Geographic distribution of clinical trials for breast cancer across the United States, 2011-2015.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 140-140
Author(s):  
Sindhu Janarthanam Malapati ◽  
Sunny R K Singh ◽  
Rohit Kumar ◽  
Jibran Ahmed ◽  
Vatsala Katiyar ◽  
...  

140 Background: Access to clinical trials is paramount for delivery of high quality cancer care. We aim to study the geographical distribution of phase 3 & 4 clinical trials for females with breast cancer across 51 states between 2011 & 2015. Methods: We searched Clinicaltrials.gov registry for phase 3 & 4 clinical trials in US for females with breast cancer & those first posted from 01/01/2011 to 12/31/2015. New cases of female breast cancer from 2011 to 2015 were estimated with U.S. Cancer Statistics Data Visualizations Tool (www.cdc.gov/cancer/dataviz). Results: We found 88 phase 3 & 4 clinical trials over 51 states. The average number (no.) of new cancer cases and no. of trials per state were 22,985 and 34.4 (range: 16 - 57) respectively. On average, each state had 0.003 (SD: 0.002) trials per case. States with maximum number of cases and trials were California, New York, Texas and Florida. These accounted for 30.7% of total cases, but only 12.5% of total trials. Also, these four states had the lowest no. of clinical trials per case while District of Columbia had the highest (0.0123). The states with the lowest no. of clinical trials included Rhode Island, Vermont, Wyoming & Alaska (3.7% of total trials). Table with data regarding states with lowest and highest cancer burden is attached. Conclusions: For breast cancer in females during the years 2011 to 2015, the ratio of available phase 3 & 4 clinical trials to new cancer cases was quite low when examined state-wise. The gap widened as the cancer burden increased resulting in the lowest no. of clinical trials per case in the states with maximum cancer burden. This highlights the need of better allocation of resources and efforts across the nation when conducting clinical trials. [Table: see text]

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Opeolu Adeoye ◽  
Dawn Kleindorfer

Background: In 2013, the NIH Stroke Trials Network (StrokeNET) was established to maximize efficiencies in stroke clinical trials. Successful recruitment in future trials was required for participating sites. A high volume of cases treated is a surrogate for the potential to recruit. Among Medicare-eligible acute ischemic stroke (AIS) cases, we estimated the IV rt-PA and endovascular embolectomy treatment rates at StrokeNET Regional Coordinating Centers and their partner hospitals compared with non-StrokeNET hospitals in the United States (US). Methods: We used demographics and IV rt-PA and embolectomy rates in the 2013 Medicare Provider and Analysis Review (MEDPAR) dataset. ICD-9 codes 433.xx, 434.xx and 436 identified AIS cases. ICD-9 code 99.10 defined rt-PA treatment and ICD-9 code 39.74 defined embolectomy. Demographics and treatment rates at StrokeNET and non-StrokeNET sites were compared using t-test for proportions and Chi-square test for categorical variables as appropriate. Results: Of 386,157 AIS primary diagnosis discharges, 5.1% received IV rt-PA and 0.8% had embolectomy (Table). By June 6, 2014, StrokeNET comprised 247 acute care hospitals that discharged 48,946 (13%) out of 386,157 AIS cases. rt-PA (7.4% vs 4.8%) and embolectomy (1.9% vs 0.6%) treatment rates were higher at StrokeNET hospitals. In 2013, 36% of StrokeNET hospitals treated more than 20 AIS cases with rt-PA or embolectomy compared with 6% of non-StrokeNET hospitals (P<0.0001).Conclusions StrokeNET hospitals treat more AIS cases with acute reperfusion therapies. Thus, StrokeNET could successfully recruit in acute reperfusion clinical trials depending on study size, capture of eligible patients and the number of competing trials. We likely underestimated treatment rates due to not accounting for drip-and-ship and non-Medicare cases. To further enhance enrollments in large acute reperfusion phase 3 trials, partnership with high volume non-StrokeNET hospitals may be warranted.


2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Bijou R. Hunt

Background. This paper presents data on breast cancer prevalence and mortality among US Hispanics and Hispanic subgroups, including Cuban, Mexican, Puerto Rican, Central American, and South American.Methods. Five-year average annual female breast cancer prevalence and mortality rates for 2009–2013 were examined using data from the National Health Interview Survey (prevalence) and the National Center for Health Statistics and the American Community Survey (mortality rates).Results. Overall breast cancer prevalence among US Hispanic women was 1.03%. Although the estimates varied slightly by Hispanic subgroup, these differences were not statistically significant. The breast cancer mortality rate for Hispanics overall was 17.71 per 100,000 women. Higher rates were observed among Cubans (17.89), Mexicans (18.78), and Puerto Ricans (19.04), and a lower rate was observed among Central and South Americans (10.15). With the exception of the rate for Cubans, all Hispanic subgroup rates were statistically significantly different from the overall Hispanic rate. Additionally, all Hispanic subgroups rates were statistically significantly higher than the Central and South American rate.Conclusion. The data reveal significant differences in mortality across Hispanic subgroups. These data enable public health officials to develop targeted interventions to help lower breast cancer mortality among the highest risk populations.


