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Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials Network Trials

Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials... Background: Older adults are a large and growing proportion of cancer cases in the United States, but concerns persist about whether older adults are adequately represented in the cancer clinical trials that test new options for treatment and cancer care. Methods: This paper describes adult patient enrollments by age group to the National Cancer Institute’s National Clinical Trials Network (NCTN) from 2016 to 2021, compares patient enrollment by age with the estimated incident cancer population across cancer types, and explores possible associations between patient age and patient race, ethnicity, and sex. Results: This analysis found that patients aged 18 to 69 years were overrepresented in NCTN trials, whereas patients aged 70 years and older were underrepresented compared with the estimated incident cancer population. Underrepresentation of older patients was seen across cancer types. Older patients who enrolled to NCTN trials were more likely to be non-Hispanic White than the estimated incident cancer population. Conclusions: Compared with earlier analyses, NCTN trials are enrolling greater proportions of older adults, primarily driven by higher enrollment among patients aged 65 to 74 years. There is still significant room for improvement, however, especially among patients aged 75 years and older. Additionally, patient demographics should not be viewed in isolation: older Hispanic patients, for instance, were particularly underrepresented among patients enrolled to NCTN trials. The intersection between trial enrollment and age, race, and ethnicity warrants further study so that more targeted enrollment enhancement efforts can be developed that enhance trial diversity across demographic groups. Older adults are a large and growing proportion of cancer cases Trials Network (NCTN). The analysis includes a comparison of in the United States, but concerns persist about whether older patient enrollment by age to the estimated incident cancer pop- adults are adequately represented in the cancer clinical trials ulation, overall and within certain cancer types. that test new options for treatment and cancer care (1-4). Older There are also significant concerns regarding disparities in the adult enrollment data from 2001 to 2011 for the National Cancer enrollment of racial and ethnic minorities to NCI-supported trials Institute (NCI)–supported adult trials were presented in 2012 (5). (2,6). It is important to analyze and develop interventions to ad- This paper describes updated and expanded data for adult pa- dress disparities with an understanding of the potential for inter- tient enrollments by age group from 2016 to 2021 to clinical tri- sectionality with other patient characteristics and experiences (7). als in NCI’s largest clinical trials network, the National Clinical This analysis also explores possible associations between patient Received: May 19, 2022; Revised: July 5, 2022; Accepted: July 27, 2022 Published by Oxford University Press 2022. This work is written by (a) US Government employee(s) and is in the public domain in the US. 111 Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 112 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 age and other patient demographic information that is systemati- Results cally collected across NCTN trials: race, ethnicity, and sex. This analysis includes 61 131 adult patients enrolled in the United States to 300 trials between 2016 and 2021. There were between 9524 and 11 092 patients meeting these criteria en- Methods rolled annually from 2016 to 2021. Figure 1 shows the distribu- tion of patient enrollments by age group and enrollment year. Data Enrollment by age group was similar in each of the included en- NCI supports the infrastructure for the conduct of national can- rollment years, with slightly greater enrollment of older adults cer treatment and advanced imaging clinical trials in adults, in 2021 compared with 2016 to 2020. adolescents and young adults, and children through the NCTN Comparing the age distribution of patients enrolled to trials (8,9). Cancer patients are enrolled to approximately 200 NCTN and the age distribution of incident cancer cases for all patient trials each year from more than 2000 academic and community enrollments, there was overrepresentation of younger patients oncology sites around the United States and internationally. For (59.5% of enrollments vs 42.0% of estimated incident cases) and this analysis, data for enrollments to NCTN clinical trials be- patients aged 65 to 69 years (16.9% of enrollments vs 15.9% of cases; Table 1). Patients aged 70 years and older were generally tween 2016 and 2021 were obtained from the web-based regis- underrepresented in trials, with the degree of underrepresenta- tration system for NCTN trials. The dataset included patient tion increasing with each age group. Patients aged 70 to 74 years enrollments to trial interventions for trials enrolling partici- represented 12.7% of enrollments and 14.5% of incident cases— pants aged 18 years and older and led by the adult NCTN a 1.8% difference. This difference was 4.2% for patients aged 75 groups. Enrollments outside of the United States were excluded. to 79 years, 5.4% for patients aged 80 to 84 years, and 7.1% for Key variables for the analysis were patient age at time of enroll- patients aged 85 years and older. ment, patient race, patient ethnicity, patient sex, enrollment year, There were 10 cancer types with at least 1500 enrollments from and cancer type. Giventhe focusofthisanalysisonolder adults, 2016 to 2021: bladder (n¼ 2579), breast (n¼ 16 534), colorectal age groupings were used to separate younger (18 to 64 years) and (n¼ 1644), leukemia (n¼ 2415), lung (n¼ 10 962), melanoma older (65 years and older) patients and explore enrollment within (n¼ 2492), myeloma (n¼ 1817), ovarian (n¼ 2061), prostate older adult age groups. For patients aged 65 to 84 years, 5-year age (n¼ 4829), and renal (n¼ 2491). Patient age distribution varied for groupings were used to align with the census categories. The mu- both enrollments and estimated incident cases across cancer tually exclusive age groupings used were 18-64 years, 65-69 years, types. Bladder cancer had the smallest estimated incident popula- 70-74 years, 75-79 years, 80-84 years, and 85 years and older. For tion aged 18 to 64 years, and bladder cancer trials had the lowest thecancertypeanalysis, cancer type was