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To fully characterise the differences between these antibodies, a systemic trial is needed which would also allow the measurement of cognitive changes.
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This review summarises the data already known and discusses newly available results, along with ongoing systemic trials in hepatocellular carcinoma treatment.
Recently, systemic trials using both AOs have revealed dose-dependent efficacy without any severe adverse effects [ 24, 25].
National and multinational networks such as the European Systemic Sclerosis Trial and Research EUSTARR) network or the German Network of Systemic Sclerosis (DNSS) addressed the standardization in the assessment and classification of patients.
Potential sources of between-trial heterogeneity were explored by sensitivity analyses focusing on pre-specified explanatory variables, such as the type of therapy (locoregional vs. systemic) and trial quality.
Specific to BM, a recent systemic therapy trial for patients with HER2-negative progressive breast cancer BM reported a PFS of 3.7 months despite a 63%% intracranial RR [ 31].
Other efforts also showed variable effects such as systemic erythropoietin trial in moderate HIE 18 that resulted in significant reduction of neurodevelopment disability at 18 months between the treated and controls (25% vs 44%, p=0.017).
These recent trials in CXMDj utilised very high and frequent doses of systemically delivered antisense oligonucleotides; additional work, in particular, improving delivery, efficacy and reducing dose, frequency and the potential for toxicity is very important for similar systemic therapeutic trials in humans.
No cases of symptomatic hypotension were reported in relaxin-treated subjects in any of the systemic sclerosis trials.
A pooled analysis of two adjuvant systemic chemotherapy trials reported in 2008 revealed a hazard ratio (HR) for OS of 0.76 for patients treated with 5 FU/FA.
This information is likely to be useful, especially in adaptive systemic therapy trials, and therefore, should be validated in larger prospective studies.
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