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Chimeric antigen receptor (CAR) T-cell therapy is rapidly advancing, offering promising treatments for patients with hematological malignancy. However, associated infectious complications remain a significant concern because of their contribution to patient morbidity and non-relapse mortality. Recent epidemiological insights shed light on risk factors for infections after CAR T-cell therapy. However, the available evidence is predominantly retrospective, highlighting a need for further prospective studies. Institutions are challenged with managing infections after CAR T-cell therapy but variations in the approaches taken underscore the importance of standardizing infection prevention and management protocols across different healthcare settings. Therefore, the Infectious Diseases Special Interest Group of the American Society of Transplantation and Cellular Therapy assembled an expert panel to develop best practice considerations. The aim was to guide healthcare professionals in optimizing infection prevention and management for CAR T-cell therapy recipients and advocates for early consultation of Infectious Diseases during treatment planning phases given the complexities involved. By synthesizing current evidence and expert opinion these best practice considerations provide the basis for understanding infection risk after CAR T-cell therapies and propose risk-mitigating strategies in children, adolescents, and adults. Continued research and collaboration will be essential to refining and effectively implementing these recommendations., (Copyright © 2024 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Importance: Utilization of hematopoietic cell transplantation (HCT) for hematologic cancers previously demonstrated race, ethnicity, and age-based disparities., Objective: To evaluate utilization over time by race, ethnicity, and age to determine if disparities persist in light of recent significant increases in HCT volume., Design, Setting, and Participants: This US population-based retrospective cohort study includes patients who received transplants from January 2009 to December 2018. Data collection and cleaning occurred from February 2019 to November 2021, and data analysis occurred from January 2022 to October 2023. Method 1 restricted the analysis to Surveillance, Epidemiology and End Results (SEER) reporting areas for cases and transplants. Method 2 applied SEER age-, race-, and ethnicity-specific incidence rates to corresponding US census population and included all transplants reported to the Center for International Blood and Marrow Transplant Research. Race and ethnicity groups were hierarchically defined as Hispanic (any race), non-Hispanic White, non-Hispanic Black, and non-Hispanic Other (Asian and American Indian)., Exposure: Receipt of HCT., Main Outcomes and Measures: Utilization rate of autologous or allogeneic HCT for patients with hematologic cancers by age, race, and ethnicity., Results: From 2009 to 2018, 136 280 HCTs were analyzed for 6 hematologic cancers comprising 16.7% pediatric/adolescent/young adults (0-39 years), 83.3% adults (40-84 years), 58% male, 10.3% Hispanic, 11.4% non-Hispanic Black, 3.8% non-Hispanic Other, and 74.5% non-Hispanic White patients, with 49 385 allogeneic and 86 895 autologous HCTs performed. HCT utilization increased over time for all disease, age, race, and ethnic groups. From 2017 to 2018, adult (40-84 years) allogeneic transplant utilization for acute myeloid leukemia and myelodysplastic syndrome (MDS) was similar for Hispanic and non-Hispanic White or Other patients but was lower for non-Hispanic Black patients (acute myeloid leukemia: 19% vs 13%; MDS: 9%-10% vs 5%). Similarly, autologous transplant utilization for lymphoma was similar for all race and ethnicity groups; however, autologous transplant for multiple myeloma was highest for non-Hispanic White patients and lower for all other groups (31% vs 26%-27%). In patients aged 0 to 39 years, utilization of allogeneic transplant for acute lymphoblastic leukemia was highest in Hispanic patients, followed by non-Hispanic White, Black, and Other races (acute lymphoblastic leukemia: 19%, 18%, 17%, and 16%, respectively)., Conclusions and Relevance: In this cohort study of autologous and allogeneic transplant utilization for hematologic cancers, disparities persisted for non-Hispanic Black patients. Hispanic, non-Hispanic Other, and younger age groups had increased utilization over time that was on par with non-Hispanic White patients in the most recent cohort.

Background: The long-term financial impact of cancer care has not been adequately addressed in young adults. As part of a remote intervention study, we describe medical financial distress and hardship among young adult survivors of blood cancer at study entry., Methods: Young adults were recruited from 6 US hospitals. Using a Research Electronic Data Capture link, young adults confirmed their eligibility-namely, currently 18 to 39 years of age, blood cancer diagnosis 3 or more years ago, off active treatment, and not on parent's insurance. Following consent, the baseline assessment was sent. The primary outcome measure, the Personal Financial Wellness Scale, measured financial distress (scored as severe, 1-2; high, 3-4; average, 5-6; and low to no, 7-10). Medical financial hardship encompassed material hardship, psychological impact, and coping behaviors. Descriptive summary statistics and linear regression were used., Results: Among the 126 participants, 54.5% came from minority racial or ethnic groups. Median time since diagnosis was 10 years (interquartile range = 6-16 years), with 56% having received a diagnosis when they were between 18 and 39 years of age. The overall mean (standard deviation) Personal Financial Wellness Scale score was 5.1 (2.4), but 49% reported severe or high distress. In multivariable analysis, female sex, Hispanic ethnicity, and lower income were strongly associated with worse Personal Financial Wellness Scale scores. Among participants with severe financial distress (n = 26), 72% reported 2 or more household material hardships, had worse scores across all psychological domains, and altered survivorship care because of cost (68%)., Conclusions: Nearly half of long-term young adult cancer survivors reported severe or high levels of financial distress. Individuals with severe or high distress also reported more medical financial hardship than other participants. This finding highlights the need for ongoing financial intervention in this vulnerable population., Clinicaltrials.gov: NCT05620979., (© The Author(s) 2024. Published by Oxford University Press.)

