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 Cancer and Aging: Two Tightly Interconnected Biological Processes

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1400
Author(s):  
Lieze Berben ◽  
Giuseppe Floris ◽  
Hans Wildiers ◽  
Sigrid Hatse
Keyword(s):  
Older Patients ◽  
Current Knowledge ◽  
Geriatric Oncology ◽  
Individual Treatment ◽  
Treatment Regimens ◽  
Patients With Cancer ◽  
Increased Risk ◽  
The Impact

Age is one of the main risk factors of cancer; several biological changes linked with the aging process can explain this. As our population is progressively aging, the proportion of older patients with cancer is increasing significantly. Due to the heterogeneity of general health and functional status amongst older persons, treatment of cancer is a major challenge in this vulnerable population. Older patients often experience more side effects of anticancer treatments. Over-treatment should be avoided to ensure an optimal quality of life. On the other hand, under-treatment due to fear of toxicity is a frequent problem and can lead to an increased risk of relapse and worse survival. There is a delicate balance between benefits of therapy and risk of toxicity. Robust biomarkers that reflect the body’s biological age may aid in outlining optimal individual treatment regimens for older patients with cancer. In particular, the impact of age on systemic immunity and the tumor immune infiltrate should be considered, given the expanding role of immunotherapy in cancer treatment. In this review, we summarize current knowledge concerning the mechanistic connections between aging and cancer, as well as aging biomarkers that could be helpful in the field of geriatric oncology.

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.

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.

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.

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.

Regaining a satisfactory quality of life and predicting functional decline after major cancer surgery in older adults: The Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12051-12051
Author(s):  
Isacco Montroni ◽  
Giampaolo Ugolini ◽  
Nicole Saur ◽  
Antonino Spinelli ◽  
Siri Rostoft ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Recovery ◽  
Functional Outcomes ◽  
Older Patients ◽  
Functional Decline ◽  
Geriatric Oncology ◽  
Cancer Surgery ◽  
Before And After ◽  
After Cancer

12051 Background: Older cancer patients value quality of life (QoL) and functional outcomes as much as survival but surgical studies lack specific data. The international, multicenter GOSAFE study (ClinicalTrials.gov NCT03299270) aims to evaluate patients’ QoL and functional recovery (FR) after cancer surgery and to assess predictors of FR Methods: GOSAFE prospectively collected functional and clinical data before and after major elective cancer surgery on senior adults (≥70 years). Surgical outcomes were recorded (30, 90, and 180 days post-operatively) with QoL (EQ-5D-3L) and FR (Activities of Daily Living (ADL), Timed Up and Go (TUG) and MiniCog), 26 centers enrolled patients from February 2017 to April 2019. Results: 942 patients underwent a major cancer resection. Median age was 78 (range 70-95); 52.2% males, ASA III-IV 49%. 934 (99%) lived at home, 51% lived alone, and 87% were able to go out. Patients dependent (ADL < 5) were 8%. Frailty was detected by means of G8 ≤14 in 68.8% and fTRST ≥2 in 37% of patients. Major comorbidities (CCI > 6) were reported in 36% and 21% had cognitive impairment according to MiniCog (2.2% self-reported). 25% had > 3 kg weight loss, 27% were hospitalized in the last 90 days, 54% had ≥3 medications (6% none). Postoperative overall morbidity was 39.1% (30 day) and 22.5% (90 day), but Clavien-Dindo III-IV complications were only 13.4% and 6.9% respectively. 30/90/180-day mortality was 3.6/6/8.9% (10/30/33% in patients with severe functional disability). At 3 months after surgery, QoL was stable/improved (mean EQ-5D index 0.78 was equivalent before vs. after surgery, while the EQ-5D VAS score > 60 raised from 74.3% at baseline to 80.2%, p < 0.01). 76.6% experienced postoperative FR/stability. Logistic regression analysis showed that ASA 3-4, CCI≥7 and CD III-IV complications are significantly associated with functional decline while a G8 > 14 has a positive association with functional recovery. Age is not associated with functional outcomes. Conclusions: The largest prospective study on older patients undergoing structured frailty assessment before and after major elective cancer surgery has shown that QoL remains stable/improves after cancer surgery. The majority of patients return to independence and G8 can predict functional recovery. Older patients with multiple comorbidities, high ASA score or postoperative severe complications are likely to functionally deteriorate after oncologic surgery Clinical trial information: NCT03299270 .

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
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