become an established treatment for certain patients with prostate carcinoma. W. Holt Sanders, M.D. LHRH-a are known to decrease bone mineral density. The purpose of this study Robert O. Northway, M.D. was to determine the risk of bone fracture in men receiving LHRH-a for prostate a for the treatment of prostate carcinoma. Abstracted data included the number Georgia. of monthly LHRH-a injections, age, clinical stage of disease, sites of metastases, and bone fracture history. RESULTS. Twenty of the 224 patients (9%) treated with LHRH-a for prostate carci-noma between 1988 and 1995 at 3 teaching hospitals had at least 1 bone fracture during treatment with LHRH-a. The duration of treatment to the time of fracture ranged from 1 to 96 months (mean, 22.2 months). Seven fractures (32%) were osteoporotic in nature (i.e., vertebral compression fractures or hip fractures after a fall from standing), whereas 8 fractures (36%) were associated with a significant traumatic event (i.e., a motor vehicle accident, boxing, etc.) and 5 were of mixed etiology. Two of 22 fractures (9%) were pathologic. CONCLUSIONS. This study demonstrated a 9% fracture incidence in a cohort of patients receiving LHRH-a for prostate carcinoma for up to 96 months. The incidence of osteoporotic fractures was 5%.

No abstract

Purpose: The study aims to evaluate the efficacy and toxicity of fenretinide in preventing tumor recurrence in patients with transitional cell carcinoma (TCC) of the bladder. Experimental Design: We conducted a multicenter phase III, randomized, placebo-controlled trial of fenretinide (200 mg/day orally for 12 months) in patients with non^muscle-invasive bladder TCC (stages Ta, Tis, or T1) after transurethral resection with or without adjuvant intravesical Bacillus Calmette-Guerin (BCG). Patients received cystoscopic evaluation and bladder cytology every 3 months during the 1-year on study drug and a final evaluation at 15 months. The primary endpoint was time to recurrence. Results: A total of 149 patients were enrolled; 137 were evaluable for recurrence. The risk of recurrence was considered to be ''low'' in 72% (no prior BCG) and intermediate or high in 32% (prior BCG) of the evaluable patients. Of the lower-risk group, 68% had solitary tumors and 32% had multifocal, low-grade papillary (Ta, grade 1 or grade 2) tumors. The 1-year recurrence rates by Kaplan-Meier estimate were 32.3% (placebo) versus 31.5% (fenretinide; P = 0.88 logrank test). Fenretinide was well tolerated and had no unexpected toxic effects; only elevated serum triglyceride levels were significantly more frequent on fenretinide (versus placebo). The Data Safety and Monitoring Board recommended study closure at 149 patients (before reaching the accrual goal of 160 patients) because an interim review of the data showed a low likelihood of detecting a difference between the two arms, even if the original accrual goal was met. Conclusions: Although well tolerated, fenretinide did not reduce the time-to-recurrence in patients withTa,T1, orTisTCC of the bladder.

No abstract

No abstract