Chimeric antigen receptor (CAR) T-cell therapy is a human gene therapy product where T cells from a patient are genetically modified to enable them to recognize desired target antigen(s) more effectively. In recent years, promising antitumor activity has been seen with autologous CAR T cells. Since 2017, six CAR T-cell therapies for the treatment of hematological malignancies have been approved by the Food and Drug Administration (FDA). Despite the rapid progress of CAR T-cell therapies, considerable statistical challenges still exist for this category of products across all phases of clinical development that need to be addressed. These include (but not limited to) dose finding strategy, implementation of the estimand framework, use of real-world data in contextualizing single-arm CAR T trials, analysis of safety data and long-term follow-up studies. This paper is the first step in summarizing and addressing these statistical hurdles based on the development of the six approved CAR T-cell products., (© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Low socioeconomic status (SES) is a risk factor for mortality and immune dysfunction across a wide range of diseases, including cancer. However, cancer is distinct in the use of allogeneic hematopoietic cell transplantation (HCT) as a treatment for hematologic malignancies to transfer healthy hematopoietic cells from one person to another. This raises the question of whether social disadvantage of an HCT cell donor, as assessed by low SES, might impact the subsequent health outcomes of the HCT recipient. To evaluate the cellular transplantability of SES-associated health risk, we analyzed the health outcomes of 2,005 HCT recipients who were transplanted for hematologic malignancy at 125 United States transplant centers and tested whether their outcomes differed as a function of their cell donor's SES (controlling for other known HCT-related risk factors). Recipients transplanted with cells from donors in the lowest quartile of SES experienced a 9.7% reduction in overall survival ( P = 0.001) and 6.6% increase in treatment-related mortality within 3 y ( P = 0.008) compared to those transplanted from donors in the highest SES quartile. These results are consistent with previous research linking socioeconomic disadvantage to altered immune cell function and hematopoiesis, and they reveal an unanticipated persistence of those effects after cells are transferred into a new host environment. These SES-related disparities in health outcomes underscore the need to map the biological mechanisms involved in the social determinants of health and develop interventions to block those effects and enhance the health of both HCT donors and recipients., Competing Interests: Competing interests statement:The authors declare no competing interest.

In the recent few decades, outcomes in patients diagnosed with hematological malignancies have been steadily improving. However, the improved prognosis does not distribute equally among patients from different backgrounds. Besides cancer biology, demographic and geographic disparities have been found to impact overall survival significantly. Specifically, patients from underrepresented minorities including Black and Hispanics, and those with uninsured status, having low socioeconomic status, or from rural areas have had worse outcomes historically, which is uniformly true across all major subtypes of hematological malignancies. Similar discrepancy is also seen in the health care professional field, where a gender gap and a disproportionally low representation of health care providers from underrepresented minorities have been long existing. Thus, a comprehensive strategy to mitigate disparity in the health care system is needed to achieve equity in health care., Competing Interests: Declaration of competing interest Xiaoyi Chen, Mihir Shukla and Shella Saint Fleur-Lominy declare no conflict of interest., (Copyright © 2024. Published by Elsevier Ltd.)

Chimeric antigen receptor T-cell (CAR-T) therapy has achieved durable response in patients with hematological malignancies, however, therapy-associated multisystem toxicities are commonly observed. Here, we systematically analyzed CAR-T-related gastrointestinal adverse events (GAEs) using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) between January 2017 and December 2021. Disproportionality analyses were performed using reporting odds ratios (ROR) and information component (IC). Among 105,087,611 reports in FAERS, 1518 CAR-T-related GAEs reports were identified. 23 GAEs (n = 281, 18.51%) were significantly overreported following CAR-T therapy compared with the full database, of which 11 GAEs (n = 156, 10.28%) were associated with gastrointestinal infections (GI), such as clostridium difficile colitis (n = 44 [2.90%], ROR = 5.55), enterovirus infection (n = 23 [1.52%], ROR = 20.02), and mucormycosis (n = 15 [0.99%], ROR = 3.09). Overall, the fatality rate of 11 GI-related AEs was 29.49%, especially mucormycosis causing substantial mortality with 60%. In addition, 4 of 23 overreported GAEs were related to haemorrhage and the mortality of gastrointestinal haemorrhage was 73.17%. Lastly, 29 death-related GAEs were identified. These findings could help clinicians early alert those rarely reported but lethal GAEs, thus reducing the risk of severe toxicities., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

The mortality due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) approaches 40% in recipients of chimeric antigen receptor (CAR) T cell therapy (CAR-T). The efficacy of repeated vaccine doses, including bivalent boosters, remains unknown. We examined the efficacy of repeated vaccine doses among CAR-T recipients who received at least 2 or more vaccine doses after T cell infusion. This single-center retrospective study included adults age >18 years receiving CAR-T for relapsed/refractory (R/R) B cell hematologic malignancies targeting CD19, BCMA, or CD19 and CD20 between September 2018 through March 2022 and were alive beyond 2021 to receive incremental SARS-CoV-2 vaccine doses with available seroconversion data. Multivariable analyses were performed using the design-adjusted Cox regression and logistic regression approaches with stratification. In multivariable analysis, seroconversion rates were significantly greater with a total of 4 or more vaccine doses (odds ratio [OR], 8.22; P = .008). CAR-T recipients with other B cell hematologic malignancies had significantly lower seroconversion rates and diminished Ab titers compared to those with R/R multiple myeloma (OR, .07; P = .003). One patient died due to COVID-19 in this vaccinated study cohort, accounting for a COVID-19-attributable mortality rate of 1.7%. The results provide baseline vaccine response data in a contemporary cohort including patients with diverse group of SARS-COV2 variants and support the latest Centers for Disease Control and Prevention guidelines for repeated vaccinations directed against the prevalent variant of concern., (Copyright © 2023 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Allogeneic hematopoietic stem cell transplant (allo-HSCT) is increasingly being used in the United States (US) and across the world as a curative therapeutic option for patients with certain high-risk hematologic malignancies and non-malignant diseases. However, racial and ethnic disparities in utilization of the procedure and in outcome following transplant remain major problems. Racial and ethnic minority patients are consistently under-represented in the proportion of patients who undergo allo-HSCT in the US. The transplant outcomes in these patients are also inferior. The interrelated driving forces responsible for the differences in the utilization and transplant outcome of the medical intervention are socioeconomic status, complexity of the procedure, geographical barriers, and the results of differences in the genetics and comorbidities across different races. Bridging the disparity gaps is important not only to provide equity and inclusion in the utilization of this potentially life-saving procedure but also in ensuring that minority groups are well represented for research studies about allo-HSCT. This is required to determine interventions that may be more efficacious in particular racial and ethnic groups. Various strategies at the Federal, State, and Program levels have been designed to bridge the disparity gaps with varying successes. In this review paper, we will examine the disparities and discuss the strategies currently available to address the utilization and outcome gaps between patients of different races in the US., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Chimeric antigen receptor T cell (CAR-T) immunotherapy has revolutionized the treatment of relapsed and refractory B cell-derived hematologic malignancies. Currently, there are 6 Food and Drug Administration-approved commercial CAR-T products that target antigens exclusively expressed on malignant B cells or plasma cells. However, concurrent advancement for patients with rarer and more aggressive T cell-derived hematologic malignancies have not yet been achieved. CAR-T immunotherapies are uniquely limited by challenges related to CAR-T product manufacturing and intrinsic tumor biology. In this review tailored for practicing clinician-scientists, we discuss the major barriers of CAR-T implementation against T cell-derived neoplasms and highlight specific scientific advancements poised to circumvent these obstacles. We summarize salient early-stage clinical trials implementing novel CAR-T immunotherapies specifically for patients with relapsed and/or refractory T cell neoplasms. Finally, we highlight novel manufacturing and treatment strategies that are poised to have a meaningful future clinical impact., (Copyright © 2023 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Most patients with high-risk hematologic malignancies are treated in community oncology practices near their residence. This is partly due to patients' ardent desire to be closer to home and trust in local caregivers. Treatments are increasingly complex, even as initial therapy, and more so upon relapse. Improved outcomes in the past decade are largely available through clinical trials primarily offered through academic medical centers. Limited availability of clinical trials at community oncology practices is a major contributor to outcome disparities among minorities, rural, and elderly patients, all of whom are underrepresented in clinical trials. Between 2003 and 2023, the National Cancer Institute (NCI) established programs to address these challenges: the Community Clinical Oncology Program, Minority- Based Community Clinical Oncology Program, NCI Community Cancer Centers Program, and NCI Community Oncology Research Program. However, disparities have persisted, particularly for pharmaceutical-directed clinical research. Lack of representation in clinical research results in data absenteeism, data chauvinism and hallucination, and a delay in treatment availability for high-risk hematologic malignancies in community practice. To address this, the US Congress enacted the Food and Drug Administration Omnibus Act in 2022 to help establish diversity plans that would broaden clinical trial patient enrollment in the United States. We recommend using these initiatives in community oncology practices, including the adoption of the DRIVE strategy in collaboration with pharmaceutical companies, as well as using the NCI-established programs to promote clinical trial availability for patients with high-risk malignancies treated in community oncology practices., (Copyright © 2023 by The American Society of Hematology.)

