National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

PURPOSE: National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). METHODS: The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. RESULTS: The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. CONCLUSION: In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

Socioeconomic Deprivation and Health Care Use in Patients Enrolled in SWOG Cancer Clinical Trials.

Importance: Reducing acute care use is an important strategy for improving value. Patients with cancer are at risk for unplanned emergency department (ED) visits and hospital stays (HS). Clinical trial patients have homogeneous treatment; despite this, structural barriers to care may independently impact acute care use. Objective: To examine whether ED visits and HS within 12 months of trial enrollment are more common among Medicare enrollees who live in areas of socioeconomic deprivation or have Medicaid insurance. Design, Setting, and Participants: This cohort study included patients with cancer who were 65 years or older and treated in SWOG Cancer Research Network trials from 1999 to 2018 using data linked to Medicare claims. Data were collected from 1999 to 2019 and analyzed from 2022 to 2024. Main Outcomes and Measures: Outcomes were ED visits, HS, and costs in the first year following enrollment. Neighborhood socioeconomic deprivation was measured using patients' zip code linked to the Area Deprivation Index (ADI), measured on a 0 to 100 scale for increasing deprivation and categorized into tertiles (T1 to T3). Type of insurance was classified as Medicare with or without commercial insurance vs dual Medicare and Medicaid. Demographic, clinical, and prognostic factors were captured from trial records. Multivariable regression was used, and the association of ADI and insurance with each outcome was considered separately. Results: In total, 3027 trial participants were analyzed. The median (range) age was 71 (65-98) years, 1280 (32.3%) were female, 221 (7.3%) were Black patients, 2717 (89.8%) were White patients, 90 (3.0%) had Medicare and Medicaid insurance, and 660 (22.3%) were in the areas of highest deprivation (ADI-T3). In all, 1094 patients (36.1%) had an ED visit and 983 patients (32.4%) had an HS. In multivariable generalized estimating equation, patients living in areas categorized as ADI-T3 were more likely to have an ED visit (OR, 1.34; 95% CI, 1.10-1.62; P = .004). A similar but nonsignificant pattern was observed for HS (OR, 1.36; 95% CI, 0.96-1.93; P = .08). Patients from areas with the highest deprivation had a 62% increase in risk of either an ED visit or HS (OR, 1.62; 95% CI, 1.25-2.09; P < .001). Patients with Medicare and Medicaid were 96% more likely to have an ED visit (OR, 1.96; 95% CI, 1.56-2.46; P < .001). Conclusions and Relevance: In this cohort of older patients enrolled in clinical trials, neighborhood deprivation and economic disadvantage were associated with an increase in ED visits and HS. Efforts are needed to ensure adequate resources to prevent unplanned use of acute care in socioeconomically vulnerable populations.

Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022.

PURPOSE: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations. METHODS: Trial eligibility criteria were abstracted from ClinicalTrials.gov for phase I-III US-based interventional clinical trials for patients with advanced breast, colorectal, lung, or melanoma cancers from January 2012 to December 2022. Trials were examined to determine whether patients with brain metastases were not excluded, conditionally excluded (ie, excluded in some circumstances), or wholly excluded. An interrupted time series analysis with multinomial logistic regression was used to determine whether the ASCO/FoCR/FDA recommendations were associated with changes in brain metastases criteria. RESULTS: We evaluated N = 3,077 trials. Patients with brain metastases were not excluded in 506 trials (16.4%), conditionally excluded in 2,263 trials (73.5%), and wholly excluded in 308 trials (10.0%). In the postrecommendation period, we estimated a 68% increase in the odds of brain metastases not excluded compared with conditionally excluded (odds ratio, 1.68 [95% CI, 1.06 to 2.66], P = .03). The proportion of trials in which patients with brain metastases were not excluded increased (from 11.5% v 17.3%) and conditionally excluded decreased (from 82.3% to 75.2%, P = .03). We found no difference in the proportion of trials in which patients with brain metastases were wholly excluded (7.5% v 6.2%, P = .42). CONCLUSION: The ASCO/FoCR/FDA task force recommendations were associated with a shift in patterns of brain metastases exclusion criteria from conditionally excluded to not excluded. These findings demonstrate that the cancer clinical trial community has begun to change the way trials are written to be more inclusive.

