bluuebunny/crossref_metadata_2025_split huggingface dataset:
Characterizing the authorship of phase 3 randomized clinical trials in oncology, 1960-2023.
Authors: Warner Jeremy Lyle , Bakow Brianna R. , Brown Alaina J. , Choe Jennifer Hsing , Fan Elaine , Ganta Teja , Glover Michael , Hadfield Matthew James , Hilton C. Beau , Khaki Ali Raza , Kothari Shalin , Lythgoe Mark , Nagpal Seema , Nguyen Ryan Huu-Tuan , Noyd David H , Riaz Irbaz Bin , Rooney Michael Kevin , Sethi Tarsheen Kaur , Singhi Eric Kumar , Rubinstein Sam 
Published: June 2024

11079 Background: Phase 3 randomized clinical trials (RCTs) inform the standard of care in cancer treatment yet have a mixed track record of success. In this study, we sought to 1) determine the overall success rate of phase 3 RCTs; 2) assess whether authorship patterns differ between successful (positive) and unsuccessful (negative) trials; and 3) explore if individual authors have distinct track records of success. Methods: The HemOnc knowledgebase (KB) was queried for initial publications of phase 3 RCTs of systemic anticancer therapy; those without primary outcome described were excluded. RCTs were labeled positive if the primary endpoint was met per HemOnc standard criteria (P value ≤ 0.05 or hazard ratio upper bound ≤ 1 for any experimental arm[s]) and negative if they did not meet these criteria or if the experimental arm was statistically inferior. Trial metadata and author information were extracted from the HemOnc KB. Author positive publication rate (PPR) was defined as % of publications reporting a positive result divided by total number of eligible publications. Prolific authors were defined as those with 6+ eligible publications. Author count for manuscripts reporting positive vs negative results was evaluated with the Mann-Whitney U test; other statistics were descriptive. Results: 3328 studies met criteria as of February 5, 2024; these were associated with 3305 initial publications between 1960-2023, involving 25,412 unique authors. 1474 (44.3%) of the studies were positive. Publications reporting positive trial results had, on average, 3 more authors, median (interquartile range) of 18 (12-23) vs 15 (11-20), p<0.0001. The mean (±SD) PPR for n=1967 prolific authors was 47.7% (±22.3%). The PPR was not related to individual author output; mean PPR for non-prolific authors was 48.0% (SD not reported). Differences in PPR were apparent by the disease under study and the years of publication (Table). Among the 46 prolific authors who had a PPR 2+ SD above the mean, 26 (55%) were from China followed by Italy with 3 (6%). Conclusions: Despite known positive publication bias, the success rate of published phase 3 RCTs remains <50%. Publications reporting positive results had significantly more authors; this finding requires further study including adjustment for trial sample size. Significant variation in PPR amongst fields could be due to watershed therapeutic advances, differential selection of primary endpoints, and/or selective reporting of results. Finally, a signal for geographic association of outlier PPRs suggests the need for further investigation. [Table: see text]
Effects of prehab or rehabilitation on upper extremity disability and quality of life after breast cancer surgery.
