Open Access

ARTICLE

Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases

Ulf W. Tunn¹, Amulf Stenzl², Wolfgang Schultze-Seemann³, Arne Strauss⁴, Manfred Kindler⁵, Kurt Miller⁶, Manfred P. Wirth⁷, Niko Zantl⁸, Matthias Schulze⁹, Christoph May¹⁰, Amelie Ruebel¹⁰, Katrin Birkholz¹⁰, Viktor Gruenwald¹¹

1 Department of Urology, Hospital Offenbach, Offenbach, Germany
2 Department of Urology, University Hospital Tübingen, Tübingen, Germany
3 Department of Urology, University Hospital Freiburg, Freiburg, Germany
4 Department of Urology, University Hospital Göttingen, Göttingen, Germany
5 Urology Outpatient Department, Berlin, Germany
6 Department of Urology, University Hospital Charité, Berlin, Germany
7 Department of Urology, University Hospital Dresden, Dresden, Germany
8 Department of Urology, University Hospital München, München, Germany
9 Urology Outpatient Department, Markkleeberg, Germany
10 Novartis Pharma GmbH, Nuremberg, Germany
11 Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany
Address correspondence to Prof. Dr. Gruenwald, Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Carl-NeubergStr.1, 30625 Hannover, Germany

Canadian Journal of Urology 2012, 19(3), 6261-6267.

Abstract

Introduction: Approximately 30% of patients with renal cell cancer (RCC) develop bone metastasis, causing skeletal-related events (SREs): pathologic fracture, spinal cord compression, surgery to bone, and radiotherapy. Zoledronic acid demonstrated significant clinical benefit in RCC patients in a retrospective analysis. The primary objective of this prospective study was to evaluate the proportion of patients experiencing ≥ 1 SRE during 12 months of zoledronic acid treatment and to verify the retrospective data.
Materials and methods: Fifty patients with histologically confirmed RCC and evidence of ≥ 1 cancer-related bone lesion, and ≤ 3 prior bisphosphonate applications were enrolled across 19 German centers between 2004 and 2007. Patients received 4 mg zoledronic acid every 3 weeks for 12 months, followed by a follow-up period assessing overall survival for an additional 12 months. Bone lesions were diagnosed using bone scan or MRI-quickscan. At least one lesion had to be confirmed by x-ray, CT, or MRI scan. Additional bone scans were performed after completion of study treatment and when clinically indicated. In cases of suspected or evident SRE, radiological confirmation was required.
Results: A total of 49 out of 50 enrolled patients were treated. Only 11 patients (22.4%) experienced any SRE by month 12. Patients with > 6 lesions and higher baseline MSKCC (Memorial Sloan-Kettering Cancer Center) scores had a higher risk for SREs. Zoledronic acid was generally well tolerated, affirming its known safety profile.
Conclusions: This prospective study confirms prior findings regarding the efficacy of zoledronic acid in patients with metastatic (m)RCC, supporting its beneficial use in this patient population.

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