The goal of this study was to evaluate, in patients with prostate cancer, the toxicity profile and biologic activity of the bispecific antibody MDXH210, which has specificity for the non-ligand-binding site of the high-affinity immunoglobulin G receptor (Fc gamma RI) and the extracellular domain of the HER-2/neu proto-oncogene product. Patients with prostate cancer that expressed HER-2/neu were entered into a phase I dose-escalation trial of MDXH210. Patients received an intravenous infusion MDXH210 during a period of 2 h three times per week for 2 weeks and were monitored for toxicity. Pharmacokinetic and pharmacodynamic parameters were measured and included the biologic end points of monocyte-bound MDXH210, cytokine production, and clinical response. Seven patients were treated with MDXH210 doses ranging from 1 to 8 mg/m2. In general, MDXH210 was well tolerated, with only mild infusion-related malaise, fever, chills, and myalgias. No dose-limiting toxic effects were observed. Biologic effects included induction of low plasma concentrations of tumor necrosis factor-alpha and interleukin-6 observed immediately after MDXH210 infusion and 70% saturation of circulating monocyte-associated Fc gamma RI with MDXH210 at a dose level of 4 to 8 mg/m2. Five of six patients had stable prostate-specific antigen levels during the course of 40 days or more. Circulating plasma HER-2/neu levels decreased by 80% at days 12 and 29 (p = 0.03 and 0.06, respectively, by the Wilcoxon signed rank test). MDXH210 can be given safely to patients with HER-2/neu-positive prostate cancer in doses of at least 8 mg/m2. At the doses studied, biologic activity was demonstrated and characterized by binding of MDXH210 to circulating monocytes, release of monocyte-derived cytokines, a decrease in circulating HER-2/neu, and short-term stabilization of prostate-specific antigen levels.

Aged↗

PubMedDate not supplied

CT diagnosis of bowel herniation at pelvic fracture site.

We report the rare, but potentially fatal, complication of bowel herniation through a pelvic fracture. Findings on CT led to detection of this abnormality.

Adult↗

PubMedDate not supplied

Neurovascular complications of dialysis and transplantation.

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Acute Kidney Injury↗

PubMedDate not supplied

Local authority catering with frozen food.

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Costs and Cost Analysis↗

PubMedDate not supplied

An examination of the factor structure of the Frenchay Activities Index.

The Frenchay Activities Index (FAI) was administered to an elderly non-stroke subject group with the objective of evaluating the underlying factor structure of the index. Data analysis yielded three factors which were labelled indoor domestic chores, outdoor domestic chores, and outdoor social activities. This factor structure is compared with that previously published. It is argued that lifestyle activities should be considered within a framework which distinguishes between indoor/outdoor and work/leisure activities.

Activities of Daily Living↗

PubMedDate not supplied

Lifestyle activities of the elderly: composition and determinants.

Recent work suggests that lifestyle can be considered using a 2 x 2 model of indoor/outdoor and work/leisure activities. This paper replicates the factor analysis of the Frenchay Activities Index (FAI) reported by Bond et al., using a group of subjects living independently in the community. Results confirmed empirically the existence of the four hypothesized dimensions of lifestyle. Further analyses demonstrated the construct validity of these dimensions by establishing their sensitivity to age, sex, domestic circumstances, and physical and cognitive status. We discuss ways in which various deficiencies in the FAI might be rectified in a revised index of activities designed to retain and clarify the four established dimensions of lifestyle. Future directions include the development of such an instrument, and its application as a rehabilitation outcome measure.

Activities of Daily Living↗