Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin’s lymphoma: A systematic review

Bellera, Carine; Praud, Delphine; Petit-Monéger, Aurélie; McKelvie-Sebileau, Pippa; Soubeyran, Pierre; Mathoulin‐Pélissier, Simone

doi:10.1016/j.ctrv.2013.01.007

Cited by 33 publications

(28 citation statements)

References 28 publications

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“…A SWOG study found that the major reason for non-accrual of older adults was due to trial unavailability or patient ineligibility [8]. Strict exclusion criteria, especially those related to functional status, organ function, and comorbidities, which are common in older patients, are major barriers to enrollment of older adults [1,9,10]. The specific exclusion of older adults based on age restrictions can also be problematic [10].…”

Section: Introductionmentioning

confidence: 99%

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials

Lackman

Vickers

Hsu

2020

Journal of Geriatric Oncology

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Section: Introductionmentioning

confidence: 99%

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials

Lackman

Vickers

Hsu

2020

Journal of Geriatric Oncology

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“…Age is one of the most robust adverse prognostic factors in lymphoma, and lymphoma incidence in older patients has continuously increased in the last decades. Unfortunately, recommendations for treatment are based on studies that have included only patients younger than 80 years, and clinical trials specifically including very elderly patients are scarce . Moreover, most pharmacological studies are conducted in the general population with results that may not be applicable to very elderly patients in whom drug metabolism and elimination may be altered.…”

Section: Discussionmentioning

confidence: 99%

Outcome of patients older than 80 years with diffuse largeB‐cell lymphoma (DLBCL) treated with “standard” immunochemotherapy: A large retrospective study from 4 institutions

Gobba

Moccia

Gulden-Sala

et al. 2017

Hematological Oncology

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Little information is available on the very elderly patients with diffuse large B-cell lymphoma (DLBCL). We performed a retrospective analysis of 281 patients >80 years old with newly diagnosed DLBCL treated in 4 referral institutions in Switzerland and Northern Italy. Primary end points were overall survival, progression-free survival, and cause-specific survival. Systemic chemotherapy was given to 239 patients, and 119 of them received rituximab in their initial treatment. At a median follow-up of 5.5 years, 5-year progression-free survival was 26% (95% confidence interval [CI], 20-32%), 5-year overall survival was 31% (95% CI, 25-37%), and 5-year cause-specific survival was 48% (95% CI, 41-55%) for the entire cohort. Rituximab and/or anthracyclines as part of initial treatment were associated with improved outcome. Cause-specific survival in patients receiving both agents approximated 60% at 5 years. At multivariate analysis, rituximab use maintained a significant prognostic impact after controlling for age, performance status, stage, haemoglobin, and lactate dehydrogenase levels. The International Prognostic Index as well as the more recently proposed revised-International Prognostic Index and National Comprehensive Cancer Center Network-International Prognostic Index could discriminate patients with significantly different outcomes. Albeit very elderly and potentially frail, there may be a potential for cure in fit DLBCL patients ≥80 years old. Accurate selection of patients able to tolerate proper immunochemotherapy is crucial.

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“…The exclusion criteria in randomized trials are often such that some of the disadvantaged groups will not be included and thus no effectiveness data will emerge [18]. The CONSORT guideline for reporting randomized controlled trials does not include an item on disadvantaged patient groups [19].…”

Section: Discussionmentioning

confidence: 99%

On decreasing inequality in health care in a cost-effective way

Malmivaara

2014

BMC Health Serv Res

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BackgroundScientific evidence indicates that access to health care services shown effective is often poorer among the disadvantaged people than among the non-disadvantaged. Advancing cost-effectiveness and equality in obtaining services shown effective are often stated as the two main objectives for health care.DiscussionThe important question is how to decrease inequality in a most cost-effective way. Some evidence indicates that effectiveness and cost-effectiveness of interventions may be high among the disadvantaged patient groups. However, the relationship between decreasing inequality and cost-effectiveness is complex and depend e.g. on clinical and health care system factors.SummaryTo expand the knowledge base for advancing equality in a cost-effective way, scientific efforts on four levels are suggested: research into ways how practitioners can provide efficient services for the disadvantaged patients, widening of scope at all levels of evidence based medicine to account also for the disadvantaged, research on quality improvement and evidence implementation, as well as benchmarking research including documentation of services among the disadvantaged.

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Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin’s lymphoma: A systematic review

Cited by 33 publications

References 28 publications

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials

Outcome of patients older than 80 years with diffuse largeB‐cell lymphoma (DLBCL) treated with “standard” immunochemotherapy: A large retrospective study from 4 institutions

On decreasing inequality in health care in a cost-effective way

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