Although racial and ethnic disparities in diagnosis, treatment, and survival have been well documented within the field of hematologic malignancies, very little work has focused on testing interventions that may reduce these disparities. The aim of this commentary is to review prior work in hematologic malignancies and explore new opportunities to develop disparity-reducing interventions by drawing from evidence-based strategies that have been successfully implemented in fields related to hematologic malignancies, including oncology and solid organ transplants. Relevant literature demonstrates that patient navigation and broader insurance coverage have been shown to reduce racial and ethnic disparities among patients with solid malignancies such as colorectal and breast cancer. Evidence-based strategies that might be most applicable to the field of hematologic malignancies include patient navigation and policy changes., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Cellular therapy has emerged as a key tool in the treatment of hematological malignancies. An advanced cell therapy known as chimeric antigen receptor T cell therapy (CAR T-cell therapy) has been approved by the United States Food and Drug Administration (FDA) as KYMRIAH by Novartis and YESCARTA by Gilead/Kite pharma in the year 2017. A chimeric receptor is composed of an extracellular antigen recognition site along with some co-stimulating and signalling domains. On the whole, it turns out to be one of the most potent receptors on T cells targeting a specific type of cancer cell based on its antigenic marker. CD19 CAR T-cell therapy is the first clinically approved therapy for lymphoma with remarkable results in complete remission of B cell lymphoblastic leukemia up to 90%. The high rate of effectiveness of the CAR T-cell therapy against B-ALL justifies the investigation and application of this therapy for fatal diseases like all types of hematological malignancies. The most critical aspect of chimeric receptor therapy is designing and building an artificial receptor that is specific to a given type of cancer. For this reason, the in silico technique is an appropriate model to investigate the integrity and effectiveness of the engineered chimeric receptor prior to commencing in vitro experiments followed by clinical trials. This computerized experimental study aids in predicting the molecular mechanism of chimeric protein and how it interacts with both ligands. We have anticipated various features of the chimeric protein in terms of qualitative analysis (structure, protein modelling, physiological properties) and functional analysis (antigenicity, allergenicity, its receptor-ligand binding ability, involving signalling pathways). Furthermore, the reliability and validation of the binding mode of the chimeric protein against receptors were performed through a complex molecular dynamics simulation for a 100 ns timeframe in an aqueous environment. The obtained simulation study showed that CD30 was a better approachable marker as compared to CD20 due to its better binding energy score and also binding conformations stability., Competing Interests: Declaration of competing interest No conflicts declared by all authors., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

We investigated gender inequality in the National Institutes of Health (NIH) funding for hematologic malignancies and cellular therapies (HMCT). The data were retrieved from the NIH Research Portfolio Online Reporting Tools (RePORT). In 2018-2019, 1834 grants totaling $799 million were awarded (men 71% vs. women 29%) to 975 principal investigators (PIs), including 680 (70%) male PIs and 295 (30%) female PIs. There was no significant gender difference in the mean grant amount per PI. Male PIs as compared to female PIs had a higher h-index (44 vs 31, p  < 0.001) , a higher number of publications (159.5 vs 94, p  < 0.001), and higher years of active research (26 vs 21, p  < 0.001). In multivariate analyses, a higher h-index independently predicted a higher mean grant amount per PI ( p  = 0.010), and female PIs were independently less likely to have a higher h-index ( p  < 0.001). Our study shows significant gender disparity in the NIH funding for HMCT research.

Chimeric antigen receptor T-cell (CAR-T) therapy is a revolutionary cancer treatment modality where a patient's own T cells are collected and engineered ex vivo to express a chimeric antigen receptor (CAR). These reprogrammed CAR-T cells, when reinfused into the same patient, stimulate a T-cell mediated immune response against the antigen-expressing malignant cells leading to cell death. The initial results from pivotal clinical trials of CAR-T agents have been promising, leading to multiple approvals in various hematologic malignancies in the relapsed setting, including acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, follicular lymphoma, and, more recently, multiple myeloma. However, since the initial trials and US Food and Drug Administration approvals, there have been significant barriers to the widespread use of this therapy. The barriers to the use of CAR-T therapy include complex logistics, manufacturing limitations, toxicity concerns, and financial burden. This review discusses potential solutions to overcome these barriers in order to make this life-changing therapy widely accessible., (© 2022. The Author(s).)