based on themain can- proportion of enrollments in this youngest age group, although cer type being enrolled in the trial. Race and ethnicity variables these patients were still overrepresented (31.2% of enrollments vs were recoded to mutually exclusive groupings reported in the NCI 23.5% of estimated incident cases). Bladder cancer trials had the Surveillance, Epidemiology, and End Results (SEER) Program data. greatest proportion of enrollments among the oldest patients aged Cancer incidence rates were obtained from the SEER 85 years and older, although this still underrepresented the inci- Program data from the SEER*Stat Database for incidence based dent patient population (4.1% of enrollments vs 14.2% of cases). on cases diagnosed between 2013 and 2018 and reported across Breast cancer had the largest estimated incident population aged 21 registries (SEER 21) (10). Diagnosis years 2013-2018 were used 18 to 64 years, and this age group was also overrepresented in because they are the most recent 6-year time period available in breast cancer trials (80.5% of enrollments vs 52.8% of cases). Age distribution also varied based on patient demographics. the SEER data. Registries included in the SEER 21 data cover Given the race and origin variable available via SEER, there were 36.4% of the US population (11). 3 groups with at least 1000 patient enrollments among both male and female patients over the 6-year period: non-Hispanic Analysis White, non-Hispanic Black, and Hispanic. There was greater en- rollment to trials of older patients who were non-Hispanic SEER incidence rates were adjusted for age using US Census White compared with patients who were non-Hispanic Black or Bureau data from the 2015-2019 American Community Survey Hispanic (Figure 2). Among female patients enrolled to trials, 5-Year Estimates. To perform the adjustment, SEER data on can- 35.5% of non-Hispanic White patients were aged 65 years and cer incidence rates by age and cancer type were multiplied by older compared with 25.1% of non-Hispanic Black patients and the 2015-2019 population estimate within that age group and, if 20.3% of Hispanic patients. A similar trend is seen for male applicable, sex (for breast, ovarian, and prostate cancers and for patients. This trend was not reflective of the incident patient the demographic subgroup analysis) to estimate the number of population. Based on the estimated incident cancer cases, a annual incident cases in the United States. We then calculated greater proportion of Hispanic patients was expected to be diag- the proportion of incident cases by age group for comparison to nosed with cancer at ages 65 years and older. Older patients the proportion of enrollments by age group. were underrepresented in trials in every demographic sub- We compared the proportion of patients in each age group group. However, Hispanic patients aged 65 years and older were for the enrolled patient population and the incident population. especially underrepresented in trials (female patients: 20.3% of The primary analysis was across enrollments to all cancer sites. enrollments vs 58.6% of estimated incident cases; male We also analyzed enrollments by cancer type within cancer patients: 39.2% of enrollments vs 69.2% of cases). types with at least 1500 enrollments included over the 6-year period. Subgroup analyses by sex, race, and ethnicity were lim- Discussion ited to categories with at least 1000 enrollments in each sub- group. We present the relative differences for assessment of This analysis found that there was overrepresentation of those practical significance and clinical importance. aged 18 to 69 years and underrepresentation of those aged 70 Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 G. E. Mishkin et al. |113 0.9% 0.6% 0.9% 0.8% 0.7% 0.8% 0.8% 100% 2.5% 2.8% 3.0% 2.8% 3.0% 2.8% 2.8% 6.4% 7.3% 7.6% 7.0% 7.3% 7.1% 8.3% 90% 12.4% 12.3% 12.5% 12.5% 12.1% 12.7% 14.6% 80% 70% 16.1% 16.4% 17.1% 17.2% 16.9% 17.1% 17.8% 85 and older y 60% 80-84 y 50% 75-79 y 70-74 y 40% 65-69 y 18-64 y 62.1% 30% 60.2% 59.3% 59.6% 59.9% 59.5% 55.5% 20% 10% 0% 2016 2017 2018 2019 2020 2021 2016-2021 (n=11 092) (n=10 176) (n=10 017) (n=10 500) (n=9822) (n=9524) (n=61 131) Figure 1. Proportion of adult enrollments to the National Cancer Institute’s National Clinical Trials Network by age at enrollment and enrollment year. years and older among patients enrolled to NCTN trials from scientific and medical justification. However, there is still signif- 2016 to 2021. Underrepresentation of older patients was seen icant room for improvement in the enrollment of older adults to across cancer types. Older patients who enrolled to NCTN trials NCTN trials. Some of the change in enrollment seen here may also reflect were more likely to be non-Hispanic White than the estimated incident cancer population. A key limitation to this analysis is a shift in enrollment by disease area in the intervening years. In that the incident cancer population is estimated based on SEER 2001-2011 and 2016-2021, breast cancer had the highest propor- tion of enrollments of younger patients, with approximately data; these data are the most comprehensive compilation of in- cident cancer cases available but may not be truly reflective of 80% of patients enrolled to breast cancer trials aged younger the US incident cancer population. Additionally, the patient de- than 65 years. These breast cancer enrollments represented mographic information is limited to what is routinely collected 40% of the overall enrollment from 2001 to 2011 compared with across NCTN trials, which includes key variables required by 27% of the enrollment from 2016 to 2021. the National Institutes of Health to monitor inclusion of women It is important to note that the characteristics of patients en- rolled in clinical trials in any given year or disease area will de- and minorities but do not capture potentially important patient characteristics such as whether patients are from rural or urban pend greatly on the available trial portfolio. The overall communities (12). enrollment within the NCTN was relatively stable from 2016 to 2019, with somewhat lower enrollment in 2020 and 2021, likely From 2001 to 2011, an average of 68% of patients enrolled each year in adult NCI Cooperative Group phase II and III treat- due to the COVID-19 pandemic, but the trials available for enroll- ment trials were aged younger than 65 years, 23% were between ment were constantly changing. In some trials, enrollment of a younger patient population is justified. As was noted for the 2016 ages 65 and 74 years, and 9% were aged 