Health inequities across the lung cancer care continuum in ten marginalized populations: a narrative review.

Background and Objective: Lung cancer remains the deadliest cancer in the United States. Although lung cancer screening and innovative treatment options are available, accessing these interventions remains a barrier for marginalized communities due to social and structural challenges that influence health care access, which has led to worse outcomes when compared to Non-Hispanic Whites (NHW) and non-marginalized populations. The objective of this study is to examine disparities in lung cancer and social/structural factors within ten critical populations (racial/ethnic minorities, low income, rural, LGBTQIA+, women, veteran and active duty, and small cell lung cancer) across the continuum of lung cancer care. Methods: Five databases (PubMed, the Cochrane Library, EMBASE, Web of Knowledge, and EBSCO Discovery Service) were queried from February 2022-June 2022. The inclusion criteria were (I) peer-reviewed academic journals published in English between the years 2000 and 2022; (II) research that focused on disparities across the lung cancer continuum; and (III) research articles addressing social and structural barriers to lung cancer health care access. A total of 95 articles and 24 reports were used for this narrative review. Key Content and Findings: Across the ten populations, consistent disparities were observed in lung cancer screening and treatment, exhibited by lower uptake in screening, treatment, clinical trials, and biomarker testing. Significant themes contributing to these disparities were socioeconomic status, transportation, language, historic trauma, provider bias or lack of cultural training, and lack of health care access, in part due to insurance coverage. Conclusions: Future studies are needed to further develop meaningful solutions to disparities in health outcomes and access for those who are at risk, diagnosed with, or surviving lung cancer from marginalized populations.

Asciminib (Scemblix): A third-line treatment option for chronic myeloid leukemia in chronic phase with or without T315I mutation.

PURPOSE: To review the pharmacology, efficacy, safety, dosing and administration, and place in therapy of asciminib, an oral tyrosine kinase inhibitor (TKI) used as a third-line treatment option for Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. SUMMARY: CML is a rare cancer caused by a chromosomal translocation that forms a fusion of the BCR and ABL1 genes on chromosomes 22 and 9. Until recently, patients for whom first-line treatment options failed were treated with TKIs that bind to the adenosine triphosphate-binding site on BCR-ABL1. However, because of similar mechanisms of action, there continues to be an unmet need in patients for whom at least 2 TKIs have failed or those with a T315I mutation unable to tolerate ponatinib. In October 2021, the Food and Drug Administration approved asciminib (Scemblix), the first TKI specifically targeting the ABL1 myristoyl pocket (STAMP) via allosteric binding, as a third-line option for patients with chronic-phase (CP)-CML. Asciminib received accelerated approval due to meeting its primary endpoint at week 24, demonstrating a major molecular response rate of 25.5% for patients on asciminib compared to 13.2% for those receiving bosutinib. In addition, patients on asciminib achieved a higher rate of complete cytogenetic response at 40.8% compared to a rate of 24.2% for bosutinib. Clinicians prescribing asciminib should monitor for increased levels of pancreatic enzymes, hypertension, cardiovascular toxicity including ischemic and thromboembolic conditions, and decreased numbers of neutrophils and platelets, as these may require treatment interruption, dose reduction, or treatment discontinuation. CONCLUSION: Asciminib is a unique targeted TKI that provides clinicians with an additional third-line and beyond treatment option for adults with CP-CML regardless of mutation status as well as a second TKI treatment option for patients harboring a T315I mutation.

The Black Church and Public Health: A Key Partnership for Theory Driven COVID-19 Recovery Efforts.

The COVID-19 epidemic has negatively impacted the Black community in the United States. Despite current disease mitigation efforts, work is still needed to ensure that Black individuals living in the United States understand their risks regarding COVID-19 infection whether vaccinated or unvaccinated. Thus, the current article posits that the Black church, in concert with public health practitioners, is a venue through which theoretically based health messages should be designed and disseminated regarding COVID-19 recovery efforts. The Health Belief Model and the Harm Reduction approach are posed as theoretical frameworks to facilitate the design of such messages.

Pralsetinib: Treatment of metastatic RET fusion-positive non-small cell lung cancer.

PURPOSE: To review the pharmacology, efficacy, safety, dosing and administration, and place in therapy of pralsetinib, a tyrosine kinase inhibitor, for the treatment of metastatic RET fusion-positive non-small-cell lung cancer (NSCLC). SUMMARY: RET fusion-positive NSCLC is a rare cancer caused by chromosomal rearrangements that lead to fusions of the RET gene with other genes, such as KIF5B and CCDC6. Until recently, patients were treated with platinum-based chemotherapy or multitargeted tyrosine kinase inhibitors. However, because of their nonspecific mechanism of action, these drugs did not have high response rates. In September 2020, the Food and Drug Administration approved pralsetinib, the first once-daily oral tyrosine kinase inhibitor, for patients with metastatic RET fusion-positive NSCLC. Pralsetinib has been demonstrated to have response rates of 57% and 70% in patients who were previously treated with platinum chemotherapy and patients who were treatment naive, respectively. Clinicians using pralsetinib should monitor for fatigue, hepatotoxicity, hemorrhagic events, hypertension, myelosuppression, pyrexia, and respiratory infections, as these may require treatment interruption, dose reduction, or treatment discontinuation. CONCLUSION: Pralsetinib is a unique targeted tyrosine kinase inhibitor approved for the treatment of patients with RET fusion-positive metastatic NSCLC who may desire a once-daily regimen.