The introduction of post-transplantation cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis has made haploidentical (haplo) hematopoietic stem cell transplantation (HSCT) a common approach in adults, but pediatric experience is limited. Based on the encouraging adult data and with the aim of decreasing the risk of graft failure, our center is increasingly using peripheral blood stem cells (PBSCs) from haplo donors with PTCy. Here we compare outcomes of bone marrow (BM) transplantation with traditional donor choices, including matched sibling donors (MSDs) and 10/10 HLA matched unrelated donors (MUDs), with those of haplo PBSC grafts in pediatric patients with hematologic malignancies. In this retrospective single-center study, the primary endpoint was the comparison of GVHD-free relapse-free survival (GRFS; defined as absence of acute GVHD [aGVHD] grade III-IV, relapse, death, or chronic GVHD [cGVHD] requiring systemic therapy) for the 3 cohorts. Secondary endpoints included overall survival (OS), relapse-free survival (RFS), nonrelapse mortality (NRM), and incidence of aGVHD and cGVHD). A total of 104 consecutive patients underwent first allogeneic (allo)-HSCT for a hematologic malignancy or myelodysplastic syndrome between January 2014 and December 2020 using a haplo family donor (PBSCs; n = 26), an MSD (BM; n = 31), or an MUD (BM; n = 47). Patient demographic and transplantation characteristics were not significantly different across the cohorts, apart from remission status, with the haplo cohort having more patients in third or later complete remission before HSCT (P < .01). The median duration of follow-up for the entire cohort was 573 days. The cumulative incidence of aGVHD (grade II-IV or grade III-IV) was not significantly different among the cohorts; however, the cumulative incidence of cGVHD at 18 months was highest in the MUD cohort (31.7%, versus 10.0% in the MSD cohort and 9.2% in the haplo cohort; P = .02). There were no differences in the 18-month cumulative incidence of relapse or NRM. OS and RFS at 18 months were 80.7% (95% confidence interval [CI], 61.7% to 100%) and 73.8% (95% CI, 55.5% to 98.1%) for the haplo cohort, 83.4% (95% CI, 72.8% to 95.5%) and 70.3% (95% CI, 57.9% to 85.3%) for the MUD cohort, and 80.9% (95% CI, 66.9% to 97.7%) and 66.5% (95% CI, 50.5% to 87.5%) for the MSD cohort, with no statistically significant differences among the cohorts. GRFS at 18 months was 61% (95% CI, 43.3% to 85.9%) for the haplo cohort, 44.6% (95% CI, 31.8% to 62.5%) for the MUD cohort, and 62.1% (95% CI, 45.7% to 84.3%) for the MSD cohort (P = .26). Haploidentical PBSC HSCT with PTCy had comparable outcomes to MSD and MUD BM HSCT and less cGVHD compared with MUD BM HSCT in children. The logistical advantages and lower resource burden of haplo HSCT with PBSCs make it a feasible alternative to MUD HSCT in children with hematologic malignancies. Given that this is a retrospective comparison of transplantation platforms rather than donor types, further prospective studies are warranted. © 2021 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc., (Copyright © 2021 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Purpose: This study evaluated risk factors predicting unplanned 30-day acute service utilization among adults subsequent to hospitalization for a new diagnosis of leukemia, lymphoma, or myeloma. This study explored the prevalence of medical complications (aligned with OP-35 measure specifications from the Centers for Medicare & Medicaid Services [CMS] Hospital Outpatient Quality Reporting Program) and the potential impact of psychosocial factors on unplanned acute care utilization., Methods: This study included 933 unique patients admitted to three acute care inpatient facilities within a nonprofit community-based health care system in southern California from 2012 to 2017. Integrated comprehensive data elements from electronic medical records and facility oncology registries were leveraged for univariate statistics, predictive models constructed using multivariable logistic regression, and further exploratory data mining, with predictive accuracy of the models measured with c-statistics., Results: The mean age of study participants was 65 years, and 55.1% were male. Specific diagnoses were lymphoma (48.7%), leukemia (35.2%), myeloma (14.0%), and mixed types (2.1%). Approximately one fifth of patients received unplanned acute care services within 30 days postdischarge, and over half of these patients presented with one or more symptoms associated with the CMS medical complication measure. The predictive models, with c-statistics ranging from 0.7 and above for each type of hematologic malignancy, indicated good predictive qualities with the impact of psychosocial functioning on the use of acute care services ( P values < .05), including lack of consult for social work during initial admission (lymphoma or myeloma), history of counseling or use of psychotropic medications (lymphoma), and past substance use (myeloma)., Conclusion: This study provides insights into patient-related factors that may inform a proactive approach to improve health outcomes, such as enhanced care transition, monitoring, and support interventions., Competing Interests: Joyce C. LaMoriEmployment: Janssen Scientific AffairsStock and Other Ownership Interests: Johnson & Johnson Besa SmithEmployment: ICON Clinical ResearchStock and Other Ownership Interests: ICON plcResearch Funding: ICON Clinical ResearchTravel, Accommodations, Expenses: ICON plc Tyler SmithEmployment: ICON Clinical Research (I)No other potential conflicts of interest were reported.

