Relationships Among Health Insurance Literacy, Financial Toxicity, and Sociodemographic Factors in Patients With Cancer.

PURPOSE: The objective of the study was to describe the prevalence of health insurance literacy (HIL) and investigate how patient-reported outcome measures assessing HIL are related to financial toxicity in patients with cancer. METHODS: We assessed HIL and financial toxicity in 404 patients enrolled between December 2019 and January 2021 at two medical centers in the United States. We conducted exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to explore and test the relationships among the factors and items. We fit structural equation models (SEMs) to find the relationships among the factors and sociodemographic/clinical characteristics. RESULTS: The EFA revealed items loaded on four factors: knowledge about health insurance, confidence related to HIL (HIL confidence), information-seeking behavior related to health insurance, and financial toxicity. The four-factor CFA model had good fit statistics (comparative fit index, 0.960; Tucker-Lewis index, 0.958; root mean square error of approximation, 0.046; and standardized root mean square residual, 0.086). In SEM, income, education level, and race positively predicted knowledge about health insurance. Knowledge about health insurance and number of total lines of cancer treatment was positively associated with HIL confidence. Higher income, older age, and HIL confidence were associated with less financial toxicity. Higher levels of financial toxicity, HIL confidence, and knowledge were associated with greater information-seeking behavior. CONCLUSION: Our findings showed how different aspects of HIL are related to financial toxicity even after adjustment for sociodemographic and clinical characteristics. Future studies should investigate the longitudinal relationships among these factors to help develop interventions to mitigate financial toxicity.

Treatment of Relapsed B/T-cell Mixed Phenotype Acute Leukemia With Blinatumomab.

Here, we describe the treatment of a patient with relapsed/refractory B/T mixed phenotype acute leukemia (MPAL) using blinatumomab monotherapy, the first bispecific T cell engager (BiTE) approved by the FDA for relapsed/refractory B cell acute lymphoblastic leukemia (B-ALL). A 64-year-old man with a history of stage 3 chronic kidney disease and type 2 diabetes mellitus was discovered to have B/T MPAL on bone marrow biopsy during hospitalization for dyspnea due to pulmonary embolism. The patient achieved brief remission with blinatumomab treatment before succumbing to neutropenic sepsis. The lack of sufficient data to guide therapy in MPAL remains a challenge, highlighting the potential of new targeted approaches such as blinatumomab to improve outcomes in relapsed/refractory MPAL.

Measurable Residual Disease in Chronic Lymphocytic Leukemia: Current Understanding and Evolving Role in Clinical Practice.

OPINION STATEMENT: Treatment of chronic lymphocytic leukemia (CLL) has evolved dramatically during the last decade, from chemoimmunotherapy (CIT)-based therapies to newer B-cell receptor (BCR) signaling targeting agents, which are sometimes given as continuous schemes. Response to treatment was traditionally defined according to clinical variables designed to assign a response category. Interest in assessing for deeper responses in CLL by the means of measurable residual disease (MRD) testing has been the subject of research during the last several years. Analyses and sub-analyses of clinical trials have shown that achieving undetectable MRD (uMRD) in CLL is an important prognostic factor. In this review, we summarize the available evidence about MRD in CLL, from the various assays available for measurement, the compartment to test, the impact of reaching uMRD according to the treatment regimen, and the results of fixed duration treatment guided by MRD trials. Finally, we summarize how MRD can be incorporated in clinical practice and how it may guide fixed duration treatment in the future should evidence continue to accumulate in that direction.

Allogeneic Hematopoietic Stem Cell Transplant for Diffuse Large B-Cell Lymphoma: Evolving Role in the Era of CAR T-Cell Therapy.

