Surveillance, Epidemiology, And End Results Incidence Research Articles

Non-Hodgkin Lymphoma - Nodal and Extranodal: 20-Year Comparative Mortality, Survival & Biologic Behavior Analysis by Age, Sex, Race, Stage, Cell Morphology/Histology, Cohort Entry Time-Period and Disease Duration: A Systematic Review of 384,651 Total NHL Cases Including 261,144 Nodal and 123,507 Extranodal Cases for Diagnosis Years 1975-2016: (SEER*Stat 8.3.6).

-To update trends in incidence and prevalence in the United States of non-Hodgkin lymphoma, examine, compare and contrast short and long-term patterns of survival and mortality, and consider the outcome impacts of anatomic location of NHL nodal and extranodal subdivisions, utilizing selected ICD-O-3 histologic oncotypes stratified by age, sex, race/ethnicity, stage, cell behavioral morphology and histologic typology, cohort entry time-period and disease duration, employing the statistical database of the National Cancer Institute SEER*Stat 8.3.6 program for diagnosis years 1975-2016.4 Methods.- A retrospective, population-based cohort study using nationally representative data from the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) program to evaluate 384,651 NHL cases for diagnosis years 1975-2016 comparing multiple variables of age, sex, race, stage, cell behavioral morphology, cohort entry time-period, disease duration and histologic oncotype. Relative survival statistics were analyzed in two cohorts: 1975-1995 and 1996-2016. Survival statistics were derived from SEER*Stat Database: Incidence - SEER 9 Regs Research Data, November 2018 Submission (1975-2016) <Katrina/Rita Population Adjustment> released April 2019, based on the November 2018 submission. - Incidence rates, relative frequency distributions, survival and mortality by age, sex, stage and cell behavioral morphology, of adult nodal (N) and extranodal (EN) NHL in 2 entrant time-periods as recorded in the SEER Program of the National Cancer Institute for diagnosis years 1975-2016 (SEER Stat 8.3.6) are summarized. Shifts in trends over time are identified, and the findings are correlated with prognosis, including short and long-term observed (actual), expected and relative survival, median observed and relative survival, mortality rates and excess death rates per 1000 people. - Trends in SEER incidence, prevalence, survival and mortality by age, sex, race, stage, cell behavioral morphology, cohort entry time-period, relative frequency and percent distribution, were examined to provide a current epidemiologic and medical-actuarial risk assessment framework for nodal (N) and extranodal (EN) non-Hodgkin's lymphoma in the 1975-2016 timeframe.

A comparison of the Optum Clinicogenomics Solid Tumor Database and the SEER Population-Based Cancer Registry.

6635 Background: Real-world data (RWD) and real-world evidence (RWE) are increasingly utilized across a range of research and regulatory applications, including biomarker discovery, risk stratification, external control arms, and post-market surveillance. Two-thirds of FDA approvals in 2021 utilized genomic data and the growing interest in targeted therapies will likely continue this trend. While genomics or any one type of RWD alone yields an incomplete view of the patient journey, Optum’s clinicogenomic data links de-identified longitudinal clinical and claims data to next-generation sequencing (NGS) results. Ensuring the value of this data requires identifying and limiting biases and maximizing diversity. Methods: To evaluate the robustness and representativeness of Optum’s Clinicogenomic Solid Tumor Database, we compared demographic and clinical characteristics to the Surveillance, Epidemiology and End Results (SEER) database across 16 solid tumor types. Variables of interest included age at diagnosis, sex, self-identified race, year of diagnosis, and metastatic status. The Optum data was derived from clinical data that includes 156 million lives and claims data that covers 95 million lives. The solid tumor sub-cohort used for this analysis included 157,164 patients diagnosed between January 1, 2011, and December 31, 2021 with linked broad-panel NGS results. SEER Incidence Data included patients diagnosed between January 1, 2011, and December 31, 2018. Using the Optum data, we also report average continuous enrollment and sequential testing frequency across all solid tumor types. Results: The overall distributions of age at diagnosis, sex and race were similar across all cancer types, with a few exceptions. On average, SEER had a larger proportions of patients 80 years and older (15% vs 7.2%, all solid tumors) and of Asian race (7.1% vs 3.2%, all solid tumors). Cancer diagnoses in the Optum data increased year over year corresponding with the increasing availability and uptake of genetic testing in oncology, while the SEER data was equally distributed across all years. The average continuous enrollment for solid tumor patients was 8.1 years in the Optum data, and 13% of patients had sequential testing results from &gt;1 time point. Conclusions: Given the increased reliance on RWD and RWE as part of the drug development and regulatory approval processes, ensuring the representativeness of clinicogenomic databases is paramount. This analysis of general patient characteristics across the Optum Clinicogenomics and SEER solid tumor databases found largely similar distributions of key variables. Observed differences between these two representative databases reflect the genetic testing landscape in oncology and provide the opportunity to investigate disparities related to accessing genetic services, corresponding targeted treatment options, and health outcomes.