Guidance on Implementing an Oral Chemotherapy Drug Repository Program in a Medically Integrated Pharmacy Setting.

Oncology drug repository programs allow patients to donate oral chemotherapy that can be redispensed to patients in need and could ultimately reduce drug waste. Medically integrated pharmacies can serve as a platform for drug repository programs because of the integration of healthcare providers and pharmacists at one location, facilitating an effective transition from donation to redispensing. Before implementing a program, pharmacies should consider state laws regarding who can donate medications, the type of setting (including open or closed systems), as well as how to assess the quality of the medication donated, expiration dates, storing and maintenance of a separate inventory, written policies and procedures, and a priority list for dispensing medications to patients. In this article, we provide the initial steps to assist states and oncology pharmacists interested in developing a drug repository program.

Prevalence and predictors of obesity-related cancers among racial/ethnic groups with metabolic syndrome.

BACKGROUND: Obesity-related cancer (ORC) is associated with higher amounts of body fat, which could increase the risk of developing cardiovascular disease (CVD). A significant factor associated with CVD is metabolic syndrome (MetS), and MetS prevalence differs by race/ethnicity. The purpose of this study was to compare the prevalence and predictors of ORCs by race/ethnicity among adults (>18) with MetS. METHODS: This was a retrospective, cross-sectional study using data from the 1999-2014 National Health and Nutrition Examination Survey (NHANES). A chi-square test was performed to determine differences in ORC prevalence between non-Hispanic White (NHW), non-Hispanic Black (NHB), and Hispanic participants with MetS. A multivariate logistic regression was used to evaluate predictors (race, sex, income, insurance, education, marital status, and smoking status) of ORC among adults with MetS. RESULTS: Of the 1,554 adults, the prevalence of ORC was 30.6% among NHWs, 51.3% in NHBs, and 54.1% in Hispanics (p = <0.001). Females were 6.27 times more likely to have an ORC compared to males (95% CI = 4.95-14.11). Compared to NHWs, NHBs were 2.1 times more likely to have an ORC (95% CI = 1.40-3.38); and Hispanics were 2.5 times more likely (95% CI = 1.39-4.77). For every 1-year unit increase in age, the odds of ORC increased by 3% (95% CI = 1.00-1.05). CONCLUSIONS: Among NHANES participants with MetS, the prevalence of ORCs was significantly higher in NHBs and Hispanics, females, and older adults with MetS. Future studies, by race/ethnicity, are warranted on mortality risk of persons with MetS and ORC.

Prevalence and predictors of patients reporting adverse drug reactions to health care providers during oral targeted cancer treatment.

BACKGROUND: Pharmacovigilance is a critical component to facilitate clinicians' decision-making to alter or discontinue therapy. However, self-administration of oral targeted therapy (OTT) requires fewer clinical visits than parenteral infusions, potentially leading to an increase in the under-reporting of adverse drug reactions (ADRs). OBJECTIVE(S): To identify factors associated with patients reporting ADRs to their health care provider (HCP) and to identify the prevalence of unreported ADRs while on OTT. METHODS: Patients aged ≥18 years who received care from a community oncology clinic and newly prescribed an OTT between August 1, 2018, and October 31, 2018, were included. Six-monthly follow-up calls were conducted by the pharmacy staff to assess for gradable ADRs-validated by the NCI Common Terminology Criteria for Adverse Events-and ungradable ADRs. Descriptive analysis was used to analyze the prevalence of unreporting ADRs, and a multivariate logistic regression model was utilized to evaluate predictors of reporting ADRs to an HCP. Predictors included sociodemographic factors, severity of ADRs, insurance type, pharmacy setting, type of OTT, and the number of prescribed medications RESULTS: Of the 76 patients analyzed, the mean age was 63.32 ±11.55 years, 84.2% were women, 68.8% were non-Hispanic white, and 76.3% had breast cancer. During the follow-up calls, 306 ADRs were identified and 22.2% were not previously reported to an HCP. Of the unreported gradable ADRs, 63.2% were grade 1, 19.3% were grade 2, and 17.5% were grade 3. We found that for every 1-year increase in age, there was a 5% decrease in the likelihood of reporting ADRs (95% CI, 0.91-0.99), and men were 11.4 times more likely to report ADRs (95% CI, 1.29-100.8). CONCLUSION: Follow-up calls served as an outlet to collect pharmacovigilance data by identifying over 20% of unreported ADRs to HCPs, in which over one-third were moderate to severe. However, future studies are needed to further understand the statistically significant differences found in under-reporting for women and the older population.

Factors associated with adherence to follow-up calls in cancer patients receiving care at a community oncology practice.

