scholarly journals Bladder cancer. A retrospective analysis of the use of vinfluvin in real clinical practice

2021 ◽  
Vol 8 (2) ◽  
pp. 34-42
Author(s):  
A. S. Zhabina ◽  
A. I. Novikov ◽  
F. V. Moiseenko ◽  
N. M. Volkov ◽  
E. O. Stepanova ◽  
...  

Purpose of the study. There is the generalized analysis of administration of vinflunine in real clinical practice in St.Petersburg Clinical Scientific and Practical Center of Specialized medical Care (oncological).Materials and methods. This analysis gathered 27 patients with urothelial carcinoma treated using this medicine in St.Petersburg Clinical Scientific and Practical Center of Specialized medical Care (oncological). We assessed efficacy, safety profile of vinflunine in this subset of patients.Results. Clinical efficacy of vinflunine (complete response + partial response + stable disease) was 51,86 %, one patient demonstrated complete response. Median of response duration accounts for 3,4 months. Adverse events were observed in 28,4 %, most of them were 1-2 grades. 2 patients stopped therapy due to adverse events.Conclusion. In our analysis vinflunine was more effective than in randomized clinical trial and other studies from real practice in Europe. Thus, confirm expediency to administer of vinflunine for metastatic urothelial carcinoma.

2020 ◽  
Vol 16 (3) ◽  
pp. 135-142
Author(s):  
L. V. Bolotina ◽  
I. N. Zaborskiy ◽  
K. N. Safiullin ◽  
E. V. Gurin ◽  
L. N. Volodina ◽  
...  

Objective. There is the second generalized analysis of administration of vinflunine in real clinical practice in Russia.Materials and methods. This analysis gathered 15 patients with urothelial carcinoma treated using this medicine in 8 cancer centers in Russia. We assessed efficacy, safety profile of vinflunine in this subset of patients.Results. Clinical efficacy of vinflunine (complete response + partial response + stable disease) was 73.3 %, one patient demonstrated complete response. Median of response duration accounts for 3.8 months. Six-month and 1-year survival rate made up 93.3 %. Adverse events were observed in 53.5 %, with only one episode of neutropenia 4 grade.Conclusion. In our second analysis vinflunine was more effective than in randomized clinical trial and other studies from real practice in Europe. Thus, we confirm expediency to administer of vinflunine for metastatic urothelial carcinoma.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1493.2-1493
Author(s):  
C. Ramos Giráldez ◽  
M. L. Velloso Feijoo ◽  
S. Rodríguez Montero ◽  
J. L. Marenco

Background:Lupus nephritis (LN) is a potentially life-threatening complication of systemic lupus erythematosus (SLE). Standard treatment of this entity includes glucocorticoids (GC) and immunosuppressants such as cyclophosphamide (CF), with remission rates between 20 and 70%. Given its pathogenesis, the anti-CD20 antibody rituximab (RTX) may be useful, although the information available in the scientific literature remains controversial.Objectives:To evaluate the effectiveness and safety of RTX in NL refractory to conventional treatment, under real clinical practice conditions.Methods:Retrospective descriptive observational study, which included consecutive patients attended in a Rheumatology Unit who met SLICC 2012 criteria for SLE, with renal involvement, and who had received RTX for NL refractory to standard treatment. We collected different epidemiological, clinical (including other manifestations of SLE as well as previous treatments), analytical, RTX-related and adverse event variables. In all cases, renal function prior to the initiation of RTX was determined, as well as the degree of proteinuria and sediment alterations. The therapeutic response was evaluated considering partial response if they presented reduction of proteinuria in >50% compared to initial and stabilization of renal function (± 25%) or improvement of serum creatinine with respect to initial values; and complete response if they presented levels of serum creatinine <1.2mg/dL (or decrease to initial values or ± 15% of the basal value in those with creatinine ≥1,2 mg/dL), proteinuria ≤0,5 g/24h and inactive sediment. A quantitative descriptive analysis has been carried out with the statistical program IBM SPSS 24.0 for Windows.Results:Thirteen patients (11 women and 2 men) were included, with a mean age of 32.3 years and a mean follow-up time from the start of RTX of 11.09 years. Class IV NL was the most frequent (46.15%), followed by Class III NL (38.46%). Class V NL represented 7.69% and another 7.69% the combination of Class III+V. Renal failure was present in 46.2% of patients at the beginning of RTX, 84.6% hematuria and all patients presented proteinuria, of which 76.9% were confirmed to have nephrotic range and 84.6% showed hypoalbuminemia. With regard to previous treatments, all cases had received high-dose of GC and at least one immunosuppressant: 92.3% had failed to CF, a similar percentage had received azathioprine and 46.2% had failed to mycophenolate. After treatment with RTX, partial or complete response was achieved in 84.61%, infections were identified in 46.15% of patients and allergic reactions in 15.38%; most adverse events were mild and all cases developed favorably.Conclusion:RTX treatment is effective in SLE and specifically in LN. More than 80% of patients in our study with refractory LN benefited from RTX treatment. Despite the not insignificant incidence of adverse events, most were mild and resolved without sequels or complications, so we can conclude that the safety of RTX is acceptable and should be considered as a treatment option for these patients according to the good risk-benefit profile.Disclosure of Interests:Consuelo Ramos Giráldez: None declared, Maria Luisa Velloso Feijoo: None declared, Sergio Rodríguez Montero: None declared, Jose Luis Marenco Speakers bureau: ABbvie, Pfzer, lilly


2021 ◽  
Vol 26 (3S) ◽  
pp. 4558 ◽  
Author(s):  
S. V. Villevalde ◽  
A. E. Soloveva ◽  
N. E. Zvartau ◽  
N. G. Avdonina ◽  
A. N. Yakovlev ◽  
...  

