bluuebunny/crossref_metadata_2025_split huggingface dataset:
The efficacy and safety of sequential use of anlotinib and 131I for locally advanced or metastatic differentiated thyroid cancer: A single-arm phase II clinical trial.
Authors: Song Hongjun , Qiu Xian , He Ziyan , Chen Libo 
Published: June 2023

e18102 Background: Locally advanced or metastatic differentiated thyroid cancer (DTC) commonly responds poorly to radioiodine (131I) treatment alone. Tyrosine kinase inhibitors, however, have exerted promising antitumor activity in multiple advanced solid tumors. This study aimed to investigate the efficacy and safety of sequential use of anlotinib and 131I for the treatment of locally advanced or metastatic DTC. Methods: This is a single-arm phase II open-label clinical trail. The key eligibility criteria included locally advanced or metastatic 131I-avid DTC, ECOG PS of 0-1, and at least one measurable lesion. Previous tyrosine kinase inhibitor was not allowed. Patients initially received anlotinib (12 mg QD, 2 weeks on/1 week off ) for 4 cycles. At the beginning of 13th week when levothyroxine had been discontinued for 4 weeks, diagnostic 131I whole body scan (Dx-WBS) was performed, and those with 131I-avid lesions were immediately identified to undergo 131I treatment. The primary endpoint was objective response rate (ORR) . The secondary endpoints included disease control rate (DCR), biochemical response rate (BRR), time-to-response (TTR), progression-free survival (PFS), and safety. Results: From June 2021 to December 2022, a total of 16 patients with locally advanced or metastatic DTC were included. At the data cut off, 8 patients (4 males and 4 females) were withdrawn from the trial due to negative Dx-WBS, and the remaining 8 patients were subsequently treated with 131I. Six patients who had completed at least one cycle of sequential treatment were eligible for data analysis. Partial response and stable disease were found in 2 (33.33%) and 3 (50%) patients, respectively. An ORR of 33.33% [95% CI, 4.33-77.72], a DCR of 83.33% [95% CI, 35.88-99.58], a BRR of 100% [95% CI, 54.07-100.00], and a TTR of 6.34 months [95% CI, 5.85-NE] were achieved. Median PFS was not reached. Grade 3 adverse events occurred in 2 (33.33%) of the 6 subjects, including pain owing to skeletal metastasis in one patient and drug-related hypertention in the other. Conclusions: This study firstly demonstrates the favorable efficacy and safety of sequential therapy with tyrosine kinase inhibitor and 131I, suggesting anlotinib as a adjuvant option for 131I treatment of locally advanced or metastatic DTC. Randomized controlled studies on sequential therapy versus 131I treatment are warranted. Clinical trial information: ChiCTR2100045178 .
Clinical outcomes in patients with radioiodine refractory thyroid carcinoma treated with dose-reduced lenvatinib.
Authors: Au Cherry , Kim Brian , Fidler Mary Jo J. , Jelinek Michael J. 
Published: June 2023

e18104 Background: In recent years, well-differentiated thyroid cancer (WDTC) accounted for over 40,000 new cancer diagnoses annually. For patients with metastatic, iodine-131-refractory thyroid cancer, systemic therapy is sometimes warranted. Lenvatinib was FDA approved in this setting at a starting dose of 24 mg orally daily based on the SELECT trial. Many patients required dose reductions on this trial, and the use of full dose (24 mg) lenvatinib is often not feasible in clinical practice. This study characterizes the clinical outcomes of lenvatinib for WDTC in a real-world setting. Methods: This study is a retrospective chart review of all patients over 18 years old diagnosed with radioiodine refractory thyroid carcinoma who received lenvatinib at a large academic center between 05/01/2016 and 01/01/2022. Demographic information, clinical data, and treatment outcomes were obtained. Results of our study were compared to historical controls from the SELECT trial. Results: There were 38 patients included in this study. Twenty-six of 38 patients had a dose reduction prior to start of treatment per judgement of the treating physician. Of the 12 patients who started at 24 mg, 11 required a dose reduction. Starting doses of lenvatinib ranged from 4 mg to 24 mg. The mean starting dose was 17 mg. Median progression free survival and overall survival were 35.2 months and 56.2 months, respectively. Eighteen patients remain on therapy. Overall response rate was 39.5% compared to 64.8% in historical controls. Disease control rate was 63.2%. Any grade weight loss was higher in this cohort versus historical control – 92.1% vs 46.4%, respectively. Systolic ( > 20 mmHg) and diastolic ( > 10 mmHg) blood pressure changes occurred in 13.2% of patients. 16.7% of patients had a peak increase in creatinine > 0.2 mg/dL above their baseline. Conclusions: Many patients were deemed ineligible for full dose lenvatinib by the treating physician. Despite an apparently lower response rate, lower doses of lenvatinib can still provide adequate disease control with an acceptable rate of blood pressure and serum creatinine elevation. Weight loss was an almost universal side effect of lenvatinib in this real-world population and was seen at a higher frequency than the historical population.
Geographic distribution of clinical trials for common advanced-stage cancers in the United States.
Authors: Swenson Wade T. , Westergard Emily , Schroeder Zachary , Swenson Abigail P. 
Published: June 2023