75 years and older (5). In these updated data from 2016 to 2021, 59.5% of patients enrolled to 2021 enrollments, a greater proportion (80.5%) of patients en- in adult NCTN trials were aged younger than 65 years, 29.6% rolled to trials in breast cancer were aged younger than 65 years were between ages 65 and 74 years, and 10.9% were aged 75 compared with the average (59.5%) across all disease areas. One years and older. Based on these overarching data, it appears of the highest-enrolling breast cancer studies during this time pe- that NCTN trials are enrolling greater proportions of older riod was Alliance for Clinical Trials in Oncology trial A011502, adults than in the earlier time period. Enhancing enrollment of studying aspirin as adjuvant therapy in breast cancer patients older patients has been a priority for the NCI and the NCTN, (15,16). Because of the risks of aspirin in older patients, this trial with several activities potentially contributing to the greater en- was open only to patients aged 69 years and younger, and the en- rollment, including broadening clinical trial inclusion criteria to rolled patient population was largely younger. This analysis in- reduce the unnecessary exclusion of patients with well- cluded enrollments to 26 breast cancer trials; among the included managed comorbidities, which may have disproportionately ex- enrollments, the median proportion of patients aged 18 to cluded older patients (13,14). NCTN trials do not include older 64 years across these breast cancer trials was 79.7%. Because this age limits in eligibility criteria unless there is a compelling is less than a percentage point lower than the overall proportion Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 114 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 Table 1. Differences in adult enrollments to National Cancer Institute’s National Clinical Trials Network (NCTN) vs estimated cancer incidence a,b by age group and cancer type, 2016-2021 Cancer type 18-64 y, % 65-69 y, % 70-74 y, % 75-79 y, % 80-84 y, % 85 y and older, % All cancer types Enrollments (n¼ 61 131) 59.5 16.9 12.7 7.3 2.8 0.8 Incidence (n 1 723 000) 42.0 15.9 14.5 11.5 8.2 7.9 Difference þ17.5 þ1.0 1.8 4.2 5.4 7.1 Bladder Enrollments (n¼ 2579) 31.2 18.9 19.3 16.3 10.1 4.1 Incidence (n 77 000) 23.5 15.3 17.2 16.3 13.5 14.2 Difference þ7.7 þ3.6 þ2.1 0.0 3.4 10.1 Breast Enrollments (n¼ 16 534) 80.5 11.0 5.5 2.1 0.7 0.2 Incidence (n 256 000) 52.8 14.8 12.6 8.9 5.7 5.2 Difference þ27.7 3.8 7.1 6.8 5.0 5.0 Colorectal Enrollments (n¼ 1644) 72.7 12.3 7.8 4.5 2.0 0.6 Incidence (n 144 000) 41.7 13.6 12.7 11.4 9.7 10.9 Difference þ31.0 1.3 4.9 6.9 7.7 10.3 Leukemia Enrollments (n¼ 2415) 54.2 19.1 15.2 8.1 2.9 0.6 Incidence (n 50 000) 37.3 13.9 14.2 12.9 10.4 11.2 Difference þ16.9 þ5.2 þ1.0 4.8 7.5 10.6 Lung Enrollments (n¼ 10 962) 41.2 21.6 20.0 12.0 4.4 0.9 Incidence (n 212 000) 27.3 16.9 18.8 16.3 11.5 9.1 Difference þ13.9 þ4.7 þ1.2 4.3 7.1 8.2 Melanoma and/or Skin Enrollments (n¼ 2492) 66.0 15.2 9.3 5.5 2.8 1.2 Incidence (n 93 000) 44.7 13.7 13.0 10.9 8.6 9.1 Difference þ21.3 þ1.5 3.7 5.4 5.8 7.9 Myeloma Enrollments (n¼ 1817) 53.2 20.3 17.2 6.5 2.2 0.5 Incidence (n 28 000) 34.0 16.6 16.0 14.0 10.6 8.8 Difference þ19.2 þ3.7 þ1.2 7.5 8.4 8.3 Ovarian Enrollments (n¼ 2061) 54.9 18.3 14.5 8.9 2.9 0.5 Incidence (n 22 000) 50.8 13.5 11.7 9.3 7.3 7.5 Difference þ4.1 þ4.8 þ2.8 0.4 4.4 7.0 Prostate Enrollments (n¼ 4829) 36.2 25.6 20.5 12.5 4.0 1.2 Incidence (n 213 000) 37.6 23.9 18.3 11.1 5.3 3.8 Difference 1.4 þ1.7 þ2.2 þ1.4 1.3 2.6 Renal Enrollments (n¼ 2491) 61.6 15.6 12.1 7.3 3.0 0.4 Incidence (n 62 000) 47.1 16.4 14.0 10.6 6.5 5.4 Difference þ14.5 0.8 1.9 3.3 3.5 5.0 Estimated annual incident cases and incidence rates adjusted by age group calculated using Surveillance, Epidemiology, and End Results (SEER) Program data from the SEER*Stat Database for incidence based on cases diagnosed between 2013 and 2018 and reported across 21 registries. Cancer type subgroups are limited to those with at least 1500 NCTN patient enrollments between 2016 and 2021. “All cancer types” includes all incident cases and all enrollments and is not limited to the cancer types shown in this table. The “þ” symbol indicates that the proportion of enrollments was greater than the proportion of incident cases and the age group was overrepresented in trial enroll- ments. The “” symbol indicates that the proportion of enrollments was less than the proportion of incident cases and the age group was underrepresented in trial enrollments. reported for breast cancer trials, it suggests that the breast cancer aged older than 60 years and for the treatment of acute lympho- blastic leukemia in adults aged 65 years and older (17,18). Many analysis is not being skewed by particularly high enrollment of younger patients to a small number of trials. leukemia trials in the NCTN have been designed specifically to In other disease areas, there is a strong scientific and clinical answer questions in older or younger patient populations (19). rationale for conducting trials in patients within certain age SWOG Cancer Research Network trial S1318 was a phase II trial ranges because of observed differences in the disease progres- evaluating use of blinatumomab as induction and consolidation sion or treatment response. For instance, the National therapy in newly diagnosed acute lymphoblastic leukemia Comprehensive Cancer Network guidelines offer distinct princi- patients aged 65 years and older (20,21). The median age of the ples for the management of acute myeloid leukemia in patients 29 patients in this study was 75 years. As more NCTN leukemia Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 G. E. Mishkin et al. |115 Female 0.6% 0.4% 0.4% 100% 1.4% 1.4% 2.2% 3.2% 2.8% 8.1% 8.1% 9.6% 6.1% 6.5% 7.0% 90% 7.8% 7.8% 8.4% 11.0% 9.2% 13.0% 80% 10.4% 10.6% 11.1% 15.7% 70% 12.7% 13.4% 13.9% 85 and older y 60% 13.5% 80-84 y 15.4% 50% 15.6% 75-79 y 40% 70-74 y 79.7% 74.9% 65-69 y 64.5% 30% 18-64 y 47.4% 44.7% 41.4% 20% 10% 0% NHW Accruals NHB Accruals Hispanic NHW Cases NHB Cases Hispanic Cases (n=26,358) (n=3,702) Accruals (n=2,948) Male 1.2% 0.4% 1.2% 100% 2.0% 2.3% 5.4% 4.3% 7.0% 8.1% 7.2% 7.8% 6.8% 90% 10.5% 8.2% 9.5% 13.2% 11.2% 11.2% 80% 11.8% 17.2% 14.0% 70% 16.7% 15.9% 20.7% 14.9% 85 and older y 60% 17.8% 20.2% 80-84 y 20.4% 50% 16.3% 75-79 y 19.7% 40% 70-74 y 65-69 y 60.8% 30% 56.5% 18-64 y 46.6% 41.9% 20% 40.2% 30.8% 10% 0% NHW Accruals NHB Accruals Hispanic NHW Cases NHB Cases Hispanic Cases (n=20,567) (n=2,153) Accruals (n=1,407) Figure 2. Proportion of adult enrollments to the National Cancer