Interpreting cancer incidence trends: challenges due to the COVID-19 pandemic.

The considerable deficit in cancer diagnoses in 2020 due to COVID-19 pandemic disruptions in health care can pose challenges in the estimation and interpretation of long-term cancer trends. Using Surveillance, Epidemiology, and End Results (SEER) (2000-2020) data, we demonstrate that inclusion of the 2020 incidence rates in joinpoint models to estimate trends can result in a poorer fit to the data and less accurate or less precise trend estimates, providing challenges in the interpretation of the estimates as a cancer control measure. To measure the decline in 2020 relative to 2019 cancer incidence rates, we used the percent change of rates in 2020 compared with 2019. Overall, SEER cancer incidence rates dropped approximately 10% in 2020, but for thyroid cancer the decrease was as large as 18% after adjusting for reporting delay. The 2020 SEER incidence data are available in all SEER released products, except for joinpoint estimates of trends and lifetime risk of developing cancer.

Abstract A024: Enrollment of older adults in non-small cell lung cancer (NSCLC) clinical trials compared with population-based U.S. incidence

Abstract Background: Lung cancer is frequently diagnosed in older adults. As the U.S. population continues to age, understanding treatment effects in lung cancer patients ≥65 years of age is increasingly important. Despite this trend, clinical trials (CTs) have historically under-enrolled older adults, creating a disparity between trial and real-world populations. Disproportionate enrollment can create challenges in understanding utilization in subpopulations. Due to increased interest in PD-(L)1 inhibitors for non-small cell lung cancer (NSCLC) treatment, CTs examining PD-(L)1 inhibitors in the first-line (1L) setting were selected to evaluate enrollment disparity in NSCLC immunotherapy. Methods: We identified 11 CTs that investigated 1L NSCLC anti-PD-(L)1 regimens submitted to the FDA between 2016 and 2020. Descriptive statistics were calculated based on the pooled dataset and compared with incident U.S. NSCLC cases diagnosed between 2015 and 2019, based on data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. While SEER is a U.S. population-based representative sample, data from the trials included patients outside the U.S. that were submitted to support marketing applications with applicability to U.S. clinical practice. Results: A total of 7,030 patients enrolled in anti-PD-(L)1 CTs were included. In this sample, 48.2% were age ≥65 years, compared to 70.4% of incident U.S. NSCLC cases. This disparity persists with increasing age: 10.3% of enrollees were age ≥75 years and 0.5% of enrollees were age ≥85 years, compared to 34.3% and 7.2% of incident U.S. NSCLC cases, respectively. Discussion: Based on our results, older adults continue to be underrepresented in NSCLC anti-PD-(L)1 CTs, contributing to a potential treatment evidence gap. This gap widens with age and patients age ≥85 years constitute a miniscule portion (0.5%) of the CT cohort. Meanwhile, more patients will move into this group as the population ages. Aging can be associated with comorbidities and the potential for variance in patient and provider treatment preferences, which are important to acknowledge as these aspects may, in part, explain the results. Nonetheless, the gap in the number of older adults enrolled in this CT sample compared with SEER incidence demonstrates a clear need to improve recruitment in this underrepresented population. Awareness of trial-level and system-level barriers is necessary to minimize disparities. Additional research using tools such as real-world data to examine current treatment utilization, patient factors, and outcomes among underrepresented populations would increase the depth of evidence to address this disparity effectively. Citation Format: Felice Yang, Jonathon Vallejo, Oladimeji Akinboro, Catherine Lerro, Pallavi Mishra-Kalyani, Shenghui Tang, Paul G. Kluetz, Harpreet Singh, Donna R. Rivera. Enrollment of older adults in non-small cell lung cancer (NSCLC) clinical trials compared with population-based U.S. incidence [abstract]. In: Proceedings of the AACR Special Conference: Aging and Cancer; 2022 Nov 17-20; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2022;83(2 Suppl_1):Abstract nr A024.

Minority groups underrepresented in hematologic cancer trials

Minority groups underrepresented in hematologic cancer trials

Racial and regional disparities of triple negative breast cancer incidence rates in the United States: An analysis of 2011-2019 NPCR and SEER incidence data.

