Bone pain reduction in patients with metastatic breast cancer treated with ibandronate–results from a post-marketing surveillance study
- First Online:
- 137 Downloads
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).
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.
Data from this non-interventional study confirm the analgesic efficacy and safety profile of IV and oral ibandronate under real-life conditions.
KeywordsBreast cancer Bone metastases Bisphosphonates Ibandronate Pain Renal safety
- 1.World Health Organization (1996) WHO Guidelines: cancer pain relief. World Health Organization, GenevaGoogle Scholar
- 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
- 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
- 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
- 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
- 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
- 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
- 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.Pavlakis N, Schmidt R, Stockler M (2005) Bisphosphonates for breast cancer. Cochrane Database Syst Rev: CD003474Google Scholar
- 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.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