The extent of the problem of heart failure determines the priority of the intention of developing and implementing an optimal model of medical care for this group of patients. The article describes the key components of the heart failure medical care (continuity, patient routing, educational activities) and provides examples of documents, protocols, checklists that can be used in real clinical practice by specialists in medical organizations in the regions of the Russian Federation.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19260-e19260
Author(s):  
Daniel Lane ◽  
Andrew D. Norden ◽  
Andrew J. Belli ◽  
Ching-Kun Wang

e19260 Background: A recent study (Foster, Tromanhauser et al. 2019) utilizing Electronic Health Record (EHR) data found that patients with MM rarely have both serum protein electrophoresis (SPEP) and 24-hour urine protein electrophoresis (UPEP) documented in routine clinical practice settings. These elements are necessary to classify response using the International Myeloma Working Group (IMWG) consensus criteria. It could be hypothesized that adding the additional requirements for bone marrow biopsy necessary to confirm a complete response would further reduce the rate of strict adherence to the IMWG criteria in the real world (RW). Clinicians are however assessing response and progression in RW settings and often report these assessments in published literature. In this study, we survey the literature to determine how RW response is being captured and reported outside of the clinical trial setting. Methods: A systematic search was performed using Medline 2010-2019. Using a standardized grading system, English language articles were evaluated that utilized EHR data from routine clinical practice to report RW response in patients with active MM. Registry based and/or pragmatic observational studies were excluded as many had mandatory reporting procedures in place. Studies were then categorized based on methods of assessing response, progression and use of IMWG criteria. Results: The majority of studies grade 1 studies identified (21/25) utilized best response achieved based on treating physician-documented assessment and either did not specify the use of IMWG(10/21) criteria or explicitly stated they did not use conventional criteria (11/21). Progression event capture and reporting varied greatly with many using physician-documented progression, change in regimen, addition of additional agents to existing regimen, stem cell transplant, or an individually created algorithm. Conclusions: Our findings suggest that there is a need for further research on objective techniques for the assessment of RW progression and response in patients with MM. Additionally, validation of an approach that utilizes partial adherence to IMWG criteria would help in the ability to compare findings across clinical trial and RW settings. This validation work is under way, and preliminary results will be reported at the meeting.


2021 ◽  
Vol 31 (5) ◽  
pp. 613-626
Author(s):  
Vladimir V. Arkhipov ◽  
Zaurbek R. Aisanov ◽  
Sergey N. Avdeev

Asthma management approaches are improving yearly, but the problem of asthma control is still acute. Combinations of inhaled glucocorticosteroids (ICS) and long-acting β2-agonists (LABA) play a crucial role in asthma therapy, but their effectiveness in real practice can be insufficient, and asthma control level in the population remains low. Optimizing the use of these drugs, changing the usual therapy regimens, and implementing upgraded inhalers can improve adherence to treatment and inhalation technique, which affects the effectiveness of the therapy.The study aimed to describe the key characteristics of the patient population getting asthma treatment in real clinical practice and assess factors influencing asthma control, including adherence to therapy.Methods. A single-stage cross-sectional observational study in 124 primary health care centers in 22 cities of the Russian Federation included 3,214 patients > 18 years old, with a clinical diagnosis of asthma for at least 1 year, who were able to perform a spirometry test and fill out the ACQ-5 and TAI-12 questionnaires.Results. Assessment of asthma control with the ACQ-5 questionnaire showed that most patients had uncontrolled asthma (56%). Controlled and partially controlled asthma was diagnosed in 21 and 19% of patients, respectively. 4% of patients had severe uncontrolled asthma. The TAI questionnaire revealed low adherence to therapy in more than half of the patients (53.6%). The rate of patients with controlled asthma and the average annual frequency of exacerbations were significantly lower in subgroups of patients who received therapy with extrafine ICS/LABA and ICS/formoterol in single inhaler regimen, compared with controller therapy using fixed and free combinations of ICS and LABA.Conclusion. The main causes of insufficient asthma control are low adherence to treatment, inhalation errors, monotherapy with ICS, asthma with small airways dysfunction, and adverse events associated with ICS. Prescribing the combinations of ICS/LABA in the form of extra-fine aerosol and using it in the Maintenance and Reliever Therapy (MART) regimen can significantly increase asthma control, reduce the risk of adverse events, and increase patient adherence to treatment. A potential alternative to improve asthma control is administering ICS-LABA combinations once daily.


2020 ◽  
Vol 4 ◽  
pp. 23-23
Author(s):  
Cheng-Sheng Liu ◽  
Chien-Jui Cheng ◽  
Yun-Ru Liu ◽  
Shauh-Der Yeh ◽  
Shiu-Chen Jeng ◽  
...  

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