Supportive Care in Cancer

, Volume 18, Issue 10, pp 1305–1312

Bone pain reduction in patients with metastatic breast cancer treated with ibandronate–results from a post-marketing surveillance study

  • Ingo J. Diel
  • Andreas H. A. Kurth
  • Hans-Bernd Sittig
  • Harald Meden
  • Michael Maasberg
  • Andreas Sandermann
  • Raoul Bergner
Original Article

Abstract

Background

Pain relief is an important treatment goal for breast cancer patients with metastatic bone disease and treatment should be associated with a low rate of side effects. This interim analysis of a prospective non-interventional study documents the efficacy and safety of the amino-bisphosphonate ibandronate in the treatment of metastatic bone disease under real-life conditions.

Patients and methods

For up to 24 weeks 913 breast cancer patients received IV infusions of 6 mg ibandronate every 3–4 weeks or 50 mg of oral ibandronate once daily. Efficacy variables included pain severity, analgesic use, and skeletal-related events; the major safety parameter was renal function, assessed by serum creatinine levels. Subgroup analyses were performed according to pretreatment with bisphosphonates (none, ibandronate, or other bisphosphonates).

Results

At baseline, patients with ibandronate pretreatment tended to have lower mean pain scores and lower serum creatinine levels than those pre-treated with other bisphosphonates. Over the observation period, analgesic use did not increase. Among the 712 patients reporting pain at baseline, 70% achieved an improvement in pain severity during treatment with ibandronate, and there was no evidence to suggest relevant differences in mean pain reductions with IV or oral administration of ibandronate or according to prior bisphosphonate treatment. Skeletal-related events were rare (7%). Changes in serum creatinine levels during ibandronate treatment were small and both formulations of ibandronate were rated as well tolerated by physicians and patients.

Conclusions

Data from this non-interventional study confirm the analgesic efficacy and safety profile of IV and oral ibandronate under real-life conditions.

