Reliable and valid body composition assessment is important in both clinical and research settings. A multitude of methods and techniques for body composition measurement exist, all with inherent problems, whether in measurement methodology or in the assumptions upon which they are based. This review is focused on currently applied methods for in vivo measurement of body composition, including densitometry, bioimpedance analysis, dual-energy X-ray absorptiometry, computed tomography (CT), magnetic resonance techniques and anthropometry. Multicompartment models including quantification of trace elements by in vivo neutron activation analysis, which are regarded as gold standard methods, are also summarized. The choice of a specific method or combination of methods for a particular study depends on various considerations including accuracy, precision, subject acceptability, convenience, cost and radiation exposure. The relative advantages and disadvantages of each method are discussed with these considerations in mind.
The aim of this study was to investigate the prognostic value of the quantitative assessment of skeletal tumor burden on bone scintigraphy (Bone Scan Index [BSI]) in patients who have advanced metastatic castration-resistant prostate cancer (mCRPC) and are receiving RaCl We hypothesized that the BSI can serve as a prognostic biomarker of overall survival (OS) and hematologic toxicity and as a tool for response assessment in patients with mCRPC treated with RaCl This study was a retrospective investigation of a Danish cohort of mCRPC patients who received RaCl therapy between March 2014 and October 2015 and for whom baseline bone scintigraphy was available. Bone scintigraphy studies were reviewed and graded according to the extent of disease. Furthermore, an automated BSI (EXINI Bone) was obtained for baseline scintigraphy studies and follow-up scans after 3 cycles as well as at the end of therapy. Clinical outcomes were OS and occurrence of hematologic toxicity of grades 2-5. Associations between the BSI and clinical outcomes were investigated in multivariate regression models including the visual assessment of bone scintigraphy and other relevant covariates. A total of 88 patients were included. The median number of completedRaCl cycles was 4, and 27 patients (31%) completed 6 cycles. The BSI was significantly associated with OS in the multivariate analysis; the median OS for patients with a BSI of greater than 5 was 8.2 mo, and the median OS for patients with a BSI of less than or equal to 5 was 15.0 mo (hazard ratio, 2.65 [95% confidence interval, 1.5-4.71]; = 0.001). Likewise, the baseline BSI was prognostic for the occurrence of hematologic toxicity; patients with a BSI of greater than 5 had an odds ratio of 3.02 (95% confidence interval, 1.2-7.8; = 0.02) for toxicity. The BSI declined during therapy in 44% of the patients who completed 3 cycles of RaCl ( = 52) and in 84% of the patients after the end of therapy ( = 32). There was no significant association between a change in the BSI during therapy and OS. The BSI is a promising biomarker for prognostication of OS and hematologic toxicity in late-stage mCRPC patients receivingRaCl Further prospective studies are needed to evaluate the potential of the BSI for response assessment in RaCl therapy.
BackgroundOligoG is a low molecular-weight alginate oligosaccharide that improves the viscoelastic properties of cystic fibrosis (CF) mucus and disrupts biofilms, thereby potentiating the activity of antimicrobial agents. The efficacy of inhaled OligoG was evaluated in adult patients with CF.MethodsA randomised, double-blind, placebo-controlled multicentre crossover study was used to demonstrate safety and efficacy of inhaled dry powder OligoG. Subjects were randomly allocated to receive OligoG 1050 mg per day (10 capsules three times daily) or matching placebo for 28 days, with 28-day washout periods following each treatment period. The primary end-point was absolute change in percentage predicted forced expiratory volume in 1 s (FEV1) at the end of 28-day treatment. The intention-to-treat (ITT) population (n=65) was defined as randomised to treatment with at least one administration of study medication and post-dosing evaluation.ResultsIn this study, 90 adult subjects were screened and 65 were randomised. Statistically significant improvement in FEV1 was not observed in the ITT population. Adverse events included nasopharyngitis, cough and pulmonary exacerbation. The number and proportions of patients with adverse events and serious adverse events were similar between OligoG and placebo group.ConclusionsInhalation of OligoG-dry powder over 28 days was safe in adult CF subjects. Statistically significant improvement of FEV1 was not reached. The planned analyses did not indicate a significant treatment benefit with OligoG compared to placebo. Post hoc exploratory analyses showed subgroup results that indicate that further studies of OligoG in this patient population are justified.
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