Browsing by Subject "Lung cancer"
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Item Development of an inhalational formulation of Coenzyme Q₁₀ to treat lung malignancies(2011-12) Carvalho, Thiago Cardoso; McConville, Jason ThomasCancer is the second leading cause of death in the United States and its onset is highly incident in the lungs, with very low long-term survival rates. Chemotherapy plays a significant role for lung cancer treatment, and pulmonary delivery may be a potential route for anticancer drug delivery to treat lung tumors. Coenzyme Q₁₀ (CoQ₁₀) is a poorly-water soluble compound that is being investigated for the treatment of carcinomas. In this work, we hypothesize that formulations of CoQ10 may be developed for pulmonary delivery with a satisfactory pharmacokinetic profile that will have the potential to improve a pharmacodynamic response when treating lung malignancies. The formulation design was to use a vibrating-mesh nebulizer to aerosolize aqueous dispersions of CoQ₁₀ stabilized by phospholipids physiologically found in the lungs. In the first study, a method was developed to measure the surface tension of liquids, a physicochemical property that has been shown to influence the aerosol output characteristics from vibrating-mesh nebulizers. Subsequently, this method was used, together with analysis of particle size distribution, zeta potential, and rheology, to further evaluate the factors influencing the capability of this nebulizer system to continuously and steadily aerosolize formulations of CoQ₁₀ prepared with high pressure homogenization. The aerosolization profile (nebulization performance and in vitro drug deposition of nebulized droplets) of formulations prepared with soybean lecithin, dimyristoylphosphatidylcholine (DMPC), dipalmitoylphosphatidylcholine (DPPC) and distearoylphosphatidylcholine (DSPC) were evaluated. The rheological behavior of these dispersions was found to be the factor that may be indicative of the aerosolization output profile. Finally, the pulmonary deposition and systemic distribution of CoQ₁₀ prepared as DMPC, DPPC, and DSPC dispersions were investigated in vivo in mice. It was found that high drug amounts were deposited and retained in the mouse lungs for at least 48 hours post nebulization. Systemic distribution was not observed and deposition in the nasal cavity occurred at a lower scale than in the lungs. This body of work provides evidence that CoQ₁₀ may be successfully formulated as dispersions to be aerosolized using vibrating-mesh nebulizers and achieve high drug deposition in the lungs during inhalation.Item Real-world use of durvalumab for patients with unresectable, stage III non-small cell lung cancer in the United States Veterans Health Administration(2022-08-11) Moore, Amanda Marie; Frei, Christopher R.; Koeller, Jim; Reveles, Kelly R; Smyth, Hugh DC; Nooruddin , ZohraThe approval of durvalumab, an immune checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC) was based on the landmark PACIFIC trial and created a paradigm shift in the treatment landscape of unresectable, stage III NSCLC. Despite robust clinical trial data, however, limited real-world data exists regarding the use of durvalumab in clinical practice. Real-world evidence is an increasingly important tool used to understand the clinical use of a drug in a typical patient population outside of the controlled environment of a randomized interventional trial. Real-world studies are also useful in the analysis of health disparities in patient subpopulations that are typically underrepresented or excluded from clinical trials, including pregnant women, racial and ethnic minorities, and patients of advanced age. Despite efforts from governmental agencies to increase enrollment of racial and ethnic minorities in clinical trials, there is still a lack of representation by these groups in clinical studies. Notably, Black patients are underrepresented in clinical trials for the approval of immunotherapies in NSCLC, despite Black males having the highest incidence and mortality rates for lung cancer across all reported races and ethnicities in the United States. This study aimed to use real-world data of patients with unresectable, stage III NSCLC treated with durvalumab at the Veterans Health Administration (VHA) to 1) describe durvalumab treatment patterns, including treatment initiation delays, interruptions, and discontinuations, and the reasons for such, and 2) identify racial disparities in durvalumab treatment patterns between Black and white patients. Patients were identified using criteria applied to the VHA electronic health record and confirmed for inclusion by manual chart review. Overall, nearly two-in-five patients had delayed initiation of durvalumab, about one-in-five experienced a treatment interruption, and more than half of the patients permanently discontinued durvalumab before completing planned therapy. There were no significant differences in treatment patterns between Black and white patients, although a higher proportion of Black patients experienced treatment initiation delays and interruptions. These results highlight the VHA as an equal-access healthcare system, but may suggest that patients from historically