Keywords

Breast cancer Bone metastases Bisphosphonates Ibandronate Pain Renal safety 

References

  1. 1.
    World Health Organization (1996) WHO Guidelines: cancer pain relief. World Health Organization, GenevaGoogle Scholar
  2. 2.
    Aapro M, Abrahamsson PA, Body JJ, Coleman RE, Colomer R, Costa L, Crino L, Dirix L, Gnant M, Gralow J, Hadji P, Hortobagyi GN, Jonat W, Lipton A, Monnier A, Paterson AH, Rizzoli R, Saad F, Thurlimann B (2008) Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel. Ann Oncol 19:420–432CrossRefPubMedGoogle Scholar
  3. 3.
    Body JJ, Diel IJ, Bell R, Pecherstorfer M, Lichinitser MR, Lazarev AF, Tripathy D, Bergstrom B (2004) Oral ibandronate improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer. Pain 111:306–312CrossRefPubMedGoogle Scholar
  4. 4.
    Body JJ, Diel IJ, Lichinitser MR, Kreuser ED, Dornoff W, Gorbunova VA, Budde M, Bergstrom B (2003) Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 14:1399–1405CrossRefPubMedGoogle Scholar
  5. 5.
    Body JJ, Diel IJ, Lichinitzer M, Lazarev A, Pecherstorfer M, Bell R, Tripathy D, Bergstrom B (2004) 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 90:1133–1137CrossRefPubMedGoogle Scholar
  6. 6.
    Chang JT, Green L, Beitz J (2003) Renal failure with the use of zoledronic acid. N Engl J Med 349:1676–1679 discussion 1676–1679CrossRefPubMedGoogle Scholar
  7. 7.
    Coleman RE (2001) Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 27:165–176CrossRefPubMedGoogle Scholar
  8. 8.
    Conte PF, Latreille J, Mauriac L, Calabresi F, Santos R, Campos D, Bonneterre J, Francini G, Ford JM (1996) Delay in progression of bone metastases in breast cancer patients treated with intravenous pamidronate: results from a multinational randomized controlled trial. The Aredia Multinational Cooperative Group. J Clin Oncol 14:2552–2559PubMedGoogle Scholar
  9. 9.
    Diel IJ (2007) Effectiveness of bisphosphonates on bone pain and quality of life in breast cancer patients with metastatic bone disease: a review. Support Care Cancer 15:1243–1249CrossRefPubMedGoogle Scholar
  10. 10.
    Diel IJ, Body JJ, Lichinitser MR, Kreuser ED, Dornoff W, Gorbunova VA, Budde M, Bergstrom B (2004) Improved quality of life after long-term treatment with the bisphosphonate ibandronate in patients with metastatic bone disease due to breast cancer. Eur J Cancer 40:1704–1712CrossRefPubMedGoogle Scholar
  11. 11.
    Ernst DS, MacDonald RN, Paterson AH, Jensen J, Brasher P, Bruera E (1992) A double-blind, crossover trial of intravenous clodronate in metastatic bone pain. J Pain Symptom Manage 7:4–11CrossRefPubMedGoogle Scholar
  12. 12.
    Gainford MC, Dranitsaris G, Clemons M (2005) Recent developments in bisphosphonates for patients with metastatic breast cancer. Brit Med J 330:769–773CrossRefPubMedGoogle Scholar
  13. 13.
    Hortobagyi GN, Theriault RL, Porter L, Blayney D, Lipton A, Sinoff C, Wheeler H, Simeone JF, Seaman J, Knight RD (1996) Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. N Engl J Med 335:1785–1791CrossRefPubMedGoogle Scholar
  14. 14.
    Huskisson EC (1974) Measurement of pain. Lancet 2:1127–1131CrossRefPubMedGoogle Scholar
  15. 15.
    Johnson KB, Gable P, Kaime EM, Luiken G, Castillos T, Hu J (2003) Significant deterioration in renal function with the new bisphosphonate, zoledronic acid. Proc Am Soc Clin Oncol 22: abstr 2968Google Scholar
  16. 16.
    O'Rourke N, McCloskey E, Houghton F, Huss H, Kanis JA (1995) Double-blind, placebo-controlled, dose-response trial of oral clodronate in patients with bone metastases. J Clin Oncol 13:929–934PubMedGoogle Scholar
  17. 17.
    Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649–655CrossRefPubMedGoogle Scholar
  18. 18.
    Pal SK, Gupta R, Bernstein L, Mortimer J (2008) Lack of survival benefit in metastatic breast cancer with newer chemotherapy agents: The City of Hope cancer experience. ASCO 2008 Breast Cancer Symposium; Washington, DC. Abstract #95Google Scholar
  19. 19.
    Pavlakis N, Schmidt R, Stockler M (2005) Bisphosphonates for breast cancer. Cochrane Database Syst Rev: CD003474Google Scholar
  20. 20.
    Pecherstorfer M, Rivkin S, Body JJ, Diel I, Bergstrom B (2006) Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial. Clin Drug Investig 26:315–322CrossRefPubMedGoogle Scholar
  21. 21.
    Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein M, Coleman RE, Reitsma DJ, Seaman JJ, Chen BL, Ambros Y (2001) Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial. Cancer J 7:377–387PubMedGoogle Scholar
  22. 22.
    Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, Chen BL, Seaman JJ (2003) Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer 98:1735–1744CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Ingo J. Diel
    • 1
  • Andreas H. A. Kurth
    • 2
  • Hans-Bernd Sittig
    • 3
  • Harald Meden
    • 4
  • Michael Maasberg
    • 5
  • Andreas Sandermann
    • 6
  • Raoul Bergner
    • 7
  1. 1.Institute for Gynaecological Oncology, CGG-ClinicMannheimGermany
  2. 2.Department of Orthopaedics and Orthopaedic SurgeryJohannes Gutenberg UniversityMainzGermany
  3. 3.MVZ-BuntenskampGeesthachtGermany
  4. 4.Gesundheitszentrum FricktalSpital RheinfeldenRheinfeldenSwitzerland
  5. 5.Hematology Oncology Center at the St. Elisabeth Hospital MayenMayenGermany
  6. 6.WiSP Research InstituteLangenfeldGermany
  7. 7.Medical Clinic A, Klinikum der Stadt Ludwigshafen gGmbHLudwigshafenGermany

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