bluuebunny/crossref_metadata_2025_split huggingface dataset:
Source of funding and enrollment disparity in cancer clinical trials.
Authors: Riaz Irbaz Bin , Ijaz Hafsah , Naqvi Syed Arsalan Ahmed , Islam Mahnoor , Kumar Gaurav , Mumtaz Aqsa , Khakwani Kaneez Zahra Rubab , Ayaz Ahsan , Tripathi Nikita , Singh Parminder , Kamran Sophia C. , Warner Jeremy Lyle , Bryce Alan Haruo 
Published: June 2023

6559 Background: Recent findings that Black and Hispanic patients were significantly underrepresented in industry-sponsored prostate cancer trials warrant a detailed investigation across cancer types to assess the association between funding source and enrollment disparities. Methods: Phase II/III clinical trials in prostate, breast, colorectal, and lung cancers reporting age, gender, race/ethnicity, and reporting NIH or industry as the funding source were considered eligible for inclusion. For age, and gender analysis, all trials were considered eligible. For race/ethnicity analysis, trials recruiting from the United States (US) were considered eligible. Enrollment-incidence ratios (EIR) comparing trial proportion from age/gender or racial/ethnic subgroups against global cancer incidence in the corresponding group (from Global Burden of Disease) or US-population-based incidence in the corresponding racial/ethnic subgroup (from SEER 22), were computed. Trial-level EIRs were pooled using a random-effects model and subsequently stratified by funding source. A univariate meta-regression was conducted to assess the temporal changes in EIR by each funding category. Results: Of 42,390 studies initially identified, 2234 trials (1989-2021) met the eligibility criteria. Regarding age, 361 (16%) trials reported age categories by 65 years threshold. Of 698 trials recruiting from the US, 498 (71%) reported race, and 198 (28%) reported ethnicity. Regarding representation, older adults were under-represented (EIR: 0.66; 95% CI: 0.62-0.70) in the industry but not in NIH-sponsored clinical trials (0.79; 0.62-1.00). Regarding gender, no significant disparity was observed regarding the enrollment of men and women in colorectal and lung cancer clinical trials. In terms of race, there was a greater under-representation of Black patients in industry sponsored trials (0.29; 0.26-0.32) as compared to NIH-sponsored clinical trials (0.65; 0.57-0.74) [Pint <0.01]. Asian patients were significantly overrepresented in industry sponsored trials (3.17; 2.69-3.74) but not in NIH sponsored clinical trials (1.43; 0.85-2.41) [Pint <0.01]. Hispanic patients were significantly under-represented in both, industry (0.27; 0.22-0.34) and NIH-sponsored clinical trials (0.35; 0.22-0.55) [Pint 0.32]. Secondary analyses including trials recruiting exclusively from the US, and analyses by specific cancer types showed consistent results. Recruitment of older adults, men, and Black patients is decreasing over time. Conclusions: There is a consistent under-representation of older adults in industry-sponsored, and of Black and Hispanic patients in both industry-sponsored and NIH-sponsored clinical trials. The under-representation of Black patients is likely to be greater in industry-sponsored trials, which has worsened over the last three decades.
Survival analysis of patients treated at oncology practices with more aggressive end-of-life practice patterns.
Authors: Canavan Maureen , Wang Xiaoliang , Ascha Mustafa , Miksad Rebecca A. , Showalter Timothy N , Calip Gregory Sampang , Gross Cary Philip , Adelson Kerin B. 
