Presentation Characteristics, Risk Profiles and Long-Term Outcomes in a Public Health System, Minority Patient Population with Chronic Lymphocytic Leukemia.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4956-4956
Author(s):  
Sunita Nathan ◽  
Olusola Ogundipe ◽  
Perry Menini ◽  
Anshul Bamrolia ◽  
Decebal S. Griza ◽  
...  
Keyword(s):  
Public Health ◽  
African American ◽  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Health System ◽  
Public Health System ◽  
Lymphocytic Leukemia ◽  
Minority Population ◽  
Medical Comorbidity

Abstract BACKGROUND: Chronic lymphocytic leukemia (CLL) is noted to exhibit male predominance, median age of 65 years at diagnosis and variable survival. Little data exist however regarding the characteristics of CLL in the U.S. minority population. METHODS: Data from 72 patients (pts) with CLL were collected from the primarily minority population served by Cook County Hospital, Chicago, Illinois over a 6 year period, and analyzed for clinical, presentation and prognostic characteristics and long-term survival. Continuous data were analyzed via Student’s T test and categorical data via Fisher’s Exact test. Survival was ascertained via Social Security Death Index query and analyzed using Kaplan Meier life-table analyses. RESULTS: 72 pts [age at diagnosis 58.4 ± 12.1 yrs, range 31–94 yrs, 45 (62.5%) males, 27 (37.5%) females] were identified and analyzed as a retrospective cohort. 16 pts (22.2%) were < 50 yrs of age and the majority of pts (53, 73.6%) had ≥ 1 major medical comorbidity at presentation. 40 (55.5%) were African American (AA), 18 (25%) Caucasian, 6 (8.3%) Hispanic, 4 (5.5%) Middle Eastern, and 4 (5.5%) Asian. Distribution by Rai stage at diagnosis was as follows: 16 (22.2%) pts Stage 0, 17 (23.6%) Stage 1, 6 (8.3%) Stage 2, 16 (22.2%) Stage 3, 16 (22.2%) Stage 4 and 1(1.4%) Richter transformation. 17 pts (23.6%) were low risk, 24 (33.3%) were intermediate risk and 31 (43.1%) were high risk (HR). Of 65 pts in whom prognostic data were available 46 (70.8%) pts had 1 or more HR features of which 25 (54.3%) were AA. Poor prognosticators included clinical stage 3 and 4 (43.1%), beta2m > 5.0 (4%), diffuse involvement of BM (36.4%), ZAP-70 positivity (20%), CD38 positivity (15.7%) and poor cytogenetic profile (del 11q / del 17q, 23.7%). CLL-associated complications included AIHA in 8 (11.1%) pts, (3/8 Coomb’s positive), ITP in 1(1.4%) pt, hypogammaglobinemia in.20/27 (74.1%) tested pts, CLL transformation to DLBCL (Richter) in 1(1.4%) pt, and second malignancies in 6 (8.3%) pts. AA pts, comprising the largest ethnic subgroup, were significantly older than non-AA pts (60.9 ± 12.9 yrs vs 55.3 ± 10.5 yrs, p<0.0478) and were more likely to have >1 medical comorbidity than non- AA pts (55.6% vs 25.0%, p=0.014). Both advanced stage at presentation (Rai 3 and 4, AA:42.5% vs non-AA:46.9%, p=0.812) and high-risk profile (AA:67.5% vs non-AA:55.9%, p=0.34) were comparably distributed between AA and non-AA pts. A modest difference was noted between AA and non-AA pts in the likelihood of receiving treatment (52.5% vs 68.8%, p=0.23) however survival at mean follow-up of 26.5 ± 20.7 months was similar (90% vs 87.5%, p=1.0). CONCLUSIONS: The primarily minority-based, public health system patient cohort analyzed in this observational study were somewhat younger than published historical control populations at the time of CLL diagnosis. African American pts while generally older and noted to have more comorbidities, had comparable disease stage and risk profiles at presentation as non-African American pts. The numerical disparity between proportions of AA vs non-AA pts treated did not appear to impact survival in this analysis. Further investigations of diagnostic, prognostic and healthcare disparities in the underserved minority population, are warranted.

scholarly journals Cost-effectiveness Analysis of Rituximab Associated With Fludarabine and Cyclophosphamide (R-FC) for the First-line Treatment of Chronic Lymphocytic Leukemia Under the Brazilian Public Health System (SUS).

