Are ongoing trials on hematologic malignancies still excluding older subjects?

Cherubini, Antonio; Pierri, Francesca; Gasperini, Beatrice; Zengarini, Elisa; Cerenzia, Annarita; Bonifacio, Elisabetta; Falcinelli, Floriana; Lattanzio, Fabrizia

doi:10.3324/haematol.2013.087601

Cited by 17 publications

(8 citation statements)

References 16 publications

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“…Prior research suggested that this discrepancy was largely due to exclusion of subjects who are older or have comorbidities, but did not analyse how treatment urgency affects enrolment. (Augustin et al, 2017; Cherubini et al, 2013; Stone et al, 1994; Terschuren et al, 2010) Recently, the American Society of Clinical Oncology has advocated for inclusion of patients with central nervous system involvement, well-controlled HIV infection or prior malignancies, as ways to broaden trial enrolment and generalizability. (Kim et al, 2017) In our NCDB data, early treatment initiation was also associated with a significantly lower likelihood of receiving trial therapy.…”

Section: Discussionmentioning

confidence: 99%

Time to treatment is an independent prognostic factor in aggressive non‐Hodgkin lymphomas

2018

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In aggressive lymphomas, discrepancies in survival reported from experimental and observational studies may reflect selective non-enrolment of high-risk patients in trials. We examined the association between time from diagnosis to chemotherapy and overall survival in diffuse large B-cell (DLBCL), Burkitt (BL), mantle cell (MCL) and peripheral T-cell lymphoma (PTCL), using National Cancer Data Base records of 130 549 patients treated in 2004-2014. Across the histologies, patients who started chemotherapy within 7 days of diagnosis had more often high International Prognostic Index (IPI) or advanced-stage disease. The discrepancy in 3-year survival between groups treated within 7 or >30 days from diagnosis ranged from 14% in BL to 30% in MCL. After adjusting for the IPI, time to treatment was significantly associated with shorter overall survival. Using the group treated >30 days from diagnosis as reference, patients treated within 7 days had a hazard ratio of 1·38 [95% confidence interval (CI), 1·28-1·48] in DLBCL, 1·42 (95% CI, 1·22-1·66) in BL, 2·23 (95% CI, 1·79-2·78) in MCL and 1·46 (95% CI, 1·18-1·81) in PTCL. Time from diagnosis to treatment may reflect high-risk features uncaptured by standard prognostic assessments. Clinical trials should accommodate patients who need urgent therapy to improve external validity and detect treatment effects in high-risk groups.

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Section: Discussionmentioning

confidence: 99%

Time to treatment is an independent prognostic factor in aggressive non‐Hodgkin lymphomas

2018

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“…Among all adults, there are additional challenges of aging that may reduce likelihood to participate in research such as comorbid health conditions, age-related visual decline, or degenerative joint conditions that may impose mobility limitations and thus their ability to visit research sites [ 25 , 26 ]. Polypharmacy, typically defined as the use of five or more medications, is common among older adults [ 27 ] and the pharmacologic drug interaction effects from polypharmacy may make them ineligible for some studies [ 28 ]. Particularly among older Black adults, polypharmacy is associated with worse self-rated health and depression [ 29 ].…”

Section: Introductionmentioning

confidence: 99%

Willingness to Participate in Health Research Among Community-Dwelling Middle-Aged and Older Adults: Does Race/Ethnicity Matter?

Milani

Swain

Otufowora

et al. 2020

J. Racial and Ethnic Health Disparities

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Introduction Older adults, including racial and ethnic minorities, are underrepresented in research. As the US population ages, the number of older racial and ethnic minority individuals will increase. Including these individuals in research is an important step towards reducing health disparities. Methods We used data from HealthStreet, a University of Florida community engagement program which uses community health workers to assess the health of the community, to assess willingness to participate in different types of health research by race/ethnicity. Descriptive statistics and logistic regression models were used to assess willingness to participate among adults aged 50 and older, by race/ethnicity (n = 4694). Results Our sample was 42.0% non-Hispanic White, 52.8% non-Hispanic Black, and 5.2% Hispanic. Non-Hispanic White participants reported more past research participation than non-Hispanic Black and Hispanic participants (28.7% vs. 19.0% and 19.2%, respectively). Compared with non-Hispanic White participants, non-Hispanic Black participants were less willing to participate in most types of studies, while Hispanic participants were less willing to participate in studies that might be seen as invasive (required blood sample, genetic sample, or participants to take medicine, or use of medical equipment). Conclusions Our study provides investigators with a general profile of research preferences by race/ethnicity; compared with non-Hispanic White individuals, non-Hispanic Black individuals are less willing to participate in most studies, while Hispanic individuals are less willing to participate in studies that may be seen as invasive or demanding. It is imperative to include diverse older adults in health research. By tailoring research based on preferences we can improve recruitment in underrepresented populations.

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“…Barriers to incorporate frailty metrics into best clinical practice are multifactorial. Older adults in general, including those with hematologic malignancy(70), are under enrolled and understudied in clinical trials(2). Requiring aspects of frailty in clinical trial design are necessary to advance the care of aging adults.…”

Section: Discussionmentioning

confidence: 99%

Frailty in Hematologic Malignancy

Koll

Rosko

2018

Curr Hematol Malig Rep

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Purpose of Review Older adults with hematologic malignancy are a growing demographic. Estimating risk of chemotherapy toxicity based on age alone, is an unreliable estimate of quality of life, functional capacity, or risk of treatment complications. Recent Findings Dedicated geriatric assessment tools can aid the clinician in identifying geriatric syndromes such as frailty, resulting in improved prognostication to decrease morbidity and mortality. Frailty is not synonymous with individual performance status and is dynamic. Summary Establishing the patient goals, values and preferences is central to the consideration of malignant hematology decision process. Careful considerations of available data on the patient’s prognosis based on estimated life expectancy, geriatric assessment data, and age-specific cancer mortality, with and without treatment, can reconcile the risks and benefits. Assessments of frailty, can aid the clinical feasibility and burden of the treatment to the patient and family in the context of each patient’s unique needs.

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Are ongoing trials on hematologic malignancies still excluding older subjects?

Cited by 17 publications

References 16 publications

Time to treatment is an independent prognostic factor in aggressive non‐Hodgkin lymphomas

Time to treatment is an independent prognostic factor in aggressive non‐Hodgkin lymphomas

Willingness to Participate in Health Research Among Community-Dwelling Middle-Aged and Older Adults: Does Race/Ethnicity Matter?

Frailty in Hematologic Malignancy

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