Clinical benefit of zoledronic acid for the prevention of skeletal complications in patients with prostate cancer based on history of skeletal complications

Le résumé fourni par la source

4576 Background: We previously reported the efficacy and safety of 4 mg zoledronic acid (Zol) at 15 mo compared with placebo in patients with bone metastases from prostate cancer (Saad et al. J Natl Cancer Inst. 2002;94:1458–1468). We report here the results of a retrospective analysis performed to determine the clinical benefit of Zol in men with prostate cancer based on patients' history of skeletal complications before study entry. Methods: Data were analyzed for patients treated with 4 mg Zol or placebo every 3–4 weeks for 24 months. Patients were retrospectively stratified according to history of a skeletal-related event (SRE) before study entry. Results: Of 422 patients randomized to 4 mg Zol or placebo, 147 completed the 15-month study and 133 elected to enter 9-month extension. Approximately one third of patients had an SRE before study entry. In the placebo group, 51% of patients with a history of an SRE developed an on-study SRE vs 47% of patients without an SRE before study entry. Regardless of SRE history, Zol treatment reduced skeletal morbidity compared with placebo. Multiple event analysis demonstrated that among patients with an SRE before study entry, the risk of developing an SRE was reduced by 40% for patients treated with Zol 4 mg vs placebo (hazard ratio = 0.603; P = .028). For patients without an SRE before study entry, the risk of developing an on-study SRE was also reduced (33%) relative to placebo (hazard ratio = 0.670; P = .027). In the placebo group, median time to first SRE appeared to be shorter for patients with a prior SRE vs no prior SRE. However, in both stratification groups Zol 4 mg extended median time to first SRE relative to placebo (361 days vs 258 days for placebo in patients with a prior SRE and 499 days vs 337 days for placebo in patients without a prior SRE; P = .066 and .065, respectively). Conclusions: This exploratory analysis suggests that Zol provides clinical benefit in patients with advanced prostate cancer and bone metastases independent of their prior history of skeletal complications. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Pharmaceuticals Corp.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.