scholarly journals Use of new anticoagulants for the treatment of venous thromboembolism in the context of the results of the XALIA study — clinical trials and routine clinical practice

2016 ◽  
Vol 22 (1) ◽  
pp. 28-36
Author(s):  
Tomasz Urbanek
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Routine Clinical Practice ◽  
New Anticoagulants

scholarly journals New insights into treatment of venous thromboembolism

Hematology ◽  
2014 ◽  
Vol 2014 (1) ◽  
pp. 297-305 ◽  
Author(s):  
Stephan Moll
Keyword(s):  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Clinical Management ◽  
Routine Clinical Practice ◽  
Acute Management ◽  
Clinical Context ◽  
High Profile ◽  
New Anticoagulants ◽  
Important Challenge

Abstract Several advances have occurred over the last 2 years in the clinical management of venous thromboembolism (VTE), as evidenced by several high-profile publications in top-tier medical journals. The translation of the knowledge gained into routine clinical practice is an important challenge so that VTE is managed optimally and established and new anticoagulants are used effectively and safely. This chapter reviews issues of VTE treatment from acute management to treatment of long-term complications, addressing new data gained in the last 2 years and putting them into a clinical context, with the goal of improved everyday VTE management.

scholarly journals Underestimated Value of Sarcopenia in Gastric Cancer Surgery

2020 ◽  
Vol 19 (1-2) ◽  
pp. 12-19
Author(s):  
Martynas Lukšta ◽  
Raminta Lukšaitė-Lukštė ◽  
Augustinas Baušys ◽  
Kęstutis Strupas
Keyword(s):  
Gastric Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Treatment Strategies ◽  
Significant Risk ◽  
Bioelectrical Impedance ◽  
Significant Risk Factor ◽  
Impedance Analysis ◽  
Routine Clinical Practice ◽  
Gastric Cancer Treatment

Surgery remains the only potentially curative option for gastric cancer, although it is related to high postoperative morbidity and mortality rate. Approximately every second gastric cancer patient is diagnosed with sarcopenia, which is a significant risk factor for postoperative complications and poor long-term outcomes. However, sarcopenia is underestimated in routine clinical practice, since it remains the interest of clinical trials. Sarcopenia diagnostic criteria are not fully standardized, but it consists of tests for muscle strength, quantity and quality. They include grip strength, chair stand test, computed tomography, magnetic resonance imaging, ultrasound, bioelectrical impedance analysis and densitometry tests. Regarding the growing evidence for sarcopenia impact on surgical gastric cancer treatment results, it is a high probability that sarcopenia assessment will come to routine clinical practice. Although, until then there is a need for further clinical trials to standardize the diagnostic and to find effective treatment strategies.

A review of the patterns of docetaxel use for hormone refractory prostate cancer (HRPC) at the Princess Margaret Hospital

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16161-e16161
Author(s):  
S. N. Chin ◽  
L. Wang ◽  
A. Lau ◽  
M. Moore ◽  
S. S. Sridhar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Median Duration ◽  
Response Rates ◽  
Routine Clinical Practice ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
First Line

e16161 Background: Docetaxel is standard of care for the treatment of HRPC, based on two large randomized clinical trials. The aim of this study was to determine if docetaxel use and effectiveness in routine clinical practice was similar to that seen in the TAX 327 randomized phase III clinical trial. Methods: A retrospective chart review was undertaken to assess patterns of docetaxel use for HRPC at our institution for the 2-year period since its approval for the first-line treatment of HRPC in 2005. Results: Eighty-eight patients, median age 71 and baseline PSA 107, received docetaxel in the first line setting. Main reasons for initiating docetaxel were rising PSA (90%) and progressive symptoms (71%). Eighteen percent of patients received docetaxel for rising PSA alone. A median of 7 cycles was administered. PSA response rates were 61%, time to response 1.5 months, and response duration 6.8 months. Disease progression was the most common reason for treatment discontinuation (36%). Main toxicities were fatigue (32%) and neuropathy (22%). Kaplan Meier survival analysis showed median duration of survival was 15.9 months (95% CI 12.4–20.5) from first drug use. 1-year survival was 0.63 (95% CI 0.52–0.72). Post-docetaxel, 36 patients received second-line treatment, mostly with mitoxantrone (89%). Second-line response rates were 22%, and median duration of response was 4 months. Conclusions: In routine clinical practice, docetaxel is a well-tolerated regimen for the treatment of HRPC. Response rates and toxicity profiles were comparable to the randomized trials. However, compared with the TAX 327 clinical trial, survival was slightly shorter than expected (15.9 vs. 18.9 months), possibly due to inclusion of patients with poorer performance status and comorbidities, who may be excluded from clinical trials. Second-line response rates were also comparable with previous reports. No significant financial relationships to disclose.

scholarly journals The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: The case of the Institut Gustave Roussy

2012 ◽  
Vol 6 (2) ◽  
pp. 204-210 ◽  
Author(s):  
Monica Arnedos ◽  
Fabrice André ◽  
Françoise Farace ◽  
Ludovic Lacroix ◽  
Benjamin Besse ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Personalized Cancer Medicine ◽  
Cancer Medicine ◽  
Personalized Cancer

scholarly journals Trial in Progress: Real-World Safety and Effectiveness of Brentuximab Vedotin in Adults with CD30+ Lymphoma in China