Dynamic zero-COVID policy and healthcare utilization patterns in China during the Shanghai COVID-19 Omicron outbreak.

BACKGROUND: In April 2022, an outbreak of the SARS-CoV-2 virus Omicron variant in Shanghai precipitated an extensive lockdown. We assessed changes in healthcare utilization during this outbreak and investigated the relationship between the stringency of mitigation strategies and disruptions in healthcare utilization. METHODS: Using provincial-level data from routine health information systems covering all hospitals across Mainland China, we conducted an interrupted time series analysis to examine changes in healthcare utilization during the Shanghai outbreak. Linear regression was used to evaluate the direction and magnitude of the association between the relative changes in the move-out movement index, a proxy for the stringency in population-level mitigation strategies, and the estimated relative changes in healthcare utilization. RESULTS: Overall, there were 22.9 billion outpatient visits and 1.2 billion discharged inpatients during the study period from January 2016 to May 2022, including 9.1 billion (39.7%) and 0.46 billion (38.2%) in the post-COVID-19 period (January 2020-May 2022), respectively. From March through May 2022, the outbreak resulted in an accumulative loss of 23.5 million (47%) outpatient visits and 0.6 million (55%) discharged inpatients in Shanghai, and a loss of 150.3 million (14%) outpatient visits and 3.6 million (7%) discharged inpatients in other regions. We find that for every 10-percentage point reduction in the relative change of move-out index, a 2.7 (95% CI: 2.0-3.4) percentage point decline in the relative change of outpatient visits, and a 4.3 (95% CI: 3.5-5.2) percentage points decline in the relative change of inpatient discharges. CONCLUSIONS: The Shanghai COVID-19 Omicron outbreak associates with a substantial reduction in outpatient visits and inpatient discharges within Shanghai and other regions in China. The stringency of the COVID-19 lockdown policies associates with more profound reductions in healthcare utilization.

In April 2022, outbreaks in Shanghai owing to the SARS-CoV-2 virus Omicron variant prompted China's most extensive lockdown since the 2020 Wuhan shutdown. We use mathematical models to study the impact of stringent lockdown measures on the nation's use of healthcare services. We estimate that Omicron outbreak have reduced the number of outpatient visits and inpatients discharged from hospitals by 47% and 55%, respectively, in Shanghai alone, and 14% and 7% at the nationwide level. We show there is a direct correlation between increased level of strictness of lockdown strategies and reduction in healthcare usage. Our findings highlight the importance of investing in preparations of future pandemics, so that access to essential healthcare facilities is unaffected.

Universal Viral Screening of Patients with Newly Diagnosed Cancer in the United States: A Cost-efficiency Evaluation.

Recommendations for universal screening of patients with cancer for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) are inconsistent. A recent multisite screening study (S1204) from the SWOG Cancer Research Network found that a substantial number of patients with newly diagnosed cancer had previously unknown viral infections. The objective of this study was to determine the cost-efficiency of universal screening of patients with newly diagnosed cancer. We estimated the cost-efficiency of universal screening of new cancer cases for HBV, HCV, or HIV, expressed as cost per virus detected, from the health care payer perspective. The prevalence of each virus among this cohort was derived from S1204. Direct medical expenditures included costs associated with laboratory screening tests. Costs per case detected were estimated for each screening strategy. Secondary analysis examined the cost-efficiency of screening patients whose viral status at cancer diagnosis was unknown. Among the possible options for universal screening, screening for HBV alone ($581), HCV alone ($782), HBV and HCV ($631) and HBV, HCV, and HIV ($841) were most efficient in terms of cost per case detected. When screening was restricted to patients with unknown viral status, screening for HBV alone ($684), HBV and HCV ($872), HBV and HIV ($1,157), and all three viruses ($1,291) were most efficient in terms of cost per newly detected case. Efficient viral testing strategies represent a relatively modest addition to the overall cost of managing a patient with cancer. Screening for HBV, HCV, and HIV infections may be reasonable from both a budget and clinical standpoint. SIGNIFICANCE: Screening patients with cancer for HBV, HCV, and HIV is inconsistent in clinical practice despite national recommendations and known risks of complications from viral infection. Our study shows that while costs of viral screening strategies vary by choice of tests, they present a modest addition to the cost of managing a patient with cancer.

Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP).

PURPOSE: Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established infrastructure for conducting a biomarker-driven master protocol in molecularly targeted therapies. We compared characteristics of patients enrolled in Lung-MAP with those of patients in advanced non-small-cell lung cancer (NSCLC) trials to examine if master protocols improve trial access. METHODS: We examined patients enrolled in Lung-MAP (2014-2020) according to sociodemographic characteristics. Proportions for characteristics were compared with those for a set of advanced NSCLC trials (2001-2020) and the US advanced NSCLC population using SEER registry data (2014-2018). Characteristics of patients enrolled in Lung-MAP treatment substudies were examined in subgroup analysis. Two-sided tests of proportions at an alpha of .01 were used for all comparisons. RESULTS: A total of 3,556 patients enrolled in Lung-MAP were compared with 2,215 patients enrolled in other NSCLC studies. Patients enrolled in Lung-MAP were more likely to be 65 years and older (57.2% v 46.3%; P < .0001), from rural areas (17.3% v 14.4%; P = .004), and from socioeconomically deprived neighborhoods (42.2% v 36.7%, P < .0001), but less likely to be female (38.6% v 47.2%; P < .0001), Asian (2.8% v 5.1%; P < .0001), or Hispanic (2.4% v 3.8%; P = .003). Among patients younger than 65 years, Lung-MAP enrolled more patients using Medicaid/no insurance (27.6% v 17.8%; P < .0001). Compared with the US advanced NSCLC population, Lung-MAP under represented patients 65 years and older (57.2% v 69.8%; P < .0001), females (38.6% v 46.0%; P < .0001), and racial or ethnic minorities (14.8% v 21.5%; P < .0001). CONCLUSION: Master protocols may improve access to trials using novel therapeutics for older patients and socioeconomically vulnerable patients compared with conventional trials, but specific patient exclusion criteria influenced demographic composition. Further research examining participation barriers for under represented racial or ethnic minorities in precision medicine clinical trials is warranted.

Medicaid Expansion of the Patient Protection and Affordable Care Act and Participation of Patients With Medicaid in Cancer Clinical Trials.

Importance: The Patient Protection and Affordable Care Act (ACA) Medicaid expansion resulted in increased use of Medicaid insurance nationwide. However, the association between Medicaid expansion and access to clinical trials has not been examined to date. Objective: To examine whether the implementation of ACA Medicaid expansion was associated with increased participation of patients with Medicaid insurance in cancer clinical trials. Design, Setting, and Participants: Data for this cohort study of 51 751 patients were from the SWOG Cancer Research Network. All patients aged 18 to 64 years and enrolled in treatment trials with Medicaid or private insurance between April 1, 1992, and February 29, 2020, were included. Interrupted time-series analysis with segmented logistic regression was used. The monthly unemployment rate and presidential administration were adjusted to reflect potential differences in Medicaid use associated with economic conditions and national administrative policies, respectively. Data analysis was conducted between June 22, 2021, and August 5, 2022. Exposure: Implementation of Medicaid expansion on January 1, 2014, was the independent exposure variable. Main Outcomes and Measures: The number and proportion of patients by insurance type enrolled in cancer clinical trials over time were analyzed. Results: Overall, data for 51 751 patients were analyzed. Mean (SD) age was 50.6 (9.8) years, 67.3% of patients were female, 41.1% were younger than 50 years, and 9.1% used Medicaid. A 19% annual increase (odds ratio [OR], 1.19; 95% CI, 1.11-1.28; P < .001) was identified in the odds of patients using Medicaid after the ACA Medicaid expansion, resulting in a 52% increase (OR, 1.52; 95% CI, 1.29-1.78; P < .001) compared with what was expected in the number of Medicaid patients enrolled over time. The association was greater in states that adopted Medicaid expansion in 2014 to 2015 (OR, 1.26; 95% CI, 1.15-1.38; P < .001) compared with other states (OR, 1.08; 95% CI, 0.96-1.21; P = .20; P = .04 for interaction). By February 2020, the proportion of patients with Medicaid insurance was 17.8% (95% CI, 15.0%-20.8%; P < .001), whereas the expected proportion had ACA Medicaid expansion not occurred was 6.9% (95% CI, 4.4%-10.3%; P < .001). Conclusions and Relevance: Findings suggest that implementation of ACA Medicaid expansion was associated with increased participation of patients using Medicaid in cancer clinical trials. Improved participation in clinical trials for Medicaid-insured patients is critical for socioeconomically vulnerable patients seeking access to the newest treatments available in trials and for improving confidence that trial findings apply to patients of all backgrounds.