e18503 Background: This study examines the geographic distribution of clinical trials for common types of metastatic cancer in the United States and the accessibility of these trials to the general population. Methods: We accessed the ClinicalTrials.gov website and conducted a search for interventional clinical trials that were actively recruiting patients for diagnoses of metastatic lung, colon, pancreas, breast, and prostate cancers on November 25, 2022. We identified unique zip codes for all the clinical trials offered and calculated the U.S. population living within 50 miles of a clinical trial site using geographic information system software based on 2020 census data. We created maps for each cancer type, demonstrating the geographic distribution of clinical trial access in the United States. Results: We found a significant number of clinical trials providing access for most Americans diagnosed with the most common types of metastatic cancer. The majority of the United States population lives within 50 miles of a clinical trial. The access varied by cancer type studied, from 75.0% of the United States population for metastatic colon cancer to 90.2% for metastatic lung and breast cancers. See table for details. Conclusions: When considering the accessibility of these trials, we found that a large proportion of the United States population lived within 50 miles of a clinical trial site. This suggests that while many clinical trials are available, they may not be evenly distributed across the country and may not be accessible to all individuals. [Table: see text]
Socioeconomic and demographic barriers associated with delays in pancreatic cancer germline genetic testing.
Authors: Zou Xianghui , Sidiqi Baho , Tortorella Brooke , Patruni Sunita , Rezak Leora , Alfano Catherine M. , Hollweg Christopher , Kauff Noah D. , King Daniel 
Published: June 2023

e18506 Background: Germline genetic testing is recommended for patients with pancreatic ductal adenocarcinoma (PDAC). We identified associations between patient social profiles and delays in obtaining germline genetic testing from New York’s largest healthcare system. Methods: Patients with PDAC were identified using our EMR between Mar 2016 and Feb 2022 with an IRB-approved protocol. Median income was extrapolated using zip code. Social vulnerability index (SVI) was obtained from CDC ATSDR website. Date of diagnosis (DOD) was recorded as the date of biopsy. Delays of testing were calculated as the difference between DOD and the date of germline test. Social work needs, sources of income, and insurances were captured by EMR review of social work notes. Pearson correlation, Mann-Whitney, and Chi-square tests were used for statistical analysis. Results: We identified 104 (34%) patients with germline tests. Other than ethnicity, there was no demographic difference between patients who performed tests and patients who did not (Table). Pearson analysis between income and delays showed a negative correlation (r=-0.3033, p=0.0018). Patients who received social security and were unemployed/disabled had significant delays in testing (167d) compared to patients receiving social security and retired (30d, p=0.0318) or patients receiving salaries (13d, p=0.0002). African Americans and Hispanics, classified as underserved minority, had significant delays (92d) in testing compared to those not underserved (21d, p=0.0018). In addition, African Americans had significant delays (92d) compared to White patients (13d, p=0.0002). Patients with social work needs (12 total: 6 home care, 3 transportation, 2 financial assistance) had significant delays in testing (109d) compared to those without needs (24.5d, p=0.0028). Patients from zip codes with SVI>0.5 had non-significant delays (40.5d) compared to patients from zip codes with SVI<0.5 (26d, p=0.1817). In addition, patients with Medicare had significant delays (40d) compared to those with Medicare and supplementary insurances (15d, p=0.0205). Conclusions: PDAC patients with delays in germline testing were more likely African American and Hispanic, had lower income with social work needs, received social security, or lacked supplemental insurance. Interprofessional collaborations may be required to prompt germline tests. [Table: see text]
Community resilience and its impact on chemotherapy availability: An ecological analysis.
Authors: Shour Abdul R , Anguzu Ronald , Onitilo Adedayo A. 
Published: June 2023

