Zoledronic acid improves clinical outcomes in patients with bone metastatic hormone-naïve prostate cancer in a multicenter clinical trial - Abstract

AIM: To assess whether zoledronic acid (ZOL) adds to the effect of combined androgen blockade (CAB) in patients with hormone-naive bone metastatic prostate cancer.

PATIENTS AND METHODS: Patients were treated with either a combination of CAB (luteinizing hormone-releasing hormone agonist and bicalutamide) and ZOL (CAB-Z group) or CAB-alone (historical control patients, CAB-C group). ZOL was injected intravenously at 4 mg every 4 weeks. One hundred and five and 100 patients among 205 enrolled patients were assigned to the CAB-Z group and CAB-C group, respectively. The time to prostate-specific antigen (PSA) failure in patients in the CAB-Z group was compared to that in the CAB-C group. The primary end-point of the study was the time-to-PSA failure.

RESULTS: PSA and serum N-telopeptide of type I collagen (NTx) levels were examined before treatment and every 3 months after treatment. PSA failure occurred in 42 (40.0%) patients in the CAB-Z group and 48 (48.0%) patients in the CAB-C group. The biochemical recurrence-free rate was significantly lower in patients in the CAB-C group (p=0.004, by log-rank test). The categorical biopsy Gleason score pre-treatment serum NTx and treatment with ZOL were shown to be independent predictors of PSA failure-free survival time (p=0.040, p=0.005 and p=0.026, respectively).

CONCLUSION: ZOL given with CAB as initial treatment delays the time-to-PSA failure in patients with hormone-naive bone metastatic prostate cancer.

Written by:
Okegawa T, Higaki M, Matsumoto T, Kase H, Murata A, Noda K, Noda H, Asaoka H, Oshi M, Tomoishi J, Uchida H, Higashihara E, Nutahara K.   Are you the author?
Department of Urology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan; National Hospital Organization Disaster Medical Center, Tachikawa, Tokyo, Japan; Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan; Sassa General Hospital, Nishitokyo, Tokyo, Japan; Kawakita associates General Hospital, Suginami-ku, Tokyo, Japan; NishiTokyo Central General Hospital, Nishitokyo, Tokyo, Japan; Tama-Hokubu Medical Center, Higashimurayama, Tokyo, Japan; Akiru Municipal Medical Center, Akiruno, Tokyo, Japan; Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo, Japan; Ome Municipal General Hospital, Ome, Tokyo, Japan; Hitotsubashi Hospital, Kodaira, Tokyo, Japan.  

Reference: Anticancer Res. 2014 Aug;34(8):4415-20.


PubMed Abstract
PMID: 25075079

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