Excess All-Cause Mortality in China After Ending the Zero COVID Policy.

Importance: In China, the implementation of stringent mitigation measures kept COVID-19 incidence and excess mortality low during the first years of the pandemic. However, China's decision to end its dynamic zero COVID policy (a proactive strategy that deploys mass testing and strict quarantine measures to stamp out any outbreak before it can spread) in December 2022 resulted in a surge in COVID-19 incidence and hospitalizations. Despite worldwide attention given to this event, the actual impact of this sudden shift in policy on population mortality has not been empirically estimated. Objective: To assess the association of the sudden shift in China's dynamic zero COVID policy with mortality using empirical and syndromic surveillance data. Design, Setting, and Participants: This cohort study analyzed published obituary data from 3 universities in China (2 in Beijing and 1 in Heilongjiang) and search engine data from the Baidu index (BI; weighted frequency of unique searches for a given keyword relative to the total search volume on the Baidu search engine) in each region of China from January 1, 2016, to January 31, 2023. Using an interrupted time-series design, analyses estimated the relative change in mortality among individuals 30 years and older in the universities and the change in BI for mortality-related terms in each region of China from December 2022 to January 2023. Analysis revealed a strong correlation between Baidu searches for mortality-related keywords and actual mortality burden. Using this correlation, the relative increase in mortality in Beijing and Heilongjiang was extrapolated to the rest of China, and region-specific excess mortality was calculated by multiplying the proportional increase in mortality by the number of expected deaths. Data analysis was performed from February 10, 2023, to March 5, 2023. Exposure: The end to the dynamic zero COVID policy in December 2022 in China. Main Outcomes and Measures: Monthly all-cause mortality by region. Results: An estimated 1.87 million (95% CI, 0.71 million-4.43 million; 1.33 per 1000 population) excess deaths occurred among individuals 30 years and older in China during the first 2 months after the end of the zero COVID policy. Excess deaths predominantly occurred among older individuals and were observed across all provinces in mainland China except Tibet. Conclusions and Relevance: In this cohort study of the population in China, the sudden lifting of the zero COVID policy was associated with significant increases in all-cause mortality. These findings provide valuable insights for policy makers and public health experts and are important for understanding how the sudden propagation of COVID-19 across a population may be associated with population mortality.

Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics.

BACKGROUND: Cancer-related financial hardship is a side effect of cancer diagnosis and treatment, and affects both patients and caregivers. Although many oncology clinics have increased financial navigation services, few have resources to proactively provide financial counseling and assistance to families affected by cancer before financial hardship occurs. As part of an ongoing randomized study testing a proactive financial navigation intervention, S1912CD, among sites of the National Cancer Institute Community Oncology Research Program (NCORP), we conducted a baseline survey to learn more about existing financial resources available to patients and caregivers. METHODS: The NCORP sites participating in the S1912CD study completed a required 10-question survey about their available financial resources and an optional 5-question survey that focused on financial screening and navigation workflow and challenges prior to starting recruitment. The proportion of NCORP sites offering financial navigation services was calculated and responses to the optional survey were reviewed to determine current screening and navigation practices and identify any challenges. RESULTS: Most sites (96%) reported offering financial navigation for cancer patients. Sites primarily identified patients needing financial assistance through social work evaluations (78%) or distress screening tools (76%). Sites revealed challenges in addressing financial needs at the outset and through diagnosis, including lack of proactive screening and referral to financial navigation services as well as staffing challenges. CONCLUSIONS: Although most participating NCORP sites offer some form of financial assistance, the survey data enabled identification of gaps and challenges in providing services. Utilizing community partners to deliver comprehensive financial navigation guidance to cancer patients and caregivers may help meet needs while reducing site burden.

Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality.