PURPOSE OF REVIEW: Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive lymphoma in adults. Although curable in the majority of cases, a substantial portion of patients will experience disease relapse and will die from their lymphoma. This review is aimed at summarizing the role of allogeneic hematopoietic stem cell transplant (allo-HSCT) in patients with relapsed DLBCL with a focus on its role in the era of CAR T-cell therapy RECENT FINDINGS: Allo-HSCT is primarily reserved for patients who experience disease progression or relapse after CAR T-cell therapy, largely due to the high non-relapse mortality (NRM) associated with the procedure. Disease status at the time of allo-HSCT is prognostic with complete remission (CR) associated with better outcomes. Reduced-intensity conditioning (RIC) is likely as effective as myeloablative conditioning (MAC) with less toxicity. In patients with multiply relapsed disease, including after auto-HSCT and CAR T-cell therapy, approximately one-third can be cured with allo-HSCT. Allo-HSCT should be considered a treatment modality for fit adults without major comorbid conditions whose disease can be controlled with emerging treatment modalities (e.g., bispecifics, antibody-drug conjugates).

Association of Health Insurance Literacy With Financial Hardship in Patients With Cancer.

Importance: Patient-reported financial hardship is an increasing challenge in cancer care delivery. Health insurance literacy and its association with financial hardship in patients with cancer, especially after controlling for financial literacy, have not been well examined. Objective: To examine the prevalence of and factors in the association between health insurance literacy and financial literacy as well as the overall and individual domains of financial hardship and their association with health insurance literacy, both independently and when adjusted for financial literacy, in patients with cancer. Design, Setting, and Participants: This cross-sectional survey study recruited and enrolled patients from 2 separate ambulatory infusion centers at Mayo Clinic Arizona in Phoenix, Arizona, and the University of Mississippi Medical Center in Jackson, Mississippi. Adult patients aged 18 years or older were enrolled from December 2019 to February 2020 and from August to October 2020 at Mayo Clinic Arizona (n = 299) and from September 2020 through January 2021 at the University of Mississippi Medical Center (n = 105). Survey respondents received a $5 gift card. Exposures: Surveys included questions about sociodemographic characteristics, health insurance literacy and financial literacy, financial knowledge, and financial hardship and its domains (material hardship, psychological hardship, and behavioral hardship). Main Outcomes and Measures: Financial hardship was assessed using the COST-FACIT (Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy) measure and National Health Interview Survey questions to capture information about the domains of financial hardship. The Health Insurance Literacy Measure is a validated 21-item measure of a consumer's ability to select and use health insurance. Five questions from the National Financial Capability Study assessed financial literacy. Results: A total of 404 participants were enrolled in the study. Median (IQR) age of the respondents was 63 (54-71) years, and 219 were women (54%), 307 were non-Hispanic White individuals (76%), 153 (38%) had private insurance, and 289 (72%) had solid tumors. Overall financial hardship (denoted by median COST-FACIT score <27 points) was reported by 49% (95% CI, 44%-53%) of the cohort. Prevalence of financial hardship was higher using the National Health Interview Survey questions, with 68% (95% CI, 63%-72%) of respondents reporting at least 1 hardship domain (n = 276). Sixty-six percent (95% CI, 60%-69%) of respondents (n = 265) had a high level of financial literacy. The mean (SD) Health Insurance Literacy Measure score was 64.9 (13.3) points. In multivariable analyses, each 10-point increase in the Health Insurance Literacy Measure score was associated with lower odds of financial hardship (odds ratio, 0.82; 95% CI, 0.68-0.99; P = .04). However, this association was no longer significant after adjusting for financial literacy. Conclusions and Relevance: Results of this study showed that, despite a high level of health insurance literacy and financial literacy, the prevalence of financial hardship was high. Although there were lower odds of financial hardship with increased health insurance literacy, the association was no longer significant when financial literacy was added to the model, suggesting that a high level of financial literacy may help mitigate the adverse outcome of lower health insurance literacy levels in patients with cancer.

The frequency of medical reversals in a cross-sectional analysis of high-impact oncology journals, 2009-2018.

