scholarly journals Promoting Accrual of Older Patients with Cancer to Clinical Trials: An Alliance for Clinical Trials in Oncology Member Survey (A171602)

2018 ◽  
Vol 23 (9) ◽  
pp. 1016-1023 ◽  
Author(s):  
Rachel A. Freedman ◽  
Travis J. Dockter ◽  
Jacqueline M. Lafky ◽  
Arti Hurria ◽  
Hyman J. Muss ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Patients With Cancer

International Society of Geriatric Oncology Chemotherapy Taskforce: Evaluation of Chemotherapy in Older Patients—An Analysis of the Medical Literature

2007 ◽  
Vol 25 (14) ◽  
pp. 1832-1843 ◽  
Author(s):  
Stuart M. Lichtman ◽  
Hans Wildiers ◽  
Etienne Chatelut ◽  
Christopher Steer ◽  
Daniel Budman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
International Society ◽  
Older Patients ◽  
Task Force ◽  
Geriatric Oncology ◽  
The Elderly ◽  
Prospective Data ◽  
Patients With Cancer ◽  
Effects Of Aging ◽  
Available Information

The elderly comprise the majority of patients with cancer and are the recipients of the greatest amount of chemotherapy. Unfortunately, there is a lack of data to make evidence-based decisions with regard to chemotherapy. This is due to the minimal participation of older patients in clinical trials and that trials have not systematically evaluated chemotherapy. This article reviews the available information with regard to chemotherapy and aging provided by a task force of the International Society of Geriatric Oncology (SIOG). Due to the lack of prospective data, the conclusions and recommendations made are a consensus of the participants. Extrapolation of data from younger to older patients is necessary, particularly to those patients older than 80 years, for which data is almost entirely lacking. The classes of drugs reviewed include alkylators, antimetabolites, anthracyclines, taxanes, camptothecins, and epipodophyllotoxins. Clinical trials need to incorporate an analysis of chemotherapy in terms of the pharmacokinetic and pharmacodynamic effects of aging. In addition, data already accumulated need to be reanalyzed by age to aid in the management of the older cancer patient.

scholarly journals Designing Therapeutic Clinical Trials for Older and Frail Adults With Cancer: U13 Conference Recommendations

2014 ◽  
Vol 32 (24) ◽  
pp. 2587-2594 ◽  
Author(s):  
Arti Hurria ◽  
William Dale ◽  
Margaret Mooney ◽  
Julia H. Rowland ◽  
Karla V. Ballman ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Older Patients ◽  
Adult Population ◽  
Geriatric Oncology ◽  
Cancer Therapies ◽  
Knowledge Gaps ◽  
Aging Research ◽  
Patients With Cancer ◽  
Research Guidelines

A majority of cancer diagnoses and deaths occur in patients age ≥ 65 years. With the aging of the US population, the number of older adults with cancer will grow. Although the coming wave of older patients with cancer was anticipated in the early 1980s, when the need for more research on the cancer-aging interface was recognized, many knowledge gaps remain when it comes to treating older and/or frailer patients with cancer. Relatively little is known about the best way to balance the risks and benefits of existing cancer therapies in older patients; however, these patients continue to be underrepresented in clinical trials. Furthermore, the available clinical trials often do not include end points pertinent to the older adult population, such as preservation of function, cognition, and independence. As part of its ongoing effort to advance research in the field of geriatric oncology, the Cancer and Aging Research Group held a conference in November 2012 in collaboration with the National Cancer Institute, the National Institute on Aging, and the Alliance for Clinical Trials in Oncology. The goal was to develop recommendations and establish research guidelines for the design and implementation of therapeutic clinical trials for older and/or frail adults. The conference sought to identify knowledge gaps in cancer clinical trials for older adults and propose clinical trial designs to fill these gaps. The ultimate goal of this conference series is to develop research that will lead to evidence-based care for older and/or frail adults with cancer.

scholarly journals Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey

2019 ◽  
Vol 24 (12) ◽  
Author(s):  
Florence Canouï‐Poitrine ◽  
Astrid Lièvre ◽  
Florent Dayde ◽  
Daniel Lopez‐Trabada‐Ataz ◽  
Isabelle Baumgaertner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Patients With Cancer ◽  
Multicenter Cohort

scholarly journals Changes in the Use of Comprehensive Geriatric Assessment in Clinical Trials for Older Patients with Cancer over Time

