Clinical Drug Investigation

, Volume 26, Issue 1, pp 43–48 | Cite as

Safety of Oral Ibandronate in the Treatment of Bone Metastases from Breast Cancer

Long-Term Follow-Up Experience
  • Sue-Anne McLachlan
  • David Cameron
  • Robin Murray
  • Debu Tripathy
  • Bengt Bergström
Short Communication

Keywords

Bone Metastasis Zoledronic Acid Ibandronate Extension Phase Oral Bisphosphonates 

Notes

Acknowledgements

The clinical trial and data analysis were conducted by Roche. The authors would like to thank Thomson Gardiner-Caldwell US for their editorial support.

Dr Tripathy has acted as a paid consultant for and has received honoraria and clinical research funding from Roche. Drs McLachlan, Cameron and Murray have acted as consultants for Roche.

References

  1. 1.
    Diel IJ, Solomayer EF, Bastert G. Treatment of metastatic bone disease in breast cancer: bisphosphonates. Clin Breast Cancer 2000; 1: 43–51PubMedCrossRefGoogle Scholar
  2. 2.
    Body JJ, editor. Tumor bone disease and osteoporosis in cancer patients. New York: Marcel Dekker, 2000Google Scholar
  3. 3.
    Coleman RE. Metastatic bone disease: clinical fractures, pathophysiology and treatment strategies. Cancer Treat Rev 2001; 27: 165–76PubMedCrossRefGoogle Scholar
  4. 4.
    Ali SM, Esteva FJ, Hortobagyi G, et al. Safety and efficacy of bisphosphonates beyond 24 months in cancer patients. J Clin Oncol 2001; 19: 3434–7PubMedGoogle Scholar
  5. 5.
    Banerjee D, Asif A, Striker L, et al. Short-term, high-dose pamidronate-induced acute tubular necrosis: the postulated mechanisms of bisphosphonate nephrotoxicity. Am J Kidney Dis 2003; 41: E18PubMedCrossRefGoogle Scholar
  6. 6.
    Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid. N Engl J Med 2003; 349: 1676–9PubMedCrossRefGoogle Scholar
  7. 7.
    Novartis Pharma. Zometa® (zoledronic acid). Prescribing informationGoogle Scholar
  8. 8.
    Novartis Pharma. Aredia® (pamidronate). Prescribing informationGoogle Scholar
  9. 9.
    Major P, Lipton A, Berenson J, et al. Oral bisphosphonates: a review of clinical use in patients with bone metastases. Cancer 2000; 88: 6–14PubMedCrossRefGoogle Scholar
  10. 10.
    Paterson AH, Powles TJ, Kanis JA, et al. Double-blind controlled trial of oral clodronate in patients with bone metastases from breast cancer. J Clin Oncol 1993; 11: 59–65PubMedGoogle Scholar
  11. 11.
    Atula S, Powles T, Paterson A, et al. Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Saf 2003; 26: 661–71PubMedCrossRefGoogle Scholar
  12. 12.
    Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15: 110–5PubMedGoogle Scholar
  13. 13.
    Body JJ, Diel IJ, Lichinitser M, et al. Intravenous ibandronic acid reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 2003; 14: 1399–405PubMedCrossRefGoogle Scholar
  14. 14.
    Body JJ, Diel IJ, Lichinitzer M, et al. Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies. Br J Cancer 2004; 90: 1133–7PubMedCrossRefGoogle Scholar
  15. 15.
    Body JJ, Diel IJ, Bell R, et al. Oral Ibandronic acid improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer. Pain 2004; 111: 316–2CrossRefGoogle Scholar
  16. 16.
    Tripathy D, Lichinitzer M, Lazarev A, et al. Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial. Ann Oncol 2004; 15: 743–50PubMedCrossRefGoogle Scholar
  17. 17.
    Cancer Therapy Evaluation Program, Common Toxicity Criteria Version 2.0, DCTD, NCI, NIH, DHHS [online]. 1999 Apr 30 Available from URL: http://ctep.cancer.gov/reporting/CTC-3test.html
  18. 18.
    Powles T, Paterson S, Kanis JA, et al. Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. J Clin Oncol 2002; 20: 3219–24PubMedCrossRefGoogle Scholar
  19. 19.
    Pecherstorfer M, Diel IJ, Bergström B. Long-term (4-year) safety of intravenous ibandronate in metastatic breast cancer: an open-label study [abstract]. Eur J Cancer Suppl 2004; 2: 130CrossRefGoogle Scholar
  20. 20.
    Body JJ, Diel I, Tripathy D, et al. Impact of ibandronic acid on bone pain in patients with metastatic bone disease from breast cancer [abstract no. A-34]. Support Care Cancer 2003; 11: 395–6Google Scholar
  21. 21.
    Tripathy D, Pecherstorfer M, Bartl R, et al. Reduction in risk of skeletal events with ibandronic acid in the treatment of metastatic breast cancer [abstract no. A-152]. Support Care Cancer 2003; 11: 427Google Scholar
  22. 22.
    Navarro RP, Morrow T, Baran R. Pharmacoeconomic and clinical outcomes in oncology using oral chemotherapy. Manag Care Interface 2002; 15: 55–62PubMedGoogle Scholar
  23. 23.
    De Cock E, Hutton J, Canney P, et al. Cost-effectiveness of oral ibandronic acid versus i.v. zoledronic acid and i.v. pamidronate in the treatment of metastatic bone disease in breast cancer [abstract no. 189P]. Ann Oncol 2004; 15Suppl. 3: iii50Google Scholar
  24. 24.
    Wardley A, Davidson N, Barrett-Lee P, et al. Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br J Cancer 2005; 92: 1869–76PubMedCrossRefGoogle Scholar
  25. 25.
    O’Neill VJ, Twelves CJ. Oral cancer treatment: developments in chemotherapy and beyond. Br J Cancer 2002; 87: 933–7PubMedCrossRefGoogle Scholar
  26. 26.
    Robertson AG, Reed NS, Ralston SH. Effect of oral clodronate on metastatic bone pain: a double-blind, placebo-controlled study. J Clin Oncol 1995; 13: 2427–30PubMedGoogle Scholar
  27. 27.
    Paterson AHG. Adjuvant bisphosphonate therapy: the future. Semin Oncol 2001; 28: 81–5CrossRefGoogle Scholar
  28. 28.
    Diel IJ, Solomayer EF, Costa S, et al. Reduction in new metastases in breast cancer with adjuvant clodronate treatment. N Engl J Med 1998; 339: 357–63PubMedCrossRefGoogle Scholar
  29. 29.
    Green JR. Antitumor effects of bisphosphonates. Cancer Suppl 2003; 97: 840–7Google Scholar
  30. 30.
    Yoneda T, Sasaki A, Dunstan C, et al. Inhibition of osteolytic bone metastasis of breast cancer by combined treatment with the bisphosphonate ibandronate and tissue inhibitor of the matrix metalloproteinase-2. J Clin Invest 1997; 99: 2509–17PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Sue-Anne McLachlan
    • 1
  • David Cameron
    • 2
  • Robin Murray
    • 3
  • Debu Tripathy
    • 4
  • Bengt Bergström
    • 5
  1. 1.St Vincent’s HospitalMelbourneAustralia
  2. 2.Western General HospitalEdinburghScotland
  3. 3.Peter MacCallum Cancer InstituteEast MelbourneAustralia
  4. 4.Southwestern Medical CenterUniversity of TexasDallasUSA
  5. 5.Hoffmann-La Roche Inc.NutleyUSA

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