoLens and Q Synthesis to address these issues and reduce the TTT. To our knowledge, there is also no data on interventions that can increase CBT across large health systems and simultaneously tackle both physician and other factors associated with known health disparities. Methods: A multidisciplinary team developed a new workflow for patients diagnosed with advanced NSCLC. The pilot involved collecting both tissue and blood at the time of needle biopsy and working with a single reference lab for testing. Physicians and nurses in radiology and pulmonology were in-serviced on the new workflow. As patients were being prepared for a biopsy procedure, nurses collected two tubes of blood for liquid biopsy. After the procedure, both the tissue and blood were sent to pathology and if pathology confirmed an advanced NSCLC diagnosis, both samples were sent to the reference lab for testing. The lab developed a new process to hold blood and test it only when the tissue was QNS. If QNS, tissue testing for PD- L1 was prioritized, and additional biomarker tests were completed with the blood sample. If tissue quantity was sufficient, unused blood was discarded. The lab charged for a single test regardless of whether the test was performed on tissue and/or blood. Results: The QI project ran from Sept 2021 - Dec 2022 and achieved four improvements: 1) a 39.6% increase in CBT in patients with advanced NSCLC (80.6% post-intervention), 2) a decrease of 15.7 days from diagnosis to complete liquid biopsy test results (27.2 days post-intervention, 3) increased CBT rates across all but one physician by an average of 55% (-5% to 220%), and 4) increased CBT by 8% in females and patients with Medicare, Medicaid or other noncommercial/underinsured/uninsured payors. Conclusions: This QI project demonstrated that CBT of advanced NSCLC can be improved by programs that are tailored to large health systems and individual physicians. Gains are also seen in patient populations at risk of adverse outcomes.
Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals.
Authors: Lan Bo , Xuenan Peng , Ma Fei
Published: June 2024

e23257

Background: Clinical research competence determines the quality of clinical research and the reliability of research findings and is vital in the development of new antitumor drugs and the diagnosis and treatment of breast cancer. Our study aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China and to analyze the differences among regions, departments and different hospital classifications. Methods: This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31st August 2023; this study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. The centers cover 30 provinces, and all of them are tertiary-level general hospitals or cancer hospitals. Results: A total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9%) departments received good clinical practice (GCP) training. A total of 89.3% (109/122) underwent centralized institutional review board (IRB) review. The steps of the approval process from research initiation to completion lasted 2-4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. There were more patients enrolled in registered clinical trials in specialized cancer hospitals than in general hospitals (50 and below, 50-200, and more than 200 patients from specialized cancer hospitals vs. general hospitals: 39.1%, 52.2%, and 8.7% vs. 76.9%, 16.4%, and 6.7%, respectively; p = 0.001). For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. Conclusions: Most departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality and quantity of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation and implementation of clinical research, are required in future development.
Esophageal cancer in the United States: A 21-year mortality analysis (1999-2020).
Authors: Farooq Muhammad Zain , Kamal Usama , Jamil Adeena , Fatima Eeshal , Khurram Abiha , Khan Zoha , Kamdi Zainab , Ahmed Sana , Jaglal Michael Vishal
Published: June 2024

