scholarly journals Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina

2016 ◽  
Vol 77 (1) ◽  
pp. 52-58 ◽  
Author(s):  
L. L. Zullig ◽  
A. G. Fortune-Britt ◽  
S. Rao ◽  
S. D. Tyree ◽  
P. A. Godley ◽  
...  
2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 81-81
Author(s):  
Katherine Elizabeth Reeder-Hayes ◽  
Christopher Baggett ◽  
Bradford E. Jackson ◽  
Tzy-Mey Kuo ◽  
Jacquelyne Janean Gaddy ◽  
...  

81 Background: Delays in breast cancer treatment > 60 days have been linked to decrements in outcome and constitute poor quality care. Black compared to non-Black patients are at greater risk of treatment delays across the cancer care delivery spectrum. The extent to which racial disparities in breast cancer timeliness are linked to the geographic areas where Black patients receive care is unclear. Methods: We assembled a cohort of 26,482 patients diagnosed with stage I-III breast cancer in North Carolina from 2004 to 2015 from the Cancer Information and Population Health Resource (CIPHR), a multi-payer linkage of insurance claims to cancer registry data, and enrolled for 1 year after diagnosis. We defined time to treatment (TTx) as days between diagnosis and the first claim for cancer-directed therapy (surgery or chemotherapy); patients receiving radiation before other treatments and those who did not receive cancer-directed surgery by 12 months were excluded. The main exposure was the patient’s Area Health Education Center (AHEC) region of residence. The outcome of clinically significant delay was dichotomized at 60 days. Modified Poisson regression was used to generate risk ratios for bivariate, race and age-adjusted, and fully-adjusted multivariable models including clinical characteristic. The interaction of race and AHEC region was significant; therefore all subsequent analyses were stratified by Black versus non-Black race. Results: Overall, 12.3% of Blacks were delayed > 60 days, compared to 6.8% of non-Blacks. Among non-Black patients, AHEC region of residence did not predict delay. Among Black patients, likelihood of delay varied significantly across the state’s nine AHEC regions, with a risk ratio of 1.91 (95% CI 1.30-2.79) for the lowest-performing region compared to the highest-performing region. The two highest-performing regions had the largest proportions of Black patients (25-38%), and did not contain any of the state’s five largest cities. Adjustment for age, disease stage, hormone receptor status and type of first treatment did not significantly attenuate regional differences in delay among Black patients. Conclusions: Significant racial disparities exist in timely breast cancer treatment among Black women in North Carolina. AHEC region of residence had a disproportionate impact on the likelihood of treatment delay among Black women, with higher-minority regions without large cities delivering more timely care to Black patients. Our findings suggest that local health system characteristics of AHEC regions, rather than patient-level factors, may be key determinants of care disparities among Black breast cancer patients in this context. Ongoing work includes additional multi-level modeling including AHEC-level health system factors, and stakeholder interviews in high and low performing areas to enhance understanding of patterns of care and identify intervention targets.


2021 ◽  
Author(s):  
Moataz Dowaidar

Except in human clinical trials, preclinical tests showed the potential of Salmonella bacteria for tumor therapy. There are still various challenges to tackle before salmonella bacteria may be employed to treat human cancer. Due to its pathogenic nature, attenuation is essential to minimize the host's harmful effects of bacterial infection. Loss of anticancer efficacy from bacterial virulence attenuation can be compensated by giving therapeutic payloads to microorganisms. Bacteria can also be linked to micro-or nanomaterials with diverse properties, such as drug-loaded, photocatalytic and/or magnetic-sensing nanoparticles, using the net negative charge of the bacteria. Combining bacteria-mediated cancer treatment with other medicines that have been clinically shown to be helpful but have limits may provide surprising therapeutic results. Recently, this strategy has received attention and is underway. The use of live germs for cancer treatment has not yet been approved for human clinical trials. The non-invasive oral form of administration benefits from safety, making it more suitable for clinical cancer patients.Infection of live germs through systemic means, on the other hand, involves toxicity risk. Although Salmonella bacteria can be genetically manipulated with high tumor targeting, harm to normal tissues can not be excluded when medications with nonspecific toxicity are administered. It is preferred if the action of selected drugs may be restricted to the tumor site rather than healthy tissues, thereby boosting cancer therapy safety. In recent years, many regulatory mechanisms have been developed to manage pharmaceutical distribution through live bacterial vectors. Engineered salmonella can accumulate 1000 times greater than normal tissue density in the tumor. The QS-regulated mechanism, which initiates gene expression when bacterial density exceeds a particular threshold level, also promises Salmonella bacteria for targeted medication delivery. Nanovesicle structures of Salmonella bacteria can also be used as biocompatible nanocarriers to deliver functional medicinal chemicals in cancer therapy. Surface-modified nanovesicles preferably attach to tumor cells and are swallowed by receptor-mediated endocytosis before being destroyed to release packed drugs. The xenograft methodology, which comprises the implantation of cultivated tumor cell lines into immunodeficient mice, has often been used in preclinical research revealing favorable results about the anticancer effects of genetically engineered salmonella.


Author(s):  
Martin Perez-Santos ◽  
Maricruz Anaya-Ruiz ◽  
Gabriela Sanchez-Esgua ◽  
Luis Villafaña-Diaz ◽  
Diana Barron-Villaverde

PD-L1 and ICOS are immune control points in cancer and their presence in cancer tends to have a poor prognosis. WO2019122882 patent describes a bispecific antibody that targets PDL-1/ICOS with the potential application of cancer treatment. WO2019122882 patent describes a bispecific antibody with antitumor efficacy in CT26 model through of the depletion of TReg cells and improved ratio of CD8+ T cells: TReg in tumor microenvironment. The anti-PDL-1/ICOS antibody is new; however, only preclinical assays are shown using colon carcinoma model. So far, there are no reports of clinical trials to evaluate the safety, toxicity and efficacy, but it will be of great interest to analyze in the future if this antibody surpasses the action of the combinatorial therapy in cancer.


1999 ◽  
Vol 92 (12) ◽  
pp. 1189-1193 ◽  
Author(s):  
CARRIE N. KLABUNDE ◽  
Bethesda ◽  
BRIAN C. SPRINGER ◽  
BELINDA BUTLER ◽  
Winston-Salem ◽  
...  

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.


2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.


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