Published: June 2023

6562 Background: Despite national focus on measuring and reducing end-of-life (EOL) systemic treatment among cancer patients, recent studies show a consistently high use of systemic anticancer therapy (SACT) at the EOL, as well as a shift to more targeted therapies. A criticism of measures that focus on deceased populations is that they do not account for patients who received treatment at the same time in their disease trajectory and had a positive response to therapy. We sought to explore whether being treated at an oncologically aggressive (OA) practice (defined as higher practice-level EOL SACT treatment rates), was associated with a survival benefit among patients in six common cancer types. Methods: This survival analysis used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. We included all adult patients with a confirmed diagnosis of metastatic disease in breast (mBC), colorectal (mCRC), renal cell carcinoma (mRCC) or pancreatic cancer (mPanc), or advanced disease in non-small cell lung (aNSCLC), or bladder cancer (aUC), between 2015 and 2019. The primary exposures were the practice-level risk-standardized 30-day EOL SACT rates calculated among decedents. The primary outcome was real-world overall survival (rwOS) among all patients. Adjusted hazard ratios (aHR) for each quintile of increasing OA EOL SACT rates (Q2-Q5) were estimated using disease-specific Cox proportional hazard models (reference: Q1), adjusting for patient and practice-level factors. Bonferroni correction was applied to account for multiple comparisons. Results: A total of 78,446 patients from 144 practices were included in the analysis with most patients seen at less OA practices (Q1-Q2). Patients seen at most OA practices (Q5) were less likely to be <65 (32.5% vs 38.9% in Q1), Black (6.3% vs 12.2%), have Medicare (5.9% vs 10.7%) or Medicaid (1.5% vs 4.1%). After adjusting for covariates, there was no statistically significant difference in rwOS between patients treated at the most (Q5) and the least OA practices (Q1; table). However, there was variation among the moderately OA practices. Patients with mPanc seen at moderately OA (Q2-Q4) had 12% to 19% lower hazards of deaths (aHR range 0.81-0.88), compared to those at the least OA practices (Q1), but these associations were not statistically significant (Bonferroni corrected p-values >0.05). Conclusions: When using rates of SACT at EOL to define OA practices, patients treated at these practices do not have improved survival. [Table: see text]
Use of direct oral anticoagulants (DOACs) in oncology: A phase IV study on impact of edoxaban treatment in Italian patients with cancer with venous thromboembolism during antineoplastic therapy (EDOI trial, GOIRC 05-2018).
Authors: Giovanardi Filippo , Di Maio Massimo , Gervasi Erika , Romagnani Alessandra , Damato Angela , Tiseo Marcello , Tamberi Stefano , Montesarchio Vincenzo , Grisanti Salvatore , Platania Marco , Catino Annamaria , Passalacqua Rodolfo , Bonetti Andrea Vincent , Vicario Giovanni , Finotto Silvia , Gelsomino Fabio , Pinto Carmine 
Published: June 2023

6564 Background: The EDOI Study (EUDRACT 2018-003833-14) was designed to evaluate venous thromboembolism (VTE), a common complication of cancer and cancer therapy. VTE contributes to mortality and morbidity, and may interfere with therapy. When drafting the protocol, the standard treatment for VTE consisted of low-molecular weight heparin followed by vitamin K antagonists. DOACs are as effective as vitamin K antagonists in the treatment of VTE. Edoxaban has been confirmed to be effective and safe in the treatment of VTE. Adverse events (AEs) associated with DOACs can delay or interfere with chemotherapy; to date, data regarding the impact of Edoxaban treatment on cancer treatment AEs are scanty. Methods: In this multicentric, phase IV study, patients receiving an antineoplastic treatment (and candidates for at least 3 additional months of treatment) and diagnosed with VTE, received Edoxaban as per clinical practice. Patients received between 6 and 12 months of Edoxaban and were evaluated at baseline and after 1, 3 and 6 months. Primary endpoint was the impact of Edoxaban-related AEs on antineoplastic therapy, defined as delays/interruptions/reductions due to adverse drug reactions (ADR) related to Edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions). As secondary endpoint, we assessed patient-reported outcomes (PROs) during treatment with Edoxaban (health-related quality of life: FACT-G, expectations and satisfaction with anticoagulant treatment: PACT-Q2 and ACTS). For each tool, mean scores at each time point were calculated. Results: One hundred and fifty patients were enrolled, 147 patients were evaluable. The Incidence density rate of antineoplastic therapy delay/interruption/reduction due to ADR related to Edoxaban was 0,8% per person-month (90% CI: [0,4; 1,5%] and 95% CI: [0,4; 1,6%]). For all the patient-reported outcomes, mean scores were maintained at different time points. Conclusions: The results of the study clearly show that the edoxaban treatment is well tolerated and has no relevant impact on the delivery of cancer treatments. Results in terms of quality of life and patients’ satisfaction with anticoagulant treatment are reassuring. Clinical trial information: EUDRACT 2018-003833-14 . [Table: see text]
The IMPACT of an interdisciplinary goals-of-care program on readmission rates at a comprehensive care center.
