Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Role of clinical trials in survival progress of American adolescents and young adults with cancer-and lack thereof.

ABSTRACT: In the United States, adolescent and young adult (AYA) patients with cancer have the lowest clinical trial participation rate of all age groups and slower progress in survival improvement than younger patients. Ominously, AYA clinical trial participation has been steadily decreasing since 2010, except in 15-19 year olds and AYAs with acute lymphoblastic leukemia. In order to reverse the accrual trend, multiple changes are necessary, including convincing community oncologists to pursue clinical trials on behalf of their AYA patients and to have the new National Community Oncology Research Program and National Clinical Trials Network lead a coordinated effort to increase accrual.

SUBMITTER: Bleyer A

PROVIDER: S-EPMC6077840 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

ACCESS DATA

Json Xml

Publications

Role of clinical trials in survival progress of American adolescents and young adults with cancer-and lack thereof.

Bleyer Archie A Tai Eric E Siegel Stuart S

Pediatric blood & cancer 20180418 8

In the United States, adolescent and young adult (AYA) patients with cancer have the lowest clinical trial participation rate of all age groups and slower progress in survival improvement than younger patients. Ominously, AYA clinical trial participation has been steadily decreasing since 2010, except in 15-19 year olds and AYAs with acute lymphoblastic leukemia. In order to reverse the accrual trend, multiple changes are necessary, including convincing community oncologists to pursue clinical t ...[more]

PMID: 29667766

Similar Datasets

The Clinical Trials Gap for Adolescents and Young Adults with Cancer: Recent Progress and Conceptual Framework for Continued Research.

Project description:Over the past 30 years, adolescents and young adults (AYA, 15-39 years of age) with cancer have shown significantly less improvement in survival than younger and older patients. Because evidence suggests this may be related to their low participation in cancer clinical trials, increasing accrual to these trials has become a priority for closing this "AYA gap." This paper reviews data documenting low AYA enrollment, presents a conceptual framework for research and intervention (Clinical Trials Pathway to Enrollment) and summarizes recent developments in the United States National Cancer Institute-sponsored clinical trials enterprise that are expected to improve AYA enrollment, including the National Clinical Trials Network (NCTN) and expanded scientific collaboration between the Children's Oncology Group and adult NCTN groups. While time will be required for the effects of these changes to be fully realized, they offer a mechanism for facilitating the breadth of clinical/translational research needed for advancing AYA oncology and measuring its impact.

| S-EPMC6319956 | biostudies-literature

Lack of treatment-related mortality definitions in clinical trials of children, adolescents and young adults with lymphomas, solid tumors and brain tumors: a systematic review.

Project description:BackgroundThere is a lack of standardized definition for treatment-related mortality (TRM), which represents an important endpoint in cancer. Our objective was to describe TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors.MethodsWe conducted a systematic review of studies enrolling children, adolescents and young adults with lymphomas, solid tumors and brain tumors in which an anti-cancer intervention was randomized, or all study designs in which TRM was a primary or secondary outcome. We searched Ovid MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 1980 to June 2013. Two reviewers evaluated study eligibility and abstracted data.ResultsIn total, 67 studies were included and consisted of 62 randomized therapeutic trials and 5 TRM studies. None of the studies (0/67) provided a definition for TRM. Only one randomized trial of rhabdomyosarcoma provided a definition of early death.ConclusionsWe were unable to identify any TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors. Given that a proportion of this patient population may receive intensive treatment, there is an urgent need for consensus-based definitions of TRM for use across clinical trials.

| S-EPMC4152582 | biostudies-literature

Access to Clinical Trials for Adolescents and Young Adults With Cancer: A Meta-Research Analysis.

