The efficacy and safety of oral ibandronate in the treatment of metastatic bone disease in patients with breast cancer
We read with interest D. Tripathy and coworkers study [1
], published in the May 2004 issue of Annals of Oncology. They concluded that oral ibandronate was well tolerated and an effective treatment for metastatic bone disease in patients with breast cancer. Both oral ibandronate 20 mg and 50 mg significantly reduced the skeletal morbidity period rate when compared with placebo. However, when we look at the incidence of death, it is obvious that both ibandronate 20 mg and 50 mg had a higher incidence of death when compared with placebo, but the differences among groups were not statistically significant at this level. The incidence of death was increased by 42.8% and 58% in the ibandronate 20 mg and 50 mg arms, respectively. This finding is contradictory to the literature. The bisphosphonates did not have a detrimental effect on survival [2
]; in fact, in same study, they prolonged survival significantly [3
]. Therefore, it is somewhat difficult to conclude that oral ibandronate at the doses given is safe in the treatment of metastatic bone disease in patients with breast cancer, according to the results of the study by D. Tripathy et al.
G. Utkan*,
A. Büyükçelik and
B. Yalç
n
Department of Medical Oncology, Ankara University School of Medicine, Ibni Sina Hospital, Ankara, Turkey
* Email: gungorutkan_md{at}yahoo.com
References
1. Tripathy D, Lichinitzer M, Lazarev A et al. Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial. Ann Oncol 2004; 15: 743750.[Abstract/Free Full Text]
2. Dearnaley DP, Sydes MR, Mason MD et al. A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PRO Trial). J Natl Cancer Inst 2003; 95: 13001311.[Abstract/Free Full Text]
3. Atula S, Powles T, Paterson A et al. Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Saf 2003; 26: 661671.[ISI][Medline]