Authors: Leung Cerena , Andersen Clark R. , Wilson Kaycee , Nortje Nico , George Marina C. , Flowers Christopher , Bruera Eduardo , Hui David 
Published: June 2023

6565 Background: Unplanned readmissions are associated with substantial distress for patients and their families. We hypothesized that goals-of-care (GOC) discussions, by improving goal-concordant care, may reduce unplanned readmissions. However, only a handful of studies have specifically examined this question. We assessed the implementation of a system-wide multicomponent interdisciplinary GOC (myGOC) program on the 30-day unplanned readmission rate and other hospital outcomes for medical patients at our comprehensive cancer center. Methods: In this retrospective cohort study, we compared the 30-day unplanned readmission rates in consecutive medical patients during the pre-implementation period from May 1, 2019 to December 31, 2019 and the post-implementation period from May 1, 2020 to December 31, 2020. The primary outcome was the 30-day unplanned readmission rate as defined by Vizient. Secondary outcomes included 7-day unplanned readmission rates, inpatient do-not-resuscitate (DNR) orders and supportive care consults. A multi-variate analysis model was used to examine the association between 30-day unplanned readmission rates and the implementation of the myGOC program adjusting for age, sex, race, index hospitalization type, and Sequential Organ Failure Assessment (SOFA) score. Results: This study included 7028 and 5982 unique medical patients during the pre- and post-implementation period, respectively. The 30-day unplanned readmission rates decreased from 13.7% before to 12.0% after implementation of the myGOC program. After adjusting for covariates, the myGOC implementation remained significantly associated with a reduction in 30-day unplanned readmission rates (OR [95% CI] 0.85 [0.77, 0.95], p=0.003). Other factors significantly associated with a decreased likelihood of a 30-day unplanned readmission were hematologic malignancies (vs. solid: 0.71 [0.64, 0.79]), White race (vs. Hispanic: 0.86 [0.75, 0.98]), an inpatient DNR order (0.30 [0.25, 0.37], an ICU admission (0.58 [0.48, 0.71], and an emergent admission (vs. elective: 0.86 [0.76, 0.99]). We also observed a significant decrease in 7-day unplanned readmission rates (0.75 [0.64, 0.89], p=0.0009), an increase in inpatient DNR orders (1.48 [1.35, 1.63], p<0.0001) and an increase in supportive care consults (1.22 [1.13, 1.31], p<0.0001) post-implementation. Conclusions: Implementation of a system-wide multicomponent GOC intervention was associated with a significant reduction in 30-day unplanned readmission rates after accounting for other key clinical factors.
Trends of using immune checkpoint inhibitors near end of life in limited resources setting: Experience of single cancer center in the MENA region.
Authors: Al-Rabi Kamal Hosni , Maakoseh Mohammad , Jaddoua Saad , Salah Samer , Alta'ani Omar , Yasin Abeer , Alrawshdeh Dalia , almasri Yosra , Shamiah Omar , Al-Ibraheem Akram , Abdel-Razeq Hikmat 
Published: June 2023

6566 Background: Immune checkpoint inhibitors (ICIs) are standard of care nowadays in the treatment of many solid tumors as single agent or in combination. Recent literature suggested increased use of ICI near end of life; our aim was to find the characteristics of the patients who received ICI 30 days or less before their death. Methods: Data of patients with advanced solid tumors who have (ICI) therapy and died with disease were retrospectively retrieved. Patients were categorized into those dying within 30 days of the last dose of ICI and those receiving the last dose of ICI more than 30 days before death. Variables of potential interest were compared between the two groups by the Chi-square and independent sample t-tests as appropriate. Results: A total of 411 patients were included in this analysis; 135 (33%) received the last dose of ICI within 30 days of death and 276 (67%) received their last dose more than 30 days before death. Major cancer types included: lung (n=214; 52%), kidney (n=61; 15%), melanoma (n=44; 11%), head and neck (n=41; 10%), and others (n=14; 3%). Patients’ characteristics: median age = 58, majority were males (310; 75%), 105 (26%) had ECOG PS ≥3, and 147 (36%) had brain metastasis. Patients who received the last dose of ICI within 30 days of death had more frequent ICU admissions (50 (37%) vs. 60 (22%), p=0.001, and were less likely to die under the care of the hospice care service (22 patients (16%) vs. 84 (31%), p=0.001. In addition, patients who received the last dose of ICI within 30 days of death were more likely to have a full code status (89 (66%) vs. 147 (53%), p=0.015, and have received a lower number of doses of ICI treatments (mean number of doses: 4.2 vs. 6.5 doses, p=0.001). We did not observe any significant difference between the two groups regarding type of cancer, age, gender, ECOG PS, presence of brain metastasis, number of hospital admissions, dying inside hospital, and number of emergency room visits. Conclusions: Immune checkpoint inhibitors may be overused near end of life which leads to minimal clinical benefits, less likelihood of dying under hospice care, and utilization of ICU resources.
