Doxetacel and epirubicin compared with doxetacel and prednisone in advanced castrate-resistant prostate cancer: a randomized phase II study

Background:This randomised phase II study compared the activity and safety of the combination docetaxel (D)/epirubicin (EPI) with the conventional treatment D/prednisone (P) in advanced castrate-resistant prostate cancer (CRPC) patients.Materials and Methods:Patients were randomly assigned to D 30 mg m 2 as intravenous infusion (i.v.) and EPI 30 mg m 2 i.v. every week (D/EPI arm), or D 70 mg m 2 i.v. every 3 weeks and oral P 5 mg twice daily (D/P arm). Chemotherapy was administered until disease progression or unacceptable toxicity.Results:A total of 72 patients were enrolled in the study and randomly assigned to treatment: 37 to D/EPI and 35 to D/P. The median progression-free survival (PFS) was 11.1 months (95% CI 9.2-12.6 months) in the D/EPI arm and 7.7 months (95% CI 5.7-9.4 months) in the D/P arm (P0.0002). The median survival was 27.3 months (95% CI 22.1-30.8 months) in the D/EPI arm and 19.8 months (95% CI 14.4-24.8 months) in the D/P arm (P0.003). Both regimens were generally well tolerated.Conclusion:The treatment of advanced CRPC with weekly D combined with weekly EPI was feasible and tolerable, and led to superior PFS than the treatment with 3-weekly D and oral P. © 2011 Cancer Research UK. All rights reserved.