Project description:BackgroundThe 18-year-old age limit for inclusion in clinical trials constitutes a hurdle for adolescents and young adults (AYAs) with cancer. We analyzed the impact of this age barrier on the access of AYAs to cancer trials and novel therapies.MethodsClinicalTrials.gov was searched to identify all the trials including patients with 10 malignancies relevant for AYAs (January 2007 to July 2018). The trials were categorized as pediatric (patients <18 y), adult (≥18 y), and transitional (including adult and pediatric patients). Transitional trials with a lower limit between 12 and 18 years and an upper limit younger than 40 years were considered AYA-specific.ResultsOf 2764 identified trials, 2176 were included: 79% adult, 19% transitional, 2% pediatric. Five trials were AYA-specific. The proportion of academic trials was higher for transitional (69%; 288 of 421) than for adult trials (48%; 832 of 1718) (P < .0001). The total number of new trials increased over the years (156 in 2007; 228 in 2017); however, the number of transitional trials remained stable. The availability of trials increased with age, with a major increase at age 18 years: at age 17 years, 20% (442 of 2176) of trials were potentially accessible vs 95% (2075 of 2176) at 18 years. For trials investigating targeted therapies, this increase was 460% (197 trials available at age 17 years; 901 at 18 years) and for immunotherapies, 1200% (55 at age 17 years; 658 at 18 years).ConclusionsAYAs have limited access to cancer trials and innovative therapies, with no improvement over the last decade. The 18-years-old age limit continues to be a major hurdle. Our findings are consistent with the internationally supported idea that age inclusion criteria in oncological trials should be changed.

| S-EPMC7050014 | biostudies-literature

Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials.

Project description:Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

| S-EPMC7048696 | biostudies-literature

Orthopedic toxicities among adolescents and young adults treated in DFCI ALL Consortium Trials.

Project description:Adolescent and young adult patients with acute lymphoblastic leukemia (ALL) have superior outcomes when treated on pediatric regimens. Pediatric ALL regimens rely heavily on corticosteroids and asparaginase and are known to increase the risk of osteonecrosis (ON) and fractures in children, particularly adolescents. Orthopedic toxicity among young adults treated on pediatric-inspired regimens is not well described. Here, we report the symptomatic orthopedic toxicities of patients aged 15 to 50 years treated on sequential Dana-Farber Cancer Institute ALL Consortium protocols. Among 367 patients with a median age of 23 years (range, 15-50 years; 68% aged <30 years), 60 patients were diagnosed with ON (5-year cumulative incidence, 17%; 95% confidence interval [CI], 13-22), and 40 patients experienced fracture (5-year cumulative incidence, 12%; 95% CI, 8-15). Patients aged <30 years were significantly more likely to be diagnosed with ON (5-year cumulative incidence, 21% vs 8%; P = .004). Patients treated more recently on pegaspargase-based protocols were significantly more likely to be diagnosed with ON compared with those treated on earlier trials with native Escherichia coli asparaginase (5-year cumulative incidence, 24% vs 5%; P < .001). Of the 54 ON events for which adequate information was available, surgery was performed in 25 (46%). Patients with ON had superior overall survival (OS) compared with those without (multivariable OS hazard ratio, 0.15; 95% CI, 0.05-0.46; P = .001; ON included as a time-varying exposure). Increased rates of orthopedic toxicity in late-generation protocols may be driven by the pharmacokinetic drug interaction between pegaspargase and dexamethasone, leading to higher dexamethasone exposure.

| S-EPMC8753211 | biostudies-literature

Molecular landscape of IDH-wildtype, H3-wildtype glioblastomas of adolescents and young adults (AYA)

Project description:Genome wide DNA methylation profiling of IDH-wildtype, H3-wildtype AYA glioblastomas

2022-02-12 | GSE196490 | GEO

Hypoxia-activated prodrugs and (lack of) clinical progress: The need for hypoxia-based biomarker patient selection in phase III clinical trials.

Project description:Hypoxia-activated prodrugs (HAPs) are designed to specifically target the hypoxic cells of tumors, which are an important cause of treatment resistance to conventional therapies. Despite promising preclinical and clinical phase I and II results, the most important of which are described in this review, the implementation of hypoxia-activated prodrugs in the clinic has, so far, not been successful. The lack of stratification of patients based on tumor hypoxia status, which can vary widely, is sufficient to account for the failure of phase III trials. To fully exploit the potential of hypoxia-activated prodrugs, hypoxia stratification of patients is needed. Here, we propose a biomarker-stratified enriched Phase III study design in which only biomarker-positive (i.e. hypoxia-positive) patients are randomized between standard treatment and the combination of standard treatment with a hypoxia-activated prodrug. This implies the necessity of a Phase II study in which the biomarker or a combination of biomarkers will be evaluated. The total number of patients needed for both clinical studies will be far lower than in currently used randomize-all designs. In addition, we elaborate on the improvements in HAP design that are feasible to increase the treatment success rates.

| S-EPMC6357685 | biostudies-literature

Enrollment of adolescents and young adults onto SWOG cancer research network clinical trials: A comparative analysis by treatment site and era.