Institute’s National Clinical Trials Network and estimated cancer incidence by age group, sex, race and ethnicity. All groups are mutually exclusive, limited to categories with at least 1000 enrollments in each subgroup. NHB¼ non-Hispanic Black; NHW¼ non-Hispanic White. studies focused on older patient populations report out, we ex- patients enrolled, even though the Black and Hispanic incident pect to see similarly older age distributions. cancer population tended to be older. As we consider ways to This monograph features several articles with recommenda- increase enrollment of older adults to trials, we must be sure tions and considerations for continuing to enhance the enroll- that this is not associated with lower enrollment of non-White ment of older adults to NCTN clinical trials. A particularly patients. In fact, as the estimated incidence data showed, more important takeaway from this analysis is that patient demo- representative trial enrollment should likely include more older graphics should not be viewed in isolation. As this analysis patients who are Black and Hispanic. shows, Black and Hispanic patients enrolled to adult NCTN can- Older Hispanic patients were particularly underrepresented cer trials tended to be younger than the non-Hispanic White among patients enrolled to NCTN trials. The NCI has sought to Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 116 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 6. Unger JM, Hershman DL, Osarogiagbon RU, et al. Representativeness of Black reduce barriers to trial enrollment among Hispanic patients, in- patients in cancer clinical trials sponsored by the National Cancer Institute cluding by expanding consent translation services to provide compared with pharmaceutical companies. JNCI Cancer Spectr. 2020;4(4): Spanish translations of informed consent documents for all pkaa034. NCTN trials starting in 2015. Additionally, the NCI Community 7. Alvidrez J, Greenwood GL, Johnson TL, et al. Intersectionality in public health research: a view from the National Institutes of Health. Am J Public Health. Oncology Research Program seeks to bring NCTN trials to di- 2021;111(1):95-97. verse patients in their communities (22). However, as these 8. National Cancer Institute. Division of Cancer Treatment and Diagnosis Programs findings emphasize, more needs to be done to overcome bar- and Initiatives 2013-2017. https://dctd.cancer.gov/NewsEvents/ 2017DCTDprograms.pdf. Published October 2018. Accessed August 8, 2022. riers to trial enrollment for non-White patients (23). The inter- 9. National Cancer Institute. An overview of NCI’s National Clinical Trials section between trial enrollment and age, race, ethnicity, and Network. https://ctep.cancer.gov/initiativesprograms/nctn.htm. Updated other patient characteristics such as geographic area and rural- February 17, 2022. Accessed August 8, 2022. ity warrants further study so that more targeted enrollment en- 10. National Cancer Institute Surveillance Research Program. Surveillance, Epidemiology, and End Results (SEER) Program SEER 21 Reg Research Data, hancement efforts can be developed that improve trial diversity Nov 2020 Sub (2000-2018). National Cancer Institute, DCCPS, Surveillance across demographic groups. Research Program, Surveillance Systems Branch. http://www.seer.cancer. gov. Published April 2021. 11. National Cancer Institute. Number of persons by race and Hispanic ethnicity for SEER participants (2020 Census Data). https://seer.cancer.gov/registries/ Funding data.html. Accessed August 8, 2022. 12. National Institutes of Health. NIH policy and guidelines on the inclusion of No funding was used for this study. women and minorities as subjects in clinical research. https://grants.nih. gov/policy/inclusion/women-and-minorities/guidelines.htm. Updated December 6, 2017. Accessed August 8, 2022. Notes 13. Denicoff A. CTAC Strategic Planning Working Group: CTEP Analysis of Implementing ASCO-Friends Broadened Eligibility Criteria in CTEP-Sponsored Trials. Role of the funder: Not applicable. https://deainfo.nci.nih.gov/advisory/ctac/1121/Doroshow-Denicoff.pdf. Published November 10, 2021. Accessed August 8, 2022. Disclosures: No disclosures to report. 14. Habr D, McRoy L, Papadimitrakopoulou VA. Age is just a number: considera- tions for older adults in cancer clinical trials. J Natl Cancer Inst. 2021;113(11): Author contributions: GEM: Conceptualization, Methodology, 1460-1464. Formal Analysis, Data Curation, Writing—Original Draft, 15. Alliance for Clinical Trials in Oncology. A randomized phase iii double blinded placebo controlled trial of aspirin as adjuvant therapy for HER2 nega- Writing—Review & Editing, Visualization, Project tive breast cancer: the ABC trial. https://clinicaltrials.gov/ct2/show/ Administration. AMD, AFB, And RFL: Conceptualization, NCT02927249. Updated January 10, 2022. Accessed August 8, 2022. Methodology, Writing—Review & Editing. 16. Chen WY, Ballman KV, Winer EP, et al. A randomized phase III, double- blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast Disclaimers: This article represents the opinions of the authors cancer (A011502): the Aspirin after Breast Cancer (ABC) Trial. J Clin Oncol. and not those of the National Cancer Institute. 2022;40(suppl 36):360922. 17. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia Version 1. https://www.nccn.org/pro- fessionals/physician_gls/pdf/all.pdf. Published 2022. Accessed August 8, Data Availability 18. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in The data underlying this article cannot be shared to protect the Oncology: Acute Myeloid Leukemia Version 1. https://www.nccn.org/professio- privacy of the clinical trial participants. Information to support nals/physician_gls/pdf/aml.pdf. Published 2022. Accessed August 8, 2022. 19. National Cancer Institute. NCTN leukemia trials portfolio. https://ctep.can- the findings of this analysis are available from the correspond- cer.gov/initiativesPrograms/docs/nctn_trials/NCTN_Leukemia_Trials.pdf. ing author upon reasonable request. Updated July 15, 2022. Accessed August 8, 2022. 20. Advani AS, Moseley A, O’Dwyer KM, et al. 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Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials Network Trials

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Abstract

