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Association of Sociodemographic Factors With Immunotherapy Receipt for Metastatic Melanoma in the US.

ABSTRACT: Importance:Strides to improve survival in metastatic melanoma have been made with the use of immunotherapeutic agents in the form of immune checkpoint inhibitors. Objective:To examine the factors associated with immunotherapy receipt in patients with metastatic melanoma in the era of immune checkpoint inhibitors and the Patient Protection and Affordable Care Act. Design, Setting, and Participants:This cohort study used data on 9882 patients with metastatic melanoma diagnosed from January 1, 2013, to December 31, 2016, from the National Cancer Database. Patients who did not have documentation regarding immunotherapy receipt were excluded. Data analysis was performed from July 1, 2019, to December 15, 2019. Exposure:Receipt of immunotherapy. Main Outcomes and Measures:The primary outcome was the association of receipt of immunotherapy as first-line therapy with sociodemographic factors. The secondary outcome was overall survival by receipt of immunotherapy. Results:A total of 9512 patients (mean [SD] age, 65.1 [14.4] years; 6481 [68.1%] male; 9217 [96.9%] White) met the criteria for treatment analysis. A total of 3428 (36.0%) received immunotherapy, and 6084 (64.0%) did not. Increasing age (odds ratio [OR], 0.98; 95% CI, 0.97-0.98; P?

SUBMITTER: Moyers JT

PROVIDER: S-EPMC7489862 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Association of Sociodemographic Factors With Immunotherapy Receipt for Metastatic Melanoma in the US.

Moyers Justin T JT Patel Amie A Shih Wendy W Nagaraj Gayathri G

JAMA network open 20200901 9

<h4>Importance</h4>Strides to improve survival in metastatic melanoma have been made with the use of immunotherapeutic agents in the form of immune checkpoint inhibitors.<h4>Objective</h4>To examine the factors associated with immunotherapy receipt in patients with metastatic melanoma in the era of immune checkpoint inhibitors and the Patient Protection and Affordable Care Act.<h4>Design, setting, and participants</h4>This cohort study used data on 9882 patients with metastatic melanoma diagnose ...[more]

PMID: 32876684

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Project description:BackgroundStandard clinical practice and national guidelines dictate somatic testing of metastatic colorectal cancer (mCRC) tumors to guide appropriate therapy; however, previous studies suggest that not all patients are tested. The objective of this study was to investigate potential differences in testing for mCRC by demographic and clinical factors.MethodsWe performed a retrospective review of de-identified patient data derived from electronic health records (EHRs) of 25,469 patients diagnosed with mCRC between the years 2013 and 2020. Our outcome was a receipt of the following tests: (a) biomarker testing (BRAF, KRAS, NRAS, MMR/MSI) and (b) next-generation sequencing (NGS). We interrogated our data using the machine-learning algorithm Classification and Regression Tree (CART), a unique approach to identifying combinations of, rather than individual demographic and clinical characteristics associated with receipt of testing.ResultsA total of 25,469 patients were identified with mCRC. Of these, 21,133 (83%) received either biomarker testing only (n = 12,485) or any testing (biomarker + NGS) (n = 8648). The proportion of patients who received any testing increased over calendar time for all age, race, and sex categories. Receipt of any testing was highest (90%) among younger and patients with better performance status, and there was no difference in receipt of any testing by race. The highest percentage of NGS testing was among those with better performance status, <70 years old, commercial or other governmental program payers, and low comorbidity burden; however, those who were Black or Hispanic had a lower prevalence of NGS testing than those who were White.Conclusions and relevanceConsiderable variations exist in somatic biomarker testing across subgroups of the population. Identification of genomic alterations can aid in determining targeted treatment and improving clinical outcomes; therefore, equitable use of these testing strategies, particularly NGS, is necessary.