The effects of social determinants of health on colorectal cancer screening.
Authors: Franklin Isabelle , Gambatese Rebecca , Levin Theodore R. , Ngo-Metzger Quyen , Coronado Gloria D 
Published: June 2023

6568 Background: Colorectal cancer is the 3rd leading cause of cancer death in the United States yet has consistently lagged in screening rates compared to other cancers. While patient-reported barriers have been previously described, few studies have analyzed how patients’ social needs affect screening rates. Methods: This cross-sectional study includes 3974 Kaiser Permanente (KP) patients ages 50-75 years who completed the 2020 KP National Social Needs Survey. Survey respondents were from the seven KP regions of Southern California, Northern California, Colorado, Washington, Northwest, Georgia, and Hawaii. Five Social Needs categories were assessed: Financial Strain, Housing Instability, Transportation Issues, Social Isolation, and Food Insecurity. Being up to date on CRC screening was determined from patients’ KP electronic health records, defined as meeting HEDIS criteria for screening. Multivariate analyses compared the level of social need to the respondents’ completion of colorectal screening between the years of 2019-2021, adjusting for age, sex, race/ethnicity, diagnostic category group (DxCG), neighborhood deprivation index (NDI), and insurance type. Results: Among the 3974 survey respondents, 92.2% were up to date on their colorectal cancer screening. Not being up to date on CRC screening was significantly associated with having any social need and having severe needs in four of the five social need domains adjusted for sociodemographic and health status (Table). Patients were less likely to be screened if they had severe financial strain (OR 0.54, 95% CI 0.40-0.73), severe social isolation (OR 0.52, 95%CI 0.38-0.71), severe transportation issues (OR 0.33, 95% CI 0.18-0.61), and severe food insecurity (OR 0.41, 95% CI 0.27-0.62). No significant association between screening status and the domain of severe housing instability were found (OR 0.74, 95% CI 0.52-1.06). Conclusions: Respondents with financial strain, social isolation, food insecurity, and transportation issues had lower odds of being up to date with colorectal cancer screening. Future efforts aimed to improve colorectal cancer screening rates should assess patients’ social needs and target ways to address these potential barriers to screening. [Table: see text]
Use of germline testing in patients with prostate, pancreatic, or ovarian cancer in Washington (WA) state.