2014 ◽  
Vol 8 (1) ◽  
pp. 44-50 ◽  
Author(s):  
Yao Wang ◽  
Robert K. Kanter

AbstractObjectiveNatural disasters exacerbate risks of hazardous environmental exposures and adverse health consequences. The present study determined the proportion of previously identified lead industrial sites in urban locations that are at high risk for dispersal of toxic chemicals by natural disasters.MethodsGeographic analysis from publicly available data identified former lead smelting plants that coincide with populated urban areas and with high-risk locations for natural disasters.ResultsFrom a total of 229 urban smelting sites, 66 (29%) were in relatively high-risk areas for natural disasters: flood (39), earthquake (29), tornado (3), and hurricane (2). States with urban sites at relatively high risk for natural disaster included California (15); Pennsylvania (14); New York (7); Missouri (6); Illinois (5); New Jersey (4); Kentucky (3); Florida, Oregon, and Ohio (2 each); and Indiana, Massachusetts, Rhode Island, Texas, Utah, and Washington (1 each). Incomplete historical records showed at least 10 smelting site locations were affected by natural disaster.ConclusionsForgotten environmental hazards may remain hazardous in any community. Uncertainty about risks in disasters causes disruptive public anxiety that increases difficulties in community responses and recovery. Our professional and public responsibility is to seek a better understanding of the risks of latent environmental hazards. (Disaster Med Public Health Preparedness. 2014;0:1–7)


2020 ◽  
Author(s):  
Shahan Mamoor

Bevacizumab (Avastin) is an approved treatment option by the European Medicines Agency (1) for more than a quarter billion women in the European Union, and despite having its indication withdrawn by the Food and Drug Administration in 2011 is still utilized in clinical trials in the United States (2, 3). We mined published microarray data (4) from the PROMIX trial to understand in an unbiased fashion genes most transcriptionally perturbed by bevacizumab administration and how this interacted with a standard anthracycline and taxane chemotherapeutic regimen, epirubicin and docetaxel. We report here the differential and increased expression of the hepatic leukemia factor (5, 6) in the primary tumors of women treated with bevacizumab for breast cancer.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11618-e11618
Author(s):  
R. D. Botan ◽  
M. N. Alvares ◽  
A. Hassan

e11618 Background: Treatment for male breast cancer is based on the results of large clinical trials for female breast cancer. Although peculiar differences do exist between men and women, very little is known about the prognostic factors in male breast cancer, even though female breast cancer practical conducts are widely used in male breast cancer. The rarity of this condition makes very difficult to produce randomized trials. Methods: This study is populational and epidemiological and evaluated male breast cancer patients from January 1974 to December 2001 about its prognostic characteristics. Data were collected retrospectively and the sample has been described using descriptive statistics methods. Survival curve was built using Kaplan-Meier method. Staging system was standardized as in the sixth edition of American Joint Committee on Cancer, independently on when the diagnose was made. Due to differences throughtout 35 years on therapeutic on breast cancer, treatment options were categorized in groups to make the survival evaluation possible. Results: From 45 patients with male breast cancer, 91% presented ductal histology, 26% were negative axillary, 9.1% were T1, 25% were T2, 4.5% were T3, 50% were T4 and 12.12% presented with distant metastasis at diagnose. Seventy nine percent were submitted to radical local treatment, while 34% had not been submitted to any kind of systemic treatment (neoadjuvant, adjuvant e hormone therapy). Forty percent of patients have not presented distant recurrence, while 58.3% have not presented local recurrence. A median survival of 126 months has been observed to the analyzed population, ranging from 69–182 months. Five-year survival was 72% and 10-year survival was 54%. These data agreed with the available data in the published literature. Conclusions: Male breast cancer appears to behave biologically and clinically very similar to female breast cancer, but differences do exist and need to be elucidated. Randomized multi-center clinical trials become necessary, as systematic reviews, to build higher statistic power studies. No significant financial relationships to disclose.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1542-1542
Author(s):  
Cheng-I Liao ◽  
Michelle Ann P. Caesar ◽  
Chloe Chan ◽  
Michael Richardson ◽  
Daniel Stuart Kapp ◽  
...  