Most studies of racial and ethnic survival disparities in patients with cancer diagnosed and treated in the USA have pertained to patients with solid tumours. However, increasing research on health inequities shows that these differences also extend to patients with haematological malignancies. In particular, Black and Hispanic patients with cancer have had markedly worse survival outcomes for several decades, although the need to critically evaluate and address these disparities has, for several compelling reasons, gained a greater sense of urgency. To effectively implement strategies to counteract barriers that underlie survival disparities and systemic racism, understanding the current state of survival outcomes for patients with haematological cancers who are racially or ethnically minoritised is important. In this Viewpoint, we review the specifics of outcome differences across haematological malignancies and investigate the contributions of race-associated differences in administration of treatment and genetic differences in underlying disease biology. We also provide our perspective on key actions that we feel are crucial for the haematology community to pursue to abrogate systemic racism and ensure fair and equitable care for all., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Hematopoietic cell transplantation (HCT) is a potentially curative therapy as well as a costly procedure. Published studies have examined the cost of HCT in the US and the complications that follow but little is known about the cancer-related healthcare costs and resource utilization prior to the procedure and none of the studies have examined the variability in cost based on the type of hematologic malignancy involved. The aim of this study was to estimate mean cancer-related costs and resources incurred before the HCT is performed from the time the hematologic malignancy first develops., Methods: The IBM® MarketScan® Research Databases were used to identify adult patients ≥18 years of age with commercial or Medicare supplemental insurance who had undergone allogeneic HCT for hematologic malignancies from January 1, 2008 to December 31, 2017. Healthcare utilization and costs were assessed during the 6 months prior to diagnosis (pre-diagnostic period) and the follow-up period from diagnosis just prior to the HCT (pre-HCT period). Multivariable regression models were constructed to estimate total all-cause costs and cancer-related costs as well as healthcare utilization by type in each time period., Results: A total of 2663 commercially insured patients and 266 with Medicare supplemental insurance were included in the study population. The mean-adjusted incremental cancer-related costs for commercially insured patients was $399,011 in the overall observation period including the pre-diagnostic and pre-HCT periods combined, 9% of which was incurred in the pre-diagnostic period. The corresponding mean-adjusted incremental cancer-related costs for Medicare supplemental patients was $195,575 for the same time period but the patterns of healthcare utilization were similar to the commercially insured population. Inpatient care accounted for approximately one-half the cost in both patient populations. By type of hematologic malignancy, costs were lowest for myeloproliferative disorders ($211,561) and highest for acute lymphocytic leukemia ($462,072) in the commercially insured population., Conclusion: This study demonstrates that overall patients with hematologic malignancies requiring HCT have considerable cancer-related healthcare resource utilization and costs leading up to HCT compared to the period of time prior to developing cancer., (© 2021. The Author(s).)

Background: Oncology settings increasingly use patient experience data to evaluate clinical performance. Given that older patients with hematologic malignancies are a high-risk population, this study examined factors associated with patient-reported health care experiences during the first year of their cancer diagnosis., Methods: Cross-sectional study using the 2000-2015 SEER-CAHPS® data to examine patient experiences of Medicare enrollees with a primary diagnosis of leukemia or lymphoma. The primary outcomes were three CAHPS assessments: overall care, personal doctor, and health plan overall. We estimated case-mix adjusted and fully adjusted associations between factors (i.e., clinical and sociodemographic) and the CAHPS outcomes using bivariate statistical tests and multiple linear regression., Results: The final sample included 1,151 patients, with 431 diagnosed with leukemia and 720 diagnosed with lymphoma (median time from diagnosis to survey 6 months). Patients who completed the survey further apart from the diagnosis date reported significantly higher adjusted ratings of care overall (β .39, p = .008) than those closer to diagnosis. American Indian/Alaska Native, Asian, and Pacific Islander patients had lower adjusted ratings of care overall (β - .73, p = .003) than Non-Hispanic white patients. Multimorbidity was significantly associated with higher adjusted personal doctor ratings (β .26, p = .003)., Conclusions: Unfavorable patient experiences among older adults diagnosed with hematologic malignancies warrant targeted efforts to measure and improve care quality. Future measurement of experiences of cancer care soon after diagnosis, coupled with careful sampling of high-priority populations, will inform oncology leaders and clinicians on strategies to improve care for high-risk, high-cost populations.

Objective: Restrictive eligibility criteria are a known barrier to patient enrollment into clinical trials. With the introduction of chimeric antigen receptor T-cell (CAR-T) therapy, it is imperative to ensure trials are generalizable to the intended population with appropriate safety guiderails., Methods: Using the U.S. National Library of Medicine's clinical trial database, we identified 84 clinical trials and characterized inclusion/exclusion criteria for CAR-T therapy in hematologic malignancies with a focus on age, performance status, and comorbidities, and the relationship to sponsorship, disease type, and study phase., Results: The overwhelming majority of CAR-T trials imposed restrictions on upper age (n = 54, 64%), performance status (n = 72, 86%), and renal function (n = 76, 90%). Institution-sponsored studies were more likely to have age restrictions (n = 29) than industry-sponsored (n = 20), (83% vs 45%, p < 0.01). There was no relationship between study phase and use of upper age limit restriction or study phase and affiliation with performance status restrictions. Inclusion criteria for renal function was highly variable and ambiguous; creatinine <1.2-3.0 mg/dL, creatinine clearance >20-60 mL/min, and GFR >30-70 mL/min., Conclusion: These results suggest highly variable inclusion/exclusion criteria for early phase CAR-T studies that may limit patient accessibility to therapy and emphasize the need for a standardized, evidence-based approach to patient enrollment., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Approximately 185,840 individuals will be diagnosed with hematologic malignancies in the United States in 2020. Disparities in disease incidence, prevalence, burden, mortality, and survivorship have been identified among this patient population. Contributing factors include genetic ancestry, race/ethnicity, sex, socioeconomic status, and geographic region. Historically, these inequities have been understudied. Addressing these disparities requires a systems-level approach, improving access to care and reducing biases in the clinical setting. Additional research is needed to construct comprehensive, multilevel models to explore systematic observational studies and perform strategic intervention trials to overcome these disparities.

Background: The association of community factors and outcomes after hematopoietic cell transplantation (HCT) has not been comprehensively described. Using the County Health Rankings and Roadmaps (CHRR) and the Center for International Blood and Marrow Transplant Research (CIBMTR), this study evaluated the impact of community health status on allogeneic HCT outcomes., Methods: This study included 18,544 adult allogeneic HCT recipients reported to the CIBMTR by 170 US centers in 2014-2016. Sociodemographic, environmental, and community indicators were derived from the CHRR, an aggregate community risk score was created, and scores were assigned to each patient (patient community risk score [PCS]) and transplant center (center community risk score [CCS]). Higher scores indicated less healthy communities. The impact of PCS and CCS on patient outcomes after allogeneic HCT was studied., Results: The median age was 55 years (range, 18-83 years). The median PCS was -0.21 (range, -1.37 to 2.10; standard deviation [SD], 0.42), and the median CCS was -0.13 (range, -1.04 to 0.96; SD, 0.40). In multivariable analyses, a higher PCS was associated with inferior survival (hazard ratio [HR] per 1 SD increase, 1.04; 99% CI, 1.00-1.08; P = .0089). Among hematologic malignancies, a tendency toward inferior survival was observed with a higher PCS (HR, 1.04; 99% CI, 1.00-1.08; P = .0102); a higher PCS was associated with higher nonrelapse mortality (NRM; HR, 1.08; 99% CI, 1.02-1.15; P = .0004). CCS was not significantly associated with survival, relapse, or NRM., Conclusions: Patients residing in counties with a worse community health status have inferior survival as a result of an increased risk of NRM after allogeneic HCT. There was no association between the community health status of the transplant center location and allogeneic HCT outcomes., (© 2020 American Cancer Society.)

