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PJ Online | News: Clodronate reduces the occurrence of bone metastases with breast cancer

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The Pharmaceutical Journal
Vol 269 No 7213 p271
31 August 2002

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Clodronate reduces the occurrence of bone metastases with breast cancer

Clodronate treatment reduces the occurrence of bone metastases in patients with primary operable breast cancer, a new study shows. It also improves overall survival in these patients.

Researchers from the Royal Marsden NHS Trust, London, and colleagues evaluated the effect of adjuvant clodronate on the incidence of bone metastases, other meta-stases, and survival in patients having surgery, radiotherapy, and/or drug treatment for primary operable breast cancer. They randomly assigned 1,069 patients to receive either oral clodronate (Bonefos) 1,600mg daily or placebo for two years, starting within six months of primary treatment.

A significant reduction in the occurrence of bone metastases was observed in the clodronate group during the two-year treatment period, and a non-significant reduction was seen during the follow-up period (median follow-up, 2,007 days). The researchers say that it is not possible to predict whether a longer treatment period would give rise to a more beneficial effect. With regard to non-bone metastases, there was no significant difference between the clodronate group and the placebo group during the total follow-up period or during the treatment period.

The researchers conclude that large clinical trials of adjuvant clodronate and other bisphosphonates used for longer treatment periods are needed to establish a clinical role of antiosteolytic bisphosphonate therapy for patients with primary operable breast cancer (Journal of Clinical Oncology 2002;20:3219).

In an accompanying editorial, Dr Gregory Mundy, University of Texas Health Service Centre, San Antonio, comments that "the main advantage of clodronate over other clinically used bisphosphonates is its oral availability and the fact that it has been so extensively studied. Other orally available bisphosphonates, such as aldronate and risedronate, have not been studied for this indication and should not be used if there is an alternative" (ibid, p3191).

Dr Hubert Bland, research physician, Boehringer Ingelheim, told The Journal that the company is currently applying for an extension to the licence for Bonefos in the United Kingdom for adjuvant treatment of breast cancer.

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