Giant-cell tumor of bone

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Elizabeth J. Davis, MD
Vanderbilt University
Nashville, TN

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All lines of therapy

Denosumab monotherapy

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Regimen

Study Evidence
Thomas et. al 2010 (Amgen 20040215) Phase II (RT)
Chawla et al. 2013 (Amgen 20062004) Phase II (RT)

Chemotherapy

  • Denosumab (Xgeva) as follows:
    • Cycle 1: 120 mg SC once per day on days 1, 8, 15
    • Cycle 2 onwards: 120 mg SC once on day 1

Supportive medications

  • Calcium 500 mg PO once per day
  • Vitamin D 400 IU PO once per day

28-day cycles

References

  1. Amgen 20040215: Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. Epub 2010 Feb 10. link to original article contains verified protocol PubMed
  2. Amgen 20062004: Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. Epub 2013 Jul 16. link to original article contains protocol PubMed
    1. Update: Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. Epub 2019 Nov 6. link to original article PubMed