Responder analysis of the effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer.

BACKGROUND: Denosumab, a fully human monoclonal antibody against RANK ligand, increased bone mineral density (BMD) and reduced fracture risk vs placebo in a phase 3 trial in men with prostate cancer on androgen deprivation therapy (ADT). The present analysis of this study evaluated BMD changes after 36 months in responder subgroups and in individual patients for three key skeletal sites (lumbar spine (LS), femoral neck (FN) and total hip (TH)) and the distal radius. METHODS: Men with nonmetastatic prostate cancer receiving ADT were treated with subcutaneous denosumab 60 mg (n=734) or placebo (n=734) every 6 months for up to 36 months in a phase 3, randomized, double-blind study. Patients were instructed to take supplemental calcium and vitamin D. For this BMD responder analysis, the primary outcome measure was the percentage change in BMD from baseline to month 36 at the LS, FN and TH as measured by dual-energy X-ray absorptiometry. BMD at the distal 1/3 radius at 36 months was measured in a substudy of 309 patients. RESULTS: At 36 months, significantly more patients in the denosumab arm had increases of >3% BMD from baseline at each site studied compared with placebo (LS, 78 vs 17%; FN, 48 vs 13%; TH, 48 vs 6%; distal 1/3 radius, 40 vs 7% (P<0.0001 for all)). BMD loss at the LS, FN and TH occurred in 1% of denosumab-treated patients vs 42% of placebo patients, and BMD gain at all three sites occurred in 69% of denosumab patients vs 8% of placebo patients. Lower baseline BMD was associated with higher-magnitude BMD responses to denosumab at the LS, FN and TH. CONCLUSIONS: In men with prostate cancer receiving ADT, significantly higher BMD response rates were observed with denosumab vs placebo. Patients with lower baseline T-scores benefited the most from denosumab treatment.

The effect of liposome encapsulated antineoplastic agents on transitional cell carcinoma in tissue culture.

Liposomes are microscopic vesicles composed of one or more phospholipid bilayers separated by an equal number of aqueous interspaces. These "capsules" are formed when dried lipid is combined with excess water, agitated, and warmed above the transition temperature of the lipid (the temperature at which the lipid changes from a gel state to a fluid state). If a chemical in solution is present when the vesicles form, the chemical will be trapped in either the aqueous interspaces (hydrophilic compounds), or the lipid bilayer (hydrophobic compounds). The urinary bladder is an attractive site for the topical application of liposome encapsulated compounds due to its accessibility and since the introduction of various agents, including antineoplastic compounds, into the bladder is a well established treatment option. Utilization of liposome technology may provide the means for a more effective intravesical treatment of transitional cell carcinoma.

Migrating suture masquerading as a renal pelvic carcinoma: an unusual complication of the Kock pouch.

Following a radical cystectomy and the creation of a Kock pouch, a filling defect developed in the renal pelvis that appeared to be a transitional cell carcinoma. This appearance was produced by the retrograde migration and implantation of a fragment of suture material used in the creation of the pouch. It represents a previously undescribed complication of this procedure.

Bilateral multilocular renal cysts.

Multilocular renal cystic disease is a rare, benign condition thought to occur unilaterally. We report a case of asynchronous, bilateral multilocular renal cystic disease, which suggests that unilaterality is not essential for diagnosis of this lesion.