Accrual of Adolescents and Young Adults with Cancer to Clinical Trials

Hay, Annette E.; Rae, Charlene; Fraser, Graeme; Meyer, Ralph M.; Abbott, Lesleigh S.; Bevan, Stuart; McBride, Mary L.; Cuvelier, Geoff D.E.; McKillop, Sarah; Barr, Ronald D.

doi:10.3747/co.23.2925

Cited by 20 publications

(12 citation statements)

References 22 publications

(18 reference statements)

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“…162,163 Because most community practices do not participate in the US National Cancer Institute’s National Clinical Trial Network, this subpopulation has not benefited from the standardisation of care, the incremental improvement of sequential clinical trials, or the insights derived from linking biospecimens to clinical outcomes. 164 Many other possible mechanisms could explain the survival gap in this group of patients, such as unfavourable tumour biology, unique pharmacokinetics, diagnostic delay, and poor adherence to prescribed therapies. 165–168 …”

Section: Paediatric Oncologymentioning

confidence: 99%

Future cancer research priorities in the USA: a Lancet Oncology Commission

Jaffee

Dang

Agus

et al. 2017

The Lancet Oncology

165

123

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We are in the midst of a technological revolution that is providing new insights into human biology and cancer. In this era of big data, we are amassing large amounts of information that is transforming how we approach cancer treatment and prevention. Enactment of the Cancer Moonshot within the 21st Century Cures Act in the USA arrived at a propitious moment in the advancement of knowledge, providing nearly US$2 billion of funding for cancer research and precision medicine. In 2016, the Blue Ribbon Panel (BRP) set out a roadmap of recommendations designed to exploit new advances in cancer diagnosis, prevention, and treatment. Those recommendations provided a high-level view of how to accelerate the conversion of new scientific discoveries into effective treatments and prevention for cancer. The US National Cancer Institute is already implementing some of those recommendations. As experts in the priority areas identified by the BRP, we bolster those recommendations to implement this important scientific roadmap. In this Commission, we examine the BRP recommendations in greater detail and expand the discussion to include additional priority areas, including surgical oncology, radiation oncology, imaging, health systems and health disparities, regulation and financing, population science, and oncopolicy. We prioritise areas of research in the USA that we believe would accelerate efforts to benefit patients with cancer. Finally, we hope the recommendations in this report will facilitate new international collaborations to further enhance global efforts in cancer control.

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Section: Paediatric Oncologymentioning

confidence: 99%

Future cancer research priorities in the USA: a Lancet Oncology Commission

Jaffee

Dang

Agus

et al. 2017

The Lancet Oncology

165

123

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“…In the United States, .60% of children with cancer are enrolled in clinical trials; however, for those aged .20 years, accrual decreases to 2% to 4%, raising concerns about the generalizability of trial results to the general population. [10][11][12] Notably, these rates are for a clinical trial at any point in the disease course (including at time of recurrence) and do not focus on clinical trial accrual at the initial course of treatment. Our findings showed that patients diagnosed with the top 10 cancers with the highest clinical trial accrual at initial course of treatment tended to be healthy and white and to have metastatic disease and private insurance ( Table 1).…”

Section: Discussionmentioning

confidence: 99%

Clinical Trial Accrual at Initial Course of Therapy for Cancer and Its Impact on Survival

Zaorsky

Zhang

Walter

et al. 2019

Journal of the National Comprehensive Cancer Network

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Background: This retrospective cohort study sought to characterize the accrual of patients with cancer into clinical trials at the time of diagnosis and analyze the impact of accrual on survival. Methods: The National Cancer Database (NCDB) was queried for patients enrolled in clinical trials at their initial course of treatment for 46 cancers from 2004 through 2015. Descriptive statistics were used to characterize the accrual of patients with cancer in clinical trials at diagnosis, and Kaplan-Meier graphical displays, log-rank tests, odds ratios, and stratified Cox proportional hazards models were used to analyze the impact of accrual on overall survival (OS). Strata were defined using 10 variables. Model-based adjusted survival curves of 2 groups were reverse-generated based on a Weibull distribution. Results: Of 12,097,681 patients in the NCDB, 11,576 (0.1%) were enrolled in trials. Patients in clinical trials typically had metastatic disease (30.9% vs 16.4%; P<.0001), were white (88.0% vs 84.8%; P<.0001), had private/managed care insurance (56.4% vs 41.8%; P<.0001), had fewer comorbidities (Charlson-Deyo score 0: 81.9% vs 75.7%; P<.0001, and Charlson-Deyo scores 1–3: 18.1% vs 24.3%; P<.0001) compared with those not in trials. At a median follow-up of 64 months, enrollment in a clinical trial was associated with improved OS in univariate and stratified analyses, with a median survival of 60.0 versus 52.5 months (hazard ratio, 0.876; 95% CI, 0.845–0.907; P<.0001). Stratified analysis with matched baseline characteristics between patients enrolled and not enrolled in a clinical trial showed superior OS at 5 years (95.0% vs 90.2%; P<.0001). Conclusions: Enrollment in clinical trials at first line of therapy in the United States is exceedingly low and favors young, healthy, white patients with metastatic disease and private insurance who are treated at academic medical centers. Patients with cancer treated in clinical trials live longer than those not treated in trials.

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“…who reported that 21% of young people aged 15–19 years were entered into trials, compared to 94% of children . Similar patterns of lower accrual are now reported by other countries and despite different methodologies, sufficient evidence exists to support this as an international phenomenon . While lower inclusion in trials and research has been identified since the late 90s and is recognised as a universal issue, the evidence suggests that improvements in accrual reported by some countries have not been sustained and for most countries, no improvements are reported …”

Section: Introductionmentioning

confidence: 86%

“…9 Similar patterns of lower accrual are now reported by other countries and despite different methodologies, sufficient evidence exists to support this as an international phenomenon. [10][11][12][13][14][15] While lower inclusion in trials and research has been identified since the late 90s and is recognised as a universal issue, the evidence suggests that improvements in accrual reported by some countries have not been sustained and for most countries, no improvements are reported. 16,17 Studies exploring trial inclusion rates have identified structural and organisational factors that prohibit AYA from entering studies.…”

Section: Introductionmentioning

confidence: 99%

Enhancing accrual to clinical trials of adolescents and young adults with cancer

Fern

Taylor

2018

Pediatric Blood & Cancer

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Underrepresentation of young people in cancer research is an international phenomenon and may contribute to poorer outcomes. We sought to identify systematically tested interventions and strategies to improve recruitment. The review identified 13 papers. The following four themes emerged: trial availability/regulatory factors; service configuration/place-of-care factors; recruitment methods and developmental factors specific to young people. We could not identify any studies that had employed prospective interventions to improve recruitment. Without available research studies in which to garner data on adolescents and young adults, we will always be constrained in our ability to provide evidence based care with resultant limitations on our ability to improve outcomes.

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Accrual of Adolescents and Young Adults with Cancer to Clinical Trials

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Cited by 20 publications

References 22 publications

Future cancer research priorities in the USA: a Lancet Oncology Commission

Future cancer research priorities in the USA: a Lancet Oncology Commission

Clinical Trial Accrual at Initial Course of Therapy for Cancer and Its Impact on Survival

Enhancing accrual to clinical trials of adolescents and young adults with cancer

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