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Patients with advanced breast cancer are at high risk for developing bone metastases and ensuing skeletal complications. Since the mid 1990s, intravenous (IV) pamidronate has been the international standard of care for breast cancer patients with bone metastases. Recently, a large, randomized, phase III trial in this patient population demonstrated that 4mg zoledronic acid, a new-generation bisphosphonate, was safe and significantly reduced the overall risk of skeletal complications compared with pamidronate. Zoledronic acid has also been shown to provide consistent, durable pain reduction in these patients compared with placebo. Based on these results, zoledronic acid is rapidly becoming the new international standard for patients with bone metastases from breast cancer.
More than 200,000 women in the US are diagnosed with breast cancer each year1 and, among the approximate one-third of these patients who develop advanced disease, 65–75% will develop bone metastases.2 These patients are at high risk for skeletal complications, including pathologic fractures, spinal cord compression, and debilitating bone pain. In fact, studies have demonstrated that in the absence of bisphosphonate therapy nearly 70% of breast cancer patients with bone metastases will experience a skeletal complication within two years, with an annual incidence of approximately four events per year (see Figure 1).3,4 Moreover, breast cancer patients have a long median survival after diagnosis of bone metastases (in the range of two to three years), during which they often suffer from significant skeletal morbidity that can have a devastating effect on quality of life.2,5
Traditional options for the treatment of patients with bone metastases from advanced breast cancer include standard anti-neoplastic therapies, surgery to treat or prevent fractures, and radiotherapy to stabilize bone lesions, prevent fractures, and palliate severe bone pain. In addition, these patients often receive systemic analgesic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) or opioids. Recently, bisphosphonates have emerged as the standard for the prevention of skeletal complications in breast cancer patients with bone metastases. Bisphosphonates are potent inhibitors of bone resorption and have been shown to significantly reduce the percentage of patients with skeletal complications, delay the median time to first skeletal event, reduce the need for radiotherapy, and palliate bone pain compared with placebo in randomized, controlled trials.6