Background: Older adults are a large and growing proportion of cancer cases in the United States, but concerns persist about whether older adults are adequately represented in the cancer clinical trials that test new options for treatment and cancer care. Methods: This paper describes adult patient enrollments by age group to the National Cancer Institute’s National Clinical Trials Network (NCTN) from 2016 to 2021, compares patient enrollment by age with the estimated incident cancer population across cancer types, and explores possible associations between patient age and patient race, ethnicity, and sex. Results: This analysis found that patients aged 18 to 69 years were overrepresented in NCTN trials, whereas patients aged 70 years and older were underrepresented compared with the estimated incident cancer population. Underrepresentation of older patients was seen across cancer types. Older patients who enrolled to NCTN trials were more likely to be non-Hispanic White than the estimated incident cancer population. Conclusions: Compared with earlier analyses, NCTN trials are enrolling greater proportions of older adults, primarily driven by higher enrollment among patients aged 65 to 74 years. There is still significant room for improvement, however, especially among patients aged 75 years and older. Additionally, patient demographics should not be viewed in isolation: older Hispanic patients, for instance, were particularly underrepresented among patients enrolled to NCTN trials. The intersection between trial enrollment and age, race, and ethnicity warrants further study so that more targeted enrollment enhancement efforts can be developed that enhance trial diversity across demographic groups. Older adults are a large and growing proportion of cancer cases Trials Network (NCTN). The analysis includes a comparison of in the United States, but concerns persist about whether older patient enrollment by age to the estimated incident cancer pop- adults are adequately represented in the cancer clinical trials ulation, overall and within certain cancer types. that test new options for treatment and cancer care (1-4). Older There are also significant concerns regarding disparities in the adult enrollment data from 2001 to 2011 for the National Cancer enrollment of racial and ethnic minorities to NCI-supported trials Institute (NCI)–supported adult trials were presented in 2012 (5). (2,6). It is important to analyze and develop interventions to ad- This paper describes updated and expanded data for adult pa- dress disparities with an understanding of the potential for inter- tient enrollments by age group from 2016 to 2021 to clinical tri- sectionality with other patient characteristics and experiences (7). als in NCI’s largest clinical trials network, the National Clinical This analysis also explores possible associations between patient Received: May 19, 2022; Revised: July 5, 2022; Accepted: July 27, 2022 Published by Oxford University Press 2022. This work is written by (a) US Government employee(s) and is in the public domain in the US. 111 Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 112 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 age and other patient demographic information that is systemati- Results cally collected across NCTN trials: race, ethnicity, and sex. This analysis includes 61 131 adult patients enrolled in the United States to 300 trials between 2016 and 2021. There were between 9524 and 11 092 patients meeting these criteria en- Methods rolled annually from 2016 to 2021. Figure 1 shows the distribu- tion of patient enrollments by age group and enrollment year. Data Enrollment by age group was similar in each of the included en- NCI supports the infrastructure for the conduct of national can- rollment years, with slightly greater enrollment of older adults cer treatment and advanced imaging clinical trials in adults, in 2021 compared with 2016 to 2020. adolescents and young adults, and children through the NCTN Comparing the age distribution of patients enrolled to trials (8,9). Cancer patients are enrolled to approximately 200 NCTN and the age distribution of incident cancer cases for all patient trials each year from more than 2000 academic and community enrollments, there was overrepresentation of younger patients oncology sites around the United States and internationally. For (59.5% of enrollments vs 42.0% of estimated incident cases) and this analysis, data for enrollments to NCTN clinical trials be- patients aged 65 to 69 years (16.9% of enrollments vs 15.9% of cases; Table 1). Patients aged 70 years and older were generally tween 2016 and 2021 were obtained from the web-based regis- underrepresented in trials, with the degree of underrepresenta- tration system for NCTN trials. The dataset included patient tion increasing with each age group. Patients aged 70 to 74 years enrollments to trial interventions for trials enrolling partici- represented 12.7% of enrollments and 14.5% of incident cases— pants aged 18 years and older and led by the adult NCTN a 1.8% difference. This difference was 4.2% for patients aged 75 groups. Enrollments outside of the United States were excluded. to 79 years, 5.4% for patients aged 80 to 84 years, and 7.1% for Key variables for the analysis were patient age at time of enroll- patients aged 85 years and older. ment, patient race, patient ethnicity, patient sex, enrollment year, There were 10 cancer types with at least 1500 enrollments from and cancer type. Giventhe focusofthisanalysisonolder adults, 2016 to 2021: bladder (n¼ 2579), breast (n¼ 16 534), colorectal age groupings were used to separate younger (18 to 64 years) and (n¼ 1644), leukemia (n¼ 2415), lung (n¼ 10 962), melanoma older (65 years and older) patients and explore enrollment within (n¼ 2492), myeloma (n¼ 1817), ovarian (n¼ 2061), prostate older adult age groups. For patients aged 65 to 84 years, 5-year age (n¼ 4829), and renal (n¼ 2491). Patient age distribution varied for groupings were used to align with the census categories. The mu- both enrollments and estimated incident cases across cancer tually exclusive age groupings used were 18-64 years, 65-69 years, types. Bladder cancer had the smallest estimated incident popula- 70-74 years, 75-79 years, 80-84 years, and 85 years and older. For tion aged 18 to 64 years, and bladder cancer trials had the lowest thecancertypeanalysis, cancer type was based on themain can- proportion of enrollments in this youngest age group, although cer type being enrolled in the trial. Race and ethnicity variables these patients were still overrepresented (31.2% of enrollments vs were recoded to mutually exclusive groupings reported in the NCI 23.5% of estimated incident cases). Bladder cancer trials had the Surveillance, Epidemiology, and End Results (SEER) Program data. greatest proportion of enrollments among the oldest patients aged Cancer incidence rates were obtained from the SEER 85 years and older, although this still underrepresented the inci- Program data from the SEER*Stat Database for incidence based dent patient population (4.1% of enrollments vs 14.2% of cases). on cases diagnosed between 2013 and 2018 and reported across Breast cancer had the largest estimated incident population aged 21 registries (SEER 21) (10). Diagnosis years 2013-2018 were used 18 to 64 years, and this age group was also overrepresented in because they are the most recent 6-year time period available in breast cancer trials (80.5% of enrollments vs 52.8% of cases). Age distribution also varied based on patient demographics. the SEER data. Registries included in the SEER 21 data cover Given the race and origin variable available via SEER, there were 36.4% of the US population (11). 