The unprecedented technological advances in genetic engineering have resulted in the advent of the very promising chimeric antigen receptor (CAR)-T cell therapy. Based on the striking outcomes of clinical trials, the first two commercial CAR-T cell products, tisagenlecleucel and axicabtagene ciloleucel, have been approved in both the United States and Europe for the treatment of patients with highly aggressive CD19-positive hematological malignancies. Despite the initial remarkable responses many patients finally relapse, implying the presence of resistance mechanisms. In this review, we describe the limitations and resistance mechanisms to anti-CD19 CAR-T cells and address potential strategies to overcome CAR-T cell barriers., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Patients with hematologic malignancies (HM) often receive aggressive care at the end of life (EOL). Early palliative care (PC) has been shown to improve EOL care outcomes, but its benefits are less established in HM than in solid tumors. Objectives: We sought to describe the use of billed PC services among Medicare beneficiaries with HM. We hypothesized that receipt of early PC services (rendered >30 days before death) may be associated with less aggressive EOL care. Design: Retrospective cohort analysis Setting/Subjects: Using the Surveillance, Epidemiology, and End Results-Medicare registry, we studied patients with leukemia, lymphoma, myeloma, myelodysplastic syndrome, or myeloproliferative neoplasm who died between 2001 and 2015. Measurements: We described trends in the use of PC services and evaluated the association between early PC services and metrics of EOL care aggressiveness. Results: Among 139,191 decedents, the proportion receiving PC services increased from 0.4% in 2001 to 13.3% in 2015. Median time from first encounter to death was 10 days and 84.3% of encounters occurred during hospitalizations. In patients who survived >30 days from diagnosis ( N  = 120,741), the use of early PC services was more frequent in acute leukemia, women, and black patients, among other characteristics. Early PC services were associated with increased hospice use and decreased health care utilization at the EOL. Conclusion: Among patients with HM, there was an upward trend in PC services, and early PC services were associated with less aggressive EOL care. Our results support the need for prospective trials of early PC in HM.

Hematopoietic cell transplantation (HCT) is an effective treatment for many hematologic malignancies, and its utilization continues to rise. However, due to the difficult logistics and high cost of HCT, there are significant barriers to accessing the procedure; these barriers are likely greater for older patients. Although numerous factors may influence HCT access, no formal analysis has detailed the cumulative barriers that have been studied thus far. We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to better categorize the barriers to access and referral to HCT, with a focus on the subgroup of older patients. We searched for articles published in English from PubMed, Embase, Cumulative Index for Nursing and Allied Health, and Cochrane Central Register of Controlled Trials between the database inception and January 31, 2020. We selected articles that met the following inclusion criteria: (1) study design: qualitative, cross-sectional, observational cohort, or mixed-method study designs; (2) outcomes: barriers related to patient and physician access to HCT; and (3) population: adults aged ≥18 years with hematologic malignancies within the United States. Abstracts without full text were excluded. QUALSYST methodology was used to determine article quality. Data on the barriers to access and referral for HCT were extracted, along with other study characteristics. We summarized the findings using descriptive statistics. We included 26 of 3859 studies screened for inclusion criteria. Twenty studies were retrospective cohorts and 4 were cross-sectional. There was 1 prospective cohort study and 1 mixed-method study. Only 1 study was rated as high quality, and 16 were rated as fair. Seventeen studies analyzed age as a potential barrier to HCT referral and access, with 16 finding older age to be a barrier. Other consistent barriers to HCT referral and access included nonwhite race (n = 16/20 studies), insurance status (n = 13/14 studies), comorbidities (n = 10/11 studies), and lower socioeconomic status (n = 7/8 studies). High-quality studies are lacking related to HCT barriers. Older age and nonwhite race were consistently linked to reduced access to HCT. To produce a more just health care system, strategies to overcome these barriers for vulnerable populations should be prioritized. Examples include patient and physician education, as well as geriatric assessment guided care models that can be readily incorporated into clinical practice., (Copyright © 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)

Burnout is a significant problem in the medical community, including among pediatric hematology/oncology (PHO) faculty. However, the prevalence of burnout, its associated risk factors, and outcomes within PHO fellows are unknown. We present the results of a cross-sectional study of PHO fellows from 21 training programs. A total of 45/115 fellows (39.1%) met criteria for high level of burnout. Fellows who met criteria for high burnout also demonstrated poor outcomes including decreased empowerment, increased doctor-centered care, decreased self-assessed humanism, and decreased satisfaction with training. Further longitudinal investigation is needed to better understand burnout and the causative factors affecting PHO fellows., (© 2020 Wiley Periodicals, Inc.)

Patients with hematologic malignancies are thought to receive more aggressive end-of-life (EOL) care and have suboptimal hospice use compared with patients with solid tumors, but descriptions of EOL outcomes from comprehensive cohorts have been lacking. We used the population-based Surveillance, Epidemiology, and End Results-Medicare dataset to describe hospice use and indicators of aggressive EOL care among Medicare beneficiaries who died of hematologic malignancies in 2008-2015. Overall, 56.5% of decedents used hospice services for median 9 days (interquartile range, 3-27), 33.0% died in an acute hospital setting, 36.8% had an intensive care unit (ICU) admission in the last 30 days of life, and 13.3% received chemotherapy within the last 14 days of life. Hospice use was associated with 96% lower probability of inpatient death (adjusted risk ratio [aRR], 0.038; 95% confidence interval [CI], 0.035-0.042), 44% lower probability of an ICU stay in the last 30 days of life (aRR, 0.56; 95% CI, 0.54-0.57), and 62% decrease in chemotherapy use in the last 14 days of life (aRR, 0.38; 95% CI, 0.35-0.41). Hospice enrollees spent on average 41% fewer days as inpatient during the last month of life (adjusted means ratio, 0.59; 95% CI, 0.57-0.60) and had 38% lower mean Medicare spending in the last month of life (adjusted means ratio, 0.62; 95% CI, 0.61-0.64). These associations were consistent across histologic subgroups. In conclusion, EOL care quality outcomes and hospice enrollment were suboptimal among older decedents with hematologic cancers, but hospice use was associated with a consistent decrease in aggressive care at EOL., (© 2020 by The American Society of Hematology.)