2021 ◽  
Author(s):  
Bruno Azevedo ◽  
Adriana Carvalho ◽  
Andre Deeke Sasse
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Chronic Lymphocytic Leukemia ◽  
Health System ◽  
Public Health System ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
First Line ◽  
System Perspective ◽  
First Line Treatment

Abstract BACKGROUNDChronic Lymphocytic leukemia is the most common leukemia in the western world. In the last decade, treatment options expanded with an expressive rise in treatment costs. In Brazil the overall cancer treatment costs are rising mainly due to the judicialization law suits. The efficacy and safety of associating rituximab to fludarabine and cyclophosphamide (R-FC) for the treatment of chronic lymphocytic leukemia has been demonstrated by the CLL8 trial, which was conducted in previously untreated patients positioning the immunochemotherapy regimen as the standard choice for physically fit patients. Considering this scenario, the current study has as objective to evaluate the cost-effectiveness of the addition of rituximab to the FC protocol considering the Brazilian public health system perspective. METHODSWe developed a Markov model with three health states to extrapolate the CLL8 trial results. The transition probabilities and adverse events incidence were obtained from the trial published data. The costs were assessed from Brazil’s ministry of health pricing database (public available). A simplified treatment algorithm was developed according to the current available treatment options in the Brazilian public health system and assuming the availability of rituximab. RESULTSThe addition of rituximab to the FC regimen results in an incremental cost-effectiveness ratio (ICER) of 8389 USD (45003,86 BRL) per year life free of progression. The sensititvity analysis conducted shows a From the Brazilian public health system perspective, the combination of rituximab with the FC chemotherapy represents a cost-effective strategic approach for first-line treatment of patients with CLL.CONCLUSIONSconsidering the data described in this study, we cqn conclude that the addition of rituximab to the first-line treatment of CLL is cost-effective strategy for the Brazil public health system. With the advent of new drugs and new treatment regimens that presents positive clinical outcomes in patients refratary to the R-FC regimen (del17p, p53 mutations), new studies must be conducted to evaluate their cost-effectiveness considering this population of patients.

scholarly journals Epidemic of plague amidst COVID-19 in Madagascar: efforts, challenges, and recommendations

2021 ◽  
Vol 49 (1) ◽  
Author(s):  
Abdullahi Tunde Aborode ◽  
Ana Carla dos Santos Costa ◽  
Anmol Mohan ◽  
Samarth Goyal ◽  
Aishat Temitope Rabiu ◽  
...  
Keyword(s):  
Public Health ◽  
Health System ◽  
Public Health System ◽  
Healthcare Sector ◽  
The Face ◽  
Endemic Areas

AbstractThe plague has been wreaking havoc on people in Madagascar with the COVID-19 pandemic. Madagascar’s healthcare sector is striving to respond to COVID-19 in the face of a plague outbreak that has created a new strain on the country’s public health system. The goal and activities of the gradual epidemic of plague in Madagascar during COVID-19 are described in this research. In order to contain the plague and the COVID-19 pandemic in this country, we have suggested long-term recommendations that can help to contain the outbreak so that it may spread to non-endemic areas.

scholarly journals Comparative Evaluation of Ibrutinib in Treatment of Chronic Lymphocytic Leukemia Using Simulation Modeling

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1299-1299
Author(s):  
Siyang Peng ◽  
Feng Pan ◽  
Sonja Sorensen ◽  
Emily Dorman ◽  
Yingxin Xu ◽  
...  
Keyword(s):  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Sample Size ◽  
Simulation Modeling ◽  
Patient Characteristics ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Significant Heterogeneity ◽  
Bulky Disease

