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R Lan, M Hadj-Saïd, J-M Foletti, E Massereau, C Chossegros
Ahead of Print article withdrawn by publisher
April 22, 2018: Medicina Oral, Patología Oral y Cirugía Bucal
Noopur Raje, Garson David Roodman, Wolfgang Willenbacher, Kazuyuki Shimizu, Ramón García-Sanz, Evangelos Terpos, Lisa Kennedy, Lorenzo Sabatelli, Michele Intorcia, Guy Hechmati
OBJECTIVE: A large, pivotal, phase 3 trial in patients with newly diagnosed multiple myeloma (MM) demonstrated that denosumab, compared with zoledronic acid, was non-inferior for the prevention of skeletal-related events (SREs), extended the observed median progression-free survival (PFS) by 10.7 months, and showed significantly less renal toxicity. The cost-effectiveness of denosumab vs zoledronic acid in MM in the US was assessed from societal and payer perspectives. METHODS: The XGEVA Global Economic Model was developed by integrating data from the phase 3 trial comparing the efficacy of denosumab with zoledronic acid for the prevention of SREs in MM...
May 2018: Journal of Medical Economics
Claire Egloff-Juras, Aurélie Gallois, Julia Salleron, Vincent Massard, Gilles Dolivet, Julie Guillet, Bérengère Phulpin
BACKGROUND: Osteonecrosis of the jaw is a very delicate side effect of Denosumab. The aim of this retrospective study was to assess the occurrence rate of Denosumab-related osteonecrosis of the jaw (DRONJ) at the Cancer Institute of Lorraine (ICL) and to highlight necrosis risk factors. METHODS: To that purpose, we analyzed the medical records of 249 consecutive patients treated with Denosumab at the ICL during the past 5 years. Patients who received orofacial radiotherapy or a previous treatment with a bisphosphonate were excluded...
January 2018: Journal of Oral Pathology & Medicine
John Acquavella, Vera Ehrenstein, Morten Schiødt, Uffe Heide-Jørgensen, Anders Kjellman, Svein Hansen, Cecilia Larsson Wexell, Bente Brokstad Herlofson, Sven Erik Noerholt, Haijun Ma, Katarina Öhrling, Rohini K Hernandez, Henrik Toft Sørensen
OBJECTIVE: Osteonecrosis of the jaw (ONJ) is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. METHODS: As part of a comprehensive pharmacovigilance plan, developed with regulators' input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously) or zoledronic acid (4 mg intravenously, adjusted for renal function)...
2016: Clinical Epidemiology
C V Lyttle, H Patterson
A patient was referred by a clinical oncologist regarding a non-healing area of bone in the lower jaw. The patient was taking denosumab (Prolia(®), Xgeva(®)) when they had a tooth extracted and the area failed to heal. Following suspension of the drug, the area healed with mucosal coverage. This new class of drugs are being increasingly used as an alternative antiresorptive drug to bisphosphonates and are licenced in the UK for prevention of osteoporotic fractures and prevention of skeletal-related events (SREs) in patients with metastatic cancer...
June 24, 2016: British Dental Journal
Harlene Kaur Sidhu
Most dental professionals will have, or will soon, encounter patients prescribed this novel alternative antiresorptive drug to bisphosphonates, denosumab (Prolia®, Xgeva®). Denosumab is licensed in the UK for the prevention of osteoporotic fractures in postmenopausal women and the prevention of skeletal-related events (SRE) in adults with bone metastases. The presence of osteonecrosis of the jaw in patients receiving non-bisphosphonate antiresorptives has led to the introduction of the term antiresorptive-related osteonecrosis of the jaw or ARONJ...
June 2015: Dental Update
(no author information available yet)
No abstract text is available yet for this article.
May 2015: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Juan Jose Perez Ruixo, Sameer Doshi, Winnie Sohn, Andrew Chow
Denosumab (XGEVA®) is a recombinant, fully human IgG2 monoclonal antibody directed against the receptor activator of nuclear factor kappa-B ligand (RANKL) that prevents differentiation of osteoclast precursors into mature osteoclasts and acceleration of bone resorption, resulting in the inhibition of osteoclast activation. Denosumab is indicated for the prevention of skeletal-related events (SREs) in adult patients with bone metastases from solid tumors at the dose of 120 mg administered subcutaneously (SC) every 4 weeks...