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4552-4552
Author(s):  
Pengpeng Xu ◽  
Mingci Cai ◽  
Wendy Zhang ◽  
Wei Li Zhao
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Survival Rate ◽  
Real World ◽  
Brentuximab Vedotin ◽  
Routine Clinical Practice ◽  
Inclusion Criteria ◽  
Real World Data

Abstract Background: Clinical trials have demonstrated the effectiveness of the CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) for the treatment of classical Hodgkin lymphoma (HL) and non-Hodgkin lymphoma(e.g. ALCL, PTCL-NOS, AITL, CTCL and etc.). While clinical trials are critical for establishing efficacy, collection of real-world data outside of the controlled trial setting is important to evaluate how interventions are applied and assess the effectiveness of new treatments in routine clinical practice. Inclusion criteria are often rather restrictive compared with the patient populations seen by physicians in daily practice. There are limited real-world data related to treatment with BV in China. Our study aims to obtain timely real-world knowledge in terms of safety and effectiveness of BV in CD30+ lymphoma patients in China. Study Design and Methods: The study (NCT04837222) is a real-world, prospective, multicenter study to evaluate the safety and effectiveness of BV in patients with CD30+ lymphoma in China. Consecutive CD30+ lymphoma patients treated with BV as a part of standard clinical practice will be enrolled. Key inclusion criteria includes adult patients undergoing treatment with BV or to be received with BV, patient/legal guardian must be able to read, understand, and sign the Informed Consent Form, CD30+ lymphoma by INV (any CD30 expression). Exclusion criteria includes patient who currently participates in or with plan to participate in any interventional clinical trial, any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study. As CD30+ lymphoma is not a common disease and the affordability of novel treatment is limited, 1000 patients with CD30+ lymphoma will be recruited from almost 30 hematology centers. The physician will determine the treatment regimen, as well as the frequency of laboratory and clinical assessment according to her/his routine practice. All patients will be followed up per routine clinical practice and data will be documented at baseline/3/6/9/12/18/24 months unless withdrawal of Informed Consent, death or loss of follow-up, whichever comes first. Loss to follow-up will be minimized through active contact with participating patients thereafter to ensure almost all clinically relevant outcomes will be captured. The primary endpoint is serious adverse events. Secondary endpoints include adverse events, adverse drug reaction, dose adjustment, characteristics of patients receiving BV, use of BV, number of BV cycles administered, disease characteristics, time to next treatment, overall response rate, duration of response, progression free survival rate, overall survival rate, quality of life and cost-effectiveness ratio. Descriptive analysis will be performed for data analysis. Disclosures Zhang: Takeda Pharmaceuticals: Current Employment.

scholarly journals Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Psychometric Properties ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Routine Clinical Practice ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Numeric Rating

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

P3849Baseline profile of patients treated for acute venous thromboembolism in routine clinical practice according to age and renal function in the RE-COVERY DVT/PE global cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
W Ageno ◽  
I B Casella ◽  
C K Han ◽  
S Schellong ◽  
S Schulman ◽  
...  
Keyword(s):  
Renal Function ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Observational Study ◽  
Anticoagulant Therapy ◽  
Patient Characteristics ◽  
Routine Clinical Practice ◽  
Moderate Renal Impairment ◽  
Acute Venous Thromboembolism

Abstract Background Observational studies provide the opportunity to evaluate routine practice without the selection and treatment criteria imposed in randomized clinical trials (RCTs). Purpose Using data from the RE-COVERY DVT/PE global observational study (enrolment January 2016 to May 2017), we describe the baseline profile of patients treated for acute venous thromboembolism (VTE) in routine clinical practice according to age and renal function. Methods Baseline patient characteristics, clinical features (comorbidities/medical history), and anticoagulant therapy were tabulated descriptively for the subgroups of age (<75, ≥75 years) and creatinine clearance (<30, 30 to <50 [moderate impairment], 50 to <80 [mild impairment], ≥80 mL/min). Anticoagulant therapy at baseline and at hospital discharge or 14 days after diagnosis (whichever was later) was recorded. Results In this observational study of 6122 patients with acute deep vein thrombosis, the proportions of patients at baseline who were ≥75 years of age (25.2%) or who had mild to moderate renal impairment (38.1%) were higher than in RCTs of non-vitamin K antagonist oral anticoagulants (NOACs) for acute VTE treatment (∼12–13% elderly and ∼26–29% with mild or moderate renal impairment) (from analyses of the RE-COVER trials; Hokusai-VTE and AMPLIFY). Older patients and those with renal impairment were more often female and were more likely to have comorbidities than the younger or normal renal function groups (Table). At the time of hospital discharge or 14 days after diagnosis, whichever was later, the majority was treated with NOACs (54%). Vitamin K antagonists were prescribed to approximately 1 in 5 patients. The use of NOACs decreased with worsening renal function, whereas the proportions treated with parenteral anticoagulation alone increased in the moderate renal impairment group compared with patients with normal renal function. Conclusion The population treated for acute VTE in routine clinical practice includes more elderly and renally impaired patients than represented in RCTs. These baseline data provide a snapshot of patient characteristics and patterns of anticoagulant therapy. Acknowledgement/Funding Funded by Boehringer Ingelheim

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