Abstract Background Treatment options for chronic lymphocytic leukemia (CLL) patients who received prior therapy are limited, especially for patients in high risk categories, such as del 17p; new therapies are urgently needed. In the Phase III RESONATE (Byrd, 2014), single agent ibrutinib, an oral, once-a-day, first-in-class covalent Bruton's tyrosine kinase inhibitor, was associated with improved progression-free survival (PFS, HR=0.215), overall survival (OS, HR=0.387) and overall response rate (ORR, 63% vs. 4%) compared with ofatumumab alone. Here we assessed the availability and comparability of clinical data for key therapies used in pre-treated CLL patients with ibrutinib and project long-term outcomes of ibrutinib for comparable studies using a simulation model. Methods A systematic literature review (SLR) identified relapsed or refractory CLL clinical trials on the following regimens: bendamustine ± rituximab (BR), fludarabine + cyclophosphamide + rituximab (FCR), ofatumumab, idelalisib + rituximab (IR), and rituximab. Patient populations and outcomes (ORR, PFS, and OS) were compared. A health state model was then developed to simulate long-term PFS and OS, comparing other therapies with ibrutinib. The model simulated treatment of a cohort of patients with pre-treated CLL until death or until disease progression, at which point they were simulated to receive subsequent treatment or best supportive care. Available Kaplan-Meier data were used to estimate longer-term projections of PFS and OS of comparable trials. Results The SLR identified few (n=36) relevant trials, only 4 of which were RCTs; comparison to ibrutinib through a common comparator was not possible. Pivotal trials was identified for each therapy based on the comparability to the RESONATE population, largest sample size and greatest amount of data reported. Selected trials (Table) showed significant heterogeneity between study populations, including variations in adverse cytogenetics (e.g. del 17p, del 11q), treatment line, and other characteristics (e.g. bulky disease) which have important ramifications on health outcomes. Three trials were excluded from simulation modeling: Robak (FCR) and LeBlond (BR) consisted of less heavily pre-treated patients than RESONATE; Furman et al. 2014 (rituximab and idelalisib+rituximab), enrolled a similar population to RESONATE aside from 17 p del, however, long-term safety and efficacy outcomes are limited due to the short follow-up in the idelalisib trial. Simulation over a 10 year horizon resulted in prolonged estimated mean OS for ibrutinib compared to ofatumumab (66 months versus 39 months). Despite the ibrutinib patients consisting of more heavily pre-treated, worse adverse cytogenetics and high risk features than those included in the BR and FCR studies, naïve comparison of long-term OS was projected to be 26 months and 8 months longer with ibrutinib respectively. Conclusion Comparisons of outcomes across trials are inherently limited by differences in populations, trial designs, and measurements. In this limited, naïve comparison of high risk CLL patients, ibrutinib is reasonably expected to provide incremental OS over BR and FCR in the pre-treated CLL setting, even when considering the RESONATE patient population included more heavily pre-treated patients and those with worse cytogenetics. The most rigorous comparison, using comparative data from a head-to-head trial, indicated that ibrutinib significantly prolonged PFS and OS compared to ofatumumab, which has established activity in hard-to-treat patients. Table. Patient Characteristics Patient Characteristics RESONATE RESONATE Fischer Badoux Furman Furman Robak FCR LeBlond BR Ibrutinib Ofatumumab BR FCR Rituximab + placebo Rituximab + idelalisib Sample Size 195 196 78 284 110 110 276 58 Median age (range) 67(30- 88) 67 (37- 88) 66.5 (42-86) 60 (NA) 71 (47-92) 71 (48- 90) 63 (35-83) 75 (49-87) Del 17p, (%) 32.30% 32.70% 19.20% 7% 28.20% 23.60% 7% 12% Median # of prior therapies (range) 3 (1-12) 2 (1-13) 2 (1-5)* 2 (1-10) 3 (1-9) 3 (1-12) 1 (1-1) 1 (1-2) % ≥3 prior therapies 52.80% 45.90% 43% 31% NA NA 0% 0% % Purine analog refractory 44.60% 44.90% 28.2%~ 19%~ NA NA NA NA Disclosures Peng: Janssen: Consultancy; Evidera: Employment. Pan:Janssen: Consultancy; Evidera: Employment. Sorensen:Evidera: Employment; Janssen: Consultancy. Dorman:Janssen: Consultancy; Evidera: Employment. Xu:Janssen: Consultancy; Evidera: Employment. Sallum:Evidera: Employment; Janssen: Consultancy. Gaudig:Janssen: Employment. Sengupta:Janssen: Employment. Wildgust:Janssen Global Services: Employment. Sun:Janssen: Employment.

scholarly journals Community and health staff perceptions on non-communicable disease management in primary care in El Salvador: a qualitative study

2019 ◽  
Author(s):  
Nicole Vidal ◽  
Montserrat León ◽  
Marta Jiménez ◽  
Keven Bermúdez ◽  
Pol De Vos
Keyword(s):  
Public Health ◽  
Health Care ◽  
Primary Health Care ◽  
Health System ◽  
El Salvador ◽  
Public Health System ◽  
Term Care ◽  
Primary Health ◽  
Patient Resources

