New Data Show Bondronat(R) Prevents Bone Loss Caused by anastrozole in Women With Surgically Treated Breast Cancer

2007-06-04 09:47 611

-- One Year Results From the ARIBON Study Presented at ASCO 2007

CHICAGO, June 6 /Xinhua-PRNewswire/ -- Bondronat(R) (ibandronic acid) has been shown to prevent bone loss caused by anastrozole in post-menopausal women given adjuvant therapy for early breast cancer according to results from the ARIBON study presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.(1)

The study also found that Bondronat significantly increased bone mineral density in the treated women.(1) Whilst anastrozole is an effective breast cancer treatment, its use is associated with a decline in bone mineral density and an increased risk of bone fracture in some women.(2),(3)

"These study results are very encouraging as they demonstrate that Bondronat can prevent loss of bone in early breast cancer patients with low bone density who are given anastrozole," said Dr Jim Lester, lead study investigator, Cancer Research Centre, Weston Park Hospital, Sheffield, UK.

"anastrozole is an important therapy against breast cancer but we clearly want to avoid reducing bone density and increasing the risk of fractures and osteoporosis in our at-risk patients."

The ARIBON study evaluated the use of Bondronat, 150mg orally once a month, in post-menopausal breast cancer patients taking anastrozole who were osteopenic (had mild thinning of bones) or osteoporotic (more severe bone density loss). After one year, results showed:(1)

-- Women with osteopenia treated with Bondronat gained +2.78% and

+1.35% of bone density at the lumbar spine and hip

respectively. Patients treated with placebo lost -2.61% at the

lumbar spine and -2.34% at the hip. (p<0.001)

-- Women with osteoporosis gained +5.05% at the lumbar spine and

+2.62% at the hip after 1 year

Bondronat infused over 15 minutes does not deteriorate renal function

Data from an additional study presented at ASCO show that Bondronat 6mg, infused over 15 or 60 minutes, does not deteriorate renal function in women with advanced breast cancer and bone metastases.(4) Bondronat 6mg administered over 15 minutes every 3-4 weeks was well tolerated with a safety profile consistent with the 60 minute infusion.(4) These data reinforce previous study results which demonstrate Bondronat’s positive safety profile and good tolerability.(5)

In March 2007, the European Commission approved the administration of Bondronat as a 15 minute infusion in patients with CLcr more than or equal to 50ml/min. Bondronat is available as both intravenous (i.v.) and oral formulations. Both formulations are indicated for the prevention of skeletal events in patients with breast cancer and bone metastases.

Notes to Editors:

Dr Jim Lester, lead investigator of the ARIBON study, was awarded an ASCO Foundation Merit Award for his poster. A select number of ASCO Foundation Merit Awards are given annually to recognize outstanding abstracts submitted for consideration for presentation at an ASCO scientific meeting.

About Bondronat(R) (ibandronic acid)

Bondronat was approved by the European Commission for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases in October 2003. Bondronat has been shown to be an effective treatment for preventing bone fractures and relieving bone pain in breast cancer in three randomised trials. Additionally a good renal safety profile, demonstrated in randomised trials, means that Bondronat limits the risk of kidney deterioration or failure that has been associated with other i.v. bisphosphonates. Intravenous Bondronat has a renal safety profile which gave no increased risk of renal adverse events compared with placebo for up to four years of treatment.

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About anastrozole

anastrozole is an effective aromatase inhibitor which prolongs relapse-free survival in women with hormone receptor positive early breast cancer, and has superior efficacy and tolerability over tamoxifen.(6) anastrozole use, however, is associated with a decline in bone mineral density and increased risk of bone fracture in some women.(2),(3) Treatment for 5 years with anastrozole is associated with a bone loss of 6% to 7% at the lumbar spine and hip respectively.(3)

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at .

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(1). Lester JE, Gutcher SA, Ellis S, et al. Monthly oral ibandronate (Bondronat(TM)) prevents anastrozole-induced bone loss during adjuvant treatment for breast cancer. One year results from the ARIBON study. Poster presented at the American Society of Clinical Oncology (ASCO) annual meeting, 1-5 June 2007.

(2). Chien A, Goss P. Aromatase inhibitors and bone health in women with breast cancer. Journal of Clinical Oncology. 2006. 24;5305-5312.

(3). R. E. Coleman ATAC Trialists’ Group. Effect of anastrozole on bone mineral density: 5-year results from the ‘Arimidex’, Tamoxifen, Alone or in Combination (ATAC) trial. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 511.

(4). Moos R, Thurlimann B, Caspar C, et al. Intravenous ibandronate 6mg, infused over 15 or 60 minutes, maintains renal function in patients with breast cancer and bone metastases. Poster presented at the American Society of Clinical Oncology (ASCO) annual meeting, 1-5 June 2007.

(5). Body JJ, Lichinister M, Tjulandin SA, Coleman RE, Bergstrom B. Safety comparisons of oral ibandronate and intravenous zoledronic acid in Metastatic breast cancer patients: phase III data. Poster presented at the European Cancer Conference (ECCO), Paris, November 2005

(6). Howell A, Cuzick J, Baum M, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-2.

Source: Roche