Triple negative breast cancer (TNBC) is a more aggressive subtype resistant to conventional treatments with a poorer prognosis. This study was to update the status of TNBC and the temporal changes of its incidence rate in the US. Women diagnosed with breast cancer during 2011-2019 were obtained from the National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology and End Results (SEER) Program SEER*Stat Database which covers the entire population of the US. The TNBC incidence and its temporal trends by race, age, region (state) and disease stage were determined during the period. A total of 238,848 (or 8.8%) TNBC women were diagnosed during the study period. TNBC occurred disproportionally higher in women of Non-Hispanic Black, younger ages, with cancer at a distant stage or poorly/undifferentiated. The age adjusted incidence rate (AAIR) for TNBC in all races decreased from 14.8 per 100,000 in 2011 to 14.0 in 2019 (annual percentage change (APC) = -0.6, P = 0.024). Incidence rates of TNBC significantly decreased with APCs of -0.8 in Non-Hispanic White women, -1.3 in West and -0.7 in Northeastern regions. Women with TNBC at the age of 35-49, 50-59, and 60-69 years, and the disease at the regional stage displayed significantly decreased trends. Among state levels, Mississippi (20.6) and Louisiana (18.9) had the highest, while Utah (9.1) and Montana (9.6) had the lowest AAIRs in 2019. New Hampshire and Indiana had significant and highest decreases, while Louisiana and Arkansas had significant and largest increases in AAIR. In individual races, TNBC displayed disparities in temporal trends among age groups, regions and disease stages. Surprisingly, Non-Hispanic White and Hispanic TNBC women (0-34 years), and Non-Hispanic Black women (≥70 years) during the entire period, as well as Asian or Pacific Islander women in the South region had increased trends between 2011 and 2017. Our study demonstrates an overall decreased trend of TNBC incidence in the past decade. Its incidence displayed disparities among races, age groups, regions and disease stages. Special attention is needed for a heavy burden in Non-Hispanic Black and increased trends in certain groups.

Evaluating therapeutic bladder cancer trial disparities in race/ethnicity.

446 Background: Racial clinical trial disparities in bladder cancer outcomes remains a critical problem in the United States. This study sought to examine representation by race and sex among therapeutic bladder cancer clinical trials that informs the standard of care in bladder cancer management. Methods: Published clinical trial data that inform clinical management were identified from the National Comprehensive Cancer Network guidelines and by clinician input from 2009 to 2021. The characteristics of participants, including sex and race, were collected. Clinical trials were categorized by clinical setting: metastatic bladder cancer (MBC), muscle invasive bladder cancer (MIBC), and non-muscle invasive (NMIBC). Bladder cancer incidence by race were collected from the Surveillance, Epidemiology, and End Results (SEER) Program. SEER incidence data by race was compared to the racial/ethnic breakdown of bladder cancer clinical trial participants and evaluated using hypothesis testing (chi-square). Results: A total of 28 clinical trials were assessed, with a pooled sample of 8003 participants. race was reported for 1786 participants. A total of 17 clinical trials did not report race. The population data from SEER details bladder cancer distributions as 89.52% White, 5.80% Black, 0.33% American Indian/Alaska Native, and 4.36% Asian or Pacific Islander. Chi-square analysis demonstrated significant differences in racial representation for MBC (p&lt; 0.0001) and NMIBC (p=0.0423) settings. No significant differences were observed in the MIBC (p= 0.1954) setting. Conclusions: This study observed that the distributions of race in MBC and NMIBC clinical trials are different from that of the population affected by bladder cancer. It is imperative for therapeutic cancer clinical trials to achieve adequate representation to ensure standard of care therapies in bladder cancer management benefits all.[Table: see text]

Racial and ethnic disparities among participants in precision oncology clinical studies.