Background: While tacrolimus and sirolimus (T/S)-based graft-versus-host disease (GvHD) prophylaxis has been effective in preventing acute GvHD post hematopoietic cell transplantation (HCT), its efficacy and long-term outcome in matched (MUD) and mismatched unrelated donor (mMUD) setting is not well defined., Methods: Herein, we evaluated a consecutive case-series of 482 patients who underwent unrelated donor HCT (2005-2013) with T/S-based GvHD prophylaxis., Results: With a median follow-up of 6.2 years (range = 2.4-11.3), the 5-year overall survival (OS) and relapse/progression-free survival were 47.5% (95% confidence interval [CI]: 43.0-52.0) and 43.6% (95% CI: 39.1-48.1), respectively; and the 5-year cumulative incidence of nonrelapse mortality (NRM) and relapse were 24.9%, and 31.5%, respectively. In this cohort, mMUD was associated with worse OS (39.0% versus 50.7% at 5 y; P = 0.034), primarily due to greater risk of NRM (33.5% versus 21.7%; P = 0.038). While rates of relapse, acute (II-IV or III-IV) or chronic GvHD (limited or extensive) were not different, death caused by chronic GvHD (20.8% versus 12.8%; P = 0.022) and infection (33.0% versus 18.1%; P < 0.01) were significantly greater in mMUD. In multivariable analysis, high-risk disease (hazard ratio [HR] = 2.21, 95% CI: 1.16-4.23; P < 0.01) and mMUD (HR = 1.55, 95% CI: 1.15-2.08; P = 0.004) were independent predictive factors for OS., Conclusions: T/S-based GvHD prophylaxis is an effective and acceptable GvHD prophylactic regimen. However, survival after mMUD remained poor, possibly related to the severity of chronic GvHD.

Human herpesvirus 6B (HHV-6B) frequently reactivates after allogeneic hematopoietic cell transplantation (HCT). There are no randomized studies of antiviral treatments to prevent HHV-6B reactivation. Brincidofovir has high in vitro activity against HHV-6B and other DNA viruses, but its in vivo activity for HHV-6B has not been demonstrated. We performed a post hoc analysis of a randomized controlled trial of twice-weekly oral brincidofovir for cytomegalovirus prophylaxis after allogeneic HCT to study the effect of brincidofovir on HHV-6B reactivation. We included patients randomized within 2 weeks of HCT and who received at least 6 consecutive doses of study drug after randomization. We tested plasma for HHV-6B through week 6 post-HCT. The cohort consisted of 92 patients receiving brincidofovir and 61 receiving placebo. The cumulative incidence of HHV-6B plasma detection through day 42 post-HCT was significantly lower among patients receiving brincidofovir (14.2%) compared with placebo (32.4%; log-rank, 0.019). In an adjusted Cox model, brincidofovir exposure remained associated with a lower hazard for HHV-6B plasma detection (hazard ratio, 0.40; 95% confidence interval, 0.20-0.80). In conclusion, brincidofovir prophylaxis reduced HHV-6B reactivation after allogeneic HCT in a post hoc analysis of a randomized controlled trial. These data support the study of intravenous brincidofovir for HHV-6B prophylaxis., (© 2020 by The American Society of Hematology.)

Objectives: To identify factors limiting and facilitating patient-centered communication (PCC) in the United States hematology-oncology setting, with a focus on multiple myeloma (MM), given the limited attention to PCC and rapid pace of change that has taken place in this setting., Methods: A literature search was performed from 2007 to 2017 to identify published articles and congress abstracts related to clinician-patient communication and treatment decision-making in oncology. Search results were evaluated by year of publication and disease area. A thematic assessment was performed to identify factors limiting and promoting PCC for patients with MM and other hematologic malignancies., Results: Of the 6673 publications initially retrieved, 18 exclusively reported findings in patients with hematologic malignancies and were included in this review. We identified three critical, but modifiable, barriers to PCC in the hematologic malignancy setting, including insufficient information exchange, treatment goal misalignment, and discordant role preferences in treatment decision-making. Factors that enhanced interaction quality included educational programs for clinicians and patients., Conclusions: Patients with MM and other hematologic malignancies experience a distinct set of challenges that may affect PCC., Practice Implications: Clinicians have the opportunity to improve patient care by proactively addressing the identified barriers and implementing strategies demonstrated to improve PCC., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Management of hematologic malignancies in older patients is complex and, with recent and anticipated trends in demographics, increasingly common. As a large, nationally integrated medical system the Veterans Affairs has the potential to lead in research to benefit these patients. In this review we describe the evolving treatment paradigms of hematologic malignancies and how they are best fit with older patients through comprehensive evaluation of key vulnerabilities. We also discuss optimization of supportive care and navigation services to target identified risks and challenges aimed at ameliorating the patient's burden of cancer and treatment. Lastly, we discuss opportunities in design of prospective clinical trials to better align with real-world cases, thereby expanding enrollment of and applicability to older patients with hematologic malignancies., (Published by Elsevier Inc.)

