scholarly journals NCDB Analysis of Melanoma 2004–2015: Epidemiology and Outcomes by Subtype, Sociodemographic Factors Impacting Clinical Presentation, and Real-World Survival Benefit of Immunotherapy Approval

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1455
Author(s):  
Sunny R. K. Singh ◽  
Sindhu J. Malapati ◽  
Rohit Kumar ◽  
Christopher Willner ◽  
Ding Wang

Background: The incidence of invasive melanoma is rising, and approval for the first immune checkpoint inhibitor (ICI) to treat metastatic melanoma occurred in 2011. We aim to describe the epidemiology and outcomes in recent years, sociodemographic factors associated with the presence of metastasis at diagnosis, and the real‐world impact of ICI approval on survival based on melanoma subtype and race. Methods: This is a retrospective analysis of the National Cancer Database (NCDB) from the years 2004–2015. The primary outcome was the overall survival of metastatic melanoma by subtype. Secondary outcomes included sociodemographic factors associated with the presence of metastasis at diagnosis and the impact of treatment facility type and ICI approval on the survival of metastatic melanoma. Results: Of the 419,773 invasive melanoma cases, 93.80% were cutaneous, and 4.92% were metastatic at presentation. The odds of presenting with metastatic disease were higher in African Americans (AA) compared to Caucasians (OR 2.37; 95% CI 2.11–2.66, p < 0.001). Treatment of metastatic melanoma at an academic/research facility was associated with lower mortality versus community cancer programs (OR 0.75, 95 % CI 0.69–0.81, p-value<0.001). Improvement in survival of metastatic melanoma was noted for Caucasians after the introduction of ICI (adjusted HR 0.80, 95% CI 0.78–0.83, p < 0.001); however, this was not statistically significant for AA (adjusted HR 0.80, 95% CI 0.62–1.02, p‐value = 0.073) or ocular cases (HR 1.03, 95% CI 0.81–1.31, p‐value 0.797). Conclusion: Real‐world data suggest a 20% improvement in survival of metastatic melanoma since the introduction of ICI. The disproportionately high odds of metastatic disease at presentation in AA patients with melanoma suggest the need for a better understanding of the disease and improvement in care delivery.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19333-e19333
Author(s):  
Sunny R K Singh ◽  
Sindhu Janarthanam Malapati ◽  
Rohit Kumar ◽  
Ding Wang

e19333 Background: Metastatic melanoma historically had a very poor prognosis and survival until the utilization of immunotherapy. Ipilimumab, the first immune checkpoint (ICP) inhibitor was approved in March 2011, followed soon after by the approval of PD-1 and PD-L1 inhibitors. We aim to conduct a real-world analysis of survival outcomes before and after 2011 in metastatic melanoma and its subtypes. We will also explore the impact of race on the clinical presentation and outcomes of melanoma. Methods: Adults with metastatic melanoma were identified from the NCDB (2004-2015). Kaplan Meier method was used to estimate survival and Cox proportional hazards model was used to determine hazard ratio (HR) for death after adjusting for age, race, sex, comorbidity index, melanoma type, education, income, insurance, facility type and geographical location. Odds of having metastatic disease at diagnosis were estimated using multivariate log regression analysis. Results: Of the 20,691 metastatic melanoma cases, 19,492 (94.2%) were cutaneous, 326 (1.6%) were ocular and 873 (4.2%) were mucosal. The effect of immunotherapy use on survival in metastatic melanoma was assessed by comparing years 2011-2015 versus 2004-2010. After the introduction of immunotherapy in 2011, the adjusted survival for metastatic melanoma had improved in Caucasians (HR 0.80, p < 0.001, CI 0.77-0.83) but not in African Americans (HR 0.80, p value = 0.08, CI 0.62-1.03). Although, AA constituted a minority in each melanoma group (1.7% cases of cutaneous, 1.5% of ocular and 8.1% of mucosal melanoma), their odds of having metastatic disease at onset was higher in both cutaneous (OR 2.60, p < 0.001 CI 2.28-2.95) and mucosal melanoma (OR 1.85, p < 0.001 CI 1.39-2.47) compared to Caucasians. Conclusions: Real-world data suggested a 20% improvement in survival of metastatic melanoma since the introduction of ICP inhibitors except in the subgroups of ocular melanoma and African Americans. The disproportionately high odds of metastatic disease at presentation in African American patients with melanoma suggests the need for improvement in care delivery, specifically in terms of early detection. [Table: see text]


2021 ◽  
Author(s):  
Lakshmi Digala ◽  
Shivika Prasanna ◽  
Praveen Rao ◽  
Adnan Qureshi ◽  
Raghav Govindarajan

Abstract Background: Myasthenia gravis (MG) is an auto-immune disease, and the mainstay of therapy is immunomodulation. Such patients are at high risk of acquiring any infections. Hence, we sought to determine the impact of the current global pandemic COVID-19 infection in MG patients.Methods: For our study, we used Cerner Real-World DataTM that was provided through Cerner’s HealtheDataLab research tool. We ran a database query from January 2019 to July 2020 in our study. To extract these patients’ data, we used ICD 9-CM, ICD-10, and SNOMED-CT codes. We report data using means, range, and prevalence rates. The p-values were calculated using the two-sample t-test and Pearson’s chi-squared test. Results:In the COVID-19 data set, a total of twenty-seven myasthenia patients were identified with a positive COVID-19 infection, and four diagnosed with an exacerbation. Male to female ratio was equal and one unknown gender (3.7%) with a mean (± SD) age of 64.33 ± 18.42 years. This study group was compared with a non-COVID-19 data set in which a total of sixty-four myasthenia patients were identified, and twenty-three had an exacerbation. Among the hospitalized patients in the two groups, the mean length of hospitalization for all the myasthenia patients in the COVID-19 data set was 8.28 days (n=7), and the non-COVID-19 set was 4.33 days (n=6), and it was statistically significant (p-value= 0.007). Conclusion: The mean length of hospital stay is prolonged in Myasthenia patients who tested positive for COVID-19.


