Journal of Cancer Research and Clinical Oncology

, Volume 134, Issue 12, pp 1303–1310 | Cite as

Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease

  • Kyriaki Mystakidou
  • Evangelia Stathopoulou
  • Efi Parpa
  • Vassilios Kouloulias
  • Evangelia Kouskouni
  • Lambros Vlahos
Original Paper

Abstract

Purpose

This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid for metastatic bone disease.

Methods

Patients ≥18 years with breast, prostate, lung, urogenital or colon cancer received IV ibandronic acid 6 mg infused over 15 min every 28 days or oral ibandronic acid 50 mg/day. Clinical response was determined using bone scintigraphy, radiography and serum C-terminal telopeptide of type I collagen (S-CTX) at months 3–6. Adverse events and biochemical safety measures were recorded.

Results

A total of 84.6 and 88.5% of patients had a complete/partial response to IV and oral ibandronic acid, respectively. Median percentage decreases in S-CTX were −39 and −35%, respectively. Bone pain scores decreased and analgesic use increased from month 0–3 and were stable from months 3–6. Both formulations improved physical and functioning scores.

Conclusion

Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.

Keywords

Bone markers Bone metastases Efficacy Ibandronic acid Intravenous Oral Safety 

Notes

Acknowledgment

The authors received assistance from a medical communications agency in drafting the manuscript.

Conflict of interest

None of the authors has a conflict of interest.

Funding source

There is no sponsor or funding source to declare.

