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Financial Toxicity Encountered in Therapeutic Radiopharmaceutical Clinical Development for Ovarian Cancer.

ABSTRACT: Financial toxicity or the debt a cancer survivor incurs from the costs of their medical cancer care is an understudied aspect in the clinical development of experimental therapeutic agents. The United States National Cancer Institute (NCI) Cancer Therapy Evaluation Program studies experimental therapeutic agents like radiopharmaceuticals in both early and late phase trials, which provide opportunities to comprehend more clearly the possible sources of financial toxicity incurred by cancer survivors. We reviewed the academic scholarship describing fiscal and social costs involved in the development of therapeutic radiopharmaceuticals. Because many ovarian cancer survivors outlive their disease through initial and, perhaps, multiple treatment courses, these women and their treatments provide context for our discussion on financial toxicity. 16 (27%) of 60 articles discuss financial toxicity incurred by women with ovarian cancer; none described financial toxicity associated with regulatory agency-approved or experimental therapeutic radiopharmaceuticals. Fiscal costs of radiopharmaceutical dose and schedule and social costs of individual productivity loss or asset expenditure arose as primary financial toxicities. The development of radiopharmaceuticals for women with ovarian cancer remains a high priority for the NCI Cancer Therapy Evaluation Program. Weighing radiopharmaceutical clinical benefit against measures of financial toxicity is challenging and warrants further study in prospective radiopharmaceutical clinical trials.

SUBMITTER: Kunos CA

PROVIDER: S-EPMC7464475 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Financial Toxicity Encountered in Therapeutic Radiopharmaceutical Clinical Development for Ovarian Cancer.

Kunos Charles A CA Abdallah Rita R

Pharmaceuticals (Basel, Switzerland) 20200805 8

Financial toxicity or the debt a cancer survivor incurs from the costs of their medical cancer care is an understudied aspect in the clinical development of experimental therapeutic agents. The United States National Cancer Institute (NCI) Cancer Therapy Evaluation Program studies experimental therapeutic agents like radiopharmaceuticals in both early and late phase trials, which provide opportunities to comprehend more clearly the possible sources of financial toxicity incurred by cancer surviv ...[more]

PMID: 32764223

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Project description:ImportanceFinancial toxicity (FT), unintended and unanticipated financial burden experienced by cancer patients undergoing cancer care, is associated with negative consequences and increased risk of mortality. Older patients (≥70 years) with cancer are at risk for FT, yet data are limited on FT and whether oncologists discuss FT with their patients.ObjectiveTo examine the prevalence of FT in older adults with advanced cancer, its association with health-related quality of life (HRQoL), and cost conversations between oncologists and patients.Design, setting, and participantsThis cross-sectional secondary analysis was performed on baseline data from the Improving Communication in Older Cancer Patients and Their Caregivers study, a cluster randomized trial from 31 community oncology practices across the US that was conducted from October 29, 2014, to April 28, 2017. Participants included 536 patients with advanced cancer who answered 3 questions regarding financial toxicity. Data were analyzed from September 1, 2019, to May 1, 2020.ExposureOlder patients undergoing cancer care treatments.Main outcomes and measuresThe main outcome looked at FT and its association with HRQoL. Three questions were used to identify patients 70 years or older experiencing FT. Multivariable linear regression models were used to assess the independent associations of FT with HRQoL. A single audio-recorded clinic transcript was analyzed within 4 weeks of enrollment for patients with FT. The framework method was used to identify frequency and themes related to cost conversations.ResultsThis study evaluated 536 patients 70 years or older with advanced cancer. Ninety-eight patients (18.3%) reported FT; mean (SD) age was 76.4 (5.4) years; 59 (60.2%) were female, 14 (14.3%) were Black/African American, 91 (92.9%) were not employed, and 29 (29.6%) had Medicare as their sole insurance coverage. On multivariate regression analyses, FT was associated with higher levels of depression (β = 0.81; 95% CI, 0.15-1.48), anxiety (β = 1.67; 95% CI, 0.74-2.61), and distress (β = 0.73; 95% CI, 0.08-1.39) and lower HRQoL (β = -5.30; 95% CI, -8.92 to -1.69). Among those who reported FT, 49% had a conversation with their health care professional about costs. Most conversations (79%) were initiated by oncologists or patients. Four themes were generated from cost conversations: statements regarding cost of care, ability to afford medical prescriptions, indirect consequences associated with inability to work and provide for family, and cost burden in nontreatment domains.Conclusions and relevanceIn this study, among older adults with advanced cancer, FT is associated with worse HRQoL. Almost half of conversations among patients reporting FT demonstrated costs are being actively discussed. Resources and interventions are needed to manage FT.