March 2015: Journal of Clinical Pharmacology
Beuy Joob, Viroj Wiwanitkit
No abstract text is available yet for this article.
September 2014: World Journal of Nuclear Medicine
Winnie Sohn, Mary Ann Simiens, Kelly Jaeger, Shauna Hutton, Graham Jang
AIM: The objective of this systematic review was to characterize the pharmacokinetics and pharmacodynamics of denosumab (XGEVA®), a fully human IgG2 monoclonal antibody which binds to receptor activator of nuclear factor kappa-B ligand (RANKL), for the treatment of skeletal-related events (SREs) in patients with advanced cancer and bone metastases. METHODS: A total of 708 patients (116 healthy patients and 592 patients with solid tumours or multiple myeloma and bone metastases) included in seven clinical studies were evaluated for denosumab pharmacokinetics...
September 2014: British Journal of Clinical Pharmacology
Tobias A Mattei, Ehud Mendel, Eric C Bourekas
BACKGROUND CONTEXT: Denosumab (XGeva) is a receptor activator of nuclear factor-κB ligand (RANKL)-antibody that was approved by the Food and Drug Administration (FDA) in 2010 for the prevention of skeletal fractures in patients with bone metastases from solid tumors. Although there is a widespread use of such drug in patients under risk of pathological fractures, the compatibility of denosumab therapy with percutaneous vertebroplasty (an interventional procedure commonly used for pain control in such population) has not yet been established...
June 1, 2014: Spine Journal: Official Journal of the North American Spine Society
Marvin M Goldenberg
Canagliflozin (Invokana) for type-2 diabetes; denosumab (Xgeva) for giant-cell tumor of bone; and paroxetine mesylate (Brisdelle) for vasomotor symptoms in menopause.
August 2013: P & T: a Peer-reviewed Journal for Formulary Management
Nigora Rasulova, Vladimir Lyubshin, Dauranbek Arybzhanov, Valery Krylov, Marat Khodjibekov
Breast and prostate cancer have a propensity to metastasize to bones and cause osteolysis and abnormal new bone formation. Metastases locally disrupt normal bone remodeling. Although metastases from prostate cancer have been classified as osteoblastic based on the radiographic appearance of the lesion, data gleaned from a rapid autopsy program indicate that the same prostate cancer patient may have evidence of both osteolytic and osteoblastic disease as shown by histologic examinations. Thus, bone metastases are heterogeneous, requiring combined treatment targeting on both osteolytic and osteoblastic lesions...
January 2013: World Journal of Nuclear Medicine
Maria Cristina Figueroa-Magalhães, Robert S Miller
The development of effective systemic therapies to reduce the risk of disease recurrence or metastases in early-stage breast cancer remains an important challenge. The use of bone-modifying agents (BMAs), including the bisphosphonates (BPs) and the monoclonal antibody denosumab (Xgeva), is well established for metastatic bone disease. In the adjuvant setting, some studies have shown provocative findings with some of these agents for the prevention of future breast cancer-related events, with improved survival in some subgroups...
October 2012: Oncology (Williston Park, NY)
Takeshi Yuasa, Shinya Yamamoto, Shinji Urakami, Iwao Fukui, Junji Yonese
BONE METASTASES OFTEN CREATE SERIOUS CLINICAL PROBLEMS: they lead to poor performance status due to pathologic fractures, spinal cord compression and intractable pain, commonly referred to as skeletal-related events. The receptor activator of nuclear factor-κB (RANK), the RANK ligand (RANKL), and osteoprotegerin, a decoy receptor for RANK, regulate osteoclastogenesis and may play a key role in bone metastasis. Denosumab (XGEVA; Amgen, Thousand Oaks, CA), a fully human monoclonal antibody that binds to and neutralizes RANKL, inhibits osteoclast function, prevents generalized bone resorption and local bone destruction, and has become a therapeutic option for preventing or delaying first on-study skeletal-related events in various malignancies...
2012: OncoTargets and Therapy
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