e18510 Background: Cancer patients' resilience influences treatment outcomes, but how community resilience at the ecological level affects hospitals that provide chemotherapy is poorly understood. Methods: Agency for Health Care Research and Quality 2019 ecological data were analyzed (N=3,232 counties). The number of hospitals with chemotherapy services (continuous) was the outcome. The exposure was community resilience- individuals who live with various risk factors (income-poverty ratio, crowding, communication barrier, household unemployment, disability, age 65+; no health insurance, vehicle access, and broadband internet access). Covariates included residential racial segregation-dissimilarity index- degree to which non-white and white residents were distributed across counties, scored 0-100 (integration-segregation) and income inequality scored 0-1 (equality-inequality), recategorized as 10th (low-risk), 11th-89th (moderate-risk), and 90th (high-risk) percentiles and rural-urban and region. Using STATA/MPv.17, descriptive, chi-square; adjusted negative binomial regression were performed adjusting for population weight. P-values ≤0.05 were considered statistically significant. Results: Chemotherapy services were available in 38.4% of counties. The adjusted model reveals that chemotherapy availability decreased in high-risk than in low-risk resilient areas (Coef.: -1.10, 95% CI: -1.34 - -0.86), but increased in rural than in urban areas (Coef.: 0.36, 95% CI: 0.61- 0.49). Conclusions: Chemotherapy services rose in rural than urban areas and services were less likely to be provided when community resilience was low. [Table: see text]
Assessing the translation capabilities of NCI-designated cancer websites with a focus on lung, breast, prostate and ovarian cancers.
Authors: Smith Kolton , Elmarabti Ettaib , Fried Hayley , Spaccavento Colette M. 
Published: June 2023

e18514 Background: The world is becoming more and more dependent on the internet for garnering information. Medicine is no exception, with studies suggesting that 70% of patients will consult the internet to learn more about their health. Considering the diverse population served by the United States healthcare system, it is crucial that information can be accessed by Americans of Limited English Proficiency (LEP). This is especially true when it comes to cancer, a disease affecting hundreds of thousands of LEP Americans each year. National Cancer Institute (NCI)-designated cancer treatment centers represent the cutting-edge treatment facilities in oncology. Americans diagnosed with cancer often turn to the website of the nearest NCI-designated cancer center. Our study provides a snapshot of which NCI-designated cancer center websites provide translation capabilities for patient navigations including appointment scheduling, disease information and treatment for four of the most common types of cancer. Methods: Over the course of 2022, we performed a cross-sectional review of the language and translation services available to patients on each of the 71 NCI-designated cancer center websites with a focus on lung, breast, prostate and ovarian cancers. The primary outcomes included availability of translation services, method of translation (google translator vs. written text vs. telephonic) and number of languages offered. Results: Of the 71 NCI-designated cancer center websites, 15 (21.1%) provide information on prostate, lung, ovarian and breast cancer in languages other than English. Among these, 9 (60%) provide direct translation, 1 redirects the user to the NCI website for cancer information, and 5 offer only language lines. Furthermore, of the 9 cancer centers offering direct translation on their websites, only 6 had 2 or more languages. The most common translation language was Spanish (15/15) followed by Arabic and Chinese (11/15). The availability of translated cancer information on these websites did not correlate with the prevalence of LEP in each state. Analyzing previous NCI website interrogations shows that there has been no increase in the translation capabilities of NCI websites since 2019. Conclusions: One way to improve the quality of care in patients with Limited English Proficiency by improving access to care is to increase language concordant resources. NCI designated cancer center websites are sources of cancer related health knowledge. Our research exemplified that there are areas of opportunity to improve the reachability of these recourses to the LEP population. Increasing language concordant resources acknowledges and addresses one of the barriers to care that interferes with the quality of cancer care for LEP patients, promoting shared health care decision making for better health outcomes in a vulnerable population.
Racial disparities and inequity in clinical trials of chimeric antigen receptor T-cell therapy.
Authors: Thakur Rahul Kumar , Mehta Ansh , Vegivinti Charan Thej Reddy , Hammami M Bakri Bakri , Adhikari Biplov , Subedi Roshan , Adhikari Anurag , Kumar Abhishek 
Published: June 2023

e18515 Background: Chimeric antigen receptor (CAR) T-cell therapy is a paradigm-shifting advancement in hematologic malignancies with therapeutic futility. There is growing evidence that there are disparities affecting race and ethnicity for malignancy treatments as well as under-representation of minorities in clinical trials. We analyzed the racial representation in clinical trials of CAR-T products in the US. Methods: We searched all clinical trials in PubMed for six FDA-approved CAR-T therapy for all indications. We included all phase 2 and above published trials that were conducted in the US and recorded demographic data. Results: Out of total 64 studies; 16 were included for final analysis. A total of 1678 patients enrolled in the CAR-T therapy trials. The table shows indication and demographic data of the patient. Only 9 (56%) articles reported race and 8 (50%) articles reported ethnicity. We found only 47 (3%) African Americans, 47 (3%) Asian races, and 53 (3%) Hispanic ethnicity patients were enrolled in the trials. Conclusions: Our study highlights inadequate reporting of race/ethnicity and continued under-representation of minorities in clinical trials. This is the largest study examining the generalizability of CAR-T cell therapy RCTs at a population level. The underrepresentation in RCTs is an alarming finding as the incidence of many of the diseases is quite high in such minority populations thus exposing a significant disparity in health equity and healthcare access. More insights through research and policymaking are necessary to overcome barriers to delivering equitable healthcare, especially to underrepresented minorities.[Table: see text]
Associations between micro-geographic social vulnerability and disparities in cancer incidence.
Authors: Aijazuddin Ismail , Alloghbi Abdurahman , Sukari Ammar 
Published: June 2023

