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Press Release

Oral Bondronat Shows Equal Efficacy and Superior Tolerability in First Head-to-Head Comparison with Zometa for Treatment of Metastatic Bone Disease in Cancer Patients

Roche
Posted on: 31 Oct 05

Media Release

 

 

 

 

 

EMBARGO:  31 October 2005

 

 

Oral Bondronat Shows Equal Efficacy and Superior Tolerability in First Head-to-Head Comparison with Zometa for Treatment of Metastatic Bone Disease in Cancer Patients

 

 

 

 

 

Basel, 31 October 2005 Data announced today at the European Cancer Conference (ECCO) in Paris, shows Roche’s oral Bondronat® (ibandronate) results in fewer adverse events than another commonly used bisphosphonate, zoledronic acid (Zometa), in the treatment of metastatic bone disease. These results follow earlier data from the same study which demonstrated that oral Bondronat is as effective as i.v. zoledronic acid at suppressing bone turnover markers, a surrogate measure of clinical efficacy.

 

In the study, patients with advanced breast cancer were administered either Bondronat once a day as a tablet or zoledronic acid as an infusion every 4 weeks. The results show:

o        Those patients taking oral Bondronat were nearly six times less likely to have abnormal reactions, such as flu-like symptoms, in the first three days of treatment than those taking i.v. zoledronic acid – 8% for Bondronat vs. 47% for zoledronic acid.

o        Throughout the study the proportion of patients experiencing adverse events was lower in the group taking Bondronat– 65% for Bondronat vs. 76% for zoledronic acid.

o        Fewer patients withdrew from the study in the Bondronat group compared to the group taking zoledronic acid - 2.9% versus 5.1%.

 

These data show that Bondronat offers comparable bone marker suppression and in addition has a clear tolerability benefit, particularly in the first few days of taking the drug” said Professor Jean-Jacques Body from the Institut Jules Bordet in Belgium and lead investigator of the study. ”Oral Bondronat can provide a significant advantage over zoledronic acid by limiting adverse events and hence improving patients’ quality of life.”

 

Up to 80% of patients with advanced breast cancer suffer from metastatic bone disease, the spreading of cancer from the original tumour to the bones. Treatment-related adverse events have a strong influence on physicians’ treatment choices, especially in elderly cancer patients who are most commonly affected by metastatic bone disease. With oral Bondronat physicians and patients have a bisphosphonate treatment at hand that can be conveniently taken at home and is significantly better tolerated than zoledronic acid. Unnecessary inconveniences like hospital visits and experience of adverse events can be avoided, helping patients to keep up an active lifestyle and retain personal independence.

 

Previous studies also indicate that Bondronat has a good long-term safety profile for up to two years, with renal safety similar to placebo. As a result, Bondronat does not require monthly renal monitoring and dose adjustments like zoledronic acid.

 

About the study

The 12-week, open-label study recruited breast cancer patients with advanced disease and at least one bone lesion. Patients were randomized into two arms: one arm (n=128) receiving 50 mg oral Bondronat daily, the other arm (n=126) receiving 4 mg zoledronic acid via 15 minute infusion every 4 weeks.

 

All adverse events were recorded throughout the study. Both bisphosphonates were generally well tolerated, although the proportion of patients experiencing side effects was higher in the zoledronic acid group than the Bondronat group (76% vs. 65%). In particular: the incidence of adverse events in the first three days of treatment was significantly higher in the group using zoledronic acid than those using Bondronat (47% vs. 8%); reported bone pain was higher in the zoledronic acid group than the Bondronat group (21% vs. 12%); the incidence of gastrointestinal events was slightly higher in the oral Bondronat group (23% vs. 18%); the incidence of withdrawals from the study (Bondronat 2.9%; zoledronic acid 5.1%) was lower for Bondronat.

 

Efficacy data from this study was reported earlier and showed that oral Bondronat is as effective as i.v. zoledronic acid at suppressing bone turnover markers, a surrogate measure of  clinical efficacy.

 

About Metastatic Bone Disease

Metastatic bone disease occurs when the cancerous cells from the original tumour spread to the bone via the blood stream resulting in pain, fractures and other clinical consequences. It is most commonly associated with breast, prostate, lung, kidney and thyroid cancer. In multiple myeloma, bone is the primary site of tumour and can cause extensive lesions, with a high risk of fractures and high levels of bone pain. Metastatic bone disease can also lead to skeletal related consequences including:

  • fractures
  • compression of the spine
  • hypercalcaemia (high concentrations of calcium in the blood stream)

 

In addition to bone pain and other clinical complications, patients with metastatic bone disease can suffer from disturbance in sleeping patterns and reduction in appetite. 

 

The most common sites for metastatic bone disease are the ribs, skull, pelvis, hips, vertebrae and the ends of long bones.3

 

- Ends -

For further information please contact:

At ECCO

Roche

Dr. Nina Hautzinger

Mobile +41 79 593 43 07

nina.hautzinger@roche.com

 

Shire Health

Fiona Robertson

Mobile +44 (0) 7812 414 434

fiona.robertson@shirehealthlondon.com

 

In London

Shire Health

Melissa Millard

Phone: +44 (0) 20 7108 6034

Mobile: +44 (0)7990 818 039

melissa.millard@shirehealthlondon.com

 

Shire Health

Lucie Taylor

Phone: +44 (0) 20 7108 6017

Mobile: +44 (0) 7971 122836

lucie.taylor@shirehealthlondon.com

 

 

References

 

1.       Body JJ, Lichinister M, Tjulandin SA, Coleman RE, Bergström 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

2.       Body JJ, Lichinister M, et al. Effect of oral ibandronate versus intravenous zoledronic acid on markers of bone resorption in patients with breast cancer and bone metastases: results from comparative phase III trial. Poster presented at the Association of Clinical Oncology (ASCO), Orlando, Florida, May 2005

3.       Diel IJ, Solomayer EF, Bastert G. Treatment of metastatic bone disease in breast cancer: bisphosphonates. Clin Breast Cancer 2000;1:43–51


Notes to Editors

Bondronat® (ibandronate)

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 shown effective treatment of bone fractures and pain for at least two years in three randomised trials; the relief of bone pain is currently being further assessed in a global head-to-head study with zoledronic acid. Previous (non-comparative) trials and analysis suggest that Bondronat provides bone pain relief faster and maintains it for longer than zoledronic acid. Small size loading dose studies with Bondronat demonstrated significant reduction in bone pain within three days which was sustained for at least six months. Standard treatment in larger trials showed moderate relief peaking after 8-12 weeks, continuing for up to two years.

 

Additionally, the superior renal safety profile demonstrated in two randomised trials and supported in other studies 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 comparable with placebo during two years of treatment. The effects of Bondronat on the kidney did not accumulate over time (incidence was consistently lower in the Bondronat group than in the placebo group), and there was no increased risk of renal adverse events with up to four years of Bondronat treatment.

 

Bondronat is the only bisphosphonate available in equal efficacy in i.v. and oral formulations, with the approved dosage for prevention of the complications of skeletal metastases in patients with breast cancer and bone metastases being 50 mg once daily administered orally at least 30 minutes before food, or 6 mg administered intravenously every three to four weeks.

 

For further information on Roche in Oncology go to:

www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

For more information:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

Editor's Details

Melissa Millard
Shire Health London
+44 (0)207 108 6034
melissa.millard@shirehealthlondon.com

Last updated on: 27/08/2010

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