3 groups with at least 1000 patient enrollments among both male and female patients over the 6-year period: non-Hispanic Analysis White, non-Hispanic Black, and Hispanic. There was greater en- rollment to trials of older patients who were non-Hispanic SEER incidence rates were adjusted for age using US Census White compared with patients who were non-Hispanic Black or Bureau data from the 2015-2019 American Community Survey Hispanic (Figure 2). Among female patients enrolled to trials, 5-Year Estimates. To perform the adjustment, SEER data on can- 35.5% of non-Hispanic White patients were aged 65 years and cer incidence rates by age and cancer type were multiplied by older compared with 25.1% of non-Hispanic Black patients and the 2015-2019 population estimate within that age group and, if 20.3% of Hispanic patients. A similar trend is seen for male applicable, sex (for breast, ovarian, and prostate cancers and for patients. This trend was not reflective of the incident patient the demographic subgroup analysis) to estimate the number of population. Based on the estimated incident cancer cases, a annual incident cases in the United States. We then calculated greater proportion of Hispanic patients was expected to be diag- the proportion of incident cases by age group for comparison to nosed with cancer at ages 65 years and older. Older patients the proportion of enrollments by age group. were underrepresented in trials in every demographic sub- We compared the proportion of patients in each age group group. However, Hispanic patients aged 65 years and older were for the enrolled patient population and the incident population. especially underrepresented in trials (female patients: 20.3% of The primary analysis was across enrollments to all cancer sites. enrollments vs 58.6% of estimated incident cases; male We also analyzed enrollments by cancer type within cancer patients: 39.2% of enrollments vs 69.2% of cases). types with at least 1500 enrollments included over the 6-year period. Subgroup analyses by sex, race, and ethnicity were lim- Discussion ited to categories with at least 1000 enrollments in each sub- group. We present the relative differences for assessment of This analysis found that there was overrepresentation of those practical significance and clinical importance. aged 18 to 69 years and underrepresentation of those aged 70 Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 G. E. Mishkin et al. |113 0.9% 0.6% 0.9% 0.8% 0.7% 0.8% 0.8% 100% 2.5% 2.8% 3.0% 2.8% 3.0% 2.8% 2.8% 6.4% 7.3% 7.6% 7.0% 7.3% 7.1% 8.3% 90% 12.4% 12.3% 12.5% 12.5% 12.1% 12.7% 14.6% 80% 70% 16.1% 16.4% 17.1% 17.2% 16.9% 17.1% 17.8% 85 and older y 60% 80-84 y 50% 75-79 y 70-74 y 40% 65-69 y 18-64 y 62.1% 30% 60.2% 59.3% 59.6% 59.9% 59.5% 55.5% 20% 10% 0% 2016 2017 2018 2019 2020 2021 2016-2021 (n=11 092) (n=10 176) (n=10 017) (n=10 500) (n=9822) (n=9524) (n=61 131) Figure 1. Proportion of adult enrollments to the National Cancer Institute’s National Clinical Trials Network by age at enrollment and enrollment year. years and older among patients enrolled to NCTN trials from scientific and medical justification. However, there is still signif- 2016 to 2021. Underrepresentation of older patients was seen icant room for improvement in the enrollment of older adults to across cancer types. Older patients who enrolled to NCTN trials NCTN trials. Some of the change in enrollment seen here may also reflect were more likely to be non-Hispanic White than the estimated incident cancer population. A key limitation to this analysis is a shift in enrollment by disease area in the intervening years. In that the incident cancer population is estimated based on SEER 2001-2011 and 2016-2021, breast cancer had the highest propor- tion of enrollments of younger patients, with approximately data; these data are the most comprehensive compilation of in- cident cancer cases available but may not be truly reflective of 80% of patients enrolled to breast cancer trials aged younger the US incident cancer population. Additionally, the patient de- than 65 years. These breast cancer enrollments represented mographic information is limited to what is routinely collected 40% of the overall enrollment from 2001 to 2011 compared with across NCTN trials, which includes key variables required by 27% of the enrollment from 2016 to 2021. the National Institutes of Health to monitor inclusion of women It is important to note that the characteristics of patients en- rolled in clinical trials in any given year or disease area will de- and minorities but do not capture potentially important patient characteristics such as whether patients are from rural or urban pend greatly on the available trial portfolio. The overall communities (12). enrollment within the NCTN was relatively stable from 2016 to 2019, with somewhat lower enrollment in 2020 and 2021, likely From 2001 to 2011, an average of 68% of patients enrolled each year in adult NCI Cooperative Group phase II and III treat- due to the COVID-19 pandemic, but the trials available for enroll- ment trials were aged younger than 65 years, 23% were between ment were constantly changing. In some trials, enrollment of a younger patient population is justified. As was noted for the 2016 ages 65 and 74 years, and 9% were aged 75 years and older (5). In these updated data from 2016 to 2021, 59.5% of patients enrolled to 2021 enrollments, a greater proportion (80.5%) of patients en- in adult NCTN trials were aged younger than 65 years, 29.6% rolled to trials in breast cancer were aged younger than 65 years were between ages 65 and 74 years, and 10.9% were aged 75 compared with the average (59.5%) across all disease areas. One years and older. Based on these overarching data, it appears of