PURPOSE: The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS: This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS: Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity. CONCLUSION: Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.

Adherence to Cancer Prevention Lifestyle Recommendations Before, During, and 2 Years After Treatment for High-risk Breast Cancer.

Importance: The American Institute for Cancer Research and American Cancer Society regularly publish modifiable lifestyle recommendations for cancer prevention. Whether these recommendations have an impact on high-risk breast cancer survival remains unknown. Objective: To investigate whether adherence to cancer prevention recommendations before, during, and 1 and 2 years after breast cancer treatment was associated with disease recurrence or mortality. Design, Setting, and Participants: The Diet, Exercise, Lifestyles, and Cancer Prognosis Study (DELCaP) was a prospective, observational cohort study designed to assess lifestyles before diagnosis, during treatment, and at 1 and 2 years after treatment completion, implemented ancillary to the Southwest Oncology Group (SWOG) S0221 trial, a multicenter trial that compared chemotherapy regimens in breast cancer. Participants were chemotherapy-naive patients with pathologic stage I to III high-risk breast cancer, defined as node-positive disease with hormone receptor-negative tumors larger than 1 cm or any tumor larger than 2 cm. Patients with poor performance status and comorbidities were excluded from S0221. The study was conducted from January 1, 2005, to December 31, 2010; mean (SD) follow-up time for those not experiencing an event was 7.7 (2.1) years through December 31, 2018. The analyses reported herein were performed from March 2022 to January 2023. Exposure: An aggregated lifestyle index score comprising data from 4 time points and 7 lifestyles, including (1) physical activity, (2) body mass index, (3) fruit and vegetable consumption, (4) red and processed meat intake, (5) sugar-sweetened beverage consumption, (6) alcohol consumption, and (7) smoking. Higher scores indicated healthier lifestyle. Main Outcomes and Measures: Disease recurrence and all-cause mortality. Results: A total of 1340 women (mean [SD] age, 51.3 [9.9] years) completed the baseline questionnaire. Most patients were diagnosed with hormone-receptor positive breast cancer (873 [65.3%]) and completed some education beyond high school (954 [71.2%]). In time-dependent multivariable analyses, patients with highest vs lowest lifestyle index scores experienced a 37.0% reduction in disease recurrence (hazard ratio, 0.63; 95% CI, 0.48-0.82) and a 58.0% reduction in mortality (hazard ratio, 0.42; 95% CI, 0.30-0.59). Conclusions and Relevance: In this observational study of patients with high-risk breast cancer, strongest collective adherence to cancer prevention lifestyle recommendations was associated with significant reductions in disease recurrence and mortality. Education and implementation strategies to help patients adhere to cancer prevention recommendations throughout the cancer care continuum may be warranted in breast cancer.

Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG).

PURPOSE: Clinical trial adverse event (AE) data are increasingly complex and high-dimensional, especially for trials evaluating novel targeted agents and immunotherapies. Standard approaches to summarize and analyze AEs remain generally tabular, failing to describe the nature of AEs. Novel dynamic and data visualization methods are needed to enable a more comprehensive assessment of the overall toxicity profile of treatments. METHODS: We developed methods for visualizing the numerous categorizations and types of AEs along with a dynamic approach to better reflect its highly dimensional nature without sacrificing the reporting of rare events. Circular plots displaying the proportion of maximal-grade AEs by system organ classes (SOCs) and butterfly plots displaying the proportion of AEs by severity for each AE term were developed to enable comparisons of AE patterns by treatment arm. These approaches were applied to a randomized phase III trial (S1400I; ClinicalTrials.gov identifier: NCT02785952) comparing nivolumab with nivolumab plus ipilimumab in patients with stage IV squamous non-small-cell lung cancer. RESULTS: Our visualizations revealed that patients randomly assigned to nivolumab and ipilimumab had higher rates of grade 3 or higher AEs compared with nivolumab alone for several SOCs, including musculoskeletal (5.6% v 0.8%), skin (5.6% v 0.8%), vascular (5.6% v 1.6%), and cardiac (4% v 1.6%) toxicities. They also suggested a pattern of higher prevalence of moderate GI and endocrine toxicities and showed that although the rates of cardiac and neurologic toxicities were similar, the types of events were discordant. CONCLUSION: The graphical approaches we proposed enable a more comprehensive and intuitive evaluation of toxicity types by treatment groups, which is not apparent in tabular and descriptive reporting methods.

