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| |  Denosumab Increases Overall Survival in Men With Prostate Cancer on ADT With Prevalent Vertebral Fractures: Presented at ECCO-ESMO By Chris Berrie BERLIN -- September 23, 2009 -- Denosumab increases overall survival in men with prostate cancer receiving androgen-deprivation therapy (ADT) who had prevalent vertebral fractures (PVF) at baseline, according to an analysis presented here at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO). Fred Saad, MD, Department of Urology and Oncology, Centre Hospitalier de l’Université de Montréal and Notre Dame Hospital, Montréal, Quebec, presented an analysis of a randomised, double-blind, placebo-controlled, phase 3 trial on September 21. “In terms of vertebral fractures in noncancer settings, there have been associations with subsequent clinically relevant fractures as well as increased long-term mortality that has been recorded in the osteoporosis field,” said Dr. Saad. Although ADT is central to the treatment of men with prostate cancer, there remain problems of bone loss and increased risk of fracture, with little data available in prostate cancer relating to the impact of vertebral fractures or prevalent fractures. The present analysis was designed to assess the effects of baseline PVFs on overall survival at 36 months for all patients and according to treatment. The main study included men with nonmetastatic prostate cancer on continuous ADT who were randomised to placebo (n = 734) or subcutaneous denosumab 60 mg every 6 months for a total of 6 doses (n = 734). Supplementation with calcium 1 g/day and vitamin D (>=400 IU/day) were included. Patient baseline characteristics were similar across both groups. The primary endpoint of improvements in lumbar spine bone mineral density at month 36 was observed with denosumab in the main study, with a 6.7% improvement over placebo (P < .0001). Similarly, the secondary endpoint of decreased new vertebral fractures at month 36 was met for denosumab (relative risk, 0.38; P = .006). With the present analysis for overall survival at month 36 in patients with PVF at baseline, in the overall patient population, regardless of treatment, there was a trend towards a greater death rate associated with PVF (7.6% vs 5.1% without PVF; hazard ratio [HR], 1.57; P = .062). However, when analysed according to treatment, with placebo this difference reached significance (9.2% vs 4.6%; HR, 2.14; P = .019). In contrast, with denosumab treatment this increased death rate disappeared, with no significant difference for PVF versus no PVF (HR, 1.09; P = .81). These significant changes were maintained after adjustment for risk factors of age and prior duration of ADT. Dr. Saad noted that men with prostate cancer on ADT who had PVF at baseline appeared to have shorter overall survival compared with those with no PVF at baseline. “And this even given the fact of a very short, 3-year follow-up,” he added. These findings support the association of fracture with overall survival in men with nonmetastatic prostate cancer, while also indicating that, as Dr. Saad noted, “targeting the bone has more than just bone outcomes.” Funding for this study was provided by Amgen Inc. [Presentation title: Overall Survival in Men With and Without Prevalent Vertebral Fracture Receiving Androgen Deprivation Therapy for Non-Metastatic Prostate Cancer. Abstract 7005]
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