BACKGROUND: Identifying ineffective practices that have been used in oncology is important in reducing wasted resources and harm. We sought to examine the prevalence of practices that are being used but have been shown in RCTs to be ineffective (medical reversals) in published oncology studies. METHODS: We cross-sectionally analyzed studies published in three high-impact oncology medical journals (2009-2018). We abstracted data relating to the frequency and characterization of medical reversals. RESULTS: Of the 64 oncology reversals, medications (44%) represented the most common intervention type (39% were targeted). Fourteen (22%) were funded by pharmaceutical/industry only and 56% were funded by an organization other than pharmaceutical/industry. The median number of years that the practice had been in use prior to the reversal study was 9 years (range 1-50 years). CONCLUSION: Here we show that oncology reversals most often involve the administration of medications, have been practiced for years, and are often identified through studies funded by non-industry organizations.

How to read a published clinical trial: A practical guide for clinicians.

Over the last 5 years, there have been more than 140 new drug approvals in the field of Oncology alone, all based on newly published clinical trials. These approvals have led to an ongoing change in clinical practice, offering new therapeutic options for patients. Therefore, it is important for healthcare providers to be able to appraise a clinical trial and determine its validity, understand its results, and be able to apply such results to their patients. In this guide, we provide a simplified approach tailored to practicing clinicians and trainees. The same concepts and principles apply to other medical specialties.

Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.

Importance: While there have been multiple assessments of clinical trials leading to anticancer drug approvals by the US Food and Drug Administration (FDA), the cumulative percentage of approvals based on trials with a limitation remains uncertain. Objective: To assess the percentage of clinical trials with limitations in 4 domains-lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and use of suboptimal control arms-that led to FDA approvals from June 30, 2014, to July 31, 2019. Design, Setting, and Participants: This observational analysis included all anticancer drug indications approved by the FDA from June 30, 2014, through July 31, 2019. All indications were investigated, and each clinical trial was evaluated for design, enrollment period, primary end points, and presence of a limitation in the domains of interest. The standard-of-care therapy was determined by evaluating the literature and published guidelines 1 year prior to the start of clinical trial enrollment. Crossover was examined and evaluated for optimal use. The percentage of approvals based on clinical trials with any or all limitations of interest was then calculated. Main Outcomes and Measures: Estimated percentage of clinical trials with limitations of interest that led to an anticancer drug marketing authorization by the FDA. Results: A total of 187 trials leading to 176 approvals for 75 distinct novel anticancer drugs by the FDA were evaluated. Sixty-four (34%) were single-arm clinical trials, and 123 (63%) were randomized clinical trials. A total of 125 (67%) had at least 1 limitation in the domains of interest; 60 of the 125 trials (48%) were randomized clinical trials. Of all 123 randomized clinical trials, 37 (30%) lacked overall survival benefit, 31 (25%) had a suboptimal control, and 17 (14%) used crossover inappropriately. Conclusions and Relevance: Two-thirds of cancer drugs are approved based on clinical trials with limitations in at least 1 of 4 essential domains. Efforts to minimize these limitations at the time of clinical trial design are essential to ensure that new anticancer drugs truly improve patient outcomes over current standards.

Choosing Wisely® in Hematology: Have We Made a Difference?

PURPOSE OF REVIEW: The Choosing Wisely® initiative, led by the American Board of Internal Medicine Foundation in collaboration with national professional medical societies, aims to help patients choose care that is essential, free from harm, and evidence-based. The American Society of Hematology has advocated practices specific to hematology for physicians and patients to examine carefully. Here, we summarize various barriers to adopting these practices, interventions used to improve adoption, and challenges in measuring the effectiveness of these interventions. RECENT FINDINGS: The Choosing Wisely® campaign has become an international effort with more than 20 countries worldwide having embraced it. Such widespread interest indicates that the campaign initiated an important dialog between patients and physicians about overutilization of resources. Evidence showing the positive impact of interventions on adopting these practices is accumulating, but their effect on improving clinical outcomes is uncertain. Decreasing overuse of resources is a cultural change in perspective for practitioners and patients alike. We believe that healthcare delivery is transitioning from being volume-based to value-based. As we continue to support the Choosing Wisely® campaign, we need to implement strategies to document and measure the influence of our value-based recommendations on physician practices, patient care and attitudes, and healthcare costs.