Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer.

PURPOSE: We evaluated the pharmacokinetics, safety and efficacy of the implantable Viadur++ leuprolide delivery system during 12 months in patients with advanced prostate cancer. MATERIALS AND METHODS: Our open label, multicenter, dose ranging study was done in 2 phases. The treatment phase was a stratified, randomized, parallel evaluation of the safety and efficacy of 1 or 2 implants. The safety extension phase assessed the long-term safety and efficacy of 1 implant. Implant insertion and removal, pharmacokinetic profile and patient satisfaction were also evaluated. The primary efficacy parameter was testosterone suppression for 12 months but luteinizing hormone and prostate specific antigen were also evaluated. RESULTS: Of the 51 patients 27 received 1 and 24 received 2 implants, of whom 49 completed the 12-month treatment phase. Steady serum leuprolide concentration was maintained from day 3 through the remainder of the 12-month treatment phase and for 2 months after reimplantation. Implantation and reimplantation were well tolerated and acceptable to physicians and patients. Testosterone suppression to the castrate range was 100% in each group. At 12 months mean prostate specific antigen decreased from a baseline of approximately 84% and 91% in groups 1 and 2, respectively. Serious adverse events during the study period in 15 patients were not attributable to treatment. CONCLUSIONS: The implantable leuprolide delivery system provides effective suppression of testosterone in patients with advanced prostate cancer.

Comparison between diagnostic ultrasonography and radiography in the evaluation of horses and cattle with thoracic disease: 56 cases (1984-1985).

The results of radiography and ultrasonography were compared on 56 horses and cows with lower respiratory tract disease. Ultrasonography was more sensitive than radiography for the detection of small pleural effusions and consolidations in large animals. The side of the thorax affected and the character of the pleural fluid and lung in large animals with pleural effusion can be evaluated ultrasonographically. The periphery of the lung must be affected to characterize pulmonary lesions ultrasonographically. Radiography is the best technique to characterize lesions deep within the lung when the periphery of the lung is normal.

Xeroradiographic evaluation of the equine larynx.

The normal radiographic anatomy of the equine larynx was determine by use of xeroradiography and dissection. The body and laminae of the thyroid cartilage, the muscular process of the arytenoid cartilages, and the dorsal lamina and arch of the cricoid cartilage had radiographic evidence of mineralization (calcification) and/or ossification in clinically normal horses. There was a significant (P less than 0.01) increase in the degree of mineralization of the thyroid and arytenoid cartilages with advancing age. Horses with diagnosis of arytenoid chondrosis (arytenoid chondral dysplasia, arytenoid chondropathy) by use of endoscopy had radiographic changes that included: enlargement with increased density of the arytenoid cartilage region, abnormal patterns of mineralization (dystrophic mineralization or osseous metaplasia), abnormal contour of the corniculate process(es) and laryngeal masses, sometimes obliterating part or all of the lateral laryngeal ventricles.

Scrotal reconstruction following an avulsion injury.

Scrotal reconstruction following avulsion of the scrotal skin often is a time-consuming, multistage repair. We present an alternative method of repair using a subcutaneous soft tissue expander.

Osseous cyst-like lesions of the medial femoral condyle in the horse.

Osseous cyst-like lesions of the medial femoral condyle were found in 32 horses admitted to the University of Pennsylvania between 1971 and 1978. Sex or breed predilection was not found. In 12 horses, osseous cysts were found in both hindlimbs. Of the 25 horses on which follow-up information was obtained, 16 became sound and useful between 4 months and 1 year after diagnosis. Horses that became lame before 3 years of age had a better chance for later soundness. Horses that became sound had significantly smaller cysts than those that remained lame.

Compensatory renal growth and function in postnephrectomized patients with Wilms tumor.

The objective of this study was to determine whether or not renal growth and function were adversely affected in the remaining kidneys of patients who had undergone nephrectomy for Wilms tumor. These patients received chemotherapy and some radiotherapy (tumoricidal agents which might affect the remaining kidney). Renal growth was compared between the treatment groups and normal renal growth. Hypertrophy did occur and did not appear to be affected by subsequent treatment. Renal function was minimally altered in all treatment groups irrespective of the type of treatment.

Plasma clearance of [51Cr] albumin into the intestinal tract of normal and chronically diarrheal horses.

Five clinically normal, mature horses and 11 with chronic diarrhea were given 51Cr-tagged Cohn fraction V equine albumin intravenously. All urine and feces were collected separately, and blood for plasma analysis was taken periodically for 5 to 8 days after injection of the isotope. Plasma clearance of albumin into the intestinal tract of normal horses was calculated as 0.67 +/- 0.23 (SD) ml/kg of body weight/day, with 1.33 +/- 0.69% of the 51Cr dose appearing in the feces in 5 days. Of the 11 diarrheal horses, 8 had a plasma clearance of 0.49 +/- 0.21 ml/kg/day with 1.12 +/- 0.68% of the dose of 51Cr in a 5-day fecal collection, suggesting that excessive losses of plasma protein into the bowel was not a component of their intestinal disease. The 3 other diarrheal horses had a marked protein-losing enteropathy; 1 of these horses had granulomatous enteritis due to Mycobacterium avium infection; another had severe intercellular edema of small and large intestinal mucosa, cause unknown; and intestinal biopsies were not obtained from the 3rd horse. The results suggest that: (1) as with other species that have been studied, daily loss of plasma protein into the bowel of horses is small; (2) most horses with chronic diarrhea do not have protein-losing enteropathy.