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Bondronat Achieving Better Outcomes in Metastatic Breast Cancer: Presented at IBCEF

By Chris Berrie

VIENNA, AUSTRIA -- February 21, 2006 -- Oral ibandronate (Bondronat(R)) is as effective as intravenous (IV) zoledronic acid for reducing skeletal-related effects (SREs) while providing rapid and sustained relief from metastatic bone pain and improved mobility and function in patients with metastatic breast cancer, according to an overview presented here.

Bisphosphonates are used in patients with metastatic bone disease to prevent skeletal complications, to provide a rapid and sustained relief from metastatic bone pain, and improve mobility and function, according to presenter David Cameron, MD, Consultant Medical Oncologist and Senior Lecturer in Medical Oncology, Department of Oncology, Western General Hospital, Edinburgh, Scotland.

For prevention of skeletal complications, it has been shown that both 6 mg IV and 50 mg by mouth of ibandronate can provide significant risk reductions versus placebo (40%, P = .0033; 38%, P = .0001; respectively), Dr. Cameron said during his presentation here on February 11^th at the International Breast Cancer Expert Forum: Milestones in Management, Confidence and Care (IBCEF).

The demonstration of a direct correlation between the rate of bone resorption and the rate of bone complications led a recent bone marker study based on the concept that a decrease in markers of bone resorption following bisphosphonate treatment would be indicative of a decreased incidence of SREs.

The randomised, multicentre, open-label, 12-week bone-marker study of patients with breast cancer compared oral ibandronate 50 mg/day (n = 128) and IV zoledronic acid 4 mg in 15 minute infusions every 4 weeks (n = 126), Dr. Cameron said. The primary endpoint of the study was change in carboxyterminal cross-linking telopeptide of bone collagen (CTX) at week 12.

Results show that oral ibandronate was as effective as IV zoledronic acid in reducing CTX serum levels, with reductions of 76% and 73%, respectively.

Similarly, a cross-trial comparison of 6 mg IV and 50 mg oral ibandronate with 4 mg IV zoledronic acid showed similar significant decreases in SREs versus placebo (29%, P = .0183; 38%, P < .0001; and 41%, P < .0001; respectively).

There are a number of comparative trials underway looking comparing oral ibandronate and IV zoledronic acid for prevention of SREs in patients with metastatic breast cancer, Dr. Cameron said.

In terms of long-term relief of metastatic bone pain with ibandronate, two phase 3 studies have confirmed up to 2 years of relief: MF4265, with IV ibandronate 6 mg (n = 154), showed a significant improvement (P < .001) over placebo (n = 158); and MF 4414/4434, with oral ibandronate 50 mg (n = 287), showed significant improvement (P < .001) for long-term bone pain relief over placebo (n = 277).

Similarly, the same dosings of ibandronate have been shown to maintain patients' quality of life, according to the global assessment in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 study: -45.0 placebo (n = 143) versus -10.0 IV (n = 137, P = .005); -26.8 placebo (n = 277), versus -8.3 oral (n = 287, P = .032). In particular, IV ibandronate saw the best improvements in physical, emotional and social functions, while oral ibandronate emphasised physical and role functions, Dr. Cameron said.

An open, prospective and non-randomised trial recently assessed the role of ibandronate for the rapid relief of metastatic bone pain. Results of this study evaluated an initial 6 mg IV loading dose of ibandronate for 3 consecutive days for patients with metastatic prostate, renal and bladder cancer (n = 53). The results show that 83% of patients had pain relief starting on day 2, with 25% became pain free.

Thus, Dr. Cameron said, this initial loading dose of ibandronate served to provide immediate pain relief and to eliminate the 12-week time delay expected with oral ibandronate.

There is also an ongoing phase 3 trial of metastatic bone pain that is evaluate loading doses of both ibandronate and zoledronic acid for rapid pain relief.

Dr. Cameron stressed the benefits of oral ibandronate with the inclusion of a 3 mg IV ibandronate loading dose that indeed relieves metastatic bone pain within 3 days.

The conference was sponsored by Roche.


[Presentation title: Bondronat: Achieving Better Outcomes in Metastatic Breast Cancer.]

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