Skip to main content
Erschienen in:

01.06.2013 | original report

CECOG experts’ recommendations on the use of denosumab in the prevention of skeletal-related events in bone metastases of lung cancer

verfasst von: Wolfgang Hilbe, MD, Ufuk Abacioglu, MD, Daniel M. Aebersold, MD, Mounir Bachouchi, MD, Thomas Brodowicz, MD, Prof Rabab Gaafar, MD, Gerold Holzer, MD, Andrea Mohn-Staudner, MD, Dimitar Kalev, MD, Ewa Kalinka-Warzocha, MD, Viljem Kovac, MD, Marco Siano, MD, Fulden Yumuk, MD, Lilla Tamasi, MD

Erschienen in: memo - Magazine of European Medical Oncology | Ausgabe 2/2013

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Skeletal-related events represent a substantial burden for patients with advanced cancer. Randomized, controlled studies suggested superiority of denosumab over zoledronic acid in the prevention of skeletal-related events in metastatic cancer patients, with a favorable safety profile. Experts gathered at the 2012 Skeletal Care Academy in Istanbul to bring forward practical recommendations, based on current evidence, for the use of denosumab in patients with bone metastases of lung cancer.

Recommendations

Based on current evidence, use of denosumab in lung cancer patients with confirmed bone metastases is recommended. It is important to note that clinical judgment should take into consideration the patient’s general performance status, overall prognosis, and live expectancy. Currently, the adverse event profile reported for denosumab includes hypocalcemia and infrequent occurrence of osteonecrosis of the jaw. Therefore, routine calcium and vitamin D supplementation, along with dental examination prior to denosumab initiation are recommended. There is no evidence for renal function impairment due to denosumab administration. At present, there is no rationale to discourage concomitant use of denosumab and surgery or radiotherapy.
Literatur
1.
Zurück zum Zitat Siegel R, Naishadham D, Jemal A. Cancer statistics. 2012. CA Cancer J Clin. 2012;62(1):10–29.PubMedCrossRef Siegel R, Naishadham D, Jemal A. Cancer statistics. 2012. CA Cancer J Clin. 2012;62(1):10–29.PubMedCrossRef
2.
Zurück zum Zitat Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220–41.PubMedCrossRef Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220–41.PubMedCrossRef
3.
Zurück zum Zitat Howlader N, Noone AM, Krapcho M, Neyman N, Aminou R, Waldron W, et al. SEER Cancer Statistics Review, 1975–2008, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2008/, based on November 2010 SEER data submission, posted to the SEER web site. 2011. Accessed 2 Jan 2013. Howlader N, Noone AM, Krapcho M, Neyman N, Aminou R, Waldron W, et al. SEER Cancer Statistics Review, 1975–2008, National Cancer Institute. Bethesda, MD, http://​seer.​cancer.​gov/​csr/​1975_​2008/​, based on November 2010 SEER data submission, posted to the SEER web site. 2011. Accessed 2 Jan 2013.
4.
Zurück zum Zitat Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(20 Pt 2):6243s–9.PubMedCrossRef Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12(20 Pt 2):6243s–9.PubMedCrossRef
5.
Zurück zum Zitat Sugiura H, Yamada K, Sugiura T, Hida T, Mitsudomi T. Predictors of survival in patients with bone metastasis of lung cancer. Clin Orthop Relat Res. 2008;466(3):729–36.PubMedCrossRef Sugiura H, Yamada K, Sugiura T, Hida T, Mitsudomi T. Predictors of survival in patients with bone metastasis of lung cancer. Clin Orthop Relat Res. 2008;466(3):729–36.PubMedCrossRef
6.
Zurück zum Zitat Tsuya A, Kurata T, Tamura K, Fukuoka M. Skeletal metastases in non-small cell lung cancer: a retrospective study. Lung Cancer. 2007;57(2):229–32.PubMedCrossRef Tsuya A, Kurata T, Tamura K, Fukuoka M. Skeletal metastases in non-small cell lung cancer: a retrospective study. Lung Cancer. 2007;57(2):229–32.PubMedCrossRef
7.
Zurück zum Zitat Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with non-small cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004;100(12):2613–21.PubMedCrossRef Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with non-small cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004;100(12):2613–21.PubMedCrossRef
8.
Zurück zum Zitat Sekine I, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Tamura T. Risk factors for skeletal-related events in patients with non-small cell lung cancer treated by chemotherapy. Lung Cancer. 2009;65(2):219–22.PubMedCrossRef Sekine I, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Tamura T. Risk factors for skeletal-related events in patients with non-small cell lung cancer treated by chemotherapy. Lung Cancer. 2009;65(2):219–22.PubMedCrossRef
