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.

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.

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.

scholarly journals How Is Geriatric Assessment Used in Clinical Practice for Older Adults With Cancer? A Survey of Cancer Providers by the American Society of Clinical Oncology

2020 ◽  
pp. OP.20.00442
Author(s):  
William Dale ◽  
Grant R. Williams ◽  
Amy R. MacKenzie ◽  
Enrique Soto-Perez-de-Celis ◽  
Ronald J. Maggiore ◽  
...  
Keyword(s):  
Older Adults ◽  
Geriatric Assessment ◽  
Online Survey ◽  
Task Force ◽  
Statistical Significance ◽  
Geriatric Oncology ◽  
Perceived Barriers ◽  
Patients With Cancer ◽  
Change Behavior ◽  
American Society

PURPOSE: For patients with cancer who are older than 65 years, the 2018 ASCO Guideline recommends geriatric assessment (GA) be performed. However, there are limited data on providers’ practices using GA. Therefore, ASCO’s Geriatric Oncology Task Force conducted a survey of providers to assess practice patterns and barriers to GA. METHODS: Cancer providers treating adult patients including those ≥ 65 years completed an online survey. Questions included those asking about awareness of ASCO’s Geriatric Oncology Guideline (2018), use of validated GA tools, and perceived barriers to using GA. Descriptive statistics and statistical comparisons between those aware of the Guideline and those who were not were conducted. Statistical significance was set at P < .05. RESULTS: Participants (N = 1,277) responded between April 5 and June 5, 2019. Approximately half (53%) reported awareness of the Guideline. The most frequently used GA tools, among those aware of the Guideline and those who were not, assessed functional status (69% v 50%; P < .001) and falls (62% v 45%; P < .001). Remaining tools were used < 50% of the time, including tools assessing weight loss, comorbidities, cognition, life expectancy, chemotherapy toxicity, mood, and noncancer mortality risk. GA use was two to four times higher among those who are aware of the Guideline. The most frequent barriers for those who reported being Guideline aware were lack of resources, specifically time (81.7%) and staff (77.0%). In comparison, those who were unaware of the Guideline most often reported the following barriers: lack of knowledge or training (78.4%), lack of awareness about tools (75.2%), and uncertainty about use of tools (75.0%). CONCLUSION: Among providers caring for older adults, 52% were aware of the ASCO Guideline. Some domains were assessed frequently (eg, function, falls), whereas other domains were assessed rarely (eg, mood, cognition). Guideline awareness was associated with two to four times increased use of GA and differing perceived barriers. Interventions facilitating Guideline-consistent implementation will require various strategies to change behavior.

scholarly journals Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper

2018 ◽  
Vol 10 ◽  
pp. 175883591880961 ◽  
Author(s):  
Nicolò Matteo Luca Battisti ◽  
Nienke De Glas ◽  
Mina S. Sedrak ◽  
Kah Poh Loh ◽  
Gabor Liposits ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Older Adults ◽  
Older Patients ◽  
Geriatric Oncology ◽  
Growth Factor Receptor ◽  
Standard Of Care ◽  
Cyclin Dependent Kinase ◽  
Current Standard ◽  
Oncology Review ◽  
Er Positive

The current standard of care for the management of estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer has been redefined by the introduction of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Although adults aged 65 years and older account for the majority of patients with breast cancer, limited data are available about the age-specific dosing, tolerability, and benefit of CDK4/6 inhibitors in this growing population. Older adults are under-represented in clinical trials and as a result, clinicians are forced to extrapolate from findings in younger and healthier patients when making treatment decisions for older patients. In this article, we review the limited age-specific evidence on the efficacy, toxicity, and quality of life (QoL) outcomes associated with the use of CDK4/6 inhibitors in older adults. We also describe ongoing trials evaluating CDK4/6 inhibitors in the older population and highlight that only a minority of adjuvant and metastatic trials of CDK4/6 inhibitors in the general breast cancer population includes geriatric assessments. Finally, we propose potential strategies to help guide decision making for fit and unfit older patients based on disease endocrine sensitivity, the need for rapid response and geriatric assessment.

scholarly journals What Every Oncologist Should Know About Geriatric Assessment for Older Patients With Cancer: Young International Society of Geriatric Oncology Position Paper

2018 ◽  
Vol 14 (2) ◽  
pp. 85-94 ◽  
Author(s):  
Kah Poh Loh ◽  
Enrique Soto-Perez-de-Celis ◽  
Tina Hsu ◽  
Nienke A. de Glas ◽  
Nicolò Matteo Luca Battisti ◽  
...  
Keyword(s):  
Geriatric Assessment ◽  
Older Patients ◽  
Geriatric Oncology ◽  
Treatment Decisions ◽  
Position Paper ◽  
Illustrative Case ◽  
Newly Diagnosed ◽  
Patients With Cancer ◽  
Detailed Evaluation ◽  
Oncology Practice