the highest-enrolling breast cancer studies during this time pe- that NCTN trials are enrolling greater proportions of older riod was Alliance for Clinical Trials in Oncology trial A011502, adults than in the earlier time period. Enhancing enrollment of studying aspirin as adjuvant therapy in breast cancer patients older patients has been a priority for the NCI and the NCTN, (15,16). Because of the risks of aspirin in older patients, this trial with several activities potentially contributing to the greater en- was open only to patients aged 69 years and younger, and the en- rollment, including broadening clinical trial inclusion criteria to rolled patient population was largely younger. This analysis in- reduce the unnecessary exclusion of patients with well- cluded enrollments to 26 breast cancer trials; among the included managed comorbidities, which may have disproportionately ex- enrollments, the median proportion of patients aged 18 to cluded older patients (13,14). NCTN trials do not include older 64 years across these breast cancer trials was 79.7%. Because this age limits in eligibility criteria unless there is a compelling is less than a percentage point lower than the overall proportion Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 114 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 Table 1. Differences in adult enrollments to National Cancer Institute’s National Clinical Trials Network (NCTN) vs estimated cancer incidence a,b by age group and cancer type, 2016-2021 Cancer type 18-64 y, % 65-69 y, % 70-74 y, % 75-79 y, % 80-84 y, % 85 y and older, % All cancer types Enrollments (n¼ 61 131) 59.5 16.9 12.7 7.3 2.8 0.8 Incidence (n 1 723 000) 42.0 15.9 14.5 11.5 8.2 7.9 Difference þ17.5 þ1.0 1.8 4.2 5.4 7.1 Bladder Enrollments (n¼ 2579) 31.2 18.9 19.3 16.3 10.1 4.1 Incidence (n 77 000) 23.5 15.3 17.2 16.3 13.5 14.2 Difference þ7.7 þ3.6 þ2.1 0.0 3.4 10.1 Breast Enrollments (n¼ 16 534) 80.5 11.0 5.5 2.1 0.7 0.2 Incidence (n 256 000) 52.8 14.8 12.6 8.9 5.7 5.2 Difference þ27.7 3.8 7.1 6.8 5.0 5.0 Colorectal Enrollments (n¼ 1644) 72.7 12.3 7.8 4.5 2.0 0.6 Incidence (n 144 000) 41.7 13.6 12.7 11.4 9.7 10.9 Difference þ31.0 1.3 4.9 6.9 7.7 10.3 Leukemia Enrollments (n¼ 2415) 54.2 19.1 15.2 8.1 2.9 0.6 Incidence (n 50 000) 37.3 13.9 14.2 12.9 10.4 11.2 Difference þ16.9 þ5.2 þ1.0 4.8 7.5 10.6 Lung Enrollments (n¼ 10 962) 41.2 21.6 20.0 12.0 4.4 0.9 Incidence (n 212 000) 27.3 16.9 18.8 16.3 11.5 9.1 Difference þ13.9 þ4.7 þ1.2 4.3 7.1 8.2 Melanoma and/or Skin Enrollments (n¼ 2492) 66.0 15.2 9.3 5.5 2.8 1.2 Incidence (n 93 000) 44.7 13.7 13.0 10.9 8.6 9.1 Difference þ21.3 þ1.5 3.7 5.4 5.8 7.9 Myeloma Enrollments (n¼ 1817) 53.2 20.3 17.2 6.5 2.2 0.5 Incidence (n 28 000) 34.0 16.6 16.0 14.0 10.6 8.8 Difference þ19.2 þ3.7 þ1.2 7.5 8.4 8.3 Ovarian Enrollments (n¼ 2061) 54.9 18.3 14.5 8.9 2.9 0.5 Incidence (n 22 000) 50.8 13.5 11.7 9.3 7.3 7.5 Difference þ4.1 þ4.8 þ2.8 0.4 4.4 7.0 Prostate Enrollments (n¼ 4829) 36.2 25.6 20.5 12.5 4.0 1.2 Incidence (n 213 000) 37.6 23.9 18.3 11.1 5.3 3.8 Difference 1.4 þ1.7 þ2.2 þ1.4 1.3 2.6 Renal Enrollments (n¼ 2491) 61.6 15.6 12.1 7.3 3.0 0.4 Incidence (n 62 000) 47.1 16.4 14.0 10.6 6.5 5.4 Difference þ14.5 0.8 1.9 3.3 3.5 5.0 Estimated annual incident cases and incidence rates adjusted by age group calculated using Surveillance, Epidemiology, and End Results (SEER) Program data from the SEER*Stat Database for incidence based on cases diagnosed between 2013 and 2018 and reported across 21 registries. Cancer type subgroups are limited to those with at least 1500 NCTN patient enrollments between 2016 and 2021. “All cancer types” includes all incident cases and all enrollments and is not limited to the cancer types shown in this table. The “þ” symbol indicates that the proportion of enrollments was greater than the proportion of incident cases and the age group was overrepresented in trial enroll- ments. The “” symbol indicates that the proportion of enrollments was less than the proportion of incident cases and the age group was underrepresented in trial enrollments. reported for breast cancer trials, it suggests that the breast cancer aged older than 60 years and for the treatment of acute lympho- blastic leukemia in adults aged 65 years and older (17,18). Many analysis is not being skewed by particularly high enrollment of younger patients to a small number of trials. leukemia trials in the NCTN have been designed specifically to In other disease areas, there is a strong scientific and clinical answer questions in older or younger patient populations (19). rationale for conducting trials in patients within certain age SWOG Cancer Research Network trial S1318 was a phase II trial ranges because of observed differences in the disease progres- evaluating use of blinatumomab as induction and consolidation sion or treatment response. For instance, the National therapy in newly diagnosed acute lymphoblastic leukemia Comprehensive Cancer Network guidelines offer distinct princi- patients aged 65 years and older (20,21). The median age of the ples for the management of acute myeloid leukemia in patients 29 patients in this study was 75 years. As more NCTN leukemia Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 G. E. Mishkin et al. |115 Female 0.6% 0.4% 0.4% 100% 1.4% 1.4% 2.2% 3.2% 2.8% 8.1% 8.1% 9.6% 6.1% 6.5% 7.0% 90% 7.8% 7.8% 8.4% 11.0% 9.2% 13.0% 80% 10.4% 10.6% 11.1% 15.7% 70% 12.7% 13.4% 13.9% 85 and older y 60% 13.5% 80-84 y 15.4% 50% 15.6% 75-79 y 40% 70-74 y 79.7% 74.9% 65-69 y 64.5% 30% 18-64 y 47.4% 44.7% 41.4% 20% 10% 0% NHW Accruals NHB Accruals Hispanic NHW Cases NHB Cases Hispanic Cases (n=26,358) (n=3,702) Accruals (n=2,948) Male 1.2% 0.4% 1.2% 100% 2.0% 2.3% 5.4% 4.3% 7.0% 8.1% 7.2% 7.8% 6.8% 90% 10.5% 8.2% 9.5% 13.2% 11.2% 11.2% 80% 11.8% 17.2% 14.0% 70% 16.7% 15.9% 20.7% 14.9% 85 and older y 60% 17.8% 20.2% 80-84 y 20.4% 50% 16.3% 75-79 y 19.7% 40% 70-74 y 65-69 y 60.8% 30% 56.5% 18-64 y 46.6% 41.9% 20% 40.2% 30.8% 10% 0% NHW Accruals NHB Accruals Hispanic NHW Cases NHB Cases Hispanic Cases (n=20,567) (n=2,153) Accruals (n=1,407) Figure 2. Proportion of adult enrollments to the National Cancer Institute’s National Clinical Trials Network and estimated cancer incidence by age group, sex, race and ethnicity. All groups are mutually exclusive, limited to categories with at least 1000 enrollments in each subgroup. NHB¼ non-Hispanic Black; NHW¼ non-Hispanic White. studies focused on older patient populations report out, we ex- patients enrolled, even though the Black and Hispanic incident pect to see similarly older age distributions. cancer population tended to be