Authors: Wood Kelley C , Bertram Jessica , Love Kim , Kendig Tiffany , Lightner Ashley N , Mayo Stacye , Canavan Lynn DiDonato , Pergolotti Mackenzi 
Published: June 2024

11090 Background: Growing evidence and NAPBC guidelines support the need for physical and/or occupational therapy (PT/OT) to optimize recovery from surgery. Research is needed to better understand the benefits of prehab (PT/OT before surgery and continuing afterward). We performed a retrospective study to understand the effect of participating in prehab or rehab-only on outcomes after surgery. Methods: Outpatient medical record data was extracted for cases who attended prehab (n=328) or rehab-only (n=306). Outcomes were upper extremity disability (Quick-DASH) and HRQOL (PROMIS measures of physical functioning, social role functioning, and global health [physical and mental]). Outcome time points included the post-surgery PT/OT assessment (T1, M=4 weeks), and PT/OT re-assessment (T2, M=15 weeks). We used linear mixed-effect models to examine the effect of prehab on T1/T2 outcomes while controlling for covariates (age, PT/OT, payer, and time), and to examine changes in outcomes from T1 to T2 for both groups. Results: Attending prehab was associated with better outcomes at T1 (upper extremity disability, p<.001; physical functioning, p<.001; social role functioning, p<.001; and physical health p<.001) and T2 (upper extremity disability, p=.025; physical functioning, p=.045; and social role functioning, p=.028; Table). From T1 to T2, each group improved significantly: upper extremity disability (prehab: M∆=8.92, p<.001; rehab-only: M∆=17.65, p<.001), physical functioning (prehab: M∆=1.89, p<.001; rehab-only: M∆=3.51, p<.001), social role functioning (prehab: M∆=1.61, p=.009; rehab-only: M∆=3.66, p<.001), and physical health (prehab: M∆=1.73, p<.001; rehab-only: M∆=3.50, p<.001). There was no significant effect of prehab on mental health and improvement from T1 to T2 was non-significant for both groups (p>0.05). Conclusions: In this study, attending outpatient prehab PT/OT services was associated with less upper extremity disability and greater HRQOL after breast cancer surgery. After post-surgery PT/OT, prehab and rehab-only cases each improved significantly; and upper extremity disability, physical functioning and social role functioning remained better among prehab cases. Although more research is needed, these findings support the integration of PT/OT in routine care and suggest that early PT/OT may optimize outcomes. [Table: see text]
Disparities in stereotactic radiosurgery practice patterns for treatment of brain metastases: A large national cancer database study.
Authors: Taparra Kekoa A. , Shih Jonathan , Patel Manali I. , Pollom Erqi L. 
Published: June 2024

11094 Background: Brain metastases (BM) portend high mortality rates. While whole brain radiation therapy (WBRT) is a commonly used treatment strategy for BM, stereotactic radiosurgery (SRS) has less neurocognitive toxicity with comparable survival. The objective of this study was to compare treatment practice patterns for SRS vs WBRT using a large national hospital database. Methods: The National Cancer Database (NCDB) was queried for patients ≥18 years treated with radiotherapy (RT) for a BM diagnosis between 2004-2017 and with known follow-up. 12 cancers were included based on highest prevalence including: breast, colorectal, kidney/bladder, liver, lung, lymphoma, melanoma, oral cavity, pancreas, prostate, and thyroid. Patients were grouped by first course RT modality (SRS vs WBRT) confirmed by fraction number (SRS: 1-5; WBRT: 5-15). Multivariable logistic regression assessed predictors of SRS as adjusted odds ratios (aOR) with 95% confidence intervals (95%CI). Analyses were adjusted for patient and cancer characteristics. Results: Of 88,539 patients with BM, 17,734 (18%) received SRS. Median age was 64 years. Most patients were White (84%), diagnosed in 2011-2017 (58%), with a higher income (55%), more education (55%), and Medicare/Medicaid (58%). The most common cancer treated with RT for BM was lung (86%). Patients were less likely to be treated with SRS if they were Hispanic (aOR=0.85; 95%CI=0.76-0.96), lower income (aOR=0.90; 95%CI=0.86-0.95), lower education (aOR=0.87; 95%CI=0.83-0.91), with Medicare/Medicaid (aOR=0.83; 95%CI=0.79-0.87) or no insurance (aOR=0.46; 95%CI=0.41-0.51), at a Midwest hospital (aOR=0.74; 95%CI=0.71-0.78; vs Northeast), and at a community (aOR=0.28; 95%CI=0.25-0.30; vs academic) or comprehensive community cancer program (aOR=0.50; 95%CI=0.47-0.52). Patients were more likely to be treated with SRS if they were older (aOR=1.01; 95%CI=1.01-1.01), diagnosed in 2011-2017 (aOR=2.39; 95%CI=2.30-2.49; vs 2004-2010), lived farther from the hospital (aOR=1.09; 95%CI=1.07-1.11), and received chemotherapy (aOR=1.41; 95%CI=1.35-1.47). SRS was most often used to treat BM from primary colorectal cancer (aOR=1.99; 95%CI=1.65-2.40), endometrial cancer (aOR=1.52; 95%CI=1.08-2.10), kidney/bladder cancer (aOR=3.09; 95%CI=2.68-3.55), and melanoma (aOR=2.74; 95%CI=2.39-3.14), while less often used to treat BM from lymphoma (aOR=0.18; 95%CI=0.11-0.30), vs breast primary cancers. Conclusions: In one of the largest BM studies with nearly 90,000 US patients, disparities in SRS treatment patterns were identified. On adjusted analysis, SRS was less likely to be used for patients who were of Hispanic ethnicity, lower income, lower educational attainment, without private insurance, and treated at community centers. The data highlight populations with cancer and BM who may benefit from increased access to SRS.