Project description:BACKGROUND:shRNA-mediated lethality screening is a useful tool to identify essential targets in cancer biology. Ovarian cancer (OC) is extremely heterogeneous and most cases are advanced stages at diagnosis. OC has a high response rate initially, but becomes resistant to standard chemotherapy. We previously employed high throughput global shRNA sensitization screens to identify NF-kB related pathways. Here, we re-analyzed our previous shRNA screens in an unbiased manner to identify clinically applicable molecular targets. METHODS:We proceeded with siRNA lethality screening using the top 55 genes in an expanded set of 6 OC cell lines. We investigated clinical relevance of candidate targets in The Cancer Genome Atlas OC dataset. To move these findings towards the clinic, we chose four pharmacological inhibitors to recapitulate the top siRNA effects: Oxozeaenol (for MAP3K7/TAK1), BI6727 (PLK1), MK1775 (WEE1), and Lapatinib (ERBB2). Cytotoxic effects were measured by cellular viability assay, as single agents and in 2-way combinations. Co-treatments were evaluated in either sequential or simultaneous exposure to drug for short term and extended periods to simulate different treatment strategies. RESULTS:Loss-of-function shRNA screens followed by short-term siRNA validation screens identified therapeutic targets in OC cells. Candidate genes were dysregulated in a subset of TCGA OCs although the alterations of these genes showed no statistical significance to overall survival. Pharmacological inhibitors such as Oxozeaenol, BI6727, and MK1775 showed cytotoxic effects in OC cells regardless of cisplatin responsiveness, while all OC cells tested were cytostatic to Lapatinib. Co-treatment with BI6727 and MK1775 at sub-lethal concentrations was equally potent to BI6727 alone at lethal concentrations without cellular re-growth after the drugs were washed off, suggesting the co-inhibition at reduced dosages may be more efficacious than maximal single-agent cytotoxic concentrations. CONCLUSIONS:Loss-of-function screen followed by in vitro target validation using chemical inhibitors identified clinically relevant targets. This approach has the potential to systematically refine therapeutic strategies in OC. These molecular target-driven strategies may provide additional therapeutic options for women whose tumors have become refractory to standard chemotherapy.

Project description:ObjectivesFinancial toxicity is increasingly recognized as an adverse outcome of cancer treatment. Our objective was to measure financial toxicity among gynecologic oncology patients and its association with demographic and disease-related characteristics; self-reported overall health; and cost-coping strategies.MethodsFollow-up patients at a gynecologic oncology practice completed a survey including the COmprehensive Score for Financial Toxicity (COST) tool and a self-reported overall health assessment, the EQ-VAS. We abstracted disease and treatment characteristics from medical records. We dichotomized COST scores into low and high financial toxicity and assessed the correlation (r) between COST scores and self-reported health. We calculated risk ratios (RR) and 95% confidence intervals (CI) for the associations of demographic and disease-related characteristics with high financial toxicity, as well as the associations between high financial toxicity and cost-coping strategies.ResultsAmong 240 respondents, median COST score was 29. Greater financial toxicity was correlated with worse self-reported health (r = 0.47; p < 0.001). In the crude analysis, Black or Hispanic race/ethnicity, government-sponsored health insurance, lower income, unemployment, cervical cancer and treatment with chemotherapy were associated with high financial toxicity. In the multivariable analysis, only government-sponsored health insurance, lower income, and treatment with chemotherapy were significantly associated with high financial toxicity. High financial toxicity was significantly associated with all cost-coping strategies, including delaying or avoiding care (RR: 7.3; 95% CI: 2.8-19.1).ConclusionsAmong highly-insured gynecologic oncology patients, many respondents reported high levels of financial toxicity. High financial toxicity was significantly associated with worse self-reported overall health and cost-coping strategies, including delaying or avoiding care.

Project description:IntroductionLung cancer has the second-ranked morbidity rate and the first-ranked mortality rate worldwide. With the progression of the cancer condition and the advancement of new treatments, the corresponding medical expenses have risen sharply. Nowadays, financial toxicity has become one of the most common concerns in patients with cancer. However, by far, the full landscape of studies on financial toxicity is unclear in patients with lung cancer. Thus, this scoping review aims to summarise the degree, affecting factors, outcomes and intervention strategies of financial toxicity in patients with lung cancer.Methods and analysisThis scoping review will be developed following the methodology described in the Joanna Briggs Institute Manual for Evidence Synthesis on scoping review protocol, which was based on Arksey and O'Malley's methodological framework, Levac et al's recommendations for applying this framework and Peters et al's enhancements of the framework. From the day of database building to 31 December 2021, 10 English databases will be searched in the 'Abstract' field with three key search terms: "Lung", "Cancer" and "Financial toxicity". The studies' screening and data extraction will be independently performed by two reviewers (MZ and RZ). Any disagreements between the two reviewers (MZ and RZ) will be resolved by consensus, and a third reviewer (BW) will be invited if necessary. The results will be analysed and presented using tables and figures. This scoping review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.Ethics and disseminationAn ethical approval is not required for this scoping review protocol, nor for the scoping review. The results of this scoping review will be disseminated through publication in a peer-reviewed journal or presentation at conferences.RegistrationThis scoping review protocol has been registered in the Open Science Framework (https://osf.io/ub45n/?view_only=bb93eb94e1434a0f8196b3b61cffcec2).

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Financial Toxicity Encountered in Therapeutic Radiopharmaceutical Clinical Development for Ovarian Cancer.

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Financial Toxicity Encountered in Therapeutic Radiopharmaceutical Clinical Development for Ovarian Cancer.

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