Risk prediction of hepatitis B or C or HIV among newly diagnosed cancer patients.

BACKGROUND: Screening for viral infection in cancer patients is inconsistent. A mechanism to readily identify cancer patients at increased risk of existing or prior viral infection could enhance screening efforts while reducing costs. METHODS: We identified factors associated with increased risk of past or chronic hepatitis virus B, hepatitis virus C, or HIV infection before initiation of systemic cancer therapy. Data were from a multicenter prospective cohort study of 3051 patients with newly diagnosed cancer (SWOG-S1204) enrolled between 2013 and 2017. Patients completed a survey with questions pertaining to personal history and behavioral, socioeconomic, and demographic risk factors for viral hepatitis or HIV. We derived a risk model to predict the presence of viral infection in a random set of 60% of participants using best subset selection. The derived model was validated in the remaining 40% of participants. Logistic regression was used. RESULTS: A model with 7 risk factors was identified, and a risk score with 4 levels was constructed. In the validation cohort, each increase in risk level was associated with a nearly threefold increased risk of viral positivity (odds ratio = 2.85, 95% confidence interval = 2.26 to 3.60, P < .001). Consistent findings were observed for individual viruses. Participants in the highest risk group (with >3 risk factors), comprised of 13.4% of participants, were 18 times more likely to be viral positive compared with participants with no risk factors (odds ratio = 18.18, 95% confidence interval = 8.00 to 41.3, P < .001). CONCLUSIONS: A risk-stratified screening approach using a limited set of questions could serve as an effective strategy to streamline screening for individuals at increased risk of viral infection.

Automatic electronic reporting improved the completeness of AMI and stroke incident surveillance in Tianjin, China: a modeling study.

BACKGROUND: AMI and stroke are the leading causes of premature mortality and hospitalizations in China. Incidence data at the population level for the two diseases is limited and the reliability and completeness of the existing incidence registry have not been investigated. We aim to assess if the completeness of case ascertainment of AMI and stroke incidence has improved since the implementation of electronic reporting and to estimate the incidence of AMI and stroke in Tianjin, China. METHODS: We applied the DisMod II program to model the incidence of AMI and stroke from other epidemiological indicators. Inputs include mortality rates from Tianjin's mortality surveillance system, and the point prevalence, remission rates and relative risks taken from IHME's Global Burden of Disease studies. The completeness of AMI and stroke incidence reporting was assessed by comparing the sex and age-specific incidence rates derived from the incidence surveillance system with the modeled incidence rates. RESULTS: The age and sex standardized modeled incidence per 100,000 person-year decreased (p < 0.0001) from 138 in 2007 to 119 in 2015 for AMI and increased (p < 0.0001) from 520 in 2007 to 534 in 2015 for stroke. The overall completeness of incidence report was 36% (95% CI 35-38%) for AMI and 54% (95% CI 53-55%) for stroke. The completeness was higher in men than in women for both AMI (42% vs 30%, p < 0.0001) and stroke (55% vs 53%, p < 0.0001) and was higher in residents aged 30-59 than those aged 60 or older for AMI (57% vs 38%, p < 0.0001). The completeness of reporting increased by 7.2 (95% CI 4.6-9.7) and 15.7 (95% CI 14.4-16.9) percentage points for AMI and stroke, respectively, from 2007 to 2015 among those aged 30 or above. The increases were observed in both men and women (p < 0.0001) and were more profound (p < 0.0001) among those aged between 30 and 59 and occurred primarily during the 2010 and 2015 period. CONCLUSIONS: Completeness of AMI and stroke incidence surveillance was low in Tianjin but has improved in recent years primarily owing to the incorporation of an automatic reporting component into the information systems of health facilities.

Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I.

