Phase II study of vinorelbine with low dose prednisone in the treatment of hormone-refractory metastatic prostate cancer.

A phase II trial of vinorelbine and low dose prednisone in hormone-refractory metastatic prostate cancer was conducted in order to investigate its safety, efficacy and impact on quality of life. Vinorelbine was administered at the dose of 25 mg/m(2) i.v. weekly for 12 weeks and then biweekly, along with 10 mg of daily oral prednisone until time of progression. Fourteen patients, median age of 74 years, were treated. The treatment was generally well tolerated with leukopenia and anemia as the major side effects. One patient achieved partial remission and eleven remained with stable disease. One of the eleven patients with stable disease had a dramatic PSA response from 1000 to 236 ng/ml; seven of these progressed after week twelve when vinorelbine was given biweekly. PSA response occurred in 5 of 14 patients. The median time to progression was 28 weeks and the median survival was 17 months. Nine out of the 14 accrued patients were evaluable for quality of life assessment. Five of them improved, three remained unchanged and two had a slight worsening. Four patients had improvement in pain control and fatigue. Our preliminary data suggest that the combination of vinorelbine/prednisone has modest activity in metastatic prostate cancer with a very favorable toxicity profile and is very well tolerated in this group of elderly patients.

Factor VIII-related antigen in occluded human arteries and grafts.

Direct immunofluorescence was used to determine the disposition of factor VIII-related antigen (VIIIR:Ag) in occluded arteries and grafts from patients undergoing reconstructive operation. The presence of VIIIR:Ag on the luminal surface of these vessels was equated with their endothelialization according to the work of others. In 12 of the 20 arteries examined, stain for VIIIR:Ag was absent or markedly reduced from the luminal surfaces, and in six more it was only present focally. The adventitial capillaries were brightly stained in most of these specimens. Both of two saphenous vein grafts and all of six Dacron grafts stained for VIIIR:Ag along their luminal surfaces and in the adventitial capillaries as brightly as normal arteries. However, all of eight Gore-tex grafts had little or no stain for VIIIR:Ag along their luminal surfaces, and the capillaries of the adventitia were not as plentiful as those in the normal arteries and Dacron grafts. With one exception, the Gore-tex grafts had become occluded less than 1 year after implantation, while the Dacron grafts had remained patent for 2 to 8 years. Thus many of the diseased arteries and the short-lived Gore-tex grafts were characterized by relative absence of VIIIR:Ag from their luminal surfaces, presumably reflecting the loss or absence of endothelialization.