3014 Background: Precision medicine has revolutionized oncologic care in the United States (US) in the past two decades. While the US cancer population is rapidly diversifying, enrollment of a diverse patient population into clinical trials lags behind. In particular, it is unclear whether minority patients are adequately represented in precision oncology trials. Herein, we report racial/ethnic representation in precision oncology studies spanning four common cancer types (breast, lung, prostate, colorectal cancers). Methods: Completed US clinical studies incorporating precision medicine objectives based on a set of 12 precision oncology search terms (including tumor biomarker, whole exome sequencing, tumor mutation testing, gene expression signatures, tumor microarray, tumor genomics, et cetera) were identified from Clinicaltrials.gov. Studies were reviewed for reporting race/ethnicity for inclusion in the analysis. The Surveillance, Epidemiology, and End Results (SEER) database was used to determine incidence of race/ethnicity in the US cancer population, correlated with disease site and median year of enrollment for each trial. The difference in incidence (D-I) was defined as the median absolute difference in study racial enrollment and SEER incidence, with a negative value corresponding to underrepresentation. Wilcoxon signed-rank test was used to compare median D-I to a value of 0 by racial/ethnic subgroups. Results: Overall, 156 studies were identified; 40.3 and 27.5% studies enrolling from 2000 through 2020 met the inclusion criteria for racial and ethnic subgroups reporting, respectively. Of 4,418 total enrollees, 82.5% were White, 10.5% Black, 3.8% Asian, and 0.4% American Indian/Alaskan Native (AIAN). Ethnically, 6.4% were Hispanic. The D-I was +2.2% for Whites (interquartile range (IQR) = -43.7% to 25.4%; P &lt; 0.013), -0.74% AIAN (IQR = -0.8% to +5.9%; P &lt; 0.001), -2.5% Asians (IQR = -4.1% to 30.4%; P &lt; 0.152), -4.6% Blacks (IQR = -20.1% to +45.0%; P &lt; 0.001), and -8.1% Hispanics (IQR = -14.8% to + 29.6%; P &lt; 0.001). By disease site, Blacks were significantly underrepresented proportional to their cancer incidence among prostate (D-I of -11.8%, p = 0.009) and lung studies (D-I of -5.9%, p = 0.013), while prostate studies significantly overrepresented Whites (D-I +14.0%, p = 0.005). Lung studies overrepresented Asians (D-I +0.49%) consistent with the prominent role of targetable oncogene drivers in this population. Conclusions: Results demonstrate an underrepresentation of minority racial groups and an overrepresentation of Whites in precision oncology studies. Increased emphasis on equitable enrollment onto these studies is critical, as resulting precision Omic conclusions are used to stratify populations and personalize treatments. A continued lack of diversity among enrollees may further leave behind vulnerable minority populations in the era of precision oncology.

Breast Cancer Incidence Reduction in Women Treated with Subcutaneous Testosterone: Testosterone Therapy and Breast Cancer Incidence Study.

Testosterone (T) therapy has been shown to be breast protective in both pre- and post-menopausal patients. Additionally, estradiol (E) does not cause breast cancer (BC) in the majority of the world's literatures. This study aimed to investigate the incidence of invasive BC (IBC) in pre- and postmenopausal women treated with T therapy and T in combination with E (T/E). Since January 2010, a total of 2,377 pre- and post-menopausal women were treated with T or T/E implants. IBC rates were reported based on newly diagnosed IBC cases in the total study. Total cases divided by the total sample size and years in study was expressed as an incidence per 100,000 person-years (P-Ys). The BC incidence was compared with age-specific Surveillance Epidemiology and End Results (SEER) incidence rates. As of October 2020, 14 cases diagnosed with IBC have been found in 9,746 P-Y of follow up for an incidence of 144 cases per 100,000 P-Y, substantially less than the age-specific SEER incidence rates (223/100,000), placebo arm of Women's Health Initiative Study (330/100,000), and never users of hormone therapy from the Million Women Study (312/100,000). T and/or T/E pellet implants significantly reduced the incidence of BC in pre- and post-menopausal women. The addition of E did not increase the incidence over using T alone. This is the second multi-year long-term study demonstrating the benefits of T therapy in reducing the incidence of IBC.

Screening For Colorectal Cancer in the Age of Simulation Models: A Historical Lens

Screening For Colorectal Cancer in the Age of Simulation Models: A Historical Lens

Comparison of CDH1 Penetrance Estimates in Clinically Ascertained Families vs Families Ascertained for Multiple Gastric Cancers

CDH1 pathogenic variants have been estimated to confer a 40% to 70% and 56% to 83% lifetime risk for gastric cancer in men and women, respectively. These are likely to be overestimates owing to ascertainment of families with multiple cases of gastric cancer. To our knowledge, there are no penetrance estimates for CDH1 without this ascertainment bias. To estimate CDH1 penetrance in a patient cohort not exclusively ascertained based on strict hereditary diffuse gastric cancer (HDGC) criteria. Retrospective review of 75 families found to have pathogenic variants in CDH1 through clinical ascertainment and multigene panel testing at a large commercial diagnostic laboratory from August 5, 2013, to June 30, 2018. CDH1 pathogenic variants were identified in 238 individuals from 75 families. Pedigrees from those families included cancer status for 1679 relatives. Penetrance estimates are based on 41 families for which completed pedigrees were available. Gastric cancer standardized incidence ratio estimates relative to Surveillance, Epidemiology, and End Results (SEER) Program incidence for pathogenic CDH1 variants from families ascertained without regard to HDGC criteria. Among the 238 individuals with a CDH1 pathogenic variant, mean (SD) age was 49.3 (18.1) years and 63.4% were female. Ethnicity was reported for 67 of 75 (89%) families; of these 67 families, 51 (76%) reported European ancestry, whereas Asian, African, Latino, and 2 or more ancestries were reported for 4 families (6%) each. Standardized incidence ratios for gastric and breast cancer were significantly elevated above SEER incidence. Extrapolated cumulative incidence of gastric cancer at age 80 years was 42% (95% CI, 30%-56%) for men and 33% (95% CI, 21%-43%) for women with pathogenic variants in CDH1, whereas cumulative incidence of female breast cancer was estimated at 55% (95% CI, 39%-68%). International Gastric Cancer Linkage Consortium criteria were met in 25 of the 75 (33%) families; however, dispensing with the requirement of confirmation of HDGC histologic subtype, 43 (57%) would meet criteria. The cumulative incidence of gastric cancer for individuals with pathogenic variants in CDH1 is significantly lower than previously described. Because prophylactic gastrectomy can have bearing upon both physical and psychological health, further discussion is warranted to assess whether this surgical recommendation is appropriate for all individuals with pathogenic variants in CDH1.