BACKGROUND: An important issue for patients with cancer treated with novel therapeutics is how they weigh the effects of treatment on survival and quality of life (QOL). We compared QOL in patients enrolled to SWOG S1400I, a substudy of the LungMAP biomarker-driven master protocol. METHODS: SWOG S1400I was a randomized phase III trial comparing nivolumab plus ipilimumab vs nivolumab for treatment of immunotherapy-naïve disease in advanced squamous cell lung cancer. The primary endpoint was the MD Anderson Symptom Inventory-Lung Cancer severity score at week 7 and week 13 with a target difference of 1.0 points, assessed using multivariable linear regression. A composite risk model for progression-free and overall survival was derived using best-subset selection. RESULTS: Among 158 evaluable patients, median age was 67.6 years and most were male (66.5%). The adjusted MD Anderson Symptom Inventory-Lung Cancer severity score was 0.04 points (95% confidence interval [CI] = -0.44 to 0.51 points; P = .89) at week 7 and 0.12 points (95% CI = -0.41 to 0.65; P = .66) at week 13. A composite risk model showed that patients with high levels of appetite loss and shortness of breath had a threefold increased risk of progression or death (hazard ratio [HR] = 3.06, 95% CI = 1.88 to 4.98; P < .001) and that those with high levels of both appetite loss and work limitations had a fivefold increased risk of death (HR = 5.60, 95% CI = 3.27 to 9.57; P < .001)-compared with those with neither risk category. CONCLUSIONS: We found no evidence of a benefit of ipilimumab added to nivolumab compared with nivolumab alone for QOL in S1400I. A risk model identified patients at high risk of poor survival, demonstrating the prognostic relevance of baseline patient-reported outcomes even in those with previously treated advanced cancer.

Racial and Ethnic Disparity in Preference-Weighted Quality of Life: Findings from the Selenium and Vitamin E Cancer Prevention Trial.

Differences in preference-weighted health-related quality of life (HRQOL) scores by race/ethnicity may be due to social factors. Here, Short-Form Six-Dimension (SF-6D) scores are analyzed among men in a prostate cancer prevention trial to explore such differences. Selenium and vitamin E cancer prevention trial participants who completed the SF-6D at baseline, and in at least 1 of follow-up years 1, 3, and 5 were included. This study compared mean SF-6D scores across race/ethnicity at each point using a linear mixed model controlling for demographic and clinical characteristics. At baseline, 9691 men were eligible for analysis, of whom 7556 (78%) were non-Hispanic White, 1592 (16.4%) were non-Hispanic Black, and 543 (5.6%) were Hispanic. Hispanic and White participants had higher unadjusted mean SF-6D scores than Black participants at every time point (P < 0.05), while white participants had lower mean scores than Hispanic participants at every time point after baseline (P < 0.05). After adjusting for covariates, statistically significant differences in HRQOL among the 3 groups persisted. Hispanic participants had higher preference scores than White participants by 0.073 (P < 0.001), 0.075 (P < 0.001), and 0.040 (P < 0.001) in follow-up years 1, 3, and 5, respectively. Black participants had lower scores than White participants by 0.009 (P = 0.004) and 0.008 (P = 0.02) in follow-up years 1 and 3, respectively. The results suggest there is a preference-weighted HRQOL difference by race/ethnicity that cannot be explained by social and clinical variables alone. Understanding how individuals belonging to different racial/ethnic categories view their own HRQOL is necessary for culturally competent care and cost-effectiveness analyses.

Effectiveness of Adjuvant Pembrolizumab vs High-Dose Interferon or Ipilimumab for Quality-of-Life Outcomes in Patients With Resected Melanoma: A Secondary Analysis of the SWOG S1404 Randomized Clinical Trial.