9.
Zurück zum Zitat Oefelein MG, Ricchiuti V, Conrad W, Resnick MI. Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol. 2002;168(3):1005–7.PubMedCrossRef Oefelein MG, Ricchiuti V, Conrad W, Resnick MI. Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol. 2002;168(3):1005–7.PubMedCrossRef
10.
Zurück zum Zitat Rosen LS, Gordon D, Tchekmedyian S, Yanagihara R, Hirsh V, Krzakowski M, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial–the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol. 2003;21(16):3150–7.PubMedCrossRef Rosen LS, Gordon D, Tchekmedyian S, Yanagihara R, Hirsh V, Krzakowski M, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial–the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol. 2003;21(16):3150–7.PubMedCrossRef
13.
Zurück zum Zitat Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125–32.PubMedCrossRef Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125–32.PubMedCrossRef
14.
Zurück zum Zitat Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, et al. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012;7(12):1823–9.PubMedCrossRef Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, et al. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012;7(12):1823–9.PubMedCrossRef
15.
Zurück zum Zitat Peters S, Adjei AA, Gridelli C, Reck M, Kerr K, Felip E, et al. Metastatic non-small cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23(Suppl 7):vii56–64.PubMedCrossRef Peters S, Adjei AA, Gridelli C, Reck M, Kerr K, Felip E, et al. Metastatic non-small cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23(Suppl 7):vii56–64.PubMedCrossRef
16.
Zurück zum Zitat Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28(35):5132–9.PubMedCrossRef Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28(35):5132–9.PubMedCrossRef
17.
Zurück zum Zitat Fizazi K, Carducci M, Smith M, Damiao R, Brown J, Karsh L, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. Lancet. 2011;377(9768):813–22.PubMedCrossRef Fizazi K, Carducci M, Smith M, Damiao R, Brown J, Karsh L, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. Lancet. 2011;377(9768):813–22.PubMedCrossRef
18.
Zurück zum Zitat Lipton A, Fizazi K, Stopeck AT, Henry DH, Brown JE, Yardley DA, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomized, phase 3 trials. Eur J Cancer. 2012;48(16):3082–92.PubMedCrossRef Lipton A, Fizazi K, Stopeck AT, Henry DH, Brown JE, Yardley DA, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomized, phase 3 trials. Eur J Cancer. 2012;48(16):3082–92.PubMedCrossRef
20.
Zurück zum Zitat Kitazawa S, Kitazawa R. RANK ligand is a prerequisite for cancer-associated osteolytic lesions. J Pathol. 2002;198(2):228–36.PubMedCrossRef Kitazawa S, Kitazawa R. RANK ligand is a prerequisite for cancer-associated osteolytic lesions. J Pathol. 2002;198(2):228–36.PubMedCrossRef
21.
Zurück zum Zitat Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2(8):584–93.PubMedCrossRef Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002;2(8):584–93.PubMedCrossRef
22.
Zurück zum Zitat Feeley BT, Liu NQ, Conduah AH, Krenek L, Roth K, Dougall WC, et al. Mixed metastatic lung cancer lesions in bone are inhibited by noggin overexpression and Rank:Fc administration. J Bone Miner Res. 2006;21(10):1571–80.PubMedCrossRef Feeley BT, Liu NQ, Conduah AH, Krenek L, Roth K, Dougall WC, et al. Mixed metastatic lung cancer lesions in bone are inhibited by noggin overexpression and Rank:Fc administration. J Bone Miner Res. 2006;21(10):1571–80.PubMedCrossRef
23.
Zurück zum Zitat Jones DH, Nakashima T, Sanchez OH, Kozieradzki I, Komarova SV, Sarosi I, et al. Regulation of cancer cell migration and bone metastasis by RANKL. Nature. 2006; 440(7084):692–6.PubMedCrossRef Jones DH, Nakashima T, Sanchez OH, Kozieradzki I, Komarova SV, Sarosi I, et al. Regulation of cancer cell migration and bone metastasis by RANKL. Nature. 2006; 440(7084):692–6.PubMedCrossRef
24.
Zurück zum Zitat Miller RE, Roudier M, Jones J, Armstrong A, Canon J, Dougall WC. RANK ligand inhibition plus docetaxel improves survival and reduces tumor burden in a murine model of prostate cancer bone metastasis. Mol Cancer Ther. 2008;7(7):2160–9.PubMedCrossRef Miller RE, Roudier M, Jones J, Armstrong A, Canon J, Dougall WC. RANK ligand inhibition plus docetaxel improves survival and reduces tumor burden in a murine model of prostate cancer bone metastasis. Mol Cancer Ther. 2008;7(7):2160–9.PubMedCrossRef
25.
