Abstract:
OBJECTIVES:We conducted an adjusted comparison of progression-free survival (PFS) and overall survival (OS) for daratumumab monotherapy versus standard of care, as observed in a real-world historical cohort of heavily pretreated multiple myeloma patients from Czech Republic. METHODS:Using longitudinal chart data from the Registry of Monoclonal Gammopathies (RMG) of the Czech Myeloma Group, patient-level data from the RMG was pooled with pivotal daratumumab monotherapy studies (GEN501 and SIRIUS; 16 mg/kg). RESULTS:From the RMG database, we identified 972 treatment lines in 463 patients previously treated with both a proteasome inhibitor and an immunomodulatory drug. Treatment initiation dates for RMG patients were between March 2006 and March 2015. The most frequently used treatment regimens were lenalidomide-based regimens (33.4%), chemotherapy (18.1%), bortezomib-based regimens (13.6%), thalidomide-based regimens (8.0%), and bortezomib plus thalidomide (5.3%). Few patients were treated with carfilzomib-based regimens (2.5%) and pomalidomide-based regimens (2.4%). Median observed PFS for daratumumab and the RMG cohort was 4.0 and 5.8 months (unadjusted hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.94-1.39), respectively, and unadjusted median OS was 20.1 and 11.9 months (unadjusted HR, 0.61; 95% CI, 0.48-0.78), respectively. Statistical adjustments for differences in baseline characteristics were made using patient-level data. The adjusted HRs (95% CI) for PFS and OS for daratumumab versus the RMG cohort were 0.79 (0.56-1.12; p = .192) and 0.33 (0.21-0.52; p < .001), respectively. CONCLUSIONS:Adjusted comparisons between trial data and historical cohorts can provide useful insights to clinicians and reimbursement decision makers on relative treatment efficacies in the absence of head-to-head comparison studies for daratumumab monotherapy.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Jelínek T,Maisnar V,Pour L,Špička I,Minařík J,Gregora E,Kessler P,Sýkora M,Fraňková H,Adamová D,Wróbel M,Mikula P,Jarkovský J,Diels J,Gatopoulou X,Veselá Š,Besson H,Brožová L,Ito T,Hájek Rdoi
10.1080/03007995.2017.1410121subject
Has Abstractpub_date
2018-05-01 00:00:00pages
775-783issue
5eissn
0300-7995issn
1473-4877journal_volume
34pub_type
杂志文章abstract::The efficacy of parenteral mecillinam was evaluated in 105 elderly patients with lower respiratory tract infections or urinary tract infections. Another antibiotic, usually amoxycillin, was given concurrently in cases of respiratory infection. An adequate response was note in 86% of chest infections and in all of the ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998109114254
更新日期:1981-01-01 00:00:00
abstract:OBJECTIVES:Inflammatory bowel disease (IBD) is a chronic condition commonly requiring lifelong care. Both IBD and IBD-related treatments can cause significant morbidity, and it is often difficult to differentiate their relative etiologic contribution to adverse events (AEs). The objectives of this study were to assess ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1065242
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abstract::In a double-blind trial in 26 patients with symptomatic gastro-oesophageal reflux, the alginate/effervescent/antacid compound 'Gaviscon' was compared with antacid containing placebo similarly formulated. Retrosternal pain after meals and at night was significantly reduced whilst patients were taking 'Gaviscon' and the...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997509114793
更新日期:1975-01-01 00:00:00
abstract:AIM:To assess the efficacy of a strategy to improve vascular risk management in patients with type 2 diabetes mellitus (T2DM). METHODS:This was a pilot best practice implementation enhancement programme that enrolled 578 patients with T2DM. A baseline visit was followed by a concerted effort from previously trained ph...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903073035
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abstract:BACKGROUND:A double-blind randomized trial evaluated the efficacy and tolerability of rivastigmine and donepezil in patients with Alzheimer's disease (AD) over 2 years. Baseline data indicated that some patients had symptoms suggestive of concomitant Lewy body disease. This retrospective analysis investigated whether A...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1185/030079906x80279
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997909109409
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abstract:OBJECTIVE:Implantation of bone marrow mononuclear cells (BM-MNCs), including endothelial progenitor cells, into ischemic lower limbs has been shown to improve symptoms in patients with peripheral arterial diseases (PAD). This study investigated whether BM-MNC implantation (BMI) is also effective for the ischemic hands ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X1000078
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abstract:OBJECTIVE:Vildagliptin is a potent and selective dipeptidyl peptidase-IV (DPP-4) inhibitor that improves glycemic control in patients with type 2 diabetes by increasing alpha and beta-cell responsiveness to glucose. This study assessed the effect of multiple doses of vildagliptin 100 mg once daily on warfarin pharmacok...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/030079907x188008
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abstract::Objective: To assess real-world costs for patients with hemophilia A treated with bypassing agents versus factor VIII (FVIII) replacement. Methods: Claims data from a large US health insurer during 1 January 2006-30 September 2014 were used for analysis. Treated patients with hemophilia A were identified based on ≥1 m...
journal_title:Current medical research and opinion
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journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/03007995.2015.1048208
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/030079905x38196
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abstract::Studies in several populations have indicated that genetic variation at the apolipoprotein E (apoE) structural locus influences the risk of coronary artery disease (CAD) and myocardial infarction (MI). This study aimed at investigating whether apoE polymorphism has an allelic and/or genotypic impact on the risk of MI ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079902125000444
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abstract:BACKGROUND:Natalizumab is a highly effective treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Treatment with natalizumab has been associated with progressive multifocal leukoencephalopathy (PML), a rare yet serious disease of the brain. Published studies have quantified the PML risk by the pre...
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doi:10.1185/03007995.2013.869492
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journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X115531
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journal_title:Current medical research and opinion
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journal_title:Current medical research and opinion
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pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Current medical research and opinion
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journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Current medical research and opinion
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journal_title:Current medical research and opinion
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pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
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