neglected communities could benefit from additional support systems that increase access to care.Item Total and segmented direct cost-of-care for stage IV non-small cell lung cancer in a privately insured population(2011-05) Bell, Allison Miriam; Koeller, Jim; Frei, Christopher; Ryan, Laurajo; Penrod, JohnIntroduction: New treatments for stage IV (adv) NSCLC have emerged this past decade. Recent pharmacoeconomic research has focused on cost of treatment, comparative costs of therapies, and cost/cost effectiveness of adding a biologic to traditional therapy. Drug cost is thought to be a primary driver of cost change in NSCLC, yet to our knowledge, characterization of the direct cost of NSCLC has not been published since the new treatments have emerged in the guidelines. Our primary objective was to characterize the direct and segmented cost of adv NSCLC from 2000-9. We also want to determine cost impact of new therapies, and cost trend from 2000-9. Methods: This PharMetrics claims database study includes diagnosed NSCLC patients [greater than or equal to] 20 yo. Small cell lung cancer was excluded. Claims were divided into disease segments and time periods representative of changes in therapy ("pre" (2000-2), "transition" (2003-5), and "current" (2006-9) periods). Descriptive statistics (median, interquartile range (IQR)), chi-square test (nominal data), and Wilcoxan rank sum tests were performed on the data. To adjust for baseline confounders, multivariate least squares regression models were created. Results: Costs are reported as medians in terms of per patient per month (pppm). Overall monthly cost (n=969) was $10,281 pppm. Diagnosis cost $6,601 pppm, active treatment cost $9,287 pppm, and end-of life cost $12,215 pppm. There was no difference in cost between the “transition” (n=439) and “current” (n=503) periods overall or for any segment of disease. Comorbidities had no effect on cost. For patients receiving at least 5 months of active treatment medication (n=316) total median cost was $144,147 per patient ($9,371 pppm). Discussion: There was no difference in cost between the transition and current periods, in regards to either overall cost or segmented cost. The most expensive segment was end-of-life, with a median cost exceeding $12,000 pppm. Surprisingly, comorbidities had no effect on cost. Newer agents (biologics, TKIs, and pemetrexed) represent only a modest portion of cost, with a majority of cost for stage IV NSCLC comprised of non-drug costs.Item Treatment patterns and healthcare resource utilization and payments in patients with lung cancer in the Texas Medicaid program(2023-08) Ma, Xiaojing, M.S.P.S.; Lawson, Kenneth Allen, 1952-; Barner, Jamie C.; Richards, Kristin M.; Novak, SuzanneThe economic burden associated with the treatment of lung cancer is substantial. With the introduction of targeted therapy and immunotherapy, treatment options for lung cancer management have expanded in recent years. However, little is known about treatment patterns and healthcare utilization and payments for lung cancer patients enrolled in the Texas Medicaid program. The objective of this study was to evaluate treatment patterns and healthcare resource utilization and payments for lung cancer patients enrolled in Texas Medicaid. A total of 453 newly diagnosed lung cancer patients were identified between 2004 and 2021. There were significant differences in proportions of patients receiving chemotherapy, targeted therapy, and immunotherapy by treatment line (p<0.0001). Chemotherapy was the most frequently prescribed first-line treatment for enrollees with lung cancer (363, 80.1%). Immunotherapy (53, 11.7%), the second most used first-line treatment, exceeded targeted therapy (37, 8.2%). Only one-third (146) of patients received subsequent-line treatment, in which immunotherapy increased greatly. Platinum-based doublets were the main first-line treatment while single-agent chemotherapy dominated in subsequent line. Office visits (mean=19.5) and outpatient visits (mean=13.6) accounted for the majority of healthcare resource utilization during the 1-year follow-up period. Compared to the chemotherapy group, immunotherapy had a significantly higher number of office visits while targeted therapy had a significantly lower number of office visits. Targeted therapy also had a significantly lower number of ED visits. Consistent with healthcare resources utilization, payments associated with office visits and outpatient visits were primary drivers of payments. Compared to the chemotherapy group, the immunotherapy group had 160.93% higher total payments (p<0.0001), while the targeted therapy group had 29.99% lower total payments (p=0.1818). Findings from our study showed that although chemotherapy was still the mainstream treatment for lung cancer, the treatment landscape has shifted to immunotherapy. This could be attributed to a decreased utilization of chemotherapy and increased utilization of immunotherapy in subsequent-line treatment. Meanwhile, the greater use of immunotherapy might be a driving factor for more outpatient visits and office visits associated with higher payments. Future studies of real-world use of immunotherapy are needed to better understand the economic burden.