2021 ◽  
Vol 161 ◽  
pp. S608
Author(s):  
I. Fornacon-Wood ◽  
H. Mistry ◽  
C. Johnson-Hart ◽  
J.P.B. O’Connor ◽  
C. Faivre-Finn ◽  
...  

2021 ◽  
Vol 28 (4) ◽  
pp. 3201-3213
Author(s):  
Kaitlyn Howden ◽  
Camille Glidden ◽  
Razvan G. Romanescu ◽  
Andrew Hatala ◽  
Ian Scott ◽  
...  

We aimed to describe the negative and positive impacts of changes in cancer care delivery due to COVID-19 pandemic for adolescents and young adults (AYAs) in Canada, as well as the correlates of negative impact and their perspectives on optimization of cancer care. We conducted an online, self-administered survey of AYAs with cancer living in Canada between January and February 2021. Multiple logistic regression was used to identify factors associated with a negative impact on cancer care. Of the 805 participants, 173 (21.5%) experienced a negative impact on their cancer care including delays in diagnostic tests (11.9%), cancer treatment (11.4%), and appointments (11.1%). A prior diagnosis of mental or chronic physical health condition, an annual income of <20,000 CAD, ongoing cancer treatment, and province of residence were independently associated with a negative cancer care impact (p-value < 0.05). The majority (n = 767, 95.2%) stated a positive impact of the changes to cancer care delivery, including the implementation of virtual healthcare visits (n = 601, 74.6%). Pandemic-related changes in cancer care delivery have unfavorably and favorably influenced AYAs with cancer. Interventions to support AYAs who are more vulnerable to the adverse effects of the pandemic, and the thoughtful integration of virtual care into cancer care delivery models is essential.


Cancers ◽  
2021 ◽  
Vol 13 (21) ◽  
pp. 5550
Author(s):  
Morten Fink ◽  
Anders Schwartz Vittrup ◽  
Lars Bastholt ◽  
Inge Marie Svane ◽  
Marco Donia ◽  
...  

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.


2020 ◽  
Author(s):  
Bénédicte Razafinjato ◽  
Luc Rakotonirina ◽  
Jafeta Benony Andriantahina ◽  
Laura F. Cordier ◽  
Randrianambinina Andriamihaja ◽  
...  

AbstractDespite the widespread global adoption of community health (CH) systems, there are evidence gaps in how to best deliver community-based care aligned with global best practice in remote settings where access to health care is limited and community health workers (CHWs) may be the only available providers. PIVOT partnered with the Ministry of Public Health to pilot a new two-pronged approach for care delivery in rural Madagascar: one CHW provided care at a stationary CH site while 2-5 additional CHWs provided care via proactive household visits. The pilot included professionalization of the CHW workforce (i.e. recruitment, training, financial incentive) and twice monthly supervision of CHWs. We evaluated the impact of the CH pilot on utilization and quality of integrated community case management (iCCM) in the first six months of implementation (October 2019-March 2020).We compared utilization and proxy measures of quality of care (defined as adherence to the iCCM protocol for diagnosis, classification of disease severity, treatment) in the intervention commune and five comparison communes, using a quasi-experimental study design and relying on routinely collected programmatic data. Average per capita monthly under-five visits were 0.28 in the intervention commune and 0.22 in the comparison communes. In the intervention commune, 40.0% of visits were completed at the household via proactive care. CHWs completed all steps of the iCCM protocol in 77.8% of observed visits in the intervention commune (vs 49.5% in the comparison communes, p-value=<0.001). A two-pronged approach to CH delivery and professionalization of the CHW workforce increased utilization and demonstrated satisfactory quality of care. National stakeholders and program managers should evaluate program re-design at a local level prior to national or district-wide scale-up.


2021 ◽  
pp. 146808742110387
Author(s):  
Stylianos Doulgeris ◽  
Zisimos Toumasatos ◽  
Maria Vittoria Prati ◽  
Carlo Beatrice ◽  
Zissis Samaras

Vehicles’ powertrain electrification is one of the key measures adopted by manufacturers in order to develop low emissions vehicles and reduce the CO2 emissions from passenger cars. High complexity of electrified powertrains increases the demand of cost-effective tools that can be used during the design of such powertrain architectures. Objective of the study is the proposal of a series of real-world velocity profiles that can be used during virtual design. To that aim, using three state of the art plug-in hybrid vehicles, a combined experimental, and simulation approach is followed to derive generic real-world cycles that can be used for the evaluation of the overall energy efficiency of electrified powertrains. The vehicles were tested under standard real driving emissions routes, real-world routes with reversed order (compared to a standard real driving emissions route) of urban, rural, motorway, and routes with high slope variation. To enhance the experimental activities, additional virtual mission profiles simulated using vehicle simulation models. Outcome of the study consists of specific driving cycles, designed based on standard real-world route, and a methodology for real-world data analysis and evaluation, along with the results from the assessment of the impact of different operational parameters on the total electrified powertrain.


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