Modeling accrual of older adults to cancer clinical trials: (Alliance A151736).

e18132 Background: Older adults (65+ years) make up &gt; 50% of cancer patients in the US,1 yet, older patient enrollment onto trials remains &lt; 30%.2 This study’s aim was to determine the association between trial level variables and accrual rates of adults 65+ to better design trials that can more improve enrollment of these patients. Methods: We analyzed enrollment percentages of patients age 65+ in non-age specific Alliance trials with &gt; 50 patients, that completed accrual between 1995- 2015. Enrollment percentage by 65+ for each study was compared to cancer incidence percentage by 65+ according to the Surveillance, Epidemiology, and End Results (SEER) Program for the same time periods. Enrollment Disparity Difference (EDD)3, defined as the difference between SEER incidence percentage of patients 65+ and the trial percentage enrollment of 65+ was calculated for each trial ( SEER % – trial %). Univariate analyses (UVA) were performed using simple linear regression to determine trial variables associated with larger EDDs (higher disparity). Variables that had an F-test p-value &lt; 0.20 were included in a multivariable fixed-effects linear model for multivariate analysis (MVA). Results: Median age of 66,708 patients across 237 trials with 10 cancer types was 60 years. Average % of 65+ in trials was lower than average SEER comparison % 65+ per trial (37.6% vs. 57.8%). The median trial EDD, was 16.7%. On UVA, cancer type was significantly associated with higher EDD (see Table). Use of fewer modalities (1, 2, vs 3+) was associated with lower estimated EDDs (1 = -11 [+/-3.6], 2 = -8.9 [+/-3.9], F-test p = .012). On MVA, non-genitourinary (GU) cancer type, number of treatment modalities, and the phase (II or III compared to observational/other) were all significantly associated with higher EDD. Conclusions: Older adults were under-represented in this large sample of trials. This information can be used as a platform to better design disease-specific trials to improve older patient accrual, particularly in disease areas which are under-performing. Support: U10CA180821, U10CA180882, UG1CA189823: https://acknowledgments.alliancefound.org .

Incidence of Second Primary Malignancies in Patients with Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the United States.

Background New therapies for castration-resistant prostate cancer (CRPC) may be associated with increased risk of second primary malignancies (SPM). We therefore estimated the population-based incidence of SPM among patients with CRPC in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We also estimated the proportion of men with CRPC with bone metastases and overall survival. Methods We conducted a retrospective cohort study of United States (US) men aged ≥ 65 years with CRPC. Cohort entry was from January 1, 2000, to December 31, 2011, with follow-up through December 31, 2013. Castration resistance was defined by treatment with second-line systemic therapy (after surgical or medical castration). SPM were diagnoses of primary cancers (other than prostate) in SEER or Medicare data. Results Altogether 2,234 patients met eligibility criteria. Most (1,887; 84.5%) had evidence of bone metastases in Medicare claims. SPM occurred in 172 patients (incidence rate 5.9 per 100 person-years; 95% confidence interval [CI], 5.0-6.8; standardized incidence ratio = 3.1, 95% CI, 2.8-3.6, based on SEER incidence rate of all malignancies except prostate cancer among men aged ≥ 65 years). The most common SPM were lung/bronchus (n = 29, 16.9%), urinary bladder (n = 22, 12.8%), and colon/rectum (n = 21, 12.2%). Median survival was 1.2 years (95% CI, 1.1-1.3); 5-year survival was 9% (95% CI, 7-11%). Conclusions This study provides the first estimate of SPM risk in older men with CRPC in the US. The incidence rate is approximately threefold higher than the population-based cancer incidence among men without prostate cancer.

Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience

▪Background: The majority of hematologic malignancies are most frequently diagnosed in patients over 65 years of age (1). However, older adults are underrepresented in clinical trials evaluating new cancer therapies (2). This analysis quantifies age related enrollment in trials evaluating patients with hematologic malignancies submitted to FDA in support of drug approval.Methods: We retrospectively analyzed demographic datasets of patients enrolled to trials submitted to FDA in support of approval of new or supplemental indications for hematologic cancer therapies from 2005-2015. Patients enrolled in trials for hematologic malignancies were grouped into disease categories based on the diagnosis specified for trial entry and analyzed according to age distributions of <65, 65-74 and ≥ 75 years. The rates of enrollment for patients with chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and lymphomas (Hodgkin's and non-Hodgkin's lymphoma excluding CLL) were compared with the age distribution of incidence cases by site derived from the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute 2010-2014 (1).Results: We identified a total of 44,144 patients enrolled in clinical trials evaluating hematologic malignancies. Forty five percent (19908) of the patients were enrolled in lymphoma trials, 24% (10465) in chronic myeloid leukemia (CML) trials, 22% (9605) in multiple myeloma (MM) trials, 2% (1052) in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) trials and 6% were enrolled in trials classified as “other” (includes myeloproliferative neoplasms and trials enrolling multiple malignancies). Less than 1% (403) of patients were enrolled in acute lymphoblastic leukemia (ALL) trials. Greater than 50% of the patients with the exception of those enrolled in CLL and AML/MDS trials were <65 years of age. Greater than 85% of the participants in ALL trials were < 65 years of age.Compared to the U.S cancer population, clinical trials for lymphomas, CLL, CML and MM enrolled a disproportionately higher percentage of patients <65 years of age (Table 2). For participants ≥65 years in the lymphoma and CML trials, enrollment in the 65-74 year old age group was lower than the SEER incidence cases (24.6% versus 23.1% for lymphoma and 16.5% versus 20.7% for CML respectively); but the difference was less than 5%. CLL and MM trials enrolled a higher percentage of patients in the 65-74 year old age group compared with the SEER data. Patients ≥75 years of age were consistently underrepresented in lymphoma, CLL, CML and MM trials compared to the SEER incidence cases in the same age group. The greatest difference was seen for patients in CML trials: only 3.8% were ≥75 years of age compared with SEER incidence of 28.6%.Conclusion: Older adults 65-74 years of age were adequately represented in hematologic malignancy trials submitted to support approval of new or supplemental indications of cancer therapies. Despite a high number of incident cases diagnosed in this age group, adults ≥ 75 years of age were disproportionately underrepresented in malignant hematology clinical trials. The FDA has encouraged sponsors to design trials to enroll patients who are representative of their intended population. Additional strategies to increase clinical trial participation may be needed to enhance the quantity and quality of information needed to treat adults ≥75 years of age and provide an appropriate benefit-risk profile in the population that is likely to receive the treatment. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

The thyroid cancer policy model: A mathematical simulation model of papillary thyroid carcinoma in The U.S. population.

BackgroundThyroid cancer affects over ½ million people in the U.S. and the incidence of thyroid cancer has increased worldwide at a rate higher than any other cancer, while survival has remained largely unchanged. The aim of this research was to develop, calibrate and verify a mathematical disease model to simulate the natural history of papillary thyroid cancer, which will serve as a platform to assess the effectiveness of clinical and cancer control interventions.MethodsHerein, we modeled the natural pre-clinical course of both benign and malignant thyroid nodules with biologically relevant health states from normal to detected nodule. Using established calibration techniques, optimal parameter sets for tumor growth characteristics, development rate, and detection rate were used to fit Surveillance Epidemiology and End Results (SEER) incidence data and other calibration targets.ResultsModel outputs compared to calibration targets demonstrating sufficient calibration fit and model validation are presented including primary targets of SEER incidence data and size distribution at detection of malignancy. Additionally, we show the predicted underlying benign and malignant prevalence of nodules in the population, the probability of detection based on size of nodule, and estimates of growth over time in both benign and malignant nodules.ConclusionsThis comprehensive model provides a dynamic platform employable for future comparative effectiveness research. Future model analyses will test and assess various clinical management strategies to improve patient outcomes related to thyroid cancer and optimize resource utilization for patients with thyroid nodules.

PCN264 - The Burden of Selected Cancers in The United States: Health Behaviors and Healthcare Utilization of Survivors

