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

Chicago, Illinois (ots/PRNewswire)

- One Year Results From the ARIBON Study Presented at ASCO 2007
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.
For further information on Roche in Oncology go to:
www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
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 www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References:
(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.

Contact:

For further information please contact: Hanne Krog, International
Portfolio Business Manager, Bondronat, F. Hoffmann-La Roche Ltd.,
Phone: +41-(0)616-881-695, Mobile: +41-(0)796-988-376, E-mail:
hanne_greta.krog@roche.com

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