scholarly journals Exclusion Criteria of Breast Cancer Clinical Trial Protocols: A Descriptive Analysis

2021 ◽  
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle B. Rocque
Keyword(s):  
Heart Failure ◽  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Congestive Heart Failure ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Laboratory Values

Abstract Purpose: 3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004-2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free.Results: 102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500μL (1%) to 1,800μL (1%), with 1,500μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer.Conclusion: Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

scholarly journals Exclusion Criteria of Breast Cancer Clinical Trial Protocols: A Descriptive Analysis

2021 ◽  
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle B. Rocque
Keyword(s):  
Heart Failure ◽  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Congestive Heart Failure ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Laboratory Values

Abstract Purpose3% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines. MethodsThis descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004-2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free. Results102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500μL (1%) to 1,800μL (1%), with 1,500μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer. ConclusionSubstantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

Exclusion criteria of breast cancer research protocols: A descriptive analysis.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 82-82
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle Betty Rocque
Keyword(s):  
Cardiovascular Disease ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Upper Limit ◽  
Laboratory Values ◽  
History Of ◽  
Substantial Heterogeneity

82 Background: Clinical trials play an important role in advancing cancer treatments. Unfortunately, only about 3% of adults with cancer are enrolled in a clinical trial in the United States due to various barriers to enrollment. This includes restrictive eligibility criteria, which currently have no standard guidelines. The purpose of this study is to evaluate the variability of eligibility criteria. Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham (UAB) between 2004-2020. Exclusion criteria (e.g., laboratory values and comorbidities) were extracted from protocols using OnCore, an online dataset used to manage clinical trials, and ClinicalTrials.gov. Laboratory values or vital signs analyzed included liver function tests, hematologic labs, Eastern Cooperative Oncology Group (ECOG) performance status, and hypertension. Comorbid conditions included congestive heart failure, cardiovascular disease, presence of central nervous system (CNS) metastases, and history of prior cancer. Comorbid conditions were further analyzed by amount of time protocols required participants to be from initial diagnosis or exacerbation-free. Results: There were a total of 102 eligible protocols. Substantial heterogeneity was observed in exclusion criteria across liver/hematologic laboratory values and demographic/comorbidity variables. Among liver laboratory values, most protocols included an upper limit of acceptable for bilirubin (78%): 9% used the institutional upper limit of normal (ULN), 2% used 1.2xULN, 3% used 1.25xULN, 56% used 1.5xULN, 6% used 2xULN, and 2% used 3xULN. Similar variability was observed in protocols that included alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count: 1% 500mcL, 11% used 1,000mcL, 4% used 1,200mcL, 1% used 1,250mcL, 64% used 1,500mcL, and 1% used 1,800mcL. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). While most protocols included cardiovascular disease, the allowable timeframe varied between protocols: 4% did not allow an acute exacerbation within the previous 3 months, 32% did not allow within the previous 6 months, 5% did not allow within the previous 12 months, and 38 % did not specify a time frame. Protocols including history of a prior cancer as a criterion similarly had varied definitions based on timeline. Conclusions: Substantial heterogeneity was observed among clinical trial protocols. While exclusion criteria are necessary for patient safety, there is lack of evidence for current parameters. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

Abstract 21: Heart Failure and Shared Decision-making: Patients’ Perspectives Regarding Medication-related Cost Discussions

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Birju Rao ◽  
Neal W Dickert ◽  
Alanna A Morris ◽  
Candace Speight ◽  
Graham Smith ◽  
...  
Keyword(s):  
Heart Failure ◽  
Decision Making ◽  
Financial Burden ◽  
Descriptive Analysis ◽  
Cost Benefit ◽  
Patient Specific ◽  
Medication Cost ◽  
Eligibility Criteria ◽  
Reduced Ejection Fraction ◽  
Medication Costs

Background: Patients with heart failure with reduced ejection fraction (HFrEF) take on average 6 medications daily and can face considerable out-of-pocket medication costs. This issue has become particularly salient as newer medications such as sacubitril-valsartan have emerged as beneficial. As clinicians attempt to maximize benefits for this population, discussions of medication costs between patients and clinicians are critical. However, cost discussions are known to be infrequent and often suboptimal. Objective: To explore patients’ perspectives on discussing out-of-pocket medication costs with clinicians. Methods: 49 adults, aged 44-70, with HFrEF meeting general eligibility criteria for sacubitril-valsartan were recruited from outpatient heart failure clinics and inpatient services. Descriptive quantitative analysis of closed-ended and multiple-choice responses was conducted. Qualitative descriptive analysis of open-ended text data was performed. Results: About half (49%) of participants reported any previous discussion with clinicians about out-of-pocket cost related to medication. These participants described their experience with cost discussions at the time of prescription as generally positive. Specific ways these discussions were helpful included clarifying cost-benefit tradeoffs and identifying opportunities for cost reduction. Most participants (96%) were open to cost discussions with their clinician, and many (69%) specifically preferred that clinicians initiate discussions regarding medication cost. There were no differences in cost discussion preferences between participants who employed different decision-making approaches about initiation of sacubitril-valsartan or across levels of financial burden. Conclusion: Out-of-pocket cost is a relevant component of patient-centered medical decisions, particularly for patients with HFrEF. These data suggest patients with HFrEF are receptive to incorporating cost discussions into care and identify some of the ways these discussions may be helpful. Further research is needed to clarify how best to identify patient-specific cost at the time of clinical encounters and how to work with patients to make cost-benefit assessments.