To examine the prevalence, functional limitations and healthcare utilization of survivors of the highest incidence cancers in the United States (US). We included adults aged 18 years or older from Surveillance Epidemiology and End Results (SEER) 9 1973-2012, National Health Interview Survey (NHIS) 2013, and Medical Expenditure Panel Survey (MEPs) 2011. Based on SEER incidence, we examined survivors of the eleven most frequently diagnosed cancers within the United States. Chi-square tests and one-way analyses of variance were utilized to assess whether cancer survivors differed from non-cancer controls on behavioral characteristics, prevention, and cost of care. Breast, prostate, lung, hematologic malignancies, melanoma, colon/rectal, bladder, kidney/renal, uterine, thyroid and pancreatic cancers were included as the 11 cancers with highest incidence. Breast cancer was the highest incident cancer with a rate of 156.4 per 100,000 adult women. The second incident cancer was prostate cancer with a rate of 167.2 per 100,000 adult men. Fifty-eight percent of 40-64 year old adults diagnosed with cancer in the past year have pain versus 31.3% of adults without a cancer history (p=0.0002). Cancer survivors 65 years of age and older were found to have higher rates of any functional limitation than cancer-free adults (p=0.0016). An estimated 13.5 million adults with a history of cancer spend $169.4 billion (B) a year on cancer treatment. Cancers with the highest direct expenditures are breast ($39B), prostate ($37B), and hematologic malignancies ($25B). Office-based visits account for the majority of direct medical spending associated with breast (29.9%), prostate (21.9%), and lung (28.5%) cancers. Among persons with a history of cancer the prevalence of obesity is the same in men and women 67%. Understanding the utilization use, health and wellbeing of cancer survivors can inform how to approach future interventions to improve long term care.

Abstract 5231: Multiple myeloma will become a common cancer in the era of modern therapy

Abstract INTRODUCTION: Multiple myeloma (MM) is the second most common hematological malignancy in the United States (US), representing 1.4% of all newly diagnosed cancers. The annual number of new MM patients is expected to increase primarily because the population is ageing. In parallel, several new drugs with unprecedented efficacy have been approved by the FDA. We were motivated to use data from the Surveillance, Epidemiology, and End Results (SEER) Program and statistical models to estimate future numbers of MM survivors in the era of modern therapy. METHODS: We estimated future MM incidence using age-period-cohort forecasting models. We estimated all-cause mortality rates by years-since-MM-diagnosis, for cohorts of incident cases defined by age-at-diagnosis and year-of-diagnosis; here we used a proportional hazards absolute risk model with age, year, and duration effects specified using linear splines. We calculated current and future prevalence rates based on observed and extrapolated SEER incidence and mortality. We calculated corresponding numbers of MM survivors in the US by multiplying prevalence rates by official observed and projected population counts. We projected life year gains among persons with MM from prevalence forecasts incorporating more and less favorable assumptions about MM prognosis. RESULTS: We analyzed MM among black and white men and women using 1992 - 2010 SEER data and forecast to 2022. Qualitative patterns were similar in each group. As previously reported, incidence was stable or slightly increasing and highest among black men. However, survival improved in all groups between 1992 through 2010. For example, among white men aged 60-69 years at diagnosis, median survival after MM increased from 2.6 to 5.0 years. If progress continues at the same rate - a conservative assumption in light of recent advances - the projected median will increase to 7.6 years circa 2022. Among black and white men and women ages 40 - 79 years combined, the number of new MM cases is expected to increase by 28%, from 16,000 to 21,000, primarily because of population growth. However, the number of persons living with MM is conservatively expected to increase by 55%, from 76,000 to 119,000, because of improvements in prognosis as well as population growth. The cumulative life year gain between 2011 through 2022 is around 50,000 life years. If recent treatments are as promising as they appear, these estimates will be conservative. CONCLUSION: Driven by access to modern therapies with unprecedented efficacy, overall survival for patients with MM will continue to improve significantly. Consequently, our forecast is MM will become much more common in the era of modern therapy. The numbers of patients living with MM are expected to increase more quickly than the corresponding numbers of new cases. Citation Format: Philip S. Rosenberg, Ana Best, William F. Anderson, Ola Landgren. Multiple myeloma will become a common cancer in the era of modern therapy. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 5231.

Cancer incidence trends using American Community Survey estimates are not consistent with SEER for small populations

BackgroundAmerican Community Survey (ACS) estimates are said to be uncertain for small areas and small population groups. The Surveillance, Epidemiology and End Results (SEER) database uses a decennial census extrapolation methodology to yield population estimates used by cancer researchers across the country. We compared metropolitan Detroit cancer incidence estimates calculated using ACS data to those using SEER population estimates, which we considered to be the gold standard. MethodsWe generated age-adjusted cancer incidence rate estimates for 1-year, 3-year and 5-year time periods (2005–2010) using SEER and ACS population estimates for four racial/ethnic groups by sex and cancer type for residents in the tri-county Detroit area. We calculated incidence rate ratios (IRRs) with corresponding 95% confidence intervals (CIs), and compared trends. ResultsWhile the IRRs were rarely significant, there were significant differences in incidence rate estimates for Hispanic males. Additionally, interpretation of trends varied by the estimate source: the ACS-based lung cancer incidence rate estimate for Hispanic females increased from 70.59 (95% CI 44.85, 110.67) to 86.13 (95% CI 54.83, 132.44) per 100,000 women from 2007 to 2010, while the SEER incidence rate estimate decreased from 80.76 (95% CI 53.36, 119.24) to 73.54 (95% CI 49.24, 106.62). ConclusionsInconsistencies were found when comparing incidence rate estimates for small population groups using the two population estimate sources. This finding has potential implications for health disparities research.