Abstract Non-communicable Diseases (NCDs) are the leading cause of global mortality and disability, with a rising burdenin low- and middle-income countries. Their multifactorial aetiology, and their requirement of long-term care, imply the need for comprehensive approaches. From 2009, the Ministry of Health (MoH) in El Salvador has developed a national public health system based on comprehensive primary health care. This analysis explores community perceptions related to the management of NCDs in this health system. During three fieldwork periods in 2018, three complementary qualitative data collection methods were deployed. First, we used illness narrative methodology to document the life histories of people living with a chronic disease and being treated in second and third level health facilities. Second, through social mapping, we analysed support-resources that NCD patients used throughout the process of their illness. Third, semi-structured interviews were conducted with both chronic patients and health personnel working at different levels of the primary health care setting. Participants were recruited through purposive sampling, and a deductive approach was implemented for coding during the analysis phase. After grouping codes into potential themes, a thematic framework was elaborated for each method through a reflexive approach and triangulation of the data. This innovative approach of combining three well-defined qualitative analysis frameworks identified key implications for the implementation of a comprehensive first line approach to NCDs management in resource-poor settings. Following dimensionsare identified: social risk factors, barriers to care, patient resources and pathways to care, trust in community social connections, and strategies for community health promotion and prevention of NCDs. The Salvadoran public health system has been able to strengthen its comprehensive approach to NCDs, combining a clinical approach – including long term follow-up – with a preventive community-based strategy. The structural collaboration between the health system and the (self)organized community has been key to identify failings, discuss tensions and work out adapted solutions.

scholarly journals Long-Term Impact of Disasters on the Public Health System: A Multi-Case Analysis

2020 ◽  
Vol 17 (17) ◽  
pp. 6251
Author(s):  
Nina Lorenzoni ◽  
Verena Stühlinger ◽  
Harald Stummer ◽  
Margit Raich
Keyword(s):  
Public Health ◽  
Health System ◽  
Public Health System ◽  
Psychosocial Support ◽  
Holistic Approach ◽  
The Public ◽  
Preparedness Planning ◽  
Tunnel Fire ◽  
Long Term Impact

As past events have shown, disasters can have a tremendous impact on the affected population’s health. However, research regarding the long-term impact on a systems level perspective is still scarce. In this multi-case study, we analyzed and compared the long-term impacts on the public health system of five disasters which took place in Europe: avalanche (Austria), terror attack (Spain), airplane crash (Luxembourg), cable-car tunnel fire (Austria), and a flood in Central Europe. We used a mixed-methods approach consisting of a document analysis and interviews with key stakeholders, to examine the various long-term impacts each of the disasters had on health-system performance, as well as on security and health protection. The results show manifold changes undertaken in the fields of psychosocial support, infrastructure, and contingency and preparedness planning. The holistic approach of this study shows the importance of analyzing long-term impacts from the perspective of the type (e.g., disasters associated with natural hazards) and characteristic (e.g., duration and extent) of a disaster, as well as the regional context where a disaster took place. However, the identified recurring themes demonstrate the opportunity of learning from case studies in order to customize the lessons and apply them to the own-disaster-management setting.

scholarly journals The Difficult-to-Treat del 17 p Patient—A Case Report in Chronic Lymphocytic Leukemia

Medicina ◽  
2021 ◽  
Vol 58 (1) ◽  
pp. 33
Author(s):  
Ana-Maria Moldovianu ◽  
Ana Manuela Crisan ◽  
Zsofia Varady ◽  
Daniel Coriu
Keyword(s):  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Unmet Need ◽  
Treatment Strategies ◽  
Lymphocytic Leukemia ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Risk Patients ◽  
Potential Benefits

Chronic lymphocytic leukemia (CLL) treatment strategies have evolved to include mechanism-driven drugs but now raise new questions regarding their optimum timing and sequencing. In high-risk patients, switching from pathway inhibitors to allogeneic stem cell transplantation (allo-HCT) is still a matter of intense debate. We report the case of a CLL patient with 17 p deletion treated with ibrutinib as a bridge to allo-HCT. Early relapse after allo-HCT urged the initiation of salvage therapy, including donor lymphocytes infusions, ibrutinib, and venetoclax. We aim to outline and discuss the potential benefits of novel therapies, the current role of allo-HCT in CLL, drug timing and sequencing, and the unmet need to improve the long-term outcome of high-risk CLL patients.

scholarly journals Alert for TSH Measurement in High-Risk Pregnancies in Brazil

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A848-A849
Author(s):  
Lívia Marcela Santos ◽  
Déborah Buso Piccinalli Marietto ◽  
Juliana Miyuki Miura ◽  
Luisa Lacaz Martins Megale ◽  
Gabriela Terzian Ganadjian ◽  
...  
Keyword(s):  
Public Health ◽  
High Risk ◽  
Health System ◽  
Pregnant Women ◽  
Medical Records ◽  
Public Health System ◽  
Overt Hypothyroidism ◽  
Average Weight ◽  
Free T4 ◽  
Cross Sectional