BACKGROUND: Follow-up calls in the oncology setting are frequently used to augment care and encourage oral antineoplastic adherence. However, limited data are available on patient populations that would benefit from this intervention versus populations that may require alternative interventions. The purpose of this study was to identify characteristics among patients on oral antineoplastic agents that influence their likelihood to respond to follow-up calls. METHODS: Patients receiving care from one of the eight community oncology clinics within the same branch were analyzed. Patients were included if they were ≥18 years, received a new oral antineoplastic agent that was electronically prescribed between August 2018-October 2018, and picked up their first fill from their pharmacy of choice. Patients received up to six follow-up calls after picking up their first prescription. Calls were categorized as adherent (≥3 monthly interactions) or non-adherent (<3 monthly interactions). Logistic regression models were used to evaluate factors associated with follow-up call adherence. Factors included demographics, cancer stage, marital status, employment, pharmacy setting (internal pharmacy versus external pharmacy), and insurance used by the patient. Descriptive analysis was performed to analyze response rates, cancer diagnosis, and to determine the best time and day patients responded to follow-up calls. RESULTS: Data from 125 patients were analyzed, of which 65 patients (52%) were adherent to follow-up calls and the mean response rate over six months was 45% (range: 35% -- 54%). High success rates for follow-up calls were seen between 12-3 pm and on Tuesdays and Thursdays. After adjusting for covariates, patients with stage III-IV were 89% less likely to respond to follow-up calls compared to those with stage 0-II (95% CI: 0.02-0.64; p = 0.01), patients with commercial insurance were 79% less likely to adhere to follow-up calls compared to those on government insurance (95% CI: 0.06-0.71; p = 0.01), and patients using an external pharmacy had a 2.8 times increase odds of being adherent (95% CI 0.98-8.34; p = 0.05). All other factors were not significant. CONCLUSIONS: For patients taking oral antineoplastics, non-adherence to follow-up calls was observed in more than 45% of patients receiving care from a community oncology clinic. Findings demonstrated that those with advanced stages of cancer, on commercial insurance, and going to an internal pharmacy were at higher risk for not adhering to follow up calls. Therefore, alternative methods for managing adherence and side effects in these populations are warranted.

Pexidartinib (TURALIO™): The First FDA-Indicated Systemic Treatment for Tenosynovial Giant Cell Tumor.

Tenosynovial giant cell tumor is a rare proliferative tumor that arises from the synovium, bursae, or tendon sheaths due to an overproduction of colony-stimulating factor 1. Historically, treatment options for patients with local or diffuse tenosynovial giant cell tumor have been limited to surgical interventions. However, for some patients, surgical resection could worsen functional limitations and/or morbidity. In August 2019, the FDA approved pexidartinib (TURALIO™, Daiichi Sankyo), the first systemic treatment option for adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations that were not amenable to improvement with surgery. Pexidartinib is an oral tyrosine kinase inhibitor with selective inhibition of colony-stimulating factor 1 receptor and is the first systemic therapy to show significant improvement in overall response rates when compared with placebo. Clinicians using pexidartinib should monitor for liver-related adverse events, which may require treatment interruption, dose reduction, or treatment discontinuation. Pexidartinib provides a novel non-surgical treatment option for patients with tenosynovial giant cell tumor that may significantly improve patients' overall response, range of motion, physical function, tumor volume, and stiffness.

Instructional and Assessment Redesign of a Sterile Compounding Course Using Immersive Simulation.

Objective. To revise a traditional sterile compounding course to include content, competencies, and immersive simulations relevant to the current practice of sterile compounding pharmacy. Methods. Faculty and staff at the University of North Texas System College of Pharmacy made significant revisions to an existing sterile compounding course. Instruction was provided in didactic and laboratory sessions and delivered in three modules: fundamental skills, integration of skills and knowledge, and exceptions and specialty topics. Integration laboratory sessions consisted primarily of repetitive but increasingly difficult simulations that included both technician and pharmacist activities. Assessment methods included checkpoint assessments, a mock objective structured clinical examination (OSCE), a written examination, and a final comprehensive OSCE. Effectiveness of the course redesign was assessed by comparing student performance on assessments, overall course performance, and student perceptions extracted from the student course evaluation. Results. Of the 364 students enrolled in the sterile compounding course across four terms, 156 were in the pre-implementation cohort (cohort 1) and 208 were in the post-implementation cohort (cohort 2). Two hundred twenty-eight students completed the course evaluation. Course evaluations significantly demonstrated students' improved perceptions related to seven of 11 survey elements, most notably, critical thinking, integration of concepts, and students feeling challenged. Student performance on laboratory summative assessments also improved. However, written examination scores did not change. Conclusion. This novel sterile compounding course provided a practice-oriented blueprint for instruction and assessment of sterile compounding.

Evaluating Literature for Oncology Data Gaps to Improve the Quality of Standard Response Letters: A Retrospective Review.

BACKGROUND: Medical information departments are responsible for maintaining standard response letters to address health care providers' inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers. METHODS: We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available. RESULTS: Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were "use in special populations" (32%), "drug interactions" (27%), and "adverse events and safety" (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered. CONCLUSIONS: Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.