Importance: Hematopoietic cell transplantation (HCT) is a therapeutic strategy in the management of several hematological cancers. Limited data exist on the incidence and predictors of 30-day readmission after HCT., Objective: To measure the incidence of and risk factors associated with 30-day readmission following HCT in the United States., Design, Setting, and Participants: This cohort study examined patient data from the US population-based Nationwide Readmissions Database. All adults (age ≥18 years) who underwent autologous (auto-) or allogenic (allo-) HCT in US hospitals between January 1, 2012, and November 30, 2014, were included. The analysis was performed from June 2018 to February 2019., Main Outcomes and Measures: The main outcome was 30-day readmission rates for auto-HCT and allo-HCT. Factors associated with readmission, including baseline demographic characteristics and disease- and hospital-related characteristics (including annual case volume), were measured., Results: A total of 28 356 index admissions for auto-HCT in 244 centers (191 low-volume, 38 medium-volume, and 15 high-volume centers) and 17 217 index admissions for allo-HCT in 211 centers (161 low-volume, 37 medium-volume, and 13 high-volume centers) were identified during the study period. The overall 30-day readmission rates were 11.6% for auto-HCT and 24.4% for allo-HCT. The odds of readmission were significantly higher in low-volume hospitals compared with high-volume hospitals (adjusted odds ratio [aOR], 1.69; 95% CI, 1.08-2.64 for auto-HCT and aOR, 1.41; 95% CI, 1.09-1.82 for allo-HCT) but comparable to medium-volume hospitals (aOR, 1.06; 95% CI, 0.62-1.83 for auto-HCT and aOR, 1.19; 95% CI, 0.90-1.57 for allo-HCT). Other factors associated with readmission for auto-HCT included younger age (aOR for age ≥50 vs <49 years, 0.82; 95% CI, 0.68-0.98), female sex (aOR, 1.21; 95% CI, 1.06-1.36), disease type (aOR for other vs myeloma, 1.37; 95% CI, 1.06-1.77), and Elixhauser comorbidity index score (aOR for ≥20 vs 0, 1.5; 95% CI, 1.17-1.93). For allo-HCT, factors associated with readmission included disease type (aOR for acute lymphoblastic leukemia vs acute myelogenous leukemia, 1.30; 95% CI, 1.04-1.62), insurance (aOR for Medicare vs private, 1.18; 95% CI, 1.02-1.36), and Elixhauser comorbidity index score (aOR for 1-9 vs 0, 1.2; 95% CI, 1.04-1.39). Infections, neutropenic fever, and gastrointestinal symptoms were the most common reasons for readmission for both types of HCT., Conclusions and Relevance: This study found substantial rates of readmission for both types of HCT and an inverse association between hospital HCT volume and 30-day readmission. These results may provide guidance when developing quality indicators and policies penalizing hospitals for HCT readmission.

The application of machine learning in medicine has been productive in multiple fields, but has not previously been applied to analyze the complexity of organ involvement by chronic graft- versus -host disease. Chronic graft- versus -host disease is classified by an overall composite score as mild, moderate or severe, which may overlook clinically relevant patterns in organ involvement. Here we applied a novel computational approach to chronic graft- versus -host disease with the goal of identifying phenotypic groups based on the subcomponents of the National Institutes of Health Consensus Criteria. Computational analysis revealed seven distinct groups of patients with contrasting clinical risks. The high-risk group had an inferior overall survival compared to the low-risk group (hazard ratio 2.24; 95% confidence interval: 1.36-3.68), an effect that was independent of graft- versus -host disease severity as measured by the National Institutes of Health criteria. To test clinical applicability, knowledge was translated into a simplified clinical prognostic decision tree. Groups identified by the decision tree also stratified outcomes and closely matched those from the original analysis. Patients in the high- and intermediate-risk decision-tree groups had significantly shorter overall survival than those in the low-risk group (hazard ratio 2.79; 95% confidence interval: 1.58-4.91 and hazard ratio 1.78; 95% confidence interval: 1.06-3.01, respectively). Machine learning and other computational analyses may better reveal biomarkers and stratify risk than the current approach based on cumulative severity. This approach could now be explored in other disease models with complex clinical phenotypes. External validation must be completed prior to clinical application. Ultimately, this approach has the potential to reveal distinct pathophysiological mechanisms that may underlie clusters. Clinicaltrials.gov identifier: NCT00637689 ., (Copyright© 2019 Ferrata Storti Foundation.)

Background: The current study was performed to characterize the employment status of survivors of hematological cancer who have an informal caregiver from the time of diagnosis through the first 6 months of treatment., Methods: Using a mixed methods approach, semistructured interviews with survivors of hematological cancer were conducted within 6 months of the initiation of cancer treatment. Interviews assessed cancer treatment status, barriers and facilitators to employment, financial and insurance status, and relationship with the primary caregiver. These results are part of a longitudinal study of cancer survivors and informal caregivers., Results: A total of 171 patients were enrolled. Within 6 months of beginning cancer treatments, approximately 35% were no longer employed. Reasons to remain employed included financial need, employee benefits, and a sense of purpose and normalcy. Employer accommodations and supportive colleagues facilitated continued employment. Logistic regression analysis demonstrated that having a higher household income, a desire to work, nonphysical job tasks, and congruent survivor-caregiver communication were associated with greater odds of remaining employed., Conclusions: Within 6 months of initiating cancer treatment, the majority of survivors of hematological cancer had maintained employment. Because of the limitations imposed by the physical stress of cancer treatments, as well as the need to maintain employment to continue receiving employee benefits to cover such treatments, survivors of hematological cancer likely would benefit from employment accommodations that are sensitive to their unique needs. Cancer 2018;124:2824-2831. © 2018 American Cancer Society., (© 2018 American Cancer Society.)

The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx. The OCE also worked with professional societies and patient advocates on efforts to modernize clinical trial eligibility criteria, resulting in recommendations regarding minimal age, brain metastases, organ dysfunction, and human immunodeficiency virus coinfection. Altogether in 2017, the Food and Drug Administration approved 16 new drug and biologic applications, 30 supplemental drug and biologic applications, and 2 biosimilar applications in oncology.

Background: Unlike Medicare, the Veterans Health Administration (VA) health care system does not require veterans with cancer to make the "terrible choice" between receipt of hospice services or disease-modifying chemotherapy/radiation therapy. For this report, the authors characterized the VA's provision of concurrent care, defined as days in the last 6 months of life during which veterans simultaneously received hospice services and chemotherapy or radiation therapy., Methods: This retrospective cohort study included veteran decedents with cancer during 2006 through 2012 who were identified from claims with cancer diagnoses. Hospice and cancer treatment were identified using VA and Medicare administrative data. Descriptive statistics were used to characterize the changes in concurrent care, hospice, palliative care, and chemotherapy or radiation treatment., Results: The proportion of veterans receiving chemotherapy or radiation therapy remained stable at approximately 45%, whereas the proportion of veterans who received hospice increased from 55% to 68%. The receipt of concurrent care also increased during this time from 16.2% to 24.5%. The median time between hospice initiation and death remained stable at around 21 days. Among veterans who received chemotherapy or radiation therapy in their last 6 months of life, the median time between treatment termination and death ranged from 35 to 40 days. There was considerable variation between VA medical centers in the use of concurrent care (interquartile range, 16%-34% in 2012)., Conclusions: Concurrent receipt of hospice and chemotherapy or radiation therapy increased among veterans dying from cancer without reductions in the receipt of cancer therapy. This approach reflects the expansion of hospice services in the VA with VA policy allowing the concurrent receipt of hospice and antineoplastic therapies. Cancer 2016;122:782-790. © 2015 American Cancer Society., (Published 2015. This article is a U.S. Government work and is in the public domain in the USA.)