Aging is a heterogeneous process. Most newly diagnosed cancers occur in older adults, and it is important to understand a patient’s underlying health status when making treatment decisions. A geriatric assessment provides a detailed evaluation of medical, psychosocial, and functional problems in older patients with cancer. Specifically, it can identify areas of vulnerability, predict survival and toxicity, assist in clinical treatment decisions, and guide interventions in routine oncology practice; however, the uptake is hampered by limitations in both time and resources, as well as by a lack of expert interpretation. In this review, we describe the utility of geriatric assessment by using an illustrative case and provide a practical approach to geriatric assessment in oncology.

Comprehensive Geriatric Assessment for Older Patients With Cancer

2007 ◽  
Vol 25 (14) ◽  
pp. 1824-1831 ◽  
Author(s):  
Martine Extermann ◽  
Arti Hurria
Keyword(s):  
Older Adults ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Cancer Care ◽  
Older Patients ◽  
Morbidity And Mortality ◽  
Psychological State ◽  
Future Research ◽  
Oncology Patient ◽  
Patients With Cancer

Purpose During the last decade, oncologists and geriatricians have begun to work together to integrate the principles of geriatrics into oncology care. The increasing use of a comprehensive geriatric assessment (CGA) is one example of this effort. A CGA includes an evaluation of an older individual's functional status, comorbid medical conditions, cognition, nutritional status, psychological state, and social support; and a review of the patient's medications. This article discusses recent advances on the use of a CGA in older patients with cancer. Methods In this article, we provide an update on the studies that address the domains of a geriatric assessment applied to the oncology patient, review the results of the first studies evaluating the use of a CGA in developing interventions to improve the care of older adults with cancer, and discuss future research directions. Results The evidence from recent studies demonstrates that a CGA can predict morbidity and mortality in older patients with cancer. Accumulating data show the benefits of incorporating a CGA in the evaluation of older patients with cancer. Prospective trials evaluating the utility of a CGA to guide interventions to improve the quality of cancer care in older adults are justified. Conclusion Growing evidence demonstrates that the variables examined in a CGA can predict morbidity and mortality in older patients with cancer, and uncover problems relevant to cancer care that would otherwise go unrecognized.

scholarly journals Strategies to Improve Participation of Older Adults in Cancer Research

2020 ◽  
Vol 9 (5) ◽  
pp. 1571 ◽  
Author(s):  
Jennifer Liu ◽  
Eutiquio Gutierrez ◽  
Abhay Tiwari ◽  
Simran Padam ◽  
Daneng Li ◽  
...  
Keyword(s):  
Older Adults ◽  
Behavioral Interventions ◽  
Older Patients ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Targeted Interventions ◽  
Patients With Cancer ◽  
Healthcare Settings ◽  
Substantial Investment ◽  
Evidence Based Care

Cancer is a disease associated with aging. As the US population ages, the number of older adults with cancer is projected to dramatically increase. Despite this, older adults remain vastly underrepresented in research that sets the standards for cancer treatments and, consequently, clinicians struggle with how to interpret data from clinical trials and apply them to older adults in practice. A combination of system, clinician, and patient barriers bar opportunities for trial participation for many older patients, and strategies are needed to address these barriers at multiple fronts, five of which are offered here. This review highlights the need to (1) broaden eligibility criteria, (2) measure relevant end points, (3) expand standard trial designs, (4) increase resources (e.g., institutional support, interdisciplinary care, and telehealth), and (5) develop targeted interventions (e.g., behavioral interventions to promote patient enrollment). Implementing these solutions requires a substantial investment in engaging and collaborating with community-based practices, where the majority of older patients with cancer receive their care. Multifaceted strategies are needed to ensure that older patients with cancer, across diverse healthcare settings, receive the highest-quality, evidence-based care.