Abstract Introduction: The hypothyroidism during pregnancy can lead to alterations in fetal neurological formation and has metabolic impact on pregnant women. If not diagnosed and treated it can cause complications during pregnancy and childbirth, besides causing changes in fetal formation. The TSH test is not part of routine examinations of the pregnancy monitoring care in Brazilian public health system (SUS). The test is not requested in low-risk pregnant women like those at high risk. The Overt Hypothyroidism (no subclinical) is prevalent in 0.3% to 0.5% of pregnant women and is asymptomatic in 70% of these patients. Thus, in order to avoid risks to the mother and fetus health due absence of early diagnosis, it would be ideal for pregnancy monitoring care examinations in the public health system to request a TSH test, especially in high-risk pregnancies. Method: A cross-sectional observational study was approved by the Ethics Committee (CAAE 22906619.2.0000.0062) to review 83 medical records of high-risk pregnant women in a Brazilian public hospital, State of São Paulo, Brazil in 2020. Inclusion criteria: All patients who are being followed up in high-risk childbirth or are hospitalized in the high-risk sector on the maternity during the year 2020. Complete medical records containing the data proposed to be researched and results of exams to be analyzed in the research. Results: The study included the review of 83 medical records of high-risk pregnant women with average age of 30 years old, average gestational age of 31 weeks and average weight of 84 kg. From these 11.4% (n = 10) declared that they had hypothyroidism and 2.4% (n = 2) hyperthyroidism in the first consultation. The 47% (n = 39) had their TSH measured during pregnancy, of which TSH had changed 30.8% (n = 12), 5.1% (n = 2) with suppressed TSH and 25.6% (n = 10) with TSH above the limit for pregnancy. Of the pregnant women who had a diagnosis prior to the pregnancy of hypothyroidism, only 1 did not have their TSH collected during pregnancy. Of the pregnant women who had hyperthyroidism, all had TSH collected during pregnancy, but kept TSH suppressed and free T4 at the upper limit throughout the pregnancy. 10% (n = 8) had gestational bleeding, of which only 25% (n = 2) had TSH measured at some point during pregnancy, of these, one had an altered TSH, but no medication was prescribed or the test repeated. Conclusion: Recognizing that the evolution of pregnancy depends on the normal thyroid eixo, we believe that for high-risk pregnant women they should have their thyroid eixo evaluated in the first trimester.

scholarly journals Community and health staff perceptions on non-communicable disease management in El Salvador’s Health System: a qualitative study

2020 ◽  
Author(s):  
Nicole Vidal ◽  
Montserrat León-García ◽  
Marta Jiménez ◽  
Keven Bermúdez ◽  
Pol De Vos
Keyword(s):  
Public Health ◽  
Health Care ◽  
Primary Health Care ◽  
Health System ◽  
El Salvador ◽  
Public Health System ◽  
Comprehensive Approach ◽  
Social Connections ◽  
Primary Health

Abstract Background: Non-communicable Diseases (NCDs) are the leading cause of global mortality and disability, with a rising burdenin low- and middle-income countries. Their multifactorial aetiology, and their requirement of long-term care, imply the need for comprehensive approaches. From 2009, the Ministry of Health (MoH) in El Salvador has developed a national public health system based on comprehensive primary health care. This study aims to describe the different stakeholders’ perceptions about the management of NCDs along the pathways of care in this health system. Methods : During three fieldwork periods in 2018, three complementary qualitative data collection methods were deployed and conducted in settings with high prevalence of NCDs within El Salvador. First, illness narrative methodology was used to document the life histories of people living with a chronic disease and being treated in second and third level health facilities. Second, through social mapping, support resources that NCD patients used throughout the process of their illness within the same settings were analysed. Third, semi-structured interviews were conducted in the same locations, with both chronic patients and health personnel working at different levels of the primary health care setting. Participants were recruited through purposive and snowball sampling, and a deductive approach was implemented for coding during the analysis phase. After grouping codes into potential themes, a thematic framework was developed using a reflexive approach and following triangulation of the data. Results : This innovative approach of combining three well-defined qualitative methods identified key implications for the implementation of a comprehensive approach to NCD management in resource-poor settings. The following elements are identified: 1) social risk factors and barriers to care; 2) patient pathways to NCD care; 3) available resources identified through social connections mapping; 4) trust in social connections; and 5) community health promotion and NCD prevention management. Conclusions: Salvadoran public health system has been able to strengthen its comprehensive approach to NCDs, combining a clinical approach – including long term follow-up – with a preventive community-based strategy. The structural collaboration between the health system and the (self-) organised community has been key to identify failings, discuss tensions and work out adapted solutions.

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