Project description:ImportanceMultiple randomized clinical trials have shown that definitive therapy improves overall survival among patients with high-risk prostate cancer. However, many patients do not receive definitive therapy because of sociodemographic and health-related factors.ObjectiveTo identify factors associated with receipt of nondefinitive therapy (NDT) among patients aged 70 years and younger with high-risk prostate cancer.Design, setting, and participantsThis cohort study identified 72 036 patients aged 70 years and younger with high-risk prostate cancer and Charlson Comorbidity Index scores of 2 or less who were entered in the National Cancer Database between January 2004 and December 2014. Data analysis was conducted from November 2018 to December 2019.ExposureReceipt of NDT as an initial treatment approach.Main outcomes and measuresSurvival rates were compared based on receipt of definitive therapy or NDT, and sociodemographic and health-related factors were associated with the type of therapy received. Residual life expectancy was estimated from the National Center for Health Statistics to calculate person-years of life lost.ResultsA total of 72 036 men with a median (range) age of 63 (30-70) years, Charlson Comorbidity Index scores of 2 or less, and high-risk prostate cancer without regional lymph node or distant metastatic disease were analyzed. Among eligible patients, 5252 (7.3%) received NDT as an initial therapeutic strategy. On univariate and multivariate analyses, NDT was associated with worse overall survival (univariate analysis hazard ratio, 2.54; 95% CI, 2.40-2.69; P < .001; multivariate analysis hazard ratio, 2.40; 95% CI, 2.26-2.56; P < .001). Compared with patients with private insurance or managed care, those with no insurance, Medicaid, or Medicare were more likely to receive systemic therapy only (no insurance: odds ratio [OR], 3.34; 95% CI, 2.81-3.98; P < .001; Medicaid: OR, 2.92; 95% CI, 2.48-3.43; P < .001; Medicare: OR, 1.36; 95% CI, 1.20-1.53; P < .001) or no treatment (no insurance: OR, 2.63; 95% CI, 2.24-3.08; P < .001; Medicaid: OR, 1.71; 95% CI, 1.45-2.01; P < .001; Medicare: OR, 1.14; 95% CI, 1.04-1.24; P = .004). Compared with white patients, black patients were more likely to receive systemic therapy only (OR, 1.93; 95% CI, 1.74-2.14; P < .001) or no treatment (OR, 1.46; 95% CI, 1.32-1.61; P < .001), and Hispanic patients were more likely to receive systemic therapy only (OR, 1.36; 95% CI, 1.13-1.64; P = .001) or no treatment (OR, 1.36; 95% CI, 1.14-1.60; P < .001). Between 2004 and 2014, patients without insurance or enrolled in Medicaid had 1.83-fold greater person-years of life lost compared with patients with private insurance (area under the curve, 77 600 vs 42 300 person-years of life lost).Conclusions and relevanceIn this study, receipt of NDT was associated with insurance status and race/ethnicity. While treatment decisions should be individualized for every patient, younger men with high-risk prostate cancer and minimal comorbidities should be encouraged to receive definitive local therapy regardless of other factors. These data suggest that significant barriers to life-extending treatment options for patients with prostate cancer remain.

Project description:Aim: Despite the huge advancements in cancer therapies and treatments over the past decade, most patients with metastasized melanoma still die from the disease. This poor prognosis largely results from resistance to conventional chemotherapies and other cytotoxic drugs. We have previously identified 6 antigenic peptides derived from melanomas that have proven efficacious for activating CD4+ T cells in clinical trials for melanoma. Our aim was to improve pharmacodynamics, pharmacokinetic and toxicological parameters by individually encapsulating each of the 6 melanoma helper peptides within their own immunogenic nanoliposomes. Methods: We modified these liposomes as necessary to account for differences in the peptides' chemical properties, resulting in 3 distinct formulations. To further enhance immunogenicity, we also incorporated KDO2, a TLR4 agonist, into the lipid bilayer of all nanoliposome formulations. We then conducted in vivo imaging studies in mice and ex vivo cell studies from 2 patient samples who both strongly expressed one of the identified peptides. Results: We demonstrate that these liposomes, loaded with the different melanoma helper peptides, can be readily mixed together and simultaneously delivered without toxicity in vivo. These liposomes are capable of being diffused to the secondary lymphoid organs very quickly and for at least 6 days. In addition, we show that these immunogenic liposomes enhance immune responses to specific peptides ex vivo. Conclusion: Lipid-based delivery systems, including nanoliposomes and lipid nanoparticles, have now been validated for pharmacological (small molecules, bioactive lipids) and molecular (mRNA, siRNA) therapeutic approaches. However, the utility of these formulations as cancer vaccines, delivering antigenic peptides, has not yet achieved the same degree of commercial success. Here, we describe the novel and successful development of a nanoliposome-based cancer vaccine for melanoma. These vaccines help to circumvent drug resistance by increasing a patient's T cell response, making them more susceptible to checkpoint blockade therapy.

Dataset Information

Association of Sociodemographic Factors With Immunotherapy Receipt for Metastatic Melanoma in the US.

Publications

Association of Sociodemographic Factors With Immunotherapy Receipt for Metastatic Melanoma in the US.

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