e18523 Background: Disparities in cancer incidence and diagnosis are the result of complex physical-social-environmental interactions. Geography is one crucial lens for assessment of these disparities. The CDC’s Social Vulnerability Index (SVI) ranks micro-geographies such as Census Tracts based on social factors and can be used to identify health disparities in measures such as cancer incidence. Methods: Actual and age-adjusted expected incidence of common cancers were obtained from the New York State Cancer Registry for 2013-2017 at the Census Tract level. Data were merged with the CDC’s Overall SVI rating for 2016 at the Census Tract level. Analysis included 4,647 Census Tracts, accounting for 97.71% of New York State’s 2016 population (19,078,306 population included). For each cancer, actual and expected incidence were grouped by overall SVI percentile, then percentage deviation from expected cancer incidence was calculated. Pearson correlational test and two-tailed t-test were performed for incidence deviation of each cancer by overall SVI percentile. Results: In New York State, significant correlations between Census Tract Overall Social Vulnerability Index (SVI) percentile and percentage deviation from expected cancer incidence were found for 5 out of 6 cancers reported in the State Cancer Registry. Strong positive relationships between degree of vulnerability and deviation from expected incidence were found for Lung Cancer (R = 0.75, p < 0.001) and Colorectal Cancer (R = 0.67, p < 0.001). Strong negative relationships were found for Female Breast Cancer (R = -0.90, p < 0.001), Urinary Bladder Cancer (R = -0.76, p < 0.001), and Non-Hodgkin Lymphoma (R = -0.73, p < 0.001). A significant correlation was not found for Prostate Cancer, which demonstrated a bimodal relationship with higher excess incidence at low and high vulnerability ratings. Conclusions: There are statistically significant increases in reported incidence of Colorectal and Lung Cancers in more vulnerable Census Tracts in NY State. Paradoxically, there are significant decreases in reported incidence of Breast Cancer, Bladder Cancer, and Non-Hodgkin Lymphoma in more vulnerable Census Tracts. Further exploration of micro-geographic trends is critical to understand the extent to which these disparities are explained by true differences in cancer incidence or by variations in screening access and utilization. [Table: see text]
Validation of the Tagalog and Ilokano translations of the Functional Assessment of Cancer Therapy-General (FACT-G) scale for adult cancer center patients in a state-funded tertiary hospital.
Authors: Dela Cruz Earnest Caiser Quilang 
Published: June 2023

e18524 Background: Patient reported outcomes such as the health related quality of life (HRQOL) is a significant variable that should be used in clinical decision making and health policy. The Functional Assessment of Cancer Therapy - General (FACT-G), is one of the most widely used HRQOL questionnaires and to make it more accessible globally translation to local dialects are imperative for inclusive service delivery. Prior to use, the validity and reliability of these tools should be established for the population it is intended to cater. Consistent with the mission statement of the hospital the researcher wanted this service to be more accessible and equitable by addressing language differences for our non english speaking end-users. Hence, the study aimed to document validity and reliability of translated Tagalog and Ilokano versions of the FACT-G questionnaire for use in patients catered upon by the Baguio General Hospital and Medical Center (BGHMC). Methods: Psychometric evaluation of the above tools was done involving 384 adult cancer patients of BGHMC. Data management and analysis using SPSS software was used to evaluate reliability, face validity, content validity, and construct validity. An addition of cognitive interviews was done with end-users and subsequent thematic analysis aimed to improve questionnaire quality. Results: Both the Tagalog and Ilokano questionnaires had indices above the set value for reliability measured as Chronbach’s alpha of 0.968 and 0.974, content validity indices of 0.95 and 0.95, and face validity indices of 0.98 and 0.98, respectively. Construct validity was established through an exploratory factor analysis comprised of a principal components analysis and Varimax factor rotation with Kaiser normalization. Conclusions: The Tagalog and Ilokano questionnaires are reliable and valid tools for use of approximation of HRQOL of cancer patients catered by the BGHMC. With the results of the validation study it is recommended to incorporate the use of these translated questionnaires to the day to day health service provision to approximate the health-related quality of life of cancer patients. These can also be used as measures to evaluate interventions and policies that are directed towards cancer patients catered in Northern Luzon. To better these questionnaires the revised questionnaires includes the omission of the 7th item in the scale of general social and family well-being to minimize disruptions in rapport due to nature of the question. Another is the reversion of the 2nd item in the scale of general emotional well-being so that it would have the same direction on the approximation of HRQOL with the other items in the scale.