Zurück zum Zitat Miller R, Jones J, Roudier M, Dougall WC. The RANKL inhibitor OPG-Fc, either alone or in combination with docetaxel, blocks lung cancer-induced osteolytic lesions and reduces skeletal tumor burden in a murine model of non-small cell lung cancer in bone. 9th International Conference on Cancer-Induced Bone Disease;2009; Arlington, VA. Miller R, Jones J, Roudier M, Dougall WC. The RANKL inhibitor OPG-Fc, either alone or in combination with docetaxel, blocks lung cancer-induced osteolytic lesions and reduces skeletal tumor burden in a murine model of non-small cell lung cancer in bone. 9th International Conference on Cancer-Induced Bone Disease;2009; Arlington, VA.
27.
Zurück zum Zitat Saad F, Brown JE, Van Poznak C, Ibrahim T, Stemmer SM, Stopeck AT, et al. Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases. Ann Oncol. 2012; 23(5):1341–7.PubMedCrossRef Saad F, Brown JE, Van Poznak C, Ibrahim T, Stemmer SM, Stopeck AT, et al. Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases. Ann Oncol. 2012; 23(5):1341–7.PubMedCrossRef
29.
Zurück zum Zitat Lutz S, Berk L, Chang E, Chow E, Hahn C, Hoskin P, et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011;79(4):965–76.PubMedCrossRef Lutz S, Berk L, Chang E, Chow E, Hahn C, Hoskin P, et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011;79(4):965–76.PubMedCrossRef
30.
Zurück zum Zitat Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007;25(11):1423–36.PubMedCrossRef Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007;25(11):1423–36.PubMedCrossRef
31.
Zurück zum Zitat Agarawal JP, Swangsilpa T, van der Linden Y, Rades D, Jeremic B, Hoskin PJ. The role of external beam radiotherapy in the management of bone metastases. Clin Oncol (R Coll Radiol). 2006;18(10):747–60.CrossRef Agarawal JP, Swangsilpa T, van der Linden Y, Rades D, Jeremic B, Hoskin PJ. The role of external beam radiotherapy in the management of bone metastases. Clin Oncol (R Coll Radiol). 2006;18(10):747–60.CrossRef
32.
Zurück zum Zitat Hall WA, Stapleford LJ, Hadjipanayis CG, Curran WJ, Crocker I, Shu HK. Stereotactic body radiosurgery for spinal metastatic disease: an evidence-based review. Int J of Surg Oncol. 2011; 2011:979214. Hall WA, Stapleford LJ, Hadjipanayis CG, Curran WJ, Crocker I, Shu HK. Stereotactic body radiosurgery for spinal metastatic disease: an evidence-based review. Int J of Surg Oncol. 2011; 2011:979214.
33.
Zurück zum Zitat Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009; 361(8):756–65.PubMedCrossRef Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009; 361(8):756–65.PubMedCrossRef
34.
Zurück zum Zitat Fizazi K, Brown JE, Carducci M, Shore ND, Sieber P, Kueppers F, et al. editors. Denosumab in patients with metastatic prostate cancer previously treated with denosumab or zoledronic acid: 2-year open-label extension phase results from the pivotal phase 3 study. European Society of Medical Oncology;2012. Fizazi K, Brown JE, Carducci M, Shore ND, Sieber P, Kueppers F, et al. editors. Denosumab in patients with metastatic prostate cancer previously treated with denosumab or zoledronic acid: 2-year open-label extension phase results from the pivotal phase 3 study. European Society of Medical Oncology;2012.
35.
Zurück zum Zitat Stopeck AT, Lipton A, Martàn M, Body J-J, Paterson A, Steger GG, et al. editors. Denosumab in Patients with Breast Cancer and Bone Metastases Previously Treated with Zoledronic Acid or Denosumab: Results from the 2-Year Open-Label Extension Treatment Phase of a Pivotal Phase 3 Study. San Antonio Breast Cancer Symposium;2011. Stopeck AT, Lipton A, Martàn M, Body J-J, Paterson A, Steger GG, et al. editors. Denosumab in Patients with Breast Cancer and Bone Metastases Previously Treated with Zoledronic Acid or Denosumab: Results from the 2-Year Open-Label Extension Treatment Phase of a Pivotal Phase 3 Study. San Antonio Breast Cancer Symposium;2011.
Metadaten
Titel
CECOG experts’ recommendations on the use of denosumab in the prevention of skeletal-related events in bone metastases of lung cancer
verfasst von
Wolfgang Hilbe, MD
Ufuk Abacioglu, MD
Daniel M. Aebersold, MD
Mounir Bachouchi, MD
Thomas Brodowicz, MD
Prof Rabab Gaafar, MD
Gerold Holzer, MD
Andrea Mohn-Staudner, MD
Dimitar Kalev, MD
Ewa Kalinka-Warzocha, MD
Viljem Kovac, MD
Marco Siano, MD
Fulden Yumuk, MD
Lilla Tamasi, MD
Publikationsdatum
01.06.2013
Verlag
Springer Vienna
Erschienen in
memo - Magazine of European Medical Oncology / Ausgabe 2/2013
Print ISSN: 1865-5041
Elektronische ISSN: 1865-5076
DOI
https://doi.org/10.1007/s12254-013-0088-6

Weitere Artikel der Ausgabe 2/2013

memo - Magazine of European Medical Oncology 2/2013 Zur Ausgabe