New Bisphosphonate Reduces Bone Complications in Patients with Breast Cancer

New Bisphosphonate Reduces Bone Complications in Patients with Metastatic Breast Cancer

According to a recent article published in the British Journal of Cancer, the bisphosphonate ibandronate (Boniva™) reduces skeletal complications in patients with metastatic breast cancer that has spread to the bone.

As breast cancer becomes more advanced, it tends to spread throughout the body, with the bones being a common site of spread. Spread of cancer to the bone from its original site is referred to as bone metastases. Through complex biological pathways, bone metastases severely reduce the quality of life of a patient and may ultimately cause debilitating bone pain, bone fractures, spinal compression (a life-threatening condition) and/or abnormalities in calcium levels in the blood. Treatment for bone metastases is aimed primarily at reducing pain, delaying the time to fractures or reversing hypercalcemia (high levels of calcium in the blood). Treatment may consist of radiation therapy, bisphosphonates, hormone therapy, surgery, and/or chemotherapy, depending upon the type of cancer from which the metastasis originated and prior treatment. Besides the physical sequelae that can be caused by bone metastasis, such as bone fractures, the pain that it can cause may literally force patients to become bedridden. Researchers are evaluating ways in which to prevent or reduce the pain or fractures caused by bone metastasis, not just provide treatment once they occur.

Bisphosphonates are a class of drugs used for the treatment of cancer-related hypercalcemia (high levels of calcium in the blood) and treatment of bone metastases in patients with advanced cancers. Bisphosphonates decrease the rate of bone destruction in patients with bone metastases and clinical studies have demonstrated that bisphosphonates can significantly decrease the pain and number of fractures occurring from bone metastases. Research involving bisphosphonates is ongoing, as physicians are trying to determine the optimal timing of treatment with bisphosphonates in the course of cancer. In November 2003, the American Society of Clinical Oncology recommended the use of the bisphosphonates Zometa® or Aredia® for treatment of patients with bone metastasis from breast cancer. The role of bisphosphonates, in terms of their optimal duration of use, or the optimal time in the course of disease to initiate their use, is still being evaluated in clinical trials. Researchers are hopeful that bisphosphonates may help to prevent some patients from developing bone metastasis if they are administered prior to bone spread; however, results from clinical trials addressing this question will be the only way to answer this question.

Boniva™ is a third-generation bisphosphonate that may be administered into a vein (intravenous), or orally. Both Zometa® and Aredia® can only be administered intravenously, resulting in increased patient and healthcare providers’ time and resources for administration, as well as increased pain and potential for infection compared to oral administration. Currently, Boniva™ is approved for the prevention and treatment of post-menopausal osteoporosis.

Researchers from Europe recently pooled data from 2 clinical trials evaluating the oral form of Boniva™. The trials included 287 women with bone metastasis from breast cancer. Patients were treated with either Boniva™ or placebo (inactive substitute) and were evaluated for bone complications (e.g. bone fractures, spinal cord compression) in 12-week periods. Patients treated with Boniva™ had significantly fewer bone complications, and a significantly reduced need for radiation and/or surgery for the treatment of bone metastasis. Patients treated with Boniva™ had a slight increase in mild gastrointestinal disturbances compared to those who received placebo.

The researchers concluded that Boniva™ reduces bone complications and the need for radiation or surgery for bone metastasis in patients with bone metastasis from breast cancer. In addition, Boniva™ appeared very well tolerated, and is convenient for patients and healthcare providers as it is available in oral form. Patients with bone metastasis from breast cancer may wish to speak with their physician about the risks and benefits of participating in a clinical trial further evaluating Boniva™ or other therapeutic options. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( cancer.gov) and www.cancerconsultants.com. Personalized clinical trial searches are also performed on behalf of patients at cancerconsultants.com.

Reference: Body JJ, Diel IJ, Lichinitzer M, et al. Oral Ibandronate Reduces the Risk of Skeletal Complications in Breast Cancer Patients with Metastatic Bone disease: Results from Two Randomized, Placebo-Controlled Phase III studies. British Journal of Cancer. 2004;90:1133-1137.

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