Clodronate therapy in patients with breast cancer and bone metastases

Abstract EN

Purpose : to assess whether coronate can reduce frequency of skeletal morbidity in women with lytic bone metastases from breast cancer.

Methods : between 1997 and 2001, 167 patients with stage IV breast cancer with bone metastases, were randomly assigned to receive coronate at a dose of 1600 mg per day orally for 12 months, in addition to the standard specific anti-cancer therapy (87 patients) or standard anti-cancer therapy only (80 patients).

Skeletal complications, including pathological fractures, the need for radiation to bone or bone surgery, spinal cord compression and hyper-calcemia (a serum calcium concentration above 12 mg per deciliter (3.0 mmol per liter) or elevated to any degree and requiring treatment) were assessed monthly.

Bone pain, use of analgesic drugs, performance status and quality of life were assessed throughout the trial.

Results : there was no significant difference between the two groups at study entry regarding clinical characteristics.

The median time for first skeletal complication was significantly less in the control group (6.1 vs 9.7 months, p = 0.05).

The proportion of patients who had any skeletal complication in the coronate group was in general less than in the control group but the difference was not statistically significant.

Bone pains reduction was higher in the coronate group than the control group, but the difference was insignificant (p = 0.09).

Coronate was generally well tolerated and the main side effects were constipation (32 %) flatulence / dyspepsia (17 %) and anorexia (8 %).

The overall survival was not affected by clo-dronate therapy.

The median survival was 14 months in the coronate group and 13.8 months in the control group.

Conclusions : coronate is an effective supplement to conventional anticancer treatment for breast cancer with bone metastasis.

It reduces skeletal complications and relieves symptoms associated with lytic bone lesions.

Further clinical trials that recruit a larger number of patients will be needed to clearly define the role of clodr-onate in metastatic breast cancer.