L.Yu. Vladimirova, N.A. Abramova, A.A. Lyanova, A.E. Storozhakova, I.L. Popova, N.M. Tikhanovskaya, K.A. Novoselova, L.A. Ryadinskaya, M.O. Ezhova, E.A. Dzhenkova

Russian Scientific Research Oncological Institute, Rostov-on-Don, Russia
Background. Denosumab is the first osteomodifier of the new class – RANK ligand blocker; the mechanism of action of this class differs from bisphosphonates, and according to the results of clinical studies their effectiveness in bone metastases exceeds bisphosphonates. Objective: clinical evaluation of the effectiveness and safety of the use of denosumab. Цель исследования: клиническая оценка эффективности и безопасности применения деносумаба. Methods. The data of 28 patients with bone metastases from solid tumors treated with denosumab were analyzed. The drug was administered subcutaneously at a dose of 120 mg once every 28 days. As the 1st line therapy, 6 (21.5%) patients received denosumab (21.5%); 22 (78.5%) patients were pretreated with bisphosphonates and had bisphosphonate resistance; 7 (24.9%) patients received radiation therapy and/or treatment with radioactive isotopes before the initiation of therapy with denosumab. Time to the first bone event (pathological fracture, radiation therapy for bone for any reasons, surgical intervention for bone metastases, spinal cord compression, hypercalcemia), the incidence of bone events, the dynamics of pain syndrome (according to the VAS scale) were assessed. Results. The duration of therapy with denosumab was 3 to 24 months, the median was 16.8±2.3 months, the time to the first bone event against the background of therapy with denosumab was 8 to 18 months, the median was not achieved. Bone events were observed in 7 (25%) patients: pathological fracture in 2 (7.1%), surgical intervention in 1 (3.6%), spinal cord compression in 2 (7.1%), hypercalcemia – in 2 (7.1%) patients. The pain syndrome decreased by 50% at 6th month of therapy, and by by 77% at 12th month of therapy. Conclusion. Thus, denosumab showed high efficacy without clinically significant manifestations of toxicity in long-term use in patients with bone metastases from solid tumors.

About the Autors

Corresponding author: L.Yu. Vladimirova – MD, Prof., Head of the Department of Drug Treatment of Tumors, Russian Scientific Research Oncological Institute, Rostov-on-Don, Russia; e-mail:, ОRCID:,
Scopus Author ID: 7004401163

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