e23258

Background: Esophageal cancer (EC) is the sixth leading cause of cancer-related deaths in the United States, with a mere 20% survival rate in the first five years, making it a significant public health concern. Considering the lack of comprehensive evaluations of mortality trends that are undergoing substantial transformations on a global scale, this study aims to provide an update on the mortality rates of esophageal cancer and its trends in the United States. Methods: The mortality trends among adults with EC were analyzed using data from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiological Research (CDC WONDER) database, where EC was presented as a contributing or the underlying cause of death. Code C15 “Malignant Neoplasms of Esophagus” in the International Classification of Disease, tenth revision (ICD-10) was used to identify the data. Crude and age-adjusted mortality rates (AAMRs) per 100,000 people were extracted. Annual percent changes (APCs) in AAMRs with 95% CI were obtained using joint point regression analysis across different demographic (sex, race/ethnicity, and age) and geographic (state, urban-rural, and regional) subgroups. Results: Between 1999 and 2020, 309,725 documented deaths were attributed to esophageal cancer. The overall AAMR decreased from 1999-2020 (6.69 to 5.68). Males had higher consistently higher AAMRs than females (10.96 vs. 2.24). NH White had the highest overall AAMR (6.88), followed by NH Black (6.46), NH American Indian (4.95), Hispanic or Latino (3.31), and NH Asian or Pacific Islander (2.57). CMRs also increased with advancing age and were greatest in individuals over the age of 85 years. AAMR also varied by region (overall AAMR: Midwest: 7.18; Northeast: 6.75; South: 6.07; West: 5.76), and non-metropolitan areas had higher AAMR (non-core areas: 7.09; micropolitan areas: 7.19) than metropolitan areas (large central metropolitan areas: 5.75; large fringe areas: 6.33). The states in the upper 90th percentile of esophageal cancer-related AAMR were Vermont, District of Columbia, West Virginia, Ohio, New Hampshire, and Maine, and exhibited an approximately two-fold increase in AAMRs, compared to states falling in the lower 10th percentile. Conclusions: Over the last two decades, there has been an overall decline in mortality related to EC in the United States. However, demographic and geographic discrepancies in EC-related mortality persist, necessitating additional exploration and development of specifically directed treatments.
Retrospective study of BRAF inhibitor-based therapy in patients with BRAF mutated advanced solid tumors (RBAST study).
Authors: Xiao Wenxuan , Liu Ying , Hou Lei , Hou Yinyin , Wei Xin , An Gaili , Zhang Fan , Zhang Yuan , Lei Yu , Wang Haipeng , Liu Yi , Duan Baojun , Cao Fei , Sun Chao , Wang Xi , Wang Weijiang , Yang Yanping , Bai Jun
Published: June 2024

e23265

Background: BRAF mutations are frequently found in melanoma, non-small cell lung cancer (NSCLC), thyroid cancer, to a lesser degree in other tumor types. These mutations constantly activate the kinase domain and result in MAPK pathway hyperactivation. Successful inhibition of this pathway with BRAF/MEK inhibitors (BRAFi/MEKi) results in a clinically meaningful benefit for some patients. The RBAST study, to assess the efficacy and survival outcomes of BRAF inhibitor-based therapy were investigated in patients with solid tumors harboring BRAF mutations. Methods: Data was collected on a total of 697 cases of solid tumor throughout China between Sep 2018 and Dec 2023. Next Generation Sequencing (NGS) is based on the sequencing of tissue samples. Among the samples, the primary endpoints of this study were objective response rate (ORR), disease control rate (DCR), progress-free survival (PFS) and overall survival (OS). The impact of co-mutations with other genes and BRAF variant allele frequency on treatment efficacy was also assessed in this study. Results: BRAF mutations were detected in 36 cases and 15 patients received BRAFi based therapy were identified. For patients who received BRAFi therapy, the best ORR was 26.7% with 4 patients recorded partial response (PR). There were 2 patients with progressive disease giving a DCR of 86.7%. Responses were observed in 4 types of tumors. PR was observed in patients with colorectal cancer (CRC) and melanoma. Median PFS (mPFS) and median OS (mOS) of these patients were 6.0 months (95% CI: 2.3-7.0) and 17.1 months (95% CI: 4.4-NA), respectively. The co-occurring mutation rates of TP53, PTEN, FAT2 and NF1 were 40% (6/15), 20% (3/15), 20% (3/15) and 13.3% (2/15), respectively. No significant difference (p>0.05) in PFS and OS was observed in any co-occurrence of mutations. BRAF mutation variant allele frequency is not an independent prognostic factor for survival with patients received BRAF inhibitor treatment (p>0.05). Conclusions: To the best of our knowledge, this is the first retrospective study exploring BRAFi treatment effectiveness to BRAF mutated solid tumors for Chinese patients. Treatment with BRAF inhibitors is effective for BRAF mutated advanced solid tumors with DCR of 86.7%, mPFS of 6.0 months and mOS of 17.1 months. Co-mutations with other genes and BRAF variant allele frequency did not impact survival outcomes.