2019 ◽  
Vol 24 (8) ◽  
pp. 1089-1094 ◽  
Author(s):  
Olivia Le Saux ◽  
Claire Falandry ◽  
Hui K. Gan ◽  
Benoit You ◽  
Gilles Freyer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Older Patients ◽  
Patients With Cancer ◽  
Over Time

Systematic Review of Barriers to the Recruitment of Older Patients With Cancer Onto Clinical Trials

2005 ◽  
Vol 23 (13) ◽  
pp. 3112-3124 ◽  
Author(s):  
Carol A. Townsley ◽  
Rita Selby ◽  
Lillian L. Siu
Keyword(s):  
Clinical Trials ◽  
Functional Status ◽  
Older Patients ◽  
Tumor Biology ◽  
Physician Education ◽  
Cancer Clinical Trials ◽  
Comorbid Conditions ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Significant Barrier

Purpose Older patients are significantly underrepresented in cancer clinical trials. A literature review was undertaken to identify the barriers that impede the accrual of this vulnerable population onto clinical trials and to determine what specific strategies are needed to improve the representation of older patients in research studies. Methods A systematic literature search was undertaken using several different strategies to identify relevant articles. Results Nine of 31 relevant papers from 159 citations were included. Age is a significant barrier to recruitment; only a quarter to one third of potentially eligible older patients are enrolled onto trials. Physicians' perceptions, protocol eligibility criteria with restrictions on comorbid conditions, and functional status to optimize treatment tolerability are the most important reasons resulting in the exclusion of older patients. Other barriers include the lack of social support and the need for extra time and resources to enroll these patients. Conversely, older patients do not view their age as an important reason for refusing trials. Conclusion Specific clinical trials confined to older patients should be conducted to evaluate tumor biology, treatment tolerability, and the effect of comorbid conditions. Protocol designs need to stratify for age and be less restrictive with respect to exclusions on functional status, comorbidity, and previous cancers, such that results are generalizable to older patients. Physician education to dispel unfounded perceptions, improved access to available clinical trials, and provision of personnel and resources to accommodate the unique requirements of an older population are possible solutions to remove the barriers of ageism.

Geriatric Oncology and Clinical Trials

2015 ◽  
pp. e127-e131 ◽  
Author(s):  
Stuart M. Lichtman
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Geriatric Oncology ◽  
Life Changes ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Eligibility Assessment ◽  
Dose Limiting Toxicity ◽  
Meaningful Data

The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence. Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of geriatric assessment needs to be included to help with eligibility, assessment, and stratification. For future clinical trials to be truly meaningful they need to appropriately assess and incorporate the needs of the majority of the cancer population.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Rationale for heparin treatment of colon cancer

2000 ◽  
Vol 20 (03) ◽  
pp. 136-142 ◽  
Author(s):  
D. L. Ornstein ◽  
L. R. Zacharski
Keyword(s):  
Clinical Trials ◽  
Substantial Improvement ◽  
Patients With Cancer ◽  
Coagulation Mechanism ◽  
Anticoagulant Drug ◽  
Cancer Outcome ◽  
Meta Analyses ◽  
Improvement In Survival ◽  
Spectrum Of Patients ◽  
To Receive

SummaryIt is widely known that the systemic blood coagulation mechanism is often activated in malignancy, leading to an increased incidence of vascular thromboses in patients with cancer. It is not widely appreciated, however, that products of the coagulation mechanism may also support tumor growth and dissemination. Interest in this approach to cancer therapy has surged recently because of mounting evidence that the familiar anticoagulant drug, heparin, may impede tumor progression. Heparin has the capacity to modify angiogenesis, growth factor and protease activity, immune function, cell proliferation and gene expression in ways that may block malignant dissemination. Clinical trials in which heparin has been administered to a broad spectrum of patients to prevent or treat thrombosis have unexpectedly shown improvement in survival in the subset of patients with malignancy entered to these studies. Meta-analyses of clinical trials comparing unfractionated (UF) versus low molecular weight (LMW) heparin treating venous thromboembolism suggest that there may be substantial improvement in cancer outcome in patients with malignancy randomized to receive LMW heparin. These findings provide a rationale for definitive clinical trials of LMW heparin in cancer, and the results of several such studies that are currently underway are awaited with interest.

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