Abstract 3725: Subsequent gastrointestinal cancer risks of childhood and early adulthood cancer survivors

Abstract Introduction: The number of childhood/early adulthood cancer survivors has been growing due to improved cancer treatment, but subsequent malignant neoplasms (SMN) in the digestive system are an important cause of morbidity and mortality. Few studies have examined these survivors’ risks of developing various subsequent primary gastrointestinal (GI) cancers. In addition, although there have been SMN studies exclusively on Hodgkin lymphoma (HL) survivors, none have compared the GI cancer risks of young HL survivors with that of other young first primary cancer survivors. We used the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) Program registries to perform the largest analysis on the risks of developing various GI cancers in childhood/early adulthood cancer survivors. Methods: Among the patients reported to 9 SEER registries from 1973 to 2010, there were 28,858 children/young adults diagnosed with first primary cancer before 21 years of age and survived a minimum of 5 years. From these survivors, 103 GI SMNs were included in this analysis, of which 39 developed from 3,330 HL survivors. Standardized incidence ratios (SIR) were calculated using age-, sex-, race-, and calendar year-matched SEER incidence rates. Results: Relative to the general population, childhood/early adulthood cancer survivors had significantly higher risks of developing GI cancers (N = 103, SIR = 3.6, 95% CI: 2.9-4.3), esophageal cancer (N = 7, SIR = 7.0, 95% CI: 2.8-14.4), stomach cancer (N = 15, SIR = 5.6, 95% CI: 3.1-9.2), pancreatic cancer (N = 15, SIR = 5.9, 95% CI: 3.3-9.7), and colorectal cancer (N = 41, SIR = 2.5, 95% CI: 1.8-3.4). HL survivors had 6.8-fold higher risk of developing GI cancers (N = 39, 95% CI: 4.9-9.3), whereas survivors of other first primary cancers had 2.8-fold higher risk (N = 64, 95% CI: 2.1-3.5) (P-homogeneity&amp;lt;0.001). Those who received radiation treatment without chemotherapy for first primary cancer had 4.8-fold higher risk of developing GI cancers (N = 31, 95% CI: 3.2-6.8), with 8.1-fold higher risk for HL survivors (N = 23, 95% CI: 5.1-12.1) versus 2.2-fold higher risk for survivors of other primary cancers (N = 8, 95% CI: 1.0-4.3) (P-homogeneity&amp;lt;0.001). Conclusion: Childhood/early adulthood cancer survivors have significantly higher risks of developing GI cancers relative to the general population, with particularly high risks for upper GI sites and HL survivors. These novel findings may contribute to the clinical follow-up guidelines for young cancer survivors. Citation Format: Jason J. Liu, Lindsay M. Morton, Amy Berrington de González, Peter D. Inskip, Rochelle E. Curtis. Subsequent gastrointestinal cancer risks of childhood and early adulthood cancer survivors. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 3725. doi:10.1158/1538-7445.AM2015-3725

Early estimates of SEER cancer incidence for 2012: Approaches, opportunities, and cautions for obtaining preliminary estimates of cancer incidence.

The National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) program collects and publishes population-based cancer incidence data from registries covering approximately 28% (seer.cancer.gov/registries/data.html) of the US population. SEER incidence rates are released annually in April from data submitted the prior November. The time needed to identify, consolidate, clean, and submit data requires the latest diagnosis year included to be 3 years before release. Approaches, opportunities, and cautions for an earlier release of data based on a February submission are described. First, cases submitted in February for the latest diagnosis year represented 92% to 98% of those in the following November submission. A reporting delay model was used to statistically adjust counts in recent diagnosis years for cases projected in the future. February submissions required larger adjustment factors than November submissions. Second, trends were checked to assess the validity. Most cancer sites had similar annual percent change (APC) trends for February and November 2013. Male colon and rectum cancer and female lung and bronchus cancer showed an acceleration in declining APC trends only in February. Average annual percent change (AAPC) trends for the 2 submissions were similar for all sites. For the first time, preliminary 2012 incidence rates, based on February submissions, are provided. An accelerated decline starting in 2008 for male colon and rectum cancer rates and male lung cancer rates did not persist when 2012 data were added. An earlier release of SEER data is possible. Caution must be exercised when one is interpreting changing trends. Use of the more conservative AAPC is advised.