829P - Denosumab in patients with bone metastases from renal-cell carcinoma treated with anti-angiogenic therapy: a retrospective study from the GETUG (Gr...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Aline Guillot
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors A. Guillot1, C. Joly2, P. Barthelemy3, E. Meriaux4, S. Negrier5, D. Pouessel6, C. Chevreau7, H. Mahammedi8, N. Houede9, G. Roubaud10, G. Gravis11, S. Tartas12, L. Albiges13, C. Vassal1, M. Oriol1, F. Tinquaut14, S. Espenel15, S. Culine6, K. Fizazi13
  • 1Medical Oncology, Institut de Cancérologie de la Loire, 42271 - Saint Priest en Jarez/FR
  • 2Val De Marne, CHU Henri Mondor, 94000 - Créteil/FR
  • 3Medical Oncology, C.H.U. Strasbourg-Nouvel Hopital Civil, 67000 - Strasbourg/FR
  • 4Medical Oncology, Centre Francois Baclesse, 14000 - Caen/FR
  • 5Dept. Of Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 6Medical Oncology, Hôpital St. Louis, 75010 - Paris/FR
  • 7Oncology, Centre Claudius-Regaud, 31059 - Toulouse/FR
  • 8Medical Oncology, Centre Jean Perrin, 63000 - Clermont-Ferrand/FR
  • 9Medical Oncology, CHU Nimes, Caremeau, 30029 - Nimes/FR
  • 10Medical Oncology, Institute Bergonié, 33000 - Bordeaux/FR
  • 11Medical Oncology, Institute Paoli Calmettes, 13009 - Marseille/FR
  • 12Medical Oncology, Hospice Civil de Lyon centre Hospitalier Lyon Sud, Lyon/FR
  • 13Dept. Of Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 14Biostatistics, Institut de Cancérologie de la Loire, 42271 - Saint Priest en Jarez/FR
  • 15Oncology Radiotherapy, Institut de Cancérologie de la Loire, 42271 - Saint Priest en Jarez/FR



Metastatic renal-cell carcinoma (mRCC) treatment relies on anti-angiogenic therapies. Bone metastases occur in nearly 30% of mRCC and can induce symptomatic skeletal-events (SSE) such as pain requiring radiotherapy, pathologic fractures, and spinal cord compression. SSE can be prevented using bone-targeted agents, e.g. bisphosphonates or denosumab. Data about denosumab and anti-angiogenic combination are scarce.


This multicenter retrospective study led by GETUG included mRCC patients (pts) who received anti-angiogenic therapies associated with denosumab from January 2013 to December 2015. The primary endpoint was toxicity related to denosumab, especially osteonecrosis of the jaw (ONJ) and hypocalcaemia.


37 pts were identified and 36 analyzed. The mean age was 60.9 year-old (range 42-81). Twenty-four pts (68%) had an odontological consultation before denosumab introduction and 20 pts (58.3%) had a dental panoramic radiography. Five pts (13.9%) developed an ONJ, among them 3 had a dental extraction while on denosumab treatment. Only one out of the 5 pts has completely recovered from his ONJ. No grade 3-4 hypocalcaemia was reported. SSE occurred in 22 pts (61.1%) including bone pain requiring radiation, clinical fractures, and spinal compression in 22, 3, and 2 pts, respectively.


In this real life population, the incidence of SSE was very high in mRCC pts with bone metastases. The combination of denosumab with anti-angiogenic drugs was associated with a high incidence of ONJ that may have been favored by dental extraction while on treatment. The present study underlines the need to improve strategies to prevent the onset of SSE in this population of pts.

Clinical trial identification

Legal entity responsible for the study





A. Guillot: board PFIZER. S. Negrier: honoraria from Pfizer, Novartis et BMS. D. Pouessel: Board: roche, astellas, Lilly, Novartis, Sanofi Advisory: MSD, AstraZeneca. Speaker : Astellas, Janssen, Boehringer-ingelheim, Sanofi. C. Chevreau: board advisory: Pharmamar Inc, Novartis Inc. L. Albiges: consultaant or advisory role: novartis, pfizer, amgen, BMS, Bayer, Sanofi, Cerulean. K. Fizazi: consultant/advisor for Amgen Inc.,Novartis,Clovis, Pfizer, CSL, Behring, and Bayer- GlaxoSmithKline, and Genentech- speakers' bureau for Genomic Health research funding from Amgen Inc., Novartis, Bayer, and Puma. All other authors have declared no conflicts of interest.