1542 Background: To examine trends in modifiable behaviorally related cancers among men and women in the United States. Methods: Data were obtained from the United States Cancer Statistics (USCS) database for all cancers diagnosed between 2001 and 2017. Alcohol-associated cancers, HPV-associated, obesity-associated, physical inactivity-associated, and tobacco-associated were defined using ICD-O-3 site codes. SEER*Stat 8.3.8 and Joinpoint regression program 4.8.0.1 were used to calculate the trends of associated cancers expressed per 100,000. Results: In 2017 the incidence of cancers in women associated with alcohol, smoking and obesity were 168/100,000, 134/100,000 and 121/100,000 respectively. Based on analysis of trends of women from 2001 to 2017, alcohol, smoking and physical inactivity related cancers decreased with an annual percent change (APC -0.51%, -0.96%, -0.92% respectively, p < 0.001). However, there was no significant change in obesity, HPV, or post menopausal female breast cancer related cancers (APC: 0.07%, 0.09%, -0.08% respectively, p = 0.303, 0.181, 0.569). Based on age, in women less than 65, rates of obesity related cancers are increasing. Based on racial groups, all rates of cancer associated with modifiable factors are decreasing, however Hispanic women have an increasing rate of obesity related cancers (APC 0.46%, p < 0.001). When examining differences in region, all rates of cancer are decreasing or unchanged except the south has an increasing rate of obesity related cancer (APC 0.28%, p < 0.001). Using a projection model, obesity will become the highest incidence cancer in Hispanic women by 2035, surpassing alcohol and tobacco. In 2017 the incidence of cancers in men associated with tobacco, obesity, and alcohol were 209/100,000, 111/100,000 and 81/100,000 respectively. Based on analysis of trends in men alcohol, smoking, physical inactivity and obesity related cancers decreased (APC -1.42%, -1.59%, -3.15%, -0.41% respectively, p < 0.001). HPV related cancers have increased (APC 2.36%, p < 0.001). In men less than 60 years old, the rates of obesity related cancers are increasing. Using a prediction model, obesity is predicted to surpass tobacco as the most common social cause of cancer in 2020 for men 35-39, 2024 in men 40-44 and in 2030 in men 45-49. Conclusions: In women, most modifiable factors associated with cancer are decreasing except in obesity and HPV related cancers. In men, these rates of cancer are decreasing except HPV related cancers. However, rates of obesity related cancers are on the rise in Hispanic women and younger men. Obesity is set to become the major modifiable factor for many associated cancers.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18516-e18516
Author(s):  
Monaliben Patel ◽  
Lisa M. Hess ◽  
Eric Wen Su ◽  
Xiaohong Li ◽  
Debora S. Bruno

e18516 Background: Lack of diverse representation in clinical trials negatively impacts the cancer survival of patients and populations unaccounted for in clinical research. Efforts such as the 1993 NIH Revitalization Act have focused on improving the diversity of trial participants in the US. This retrospective study evaluated the racial distribution of oncology clinical trial participants using data published in clinicaltrials.gov from Jan 2010 through Dec 2020. Methods: I2E of Linguamatics (IQVIA, Inc), a natural language processing software, was used to identify participant race in oncology trials. Data extracted included trial identifier, year of completion, sponsor, cancer type, and race. Studies were limited to academic, cooperative group and government studies headquartered in the US. Clinical trial results were compared to the racial distribution of SEER 2010 data using z-test. Results: Data from 35,686 patients (14,220 enrolled to 236 phase 2 and 21,471 enrolled to 47 phase 3 trials) were available for analysis. A summary by race is provided in the Table, excluding unknown, which represented 8.5% of phase 2 and 3.5% of phase 3 trials. The proportions of white/black patients enrolled to phase 2 and phase 3 trials beginning in 2010-12 were 84.4%/11% and 83.1%/9.9%, respectively (total enrollment 84.9%/9.6%). For trials beginning in 2015-17, white/black enrollment represented 88.5%/8.1% of patients enrolled to phase 2 and 86.4%/10.1% of patients in phase 3 trials. Black patients represented 9.6% of all trial participants, in contrast with the SEER data where 12% of all patients were black (p < 0.001). For lung cancer trials, black participants represented only 7.9% of all trial participants whereas in breast cancer trials, 10.2% of participants were black, versus the SEER data specific to these tumor types (black patients represent 10.9%/11.5% of lung/breast cancer diagnoses between 2013 to 2017, both p < 0.01). Conclusions: This study suggests that over the past decade most races (other than white) have been significantly underrepresented in US oncology clinical trials, and is even more pronounced for black patients with lung cancer. Based on this analysis, there is no evidence that trial enrollment distribution, particularly of white versus black participants, has changed since 2010. Data are limited to the relative lack of studies reporting results that began enrollment after 2017. These findings suggest that the development of new strategies to improve the recruitment of racial minorities to oncology clinical trials are warranted.[Table: see text]


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