scholarly journals Estimating the number of preventable cardiovascular disease events in the United States using the EMPA-REG OUTCOME trial results and National Health and Nutrition Examination Survey

2020 ◽  
Vol 17 (4) ◽  
pp. 147916412094567
Author(s):  
Nathan D Wong ◽  
Wenjun Fan ◽  
Jonathan Pak
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Cardiovascular Disease ◽  
Confidence Interval ◽  
National Health ◽  
The United States ◽  
Eligibility Criteria ◽  
Health And Nutrition ◽  
The Difference ◽  
Event Rates

Aim: We examined eligibility and preventable cardiovascular disease events in US adults with diabetes mellitus from the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). Methods: We identified adults with diabetes mellitus eligible for EMPA-REG OUTCOME based on trial eligibility criteria available from the National Health and Nutrition Examination Surveys, 2007–2016. We estimated composite cardiovascular disease endpoints, as well as all-cause deaths, death from cardiovascular disease and hospitalizations for heart failure from trial treatment and placebo event rates, the difference indicating the preventable events. Results: Among 29,629 US adults aged ⩾18 years (representing 231.9 million), 4672 (27.3 million) had diabetes mellitus, with 342 (1.86 million) meeting eligibility criteria of EMPA-REG OUTCOME. We estimated from trial primary endpoint event rates of 10.5% and 12.1% in the empagliflozin and placebo groups, respectively, that based on the ‘treatment’ of our 1.86 million estimated EMPA-REG OUTCOME eligible subjects, 12,066 (95% confidence interval: 10,352–13,780) cardiovascular disease events could be prevented annually. Estimated annual preventable deaths from any cause, cardiovascular causes and hospitalizations from heart failure were 17,078 (95% confidence interval: 14,652–19,504), 14,479 (95% confidence interval: 12,422–16,536) and 9467 (95% confidence interval: 8122–10,812), respectively. Conclusion: Empagliflozin, if provided to EMPA-REG OUTCOME eligible US adults, may prevent many cardiovascular disease events, cardiovascular and total deaths, as well as heart failure hospitalizations.

MO19390 (SAiL): Incidence of thromboembolic events and congestive heart failure with first-line bevacizumab (Bv)-based therapy in advanced non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19003-e19003
Author(s):  
N. Pavlakis ◽  
V. Hirsh ◽  
M. Reck ◽  
Y. Wu ◽  
E. Dansin
Keyword(s):  
Heart Failure ◽  
Congestive Heart Failure ◽  
Special Interest ◽  
Locally Advanced ◽  
Thromboembolic Events ◽  
First Line ◽  
Standard Chemotherapy ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Ecog Ps

e19003 Background: MO19390 (SAiL) is a single-arm, multicenter, international trial evaluating the safety and efficacy of first-line Bv with standard chemotherapy in over 2,000 patients (pts). Methods: Key eligibility criteria were untreated locally advanced, metastatic or recurrent non-squamous NSCLC, ECOG PS 0–2, tumor not abutting major blood vessels, no uncontrolled HTN (systolic >150mmHg and/or diastolic >100mmHg) or active cardiovascular disease at baseline. Pts received Bv (7.5 or 15mg/kg) with standard chemotherapy for up to six cycles. Non-progressors proceeded to receive Bv until disease progression. The primary endpoint was safety, including the incidence of serious adverse events (SAEs) related to Bv, and the incidence of AEs of special interest. Results: Safety analyses (data cut-off July 2008) were based on 2,008 pts. Pts (%) were: male 60.1; stage IIIB/IV 19.5/80.5 (no data for 3 pts); adenocarcinoma/large cell/other 85.8/7.1/7.1; ECOG PS 0/1/2 38.1/56.1/5.8. 4.2% of pts were receiving anticoagulants at baseline. A total of 1,008 pts (50.2%) experienced at least one adverse event of special interest (all grades). Of these, 172 pts (8.6%) experienced an arterial or venous thromboembolism, which included pulmonary embolism (49 pts; 2.4%), deep vein thrombosis (40 pts; 2.0%), thrombophlebitis (26 pts; 1.3%), myocardial infarction (12 pts; 0.6%), cerebral hemorrhage (2 pts; 0.1%), cerebral ischemia (4 pts; 0.2%) and cerebrovascular accident (6 pts; 0.3%). 59 pts (2.9%) experienced congestive heart failure (CHF). Conclusions: The incidence of thromboembolic events and CHF was low in Bv-treated pts enrolled in the SAiL trial. These results, taken together with the overall safety analysis from the SAiL trial, confirm that Bv-based therapy has a well-established and manageable safety profile. Updated results will be presented. [Table: see text]

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