The influence of nodal status on progression outcomes in patients with prostate cancer: Data from the Early Prostate Cancer program at 7.4 years

Abstract

4628 Background: The Early Prostate Cancer (EPC) program is an ongoing study of the effect of adding bicalutamide (CASODEX) 150 mg to standard care (radiotherapy [RT], radical prostatectomy [RP], or watchful waiting [WW]) for men with localized or locally advanced prostate cancer. At a median 7.4 years’ follow-up, bicalutamide significantly improved objective progression-free survival (PFS) in men with locally advanced disease, irrespective of standard care, and improved overall survival in the RT setting. There was no PFS benefit in patients with localized disease. Lymph-node involvement is an established risk factor for progression, so we conducted an exploratory analysis among patients with locally advanced disease to assess the influence of this risk factor on PFS. Methods: The EPC program (n = 8113) comprises 3 randomized trials designed for combined analysis. Patients with localized (T1–2, N0/Nx) or locally advanced (T3–4, any N; or any T, N+) non-metastatic prostate cancer received bicalutamide (n = 4052) or placebo (n = 4061) once daily plus standard care. This subanalysis studied the effect of nodal status (N−, N+, Nx) in locally advanced disease. Results: In patients with locally advanced disease, PFS improvements were irrespective of nodal status. The treatment effect increased as the risk of progression increased from N− to Nx to N+ disease. The greatest reduction in risk was seen in RP patients with N+ disease. Conclusions: The reduction in risk of progression with bicalutamide was seen irrespective of nodal status. The most significant reduction in risk of progression was in RP patients with N+ disease; survival data by nodal status for these patients will be presented. [Table: see text] [Table: see text]