Castration-resistant prostate cancer (CRPC) is partially characterised by overexpression of antiapoptotic proteins, such as survivin.
In this phase 2 study, patients with metastatic CRPC (n=154) were randomly assigned (1:2 ratio) to receive standard first-line docetaxel/prednisone (control arm) or the combination of LY2181308 with docetaxel/prednisone (experimental arm). The primary objective was to estimate progression-free survival (PFS) for LY2181308 plus docetaxel. Secondary efficacy measures included overall survival (OS), several predefined prostate-specific antigen (PSA)-derived end points, and Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores. The median PFS of treated patients for the experimental arm (n=98) was 8.64 mo (90% confidence interval [CI], 7.39-10.45) versus 9.00 mo (90% CI, 7.00-10.09) in the control arm (n=51; p=0.755). The median OS for the experimental arm was 27.04 mo (90% CI, 19.94-33.41) compared with 29.04 mo (90% CI, 20.11-39.26; p=0.838). The PSA responses (≥50% PSA reduction), BPI, and FACT-P scores were similar in both arms. In the experimental arm, patients had a numerically higher incidence of grades 3-4 neutropenia, anaemia, thrombocytopenia, and sensory neuropathy. In conclusion, this study failed to detect a difference in efficacy between the two treatment groups.
Written by:
Wiechno P, Somer BG, Mellado B, Chłosta PL, Cervera Grau JM, Castellano D, Reuter C, Stöckle M, Kamradt J, Pikiel J, Durán I, Wedel S, Callies S, André V, Hurt K, Brown J, Lahn M, Heinrich B. Are you the author?
Uro-Oncology Department, Cancer Center, Warsaw, Poland.
Reference: Eur Urol. 2013 Nov 6. pii: S0302-2838(13)01134-2.
doi: 10.1016/j.eururo.2013.10.039
PubMed Abstract
PMID: 24246407
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