ECTS2013 Poster Presentations Cancer and bone: basic, translational and clinical (31 abstracts)
Effect of zoledronic acid on bone metabolism in patients with bone metastases from prostate or breast cancer: the ZOTECT Study
Peyman Hadji 1 , May Ziller 1 , Tobias Maurer 2 , Michael Autenrieth 2 , Mathias Muth 3 , Amelie Ruebel 3 , Christoph May 4 , Katrin Birkholz 3 , Erhardt Diebel 5 , Jochen Gleissneer 5 , Peter Rothe 5 & Juergen E Gschwend 2
1Philipps-University of Marburg, Universitatsklinikum Giessen und Marburg, Marburg, Germany; 2Urologische Klinik, Klinikum rechts der Isar der Technische Universitaet Muenchen, Muenchen, Germany; 3Novartis Pharma GmbH, BU Oncology, Nuernberg, Germany; 4Novartis Pharma GmbH, Biostatistics and Medical Writing, Nuernberg, Germany; 5Outpatient Center, Magdeburg, Germany.
Introduction: The prospective, single-arm, open-label ZOTECT study was designed to assess the effect of zoledronic acid (ZOL) on bone-marker levels and potential correlations with disease outcomes in bisphosphonate-naive patients with bone metastases.
Methods: Patients with bone metastases from prostate cancer (PC; n=301) or breast cancer (BC; n=99) who have not received bisphosphonates for ≥6 months were enrolled at 98 sites in Germany (from May 2006 to July 2008). Patients received ZOL (4 mg) i.v. every 4 weeks for 4 months, with a final follow-up at 12 months. The primary endpoint was change in bone marker levels at 12 months relative to baseline. Secondary assessments included skeletal-related event (SRE) rate, pain, quality of life (QoL), and prostate-specific antigen (PSA) levels. Endpoints were assessed using summary statistics by visit/tumor type and Kaplan–Meier analyses.
Results: ZOL treatment significantly decreased bone-marker levels vs baseline (amino-terminal propeptide of type I collagen (P1NP), C-terminal cross-linking telopeptide of type I collagen (CTX); P<0.0001), and this decrease was maintained through the final 1-year follow-up visit. Baseline P1NP and CTX levels correlated with the extent of bone disease (P<0.0001, each) and on-treatment decreases in marker levels. Skeletal disease burden and bone-marker levels were similar between PC and BC patients, and ZOL did not significantly influence osteoprotegerin/receptor activator of nuclear factor-κB ligand levels. During the 12-month period, only 13 SREs occurred in 11 patients. On-treatment bone-marker level changes did not correlate with SRE rate, pain scores, or QoL. Mean PSA levels were lower at study end (120 days; 92.5 μg/l) than at baseline (168.5 μg/l; Wilcoxon’s signed-rank test, P=0.27). In general, ZOL was well tolerated and adverse events were consistent with its established safety profile.
Conclusions: This study confirms that ZOL therapy significantly reduces bone turnover (measured as P1NP and CTX levels) in patients with bone metastases from PC or BC.
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Bone Abstracts
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