A Phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy

Breast Cancer Res Treat. 2008 Mar;108(1):79-85. doi: 10.1007/s10549-007-9583-y. Epub 2007 May 2.

Abstract

Background: Despite bisphosphonate treatment, most patients with metastatic breast cancer will have either progressive bone metastases or skeletal related events (SREs). We evaluated the impact of second-line ibandronate on pain control and markers of bone turnover in these patients.

Methods: Patients with either an SRE or bony progression while on clodronate or intravenous (IV) pamidronate were switched to oral ibandronate 50 mg daily for 12 weeks. Pain scores and urinary N-telopeptide were evaluated weekly for 4 weeks and at weeks 8 and 12. There was no change in systemic anti-cancer treatment in the month before or after commencing study treatment. Palliative response was defined as a > or = two-unit reduction in the worst pain score. Patient preferences between IV and oral bisphosphonate therapy were assessed.

Results: Thirty women completed the study. By week 12, patients experienced a significant improvement in pain control (OR = 0.41; P = 0.028) with 12 of 26 (46.2%) evaluable patients achieving a palliative response. Of the 23 patients who had received first-line IV pamidronate, 20 of 23 (87.0%) preferred oral therapy.

Conclusion: Patients with either progressive bone metastases or SREs while on clodronate or pamidronate may experience significant pain palliation with a switch to a more potent bisphosphonate. If confirmed by randomized trials, clinicians can start moving away from the paradigm whereby patients remain on a single bisphosphonate regimen throughout the course of their disease.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Bone Density Conservation Agents / administration & dosage*
  • Bone Diseases / drug therapy*
  • Bone Diseases / etiology
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / secondary
  • Bone and Bones / drug effects
  • Breast Neoplasms / complications*
  • Breast Neoplasms / pathology
  • Diphosphonates / administration & dosage*
  • Female
  • Humans
  • Ibandronic Acid
  • Infusions, Intravenous
  • Middle Aged
  • Pain / drug therapy*
  • Pain / etiology
  • Palliative Care*
  • Pamidronate

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • Pamidronate
  • Ibandronic Acid