Authors: Sun Qin , Shankaran Veena , Fedorenko Catherine R. , Kreizenbeck Karma L. , Ramsey Scott David 
Published: June 2023

6572 Background: Germline genetic mutations are seen in approximately 10-15% of patients with prostate, pancreatic, and ovarian cancer. While universal germline testing is recommended for patients with these cancers to inform both familial risk and therapeutic approach, underutilization of germline testing has been reported. We investigated the rates of and factors associated with germline testing in a population-based sample of patients with prostate, pancreatic, and ovarian cancer in WA state. Methods: We linked Washington state cancer registry records from 2017-2019 with claims records for two large commercial insurers, Medicare, and Medicaid. Patients with prostate (metastatic, regional node-positive, or high-risk localized), pancreatic, and ovarian (including fallopian tube and peritoneum) cancer who were diagnosed in 2017-2019 were identified. Using claims from this database, we identified patients who received germline testing in the first two years of diagnosis. We excluded those who were not continuously enrolled in a health plan during the testing period of interest or died within 3 months of diagnosis. We used a multivariate logistic regression model to investigate factors associated with germline testing. Results: Among 2,077 patients, 429 (20.7%) received germline testing. Testing rates were 6.3% (53 of 842 patients) in prostate cancer, 15.4% (118 of 765 patients) in pancreas cancer, and to 54.9% (258 of 470 patients) in ovarian cancer; median time to testing for prostate, pancreas, and ovarian cancer was 162, 133, and 64 days respectively. Testing rates were higher in later years, in patients with more advanced stage cancers and lower in Asian patients and patients with more comorbid conditions. Conclusions: Despite guideline recommendations, germline testing rates are low among cancer patients in WA state, with the lowest rates in prostate cancer patients and in Asian and higher comorbidity populations. Underutilization of germline testing may not only adversely affect treatment, but also represents a missed opportunity for testing of high-risk families. Further studies should identify and address barriers to germline testing in high-risk populations. [Table: see text]
Reporting of patient reported outcomes in randomized clinical trials (RCTs) in non-small cell lung cancer (NSCLC) patients (pts).
Authors: Palmeri Laura , Derkach Sergii , Mazur-Janik Ewelina , Soman Arundhati , Ribeiro Alves Catarina , Shah Radhika , Vidal-Fisher Liat , Shahmarvand Nahid 
Published: June 2023

6573 Background: A patient-centric approach to clinical trials has become necessary, with regulators emphasizing the importance of pts' experience. PRO is of utmost relevance for pts with cancers such as NSCLC, that are likely to be highly symptomatic and/or with an unfavorable prognosis. Methods: To evaluate the rate at which PRO included in clinical trials are made publicly available when trial results are published, we searched Citeline Trialtrove, a registry of clinical trials, for NSCLC phase 3 RCTs, recruiting during 2017-2022, with PRO listed - regardless of publication type. We excluded supportive care, radiotherapy, and unpublished trials. We identified publications associated with the trial, and extracted various parameters, including if PRO outcome was published. Results: Of 122 NSCLC RCTs identified, 66 listed at least 1 PRO. Trials were reported as full-text (43), abstract (9), 1 only in a trials registry; 13 not published. Fifty-three trials were included, all had PRO as a secondary endpoint. The sponsor was industry in the majority of the trials. Most included stage III/IV NSCLC pts, and 1st/2nd line or maintenance. 24 PRO tools were used, mainly EORTC QLQ LC13 (35 trials), EORTC QLQ C30 (34), EQ-5D-5L (14), LCSS (8), EQ-5D-3L (6). Seven trials listed 1 tool, 26 listed 2, 18 listed >3. PRO was reported in 36 (68%) of the published trials. In the subgroup of trials with disease control (DC) benefit and no overall survival (OS) benefit, PRO was reported in 15/21 (71%) trials. PRO benefit was shown in 9 of them. Of 43/53 trials published as full-text, 31 (72%) had PRO reported. A benefit in at least 1 PRO tool was reported in 21 studies, 9 did not show a PRO benefit; in 5 trials, only descriptive and no comparative analysis of PRO was reported. Of the 21 trials with PRO benefit, 19 had a DC benefit and 10 had also OS benefit. PRO was reported together with the first reporting of other outcomes in 18 (50%) trials, and after 7-32 months after the initial one in 18 trials. Conclusions: Of 122 RCTs only 66 had at least 1 planned PRO, and only 35 had it published. Even where full-text was available or no OS benefit shown, about 1/3 of the trials did not report PRO. Characteristics as disease stage, therapy line, sponsor, and primary endpoint did not differ between all included trials and those reporting PRO. The reporting rate increased compared to our previous report yet it is not satisfactory. The importance of quality of life and pts centric outcomes, and the great efforts needed from pts and operators to collect the data, should translate into routine, timely and appropriate reporting of PRO to allow a thorough assessment of treatment effect. [Table: see text]