Researchers at the Medical Oncology Unit, University of Siena, Viale Bracci 11, 53100, Siena, Italy performed a randomized phase II study which compared the activity and safety of the combination docetaxel (D)/epirubicin (EPI) with the standard of care D/prednisone (P) in men with advanced castrate-resistant prostate cancer (CRPC).
The men 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). In both groups the chemotherapy was administered until disease progression or unacceptable toxicity were experienced.
Seventy two (72) men were enrolled in this study. They were randomly assigned to treatment with 37 men to D/EPI and 35 to D/P.
1- 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 (P=0.0002).
2- 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 (P=0.003).
3- Both regimens were generally well tolerated.
The treatment of men with advanced castrate resistant prostate cancer with weekly D combined with weekly EPI was found to be both feasible, tolerable and led to superior progression free survival than the standard of care (treatment with 3-weekly D and oral P). However, the authors did not discuss overall survival, the most important issue.
Petrioli R, Pascucci A, Conca R, Chiriacò G, Francini E, Bargagli G, Fiaschi AI, Manganelli A, De Rubertis G, Barbanti G, Ponchietti R, Francini G., Br J Cancer. 2011 Feb 15;104(4):613-9.
Joel T Nowak, M.A., M.S.W.