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Intravenous ibandronate does not affect time to renal function deterioration in patients with skeletal metastases from breast cancer: phase III trial results
Author(s) -
BODY J.J.,
DIEL I.J.,
TRIPATHY D.,
BERGSTROM B.
Publication year - 2006
Publication title -
european journal of cancer care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 67
eISSN - 1365-2354
pISSN - 0961-5423
DOI - 10.1111/j.1365-2354.2005.00641.x
Subject(s) - medicine , creatinine , nephrotoxicity , renal function , placebo , breast cancer , urology , clinical trial , post hoc analysis , oncology , cancer , surgery , toxicity , pathology , alternative medicine
As patients with metastatic bone disease typically receive long‐term treatment with bisphosphonates, and often antineoplastic compounds, drug‐related safety is of considerable importance. Clinical trial data for intravenous (i.v.) ibandronate suggest that its nephrotoxic potential is comparable with placebo. We conducted a post hoc Kaplan‐Meier analysis of time to serum creatinine increase with i.v. ibandronate throughout 2 years of treatment. After 96 weeks, 12% of patients in the placebo group and 6% in the ibandronate 6 mg group (ns, P = 0.22) had defined serum creatinine increases. After 12 treatment months (48 weeks), 4% of patients receiving placebo and 2% of patients receiving ibandronate 6 mg showed increased serum creatinine. These results suggest that there is no clinically relevant change in serum creatinine levels with i.v. ibandronate 6 mg infused every 3–4 weeks for 2 years. Comparative trials to examine the renal safety of ibandronate and other i.v. bisphosphonates are warranted.