Real-world assessment of treatment-related symptoms and associated burden among African American and Caucasian patients receiving chemotherapy in the US.
Authors: Galaznik Aaron , Rusli Emelly , Holt Tracy , Kramer Mordecai , Trask Peter 
Published: June 2024

11102 Background: In the treatment of breast cancer, research has identified racial differences in the ability to receive the full dose of prescribed chemotherapy which may be due in part to cancer-treatment symptom burden. In clinical trials, evaluation by race is challenging due to enrollment disparities, with African Americans (AA) accounting for 7% of trial participants, but comprising 12% of the US total population. The objective of this study is to evaluate treatment-related symptoms and treatment burden among patients treated with chemotherapy through an electronic remote symptom monitoring system, and explore whether there were any racial differences. Methods: Patients (pts) diagnosed with multiple myeloma, breast, ovarian, or lung cancer in academic cancer practices were enrolled in Carevive’s Patient Reported Outcomes Mobile Platform (Carevive PROmpt) between September 2020 and June 2023. A total of 1000 pts received chemotherapy alone or in combination. PRO-CTCAE-derived weekly surveys assessed severity, frequency, and interference for 16 symptoms: 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 burden from treatment. Results: The mean age of pts was 60.9 (SD=12.8) years, with 75% female, and 20% AA. At the time of enrollment, fatigue was reported by roughly 48% of AA and Caucasian (C) pts. Muscle pain was noted in 38% of AA pts, followed by general pain (33%), and anxiety (30%), with constipation, decreased appetite, insomnia, nausea, and numbness/tingling occurring in over 20% of pts. A different pattern was observed in C pts, with anxiety occurring in 38%, followed by cough, decreased appetite, general pain, insomnia, muscle pain, nausea, and numbness/tingling present in 20% of pts. The proportion of pts at least “somewhat” bothered by the side effects of treatment were similar (44% AA, 45% C). Conclusions: This study enabled evaluation of symptom burden in cancer in a population closer in racial representation to the real world than in clinical trials; with AA representation being three-fold that seen in clinical trials. Consistent with a qualitative study of AA breast cancer pts, fatigue was identified as the most frequent symptom among those treated with chemotherapy either alone or in combination in the real world. Racial differences in the proportions of pts reporting pain (muscle or general) and anxiety suggest that treating physicians should consider these symptoms to ensure they do not interfere with patients’ ability to receive full chemotherapy courses. Additionally, the levels of anxiety reported in patients highlights the importance of considering concomitant psycho-oncology treatments in cancer therapy.
Evaluating the feasibility of a Mobile Audio Companion (Elly) to reduce anxiety and to improve patient-reported outcomes among patients with cancer.
