Treatment of bone metastases before the onset of pain (original) (raw)

Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration

British journal of cancer, 2005

Patients with bone metastases from breast cancer often experience substantial skeletal complications -- including debilitating bone pain -- which negatively affect quality of life. Zoledronic acid (4 mg) has been demonstrated to reduce significantly the risk of skeletal complications in these patients and is administered via a short, 15-min infusion every 3 weeks, allowing the possibility for home administration. This study compared the efficacy and safety of zoledronic acid administered in the community setting vs the hospital setting in breast cancer patients with > or =1 bone metastasis receiving hormonal therapy. After a lead-in phase of three infusions of 4 mg zoledronic acid in the hospital setting, 101 patients were randomized to receive three open-label infusions in the community or hospital setting, followed by three infusions in the opposite venue (a total of nine infusions). The Brief Pain Inventory (BPI) and the European Organisation for Research and Treatment of Canc...

Effect of bisphosphonates on pain and quality of life in patients with bone metastases

Nature Reviews Clinical Oncology, 2009

Bone is the most common organ for tumor metastasis, especially in patients with cancers of the breast or prostate