Oral ibandronate improves bone pain and preserves quality of life in patients with skeletal metastases due to breast cancer

Abstract

The objective of this study is to assess the effect of oral ibandronate on bone pain and quality of life in women with metastatic bone disease from breast cancer. In two double-blind, placebo-controlled studies, 564 patients were randomised to receive oral ibandronate, 50mg once daily, or placebo for up to 96 weeks. Throughout the studies, we assessed bone pain (on a 5-point scale from 0=none to 4=intolerable), analgesic use (7-point scale) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 [EORTC QLQ-C30], 100-point scale). Oral ibandronate significantly reduced and maintained bone-pain scores below baseline throughout the 96-week study period (at endpoint, -0.1 vs +0.2, P=0.001 vs placebo). Analgesic use increased in both groups; however, the increase was significantly less in the ibandronate group (0.60 vs 0.85, P=0.019). Although quality of life deteriorated during the study, the decrease in quality of life was significantly lower with ibandronate therapy (-8.3 vs -26.8, P=0.032). Drug-related adverse events were generally minor and as expected with oral bisphosphonates. Oral ibandronate had beneficial effects on bone pain and quality of life and was well tolerated. These results suggest that this treatment is of considerable clinical value as a co-analgesic to patients with painful bone metastases.

Efficacy of Ibandronate in Metastatic Bone Disease: Review of Clinical Data

“…Ibandronate is unique among bisphosphonates because data show that it has proven efficacy in reducing SREs as well as reducing metastatic bone-pain scores below baseline for up to 2 years [25][26][27][28], a benefit that has not been reported for zoledronic acid and other agents. Open-label studies have demonstrated that loading-dose ibandronate effectively relieves severe or opioid-resistant bone pain.…”

“…Both i.v. and oral ibandronate were associated with a statistically significant preservation of quality-of-life scores compared with placebo (p ≤ .05) [27,30].…”

“…ibandronate every 3-4 weeks and 50 mg oral ibandronate daily. The efficacy of these doses in the treatment of metastatic breast cancer patients was demonstrated in randomized, double-blind, placebo-controlled, multicenter phase III trials [25][26][27][28]. The primary end point used was the skeletal morbidity period rate (SMPR), which measures the number of 12-week periods in which each patient experienced an SRE.…”

“…Poisson multipleevent regression analyses showed that i.v. and oral ibandronate were associated with 40% and 38% risk reductions for an SRE, respectively [27,29]. Both formulations also caused significant reductions in bone-pain scores to below baseline that were maintained throughout 2 years of treatment, whereas a gradual increase in bone-pain scores was observed for placebo-treated patients (p ≤ .001 for ibandronate versus placebo at study end) ( Fig.…”

Management of bone metastases: recent advances and current status

“…They have also been shown to be effective in reducing skeletal pain [47, 60,61] and maintaining or even improving the quality of life of treated patients [60,62,63].…”