older. As we consider ways to This monograph features several articles with recommenda- increase enrollment of older adults to trials, we must be sure tions and considerations for continuing to enhance the enroll- that this is not associated with lower enrollment of non-White ment of older adults to NCTN clinical trials. A particularly patients. In fact, as the estimated incidence data showed, more important takeaway from this analysis is that patient demo- representative trial enrollment should likely include more older graphics should not be viewed in isolation. As this analysis patients who are Black and Hispanic. shows, Black and Hispanic patients enrolled to adult NCTN can- Older Hispanic patients were particularly underrepresented cer trials tended to be younger than the non-Hispanic White among patients enrolled to NCTN trials. The NCI has sought to Downloaded from https://academic.oup.com/jncimono/article/2022/60/111/6908750 by DeepDyve user on 20 December 2022 116 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 6. Unger JM, Hershman DL, Osarogiagbon RU, et al. Representativeness of Black reduce barriers to trial enrollment among Hispanic patients, in- patients in cancer clinical trials sponsored by the National Cancer Institute cluding by expanding consent translation services to provide compared with pharmaceutical companies. JNCI Cancer Spectr. 2020;4(4): Spanish translations of informed consent documents for all pkaa034. NCTN trials starting in 2015. Additionally, the NCI Community 7. Alvidrez J, Greenwood GL, Johnson TL, et al. Intersectionality in public health research: a view from the National Institutes of Health. Am J Public Health. Oncology Research Program seeks to bring NCTN trials to di- 2021;111(1):95-97. verse patients in their communities (22). However, as these 8. National Cancer Institute. Division of Cancer Treatment and Diagnosis Programs findings emphasize, more needs to be done to overcome bar- and Initiatives 2013-2017. https://dctd.cancer.gov/NewsEvents/ 2017DCTDprograms.pdf. Published October 2018. Accessed August 8, 2022. riers to trial enrollment for non-White patients (23). The inter- 9. National Cancer Institute. An overview of NCI’s National Clinical Trials section between trial enrollment and age, race, ethnicity, and Network. https://ctep.cancer.gov/initiativesprograms/nctn.htm. Updated other patient characteristics such as geographic area and rural- February 17, 2022. Accessed August 8, 2022. ity warrants further study so that more targeted enrollment en- 10. National Cancer Institute Surveillance Research Program. Surveillance, Epidemiology, and End Results (SEER) Program SEER 21 Reg Research Data, hancement efforts can be developed that improve trial diversity Nov 2020 Sub (2000-2018). National Cancer Institute, DCCPS, Surveillance across demographic groups. Research Program, Surveillance Systems Branch. http://www.seer.cancer. gov. Published April 2021. 11. National Cancer Institute. Number of persons by race and Hispanic ethnicity for SEER participants (2020 Census Data). https://seer.cancer.gov/registries/ Funding data.html. Accessed August 8, 2022. 12. National Institutes of Health. NIH policy and guidelines on the inclusion of No funding was used for this study. women and minorities as subjects in clinical research. https://grants.nih. gov/policy/inclusion/women-and-minorities/guidelines.htm. Updated December 6, 2017. Accessed August 8, 2022. Notes 13. Denicoff A. CTAC Strategic Planning Working Group: CTEP Analysis of Implementing ASCO-Friends Broadened Eligibility Criteria in CTEP-Sponsored Trials. Role of the funder: Not applicable. https://deainfo.nci.nih.gov/advisory/ctac/1121/Doroshow-Denicoff.pdf. Published November 10, 2021. Accessed August 8, 2022. Disclosures: No disclosures to report. 14. Habr D, McRoy L, Papadimitrakopoulou VA. Age is just a number: considera- tions for older adults in cancer clinical trials. J Natl Cancer Inst. 2021;113(11): Author contributions: GEM: Conceptualization, Methodology, 1460-1464. Formal Analysis, Data Curation, Writing—Original Draft, 15. Alliance for Clinical Trials in Oncology. A randomized phase iii double blinded placebo controlled trial of aspirin as adjuvant therapy for HER2 nega- Writing—Review & Editing, Visualization, Project tive breast cancer: the ABC trial. https://clinicaltrials.gov/ct2/show/ Administration. AMD, AFB, And RFL: Conceptualization, NCT02927249. Updated January 10, 2022. Accessed August 8, 2022. Methodology, Writing—Review & Editing. 16. Chen WY, Ballman KV, Winer EP, et al. A randomized phase III, double- blinded, placebo-controlled trial of aspirin as adjuvant therapy for breast Disclaimers: This article represents the opinions of the authors cancer (A011502): the Aspirin after Breast Cancer (ABC) Trial. J Clin Oncol. and not those of the National Cancer Institute. 2022;40(suppl 36):360922. 17. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia Version 1. https://www.nccn.org/pro- fessionals/physician_gls/pdf/all.pdf. Published 2022. Accessed August 8, Data Availability 18. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in The data underlying this article cannot be shared to protect the Oncology: Acute Myeloid Leukemia Version 1. https://www.nccn.org/professio- privacy of the clinical trial participants. Information to support nals/physician_gls/pdf/aml.pdf. Published 2022. Accessed August 8, 2022. 19. National Cancer Institute. NCTN leukemia trials portfolio. https://ctep.can- the findings of this analysis are available from the correspond- cer.gov/initiativesPrograms/docs/nctn_trials/NCTN_Leukemia_Trials.pdf. ing author upon reasonable request. Updated July 15, 2022. Accessed August 8, 2022. 20. Advani AS, Moseley A, O’Dwyer KM, et al. 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J Clin Oncol. 2012;30(17):2036-2038. 22. McCaskill-Stevens W, Lyss AP, Good M, et al. The NCI community oncology 4. Sedrak MS, Freedman RA, Cohen HJ, et al.; for the Cancer and Aging Research research program: what every clinician needs to know. Am Soc Clin Oncol Educ Group (CARG). Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Clin. 2021;71(1):78-92. Book. 2013;33:e84-e89. doi:10.14694/EdBook_AM.2013.33.e84. 5. Mooney M. Older Patients in NCI-sponsored Clinical Treatment Trials. https:// 23. Hamel LM, Penner LA, Albrecht TL, et al. Barriers to clinical trial enrollment meetinglibrary.asco.org/record/68859/video. Published 2012. Accessed in racial and ethnic minority patients with cancer. Cancer Control. 2016;23(4): August 8, 2022. 327-337.

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