References

  1. Berenson JR, Rosen LS, Howell A et al (2001) Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases. Cancer 91:1191–1200. doi:10.1002/1097-0142(20010401)91:7<1191::AID-CNCR1119>3.0.CO;2-0PubMedCrossRefGoogle Scholar
  2. Berruti A, Dogliotti L, Gorzegno G et al (1999) Differential patterns of bone turnover in relation to bone pain and disease extent in bone in cancer patients with skeletal metastases. Clin Chem 45:1240–1247PubMedGoogle Scholar
  3. Body JJ, Diel IJ, Lichinitser MR, for the MF 4265 Study Group et al (2003) Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 14:1399–1405. doi: 10.1093/annonc/mdg367 PubMedCrossRefGoogle Scholar
  4. Body JJ, Diel IJ, Lichinitzer M et al (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 90:1133–1137. doi: 10.1038/sj.bjc.6601663 PubMedCrossRefGoogle Scholar
  5. Body JJ, Lichinitser M, Tjulandin S, Garnero P, Bergstrom B (2007) Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases. Ann Oncol 18:1165–1171. doi: 10.1093/annonc/mdm119 PubMedCrossRefGoogle Scholar
  6. Brown JE, Thomson CS, Ellis SP, Gutcher SA, Purohit OP, Coleman RE (2003) Bone resorption predicts for skeletal complications in metastatic bone disease. Br J Cancer 89:2031–2037. doi: 10.1038/sj.bjc.6601437 PubMedCrossRefGoogle Scholar
  7. Brown JE, Cook RJ, Major P et al (2005) Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumours. J Natl Cancer Inst 97:59–69PubMedCrossRefGoogle Scholar
  8. Chang JT, Green L, Beitz J (2003) Renal failure with the use of zoledronic acid. N Engl J Med 349:1676–1679. doi: 10.1056/NEJM200310233491721 PubMedCrossRefGoogle Scholar
  9. Coleman RE (2001) Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 27:165–176. doi: 10.1053/ctrv.2000.0210 PubMedCrossRefGoogle Scholar
  10. Coleman RE (2002) The clinical use of bone resorption markers in patients with malignant bone disease. Cancer 94:2521–2533. doi: 10.1002/cncr.10522 PubMedCrossRefGoogle Scholar
  11. Coleman RE (2006) Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res 12(20 suppl):6243s–6249s. doi: 10.1158/1078-0432.CCR-06-0931 PubMedCrossRefGoogle Scholar
  12. Coleman RE, Major P, Lipton A et al (2005) Predictive value of bone resorption and formation markers in cancer patients with bone metastases receiving the bisphosphonate zoledronic acid. J Clin Oncol 23:4925–4935. doi: 10.1200/JCO.2005.06.091 PubMedCrossRefGoogle Scholar
  13. Diel IJ, Solomayer EF, Bastert G (2000) Treatment of metastatic bone disease in breast cancer: bisphosphonated. Clin Breast Cancer 1:43–51PubMedCrossRefGoogle Scholar
  14. Domchek SM, Younger J, Finkelstein DM, Seiden MV (2000) Predictors of skeletal complications in patients with metastatic breast carcinoma. Cancer 89:363–368. doi:10.1002/1097-0142(20000715)89:2<363::AID-CNCR22>3.0.CO;2-3PubMedCrossRefGoogle Scholar
  15. Garnero P (2001) Markers of bone turnover in prostate cancer. Cancer Treat Rev 27:187–192. doi: 10.1053/ctrv.2000.0213 PubMedCrossRefGoogle Scholar
  16. Heidenreich A, Ohlmann C, Olbert P, Hegele A (2003) High-dose ibandronate is effective and well tolerated in the treatment of pain and hypercalcaemia due to metastatic urologic cancer. Eur J Cancer 1(Suppl 5):S270Google Scholar
  17. Jackson GH (2005) Renal safety of ibandronate. Oncologist 10(Suppl 1):14–18. doi: 10.1634/theoncologist.10-90001-14 PubMedCrossRefGoogle Scholar
  18. Leyland-Jones B (2004) Pharmacokinetic and clinical equivalence of oral and intravenous ibandronate for metastatic bone disease. Eur J Cancer suppl 2:9–12CrossRefGoogle Scholar
  19. Lipton A, Demers L, Curley E et al (1998) Markers of bone resorption in patients treated with pamidronate. Eur J Cancer 34:2021–2026. doi: 10.1016/S0959-8049(98)00277-9 PubMedCrossRefGoogle Scholar
  20. Lipton A, Hei Y, Coleman R, Major P, Cook R (2005) Suppression of bone turnover markers by zoledronic acid and correlation with clinical outcome. J Clin Oncol 23(Suppl 16 S):115 Abstract 532Google Scholar
  21. Markowitz GS, Fine PL, D’agati VD (2002) Nephrotic syndrome after treatment with pamidronate. Am J Kidney Dis 39:1118–1122. doi: 10.1053/ajkd.2002.32797 PubMedCrossRefGoogle Scholar
  22. McPartland C, Grosjean L (2004) Treatment of painful bone metastases in Europe and Canada: the role of bisphosphonates. Ann Oncol 15(Suppl 3):iii50 abstractGoogle Scholar
  23. Menssen HD, Sakalová A, Fontana A et al (2002) Effects of long-term intravenous ibandronate therapy on skeletal-related events, survival, and bone resorption markers in patients with advanced multiple myeloma. J Clin Oncol 20:2353–2359. doi: 10.1200/JCO.2002.02.032 PubMedCrossRefGoogle Scholar
  24. Mystakidou K, Katsouda E, Stathopoulou E, Vlahos L (2005) Approaches to managing bone metastases from breast cancer: the role of bisphosphonates. Cancer Treat Rev 31:303–311. doi: 10.1016/j.ctrv.2005.03.005 PubMedCrossRefGoogle Scholar
  25. Ohlmann C, Heidenreich A (2003) Efficacy of ibandronate in the management of painful osseous metastases due to hormone refractory prostate cancer. Support Care Cancer 11:396 Abstract A–38Google Scholar
  26. Pecherstorfer M, Rivkin S, Body JJ, Diel I, Bergström 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 26:315–322. doi: 10.2165/00044011-200626060-00002 PubMedCrossRefGoogle Scholar
  27. Roodman GD (2004) Mechanisms of bone metastasis. N Engl J Med 350:1655–1664. doi: 10.1056/NEJMra030831 PubMedCrossRefGoogle Scholar
  28. Vassiliou V, Kalogeropoulou C, Giannopoulou E, Leotsinidis M, Tsota I, Kardamakis D (2007) A novel study investigating the therapeutic outcome of patients with lytic, mixed and sclerotic bone metastases treated with combined radiotherapy and ibandronate. Clin Exp Metastasis 24:169–178. doi: 10.1007/s10585-007-9066-x PubMedCrossRefGoogle Scholar
  29. Yahara J, Noguchi M, Noda S (2003) Quantitative evaluation of bone metastasis in patients with advanced prostate cancer during systemic treatment. BJU Int 92:379–384. doi: 10.1046/j.1464-410X.2003.04362.x PubMedCrossRefGoogle Scholar
  30. Yau V, Chow E, Davis L, Holden L, Schueller T, Danjoux C (2004) Pain management in cancer patients with bone metastases remains a challenge. J Pain Symptom Manage 27:1–3. doi: D:10.1016/j.jpainsymman.2003.10.003 PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Kyriaki Mystakidou
    • 1
  • Evangelia Stathopoulou
    • 2
  • Efi Parpa
    • 1
  • Vassilios Kouloulias
    • 3
  • Evangelia Kouskouni
    • 4
  • Lambros Vlahos
    • 1
  1. 1.Pain Relief and Palliative Care Unit, Department of RadiologyAreteion Hospital, University of Athens School of MedicineAmpelokipi, AthensGreece
  2. 2.Genesis Pharma SAHalandri, AthensGreece
  3. 3.Department of RadiologyAttikon University HospitalChaidari, AthensGreece
  4. 4.Department of MicrobiologyAreteion Hospital, University of Athens School of MedicineAthensGreece

Personalised recommendations