Cancer-specific mortality and competing causes of death in older adults: A prospective, multicenter cohort study (ELCAPA-19).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11547-11547 ◽  
Author(s):  
Deborah Assouan ◽  
Elena Paillaud ◽  
Philippe Caillet ◽  
Emmanuelle Kempf ◽  
Helene Vincent ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Cancer Mortality ◽  
Older Patients ◽  
Rating Scale ◽  
Mortality Rates ◽  
Test Time ◽  
Cancer Death ◽  
Multicenter Cohort Study ◽  
Patients With Cancer

11547 Background: Among older adults with cancer, comorbidities compete with cancer as the cause of death. The objectives were to quantify the proportion and rate of cancer-specific death in older patients with cancer, and to analyze the associations between geriatric factors and cancer death. Methods: Between January 2007 and December 2014, older patients with cancer were prospectively included by the ELCAPA cohort study’s eight investigating centers. Competing risk methods were used to estimate 6-month and 3-year cancer mortality rates and to probe associations between geriatric factors and cancer death. Results: A total of 1678 patients were included (mean ± standard deviation age: 81.3 ± 5.8; women: 49%). The most common cancers were colorectal (19%), breast (17%) and urinary (15%) cancers and 49% had metastasis. After a median follow-up period of 34 months, a total of 948 deaths were observed. Of the 282 deaths in non-metastatic patients, 203 (72%; 95% confidence interval (CI): [66%-77%]) were attributable to cancer. This proportion was 92% (89–94; N = 448/498) for metastatic patients. The 6-month and 3-year cancer mortality rates was respectively 12% (9–15) and 34% (29-38) for non-metastatic tumors and 45% (41–49) and 83% (80–87) for metastatic stage tumors. At 6 months, the geriatric factors independently associated with cancer death were a dependency in activities of daily living (ADL) score ≤ 5 (adjusted subhazard ratio: 2.11 (95%CI: [1.68–2.64]), mobility impairment (Timed Get Up and Go (TGUG) test time > 20 s (1.40 [1.05–1.87]) or inability to perform the TGUG (2.41 [1.67–3.48])) and comorbidities (total Cumulative Index Rating Scale-Geriatric score ≥13) (1.59 [1.23–2.06]). At 3 years, the independently associated factors were ADL ≤ 5 (1.60, [1.34–1.91]), TGUG > 20 s (1.28, [1.04–1.59]) or inability to perform TGUG (2.02 [1.47–2.79]), and cognitive impairment (1.23 [1.01–1.50]). Conclusions: Most older adults with cancer die from this disease and not from other comorbidities. However, geriatric parameters (dependency, impaired mobility, comorbidities, and cognitive impairment) are independently associated with cancer death. These geriatric impairments should be taken into account when assessing the cancer patient’s prognosis in clinical practice. Clinical trial information: NCT02884375.

Defining undertreatment and overtreatment in older patients with cancer: A scoping review of the literature.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23020-e23020
Author(s):  
Clark DuMontier ◽  
Kah Poh Loh ◽  
Paul A Bain ◽  
Rebecca A Silliman ◽  
Gregory A. Abel ◽  
...  
Keyword(s):  
Older Adults ◽  
Older Adult ◽  
Scoping Review ◽  
Standard Therapy ◽  
Older Patients ◽  
Review Of The Literature ◽  
Substantial Agreement ◽  
Explicit Definition ◽  
Patients With Cancer ◽  
Implicit Definitions

e23020 Background: The terms “undertreatment” and “overtreatment” are often used to describe the management of older adults with cancer. The aim of this scoping review was to explore the explicit and implicit definitions associated with the use of these terms. Methods: We searched PubMed (NCBI), Embase (Elsevier), and CINAHL (EBSCO) for titles and abstracts that included the terms "undertreatment" or "overtreatment" (overtreat OR undertreat OR over treat OR under treat) of older adults with cancer. We included all types of articles, cancers, and treatments. We excluded studies that only included patients younger than 60 years old or studies without a defined focus on older adults. CD and KL independently reviewed a subset of included articles to assess for inter-reviewer reliability. Results: We identified 224 primary and secondary research articles that used the terms “undertreatment” (192), “overtreatment” (72), or both (45) regarding the management of older adults with cancer. Only 14 (6.3%) articles provided an explicit definition; for the remaining articles, we derived the implicit definitions from the terms’ surrounding context. There was substantial agreement between CD and KL in their interpretation of definitions of these terms (kappa 0.81). “Undertreatment” was commonly used to imply less than “standard” therapy (130 articles, 67.7%), or less than “standard” therapy that contributed to worse outcomes (62, 32.3%). Many articles did not account for the underrepresentation of older adults in trials leading to “standard” therapy, and 24 primary studies performed no or limited adjustment for geriatric domains (e.g., function) in their analyses that suggested worse survival in older adults treated with substandard therapy. “Overtreatment” was commonly used to imply cancer treatment in an older adult whose cancer would not have caused symptoms in his/her remaining lifetime (31, 43.1%), or aggressive treatment in whom the harms of treatment outweigh its benefits (41, 56.9%). Conclusions: Nearly all articles used the terms “undertreatment” and/or “overtreatment” without an explicit definition, and we identified variability and limitations in the meanings implied by these terms.

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