Phase II Study of Loading-Dose Ibandronate Treatment in Patients with Breast Cancer and Bone Metastases Suffering from Moderate to Severe Pain

Altundag K., DİZDAR Ö., ÖZSARAN Z., ÖZKÖK S., Saip P., Eralp Y., ...More

ONKOLOGIE, vol.35, no.5, pp.254-258, 2012 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 35 Issue: 5
  • Publication Date: 2012
  • Doi Number: 10.1159/000338369
  • Journal Name: ONKOLOGIE
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.254-258
  • Hacettepe University Affiliated: Yes


Background: The aim of this study was to determine the efficacy and safety of loading-dose intravenous (i.v.) ibandronate in women with breast cancer and bone metastases. Patients and Methods: In this prospective, phase II, open-label study, 13 women with breast cancer, bone metastases, and moderate/severe bone pain received ibandronate 6 mg/day (i.v. loading-dose 15 min infusion over 3 consecutive days) with follow-up until day 14. Endpoints included pain response (primary), duration until pain response, analgesic use, Karnofsky index, safety (including hematologic, biochemical, and urine examinations), and adverse events. Results: Pain intensity decreased on days 7 and 14 versus day 1 (mean visual analogue scale score: 3.2 +/- 2.2 and 3.0 +/- 2.1 versus 6.1 +/- 0.9, respectively; p < 0.01 for both). Mean time to pain response was 8.2 +/- 3.3 days. Mean rate of analgesic use decreased (69.2%, 16.7% and 15.4% on days 1, 7 and 14, respectively). Mean Karnofsky index score increased (80.8 +/- 13.1 and 80.8 +/- 13.2, on days 7 and 14 versus 77.7 +/- 11.7 on day 1; p < 0.05 on both days). Conclusion: Bone pain and analgesic use decreased in women with breast cancer and bone metastases following loading-dose i.v. ibandronate which was well-tolerated with no renal safety concerns.