Project description:BACKGROUND:Few adolescents and young adults (AYAs, 15-39 years old) enroll onto cancer clinical trials, which hinders research otherwise having the potential to improve outcomes in this unique population. Prior studies have reported that AYAs are more likely to receive cancer care in community settings. The National Cancer Institute (NCI) has led efforts to increase trial enrollment through its network of NCI-designated cancer centers (NCICC) combined with community outreach through its Community Clinical Oncology Program (CCOP; replaced by the NCI Community Oncology Research Program in 2014). METHODS:Using AYA proportional enrollment (the proportion of total enrollments who were AYAs) as the primary outcome, we examined enrollment of AYAs onto SWOG therapeutic trials at NCICC, CCOP, and non-NCICC/non-CCOP sites from 2004 to 2013 by type of site, study period (2004-08 vs 2009-13), and patient demographics. RESULTS:Overall, AYA proportional enrollment was 10.1%. AYA proportional enrollment decreased between 2004-2008 and 2009-2013 (13.1% vs 8.5%, P < .001), and was higher at NCICCs than at CCOPs and non-NCICC/non-CCOPs (14.1% vs 8.3% and 9.2%, respectively; P < .001). AYA proportional enrollment declined significantly at all three site types. Proportional enrollment of AYAs who were Black or Hispanic was significantly higher at NCICCs compared with CCOPs or non-NCICC/non-CCOPs (11.5% vs 8.8, P = .048 and 11.5% vs 8.6%, P = .03, respectively). CONCLUSION:Not only did community sites enroll a lower proportion of AYAs onto cancer clinical trials, but AYA enrollment decreased in all study settings. Initiatives aimed at increasing AYA enrollment, particularly in the community setting with attention to minority status, are needed.

| S-EPMC7064039 | biostudies-literature

Patterns of gambling and substance use initiation in African American and White adolescents and young adults.

Project description:The focus of the current investigation is to examine the temporal relationship of gambling onset and alcohol, tobacco, and cannabis initiation in adolescents and young adults (M age = 20.3 years) by examining the prevalence and pattern of onset for each substance and gambling pairing and the associated risk between gambling and each substance use. Data were drawn from the multiwave Missouri Family Study (n = 1,349) of African American (AA; n = 450) and White families (n = 317) enriched for risk for alcohol use disorder and includes those who were assessed for gambling behaviors and problems: AA (360 males, 390 females) and White (287 males, 312 females). Findings indicated racial differences in the overall prevalence of gambling behaviors and substance use as well as patterns of initiation-particularly within gambling/alcohol and gambling/tobacco for males. Survival models revealed some similarities as well as differences across race and gender groups in associations of gambling with initiation of substances, as well as substances with initiation of gambling. Alcohol use (AA males only) and cannabis use (AA males and White females) elevated the hazards of initiating gambling. In contrast, gambling significantly elevated the hazards of initiation alcohol across 3 of 4 groups and of cannabis use in AA males only. The results highlight some overlapping as well as distinct risk factors for both gambling and substance use initiation in this cohort enriched for vulnerability to alcohol use disorder (AUD). These findings have implications for integrating gambling prevention into existing substance use prevention and intervention efforts-particularly but not exclusively for young AA males. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

| S-EPMC7064388 | biostudies-literature

Templated replication (or lack thereof) under prebiotically pertinent conditions.

Project description:Accurate replication of encoded information would have been crucial for the formation and propagation of functional ribozymes during the early evolution of life. Studies aimed at understanding prebiotically pertinent nonenzymatic reactions have predominantly used activated nucleotides. However, the existence of concentrated pools of activated monomers on prebiotic Earth is debatable. In this study, we explored the feasibility of nonenzymatic copying reactions using the more prebiotically relevant 5'-nucleoside monophosphates (5'-NMP). These reactions, involving a 20-mer primer, were performed in the presence of amphiphiles, under volcanic geothermal conditions. Interestingly, the extended primer was not comparable to the expected full length 21-mer product. Our results suggest loss of the nitrogenous base in the extended primer. This phenomenon persisted even after lowering the temperature and when different rehydration solutions were used. We envisage that the loss of the informational moiety on the incoming 5'-NMP, might be occurring during addition of this monomer to the pre-existing oligomer. Significantly, when 5'-ribose monophosphate was used, multiple additions to the aforementioned primer were observed that resulted in hybrid polymers. Such hybrid oligomers could have been important for exploring a vast chemical space of plausible alternate nucleobases, thus having important implications for the origin of primitive informational polymers.

| S-EPMC6177409 | biostudies-literature

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data