Importance: A key issue for the adjuvant treatment of patients with melanoma is the assessment of the effect of treatment on relapse, survival, and quality of life (QOL). Objective: To compare QOL in patients with resected melanoma at high risk for relapse who were treated with adjuvant pembrolizumab vs standard of care with either ipilimumab or high-dose interferon α 2b (HDI). Design, Setting, and Participants: The S1404 phase 3 randomized clinical trial was conducted by the SWOG Cancer Research Network at 211 community/academic sites in the US, Canada, and Ireland. Patients were enrolled from December 2015 to October 2017. Data analysis for this QOL substudy was completed in March 2022. Overall, 832 patients were evaluable for the primary QOL end point. Interventions: Patients were randomized (1:1) to treatment with adjuvant pembrolizumab vs standard of care with ipilimumab/HDI. Main Outcomes and Measures: Quality of life was assessed for patients at baseline and cycles 1, 3, 5, 7, and 9 after randomization using the Functional Assessment of Cancer Therapy (FACT) Biological Response Modifiers (FACT-BRM), FACT-General, Functional Assessment of Chronic Illness Therapy-Diarrhea, and European QOL 5-Dimension 3-Level scales. The primary end point was the comparison by arm of cycle 3 FACT-BRM trial outcome index (TOI) scores using linear regression. Linear-mixed models were used to evaluate QOL scores over time. Regression analyses included adjustments for the baseline score, disease stage, and programmed cell death ligand 1 status. A clinically meaningful difference of 5 points was targeted. Results: Among 1303 eligible patients (median [range] age, 56.7 [18.3-86.0] years; 524 women [40.2%]; 779 men [59.8%]; 10 Asian [0.8%], 7 Black [0.5%], 44 Hispanic [3.4%], and 1243 White [95.4%] individuals), 1188 (91.1%) had baseline FACT-BRM TOI scores, and 832 were evaluable at cycle 3 (ipilimumab/HDI = 267 [32.1%]; pembrolizumab = 565 [67.9%]). Evaluable patients were predominantly younger than 65 years (623 [74.9%]) and male (779 [58.9%]). Estimates of FACT-BRM TOI cycle 3 compliance did not differ by arm (ipilimumab/HDI, 96.0% vs pembrolizumab, 98.3%; P = .25). The adjusted cycle 3 FACT-BRM TOI score was 9.6 points (95% CI, 7.9-11.3; P < .001) higher (better QOL) for pembrolizumab compared with ipilimumab/HDI, exceeding the prespecified clinically meaningful difference. In linear-mixed models, differences by arm exceeded 5 points in favor of pembrolizumab through cycle 7. In post hoc analyses, FACT-BRM TOI scores favored the pembrolizumab arm compared with the subset of patients receiving ipilimumab (difference, 6.0 points; 95% CI, 4.1-7.8; P < .001) or HDI (difference, 17.0 points; 95% CI, 14.6-19.4; P < .001). Conclusions and Relevance: This secondary analysis of a phase 3 randomized clinical trial found that adjuvant pembrolizumab improved QOL vs treatment with adjuvant ipilimumab or HDI in patients with high-risk resected melanoma. Trial Registration: ClinicalTrials.gov identifier: NCT02506153.

Population, Clinical, and Scientific Impact of National Cancer Institute's National Clinical Trials Network Treatment Studies.

PURPOSE: In the United States, the National Cancer Institute National Cancer Clinical Trials Network (NCTN) groups have conducted publicly funded oncology research for 50 years. The combined impact of all adult network group trials has never been systematically examined. METHODS: We identified randomized, phase III trials from the adult NCTN groups, reported from 1980 onward, with statistically significant findings for ≥ 1 clinical, time-dependent outcomes. In the subset of trials in which the experimental arm improved overall survival, gains in population life-years were estimated by deriving trial-specific hazard functions and hazard ratios to estimate the experimental treatment benefit and then mapping this trial-level benefit onto the US cancer population using registry and life-table data. Scientific impact was based on citation data from Google Scholar. Federal investment costs per life-year gained were estimated. The results were derived through December 31, 2020. RESULTS: One hundred sixty-two trials comprised of 108,334 patients were analyzed, representing 29.8% (162/544) of trials conducted. The most common cancers included breast (34), gynecologic (28), and lung (14). The trials were cited 165,336 times (mean, 62.2 citations/trial/year); 87.7% of trials were cited in cancer care guidelines in favor of the recommended treatment. These studies were estimated to have generated 14.2 million (95% CI, 11.5 to 16.5 million) additional life-years to patients with cancer, with projected gains of 24.1 million (95% CI, 19.7 to 28.2 million) life-years by 2030. The federal investment cost per life-year gained through 2020 was $326 in US dollars. CONCLUSION: NCTN randomized trials have been widely cited and are routinely included in clinical guidelines. Moreover, their conduct has predicted substantial improvements in overall survival in the United States for patients with oncologic disease, suggesting they have contributed meaningfully to this nation's health. These findings demonstrate the critical role of government-sponsored research in extending the lives of patients with cancer.