Authors: Nguyen Tyra , Nikravesh Nima , Monette Tailyr , Luna-Lupercio Bianca , Salvy Sarah-Jeanne , Freedland Stephen J. , Asher Arash , Irwin Scott A. , Shirazipour Celina H. , Gresham Gillian 
Published: June 2024

11120 Background: Anxiety is one of the most commonly reported symptoms among cancer patients, and is a known risk factor for reduced health-related quality of life and other negative patient-reported outcomes (PROs). Mobile health applications (apps) are tools that can be used flexibly in patients’ preferred environments with the potential to reduce anxiety and improve quality of life. The current study sought to examine the feasibility and preliminary efficacy of a mobile audio companion app, Elly, to improve anxiety and other critical PROs among cancer patients. Methods: This was a single-site, single-arm pilot study conducted over 6-months. Adults 18 years or older with a diagnosis of cancer of any type, received treatment within 6 months of consent, and had access to an iPhone were eligible. The primary outcome was change in mean anxiety t-scores (NIH PROMIS anxiety short form (8a)) administered electronically via REDCap at baseline, 1 (primary timepoint), 3, and 6 months. Secondary outcomes included changes in NIH PROMIS depression, loneliness, social support, and perceived stress scores from baseline to 6 months. Changes in NIH PROMIS T-scores at each time point were calculated and analyzed using paired t-tests. Results: Of 53 patients who consented for the study, 38 patients (72%) were included in the analysis ( Mage: 52.8 years, SD: 11.7, 84.2% female). Most participants reported a history of breast cancer (50%), followed by ovarian (16%), hematologic (11%), and other cancer types (24%) Phone incompatibility and technological challenges were the most common reasons for screen-fails (n=15). All participants downloaded and used the app at least once, with an average of 154 app usage events across participants recorded over the study period (median: 64, range 11-1186 times). The mean baseline anxiety T-score was 63.5 (SD: 2.1). Anxiety levels decreased among participants over time, with a mean difference in anxiety T-scores of -1.9 at 30 days, -3.3 at 90 days, and -3.0 at 6 months from baseline, which was statistically (p<0.05) and clinically significant. Participants also reported improvements in perceived stress, depression symptomatology, social support, and loneliness, although statistical significance was not reached. Conclusions: Mobile apps, such as Elly, may feasibly be used to support patient-reported anxiety as well as other PROs, especially among those who present with high levels of anxiety at baseline. Efforts to increase access to mobile health apps and provide technical support for patients should be made increase equity across the cancer survivor population. Larger, multi-center randomized controlled trials are needed to build on these findings.
EROS: Engendering reproductive health within oncologic survivorship—ECOG-ACRIN E1Q11 paradoxical provision of reproductive health.
Authors: Patel Ashlesha , Lee Ju-Whei , Zaren Howard A. , Radeke Erika K , Lerner Rachel E. , Fukui Jami Aya , Makower Della F. , Tamkus Deimante , Rowland Kendrith M. , Adler William M. , Throckmorton Alyssa , ghamande sharad A. , Croley Jessica Jones , Pippas Andrew William , Qamar Rubina , Fisch Michael Jordan , Cella David , Wagner Lynne I. , Hackney Mary Helen Helen 
Published: June 2024

11123 Background: For the 10% of women diagnosed with cancer in the reproductive age, reproductive health (RH) is a critical component of oncologic survivorship. RH includes oncocontraception (OC), oncofertility (OF) and sexuality. Guidelines segregate these components resulting in fragmented reproductive health care management. 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. Intervention included RH didactics and decision aids. Childbearing interest was dichotomous, not completed childbearing (including either pregnant or future childbearing interest) or completed childbearing. The objective of this study is to determine provision of OC and OF referral by providers at the baseline visit based on patient’s self-reported childbearing interest at study entry. Chi-square tests were used to compare distribution differences in the referral status (receipt: yes vs. no) between treatment arms. Results: The EROS study enrolled 420 subjects. Of the 63.6% (267/420) completed childbearing, 62.4% (58/93) in the intervention arm and 40.2% (70/174) in the non-intervention arm received an OC referral (p=0.0006), whereas 98.9% (92/93) in the intervention arm and 93.7% (163/174) in the non-intervention arm received an OF referral (p=0.0487). Of the 36.4% (153/420) not completed childbearing, 48.3% (28/58) in the intervention arm and 33.72% (32/95) in the non-intervention arm received an OC referral (p=0.0729), while 77.6% (45/58) in the intervention arm and 70.5% (67/95) in the non-intervention arm received an OF referral (p=0.3388). Conclusions: While the intervention increased the rates of provision of oncocontraception and oncofertility for patients with completed childbearing, our study shows provision of oncofertility referrals at a markedly higher rate than oncontraception. Referral patterns were inconsistent with patient need particularly in completed (receiving OF referral) or delayed childbearing (not receiving OC referral) interest of the patient. The bias favoring oncofertility referral may reflect oncology guidelines emphasizing this aspect of reproductive health despite comprehensive needs of patient.
Unstructured EMR data hold the key to oncology studies: Methods for validating NLP-extracted phenotypes from EMR notes.
Authors: Eldridge Elizabeth H. , Trowbridge Elizabeth , Van Zandt Mui , Adam Atif , Mack Christina D. 
Published: June 2024

11133 Background: Natural language processing (NLP) parsers are advanced algorithms designed to parse values of interest from free-text stored in Electronic Medical Records (EMR). Given the importance of information stored in free-text for use in oncology research, it is crucial to understand how accurately NLP algorithms are extracting oncology-specific measures of interest. We focus on validating NLP-parsers that identify three measures critical to oncology research by evaluating how closely the NLP-parser results match manual chart abstractor review: AJCC summary cancer stage group (cancer stage), AJCC TNM stage (TNM stage), and surgical treatment of cancer (surgery). Methods: Following deployment of the parsers on 8,000 non-identifiable free-text notes housed in an aggregated non-identifiable U.S. EMR database, manual chart abstraction was performed on a random selection of notes (n=300) dated between 2008 to 2023 to validate the parsers’ accurate capture of cancer stage, TNM stage, and surgical treatment of cancer. We report true positives (TP), false positives (FP) and positive percent value (PPV). Results: The PPV of AJCC Cancer Stage was 99.0% (n=297 TP, n=3 FP). The PPV of the TNM stage NLP-parser was 97.3% for tumor stage (n=292 TP, n=8 FP), 99.0% for nodal stage (n=297 TP, n=3 FP), and 96.7% for presence of metastases (n=290 TP, n=10 FP). The PPV of the surgery parser was 87.8% (n=468 TP, n=65 FP). Conclusions: These NLP-parsers performed very well identifying the measures of interest, providing confidence in use of these derived measures which are central to oncology research. Validation is a necessary initial step in processing real-world data for use in real-world evidence generation, with unique considerations needed in the oncology research space due to key information being documented in EMR free-text rather than structured data fields.
Analysis of healthcare provider management of immune-related adverse events and concordance with NCCN Guidelines.
Authors: Rosenthal Kristen M. , Cartwright Megan , Andrie Rachael , Thompson John A. 
Published: June 2024

11136 Background: Immune checkpoint inhibitors (ICIs) are a mainstay of treatment for many cancers but can cause immune-related adverse events (irAEs) that require prompt recognition and management. In 2017, we developed an online interactive decision support tool [www.clinicaloptions.com/immuneAEtool] for healthcare providers (HCPs) with case-specific recommendations for managing irAEs from a medical oncology expert. In 2019 and 2023, we updated the tool to offer recommendations from the latest National Comprehensive Cancer Network (NCCN) Guidelines. Here, we report a comparison of self-reported irAE management from HCPs using the 2023 tool vs NCCN recommendations and a comparison of practice patterns between the 2023 and 2019 tools. Methods: To use the online tool, HCPs entered the affected organ system, symptom grade/severity, and their planned management strategy. The tool showed the NCCN management recommendation for that irAE and then asked if the recommendation changed their intended management approach. Results: From July to December 2023, 172 HCPs entered 241 case scenarios into the tool; 53% treated <10 patients/month with ICIs, and 38% of HCPs practiced in the United States. The most common irAEs involved the gastrointestinal (GI)/hepatobiliary (hep)/pancreatic (29% of cases) or dermatologic/oral (19%) systems. Overall, the planned irAE management strategy of HCPs matched the NCCN recommendations in 55% of cases, an increase from the 49% concordance rate in our 2019 analysis. In the current analysis, the lowest concordance was observed for infusion-related reactions (20%), musculoskeletal irAEs (46%), and dermatologic/oral mucosa irAEs (46%; Table). Furthermore, US HCPs had a lower overall concordance rate (46%) than non-US HCPs (66%). Approximately one half (56%) of all HCPs indicated that the NCCN recommendations in the tool changed their management plan. Conclusions: These data suggest that many HCPs are challenged to optimally manage irAEs and are not managing their patients in concordance with NCCN guidelines. A detailed analysis of HCP irAE management vs NCCN recommendations, including by organ system and severity, along with a comparison of 2023 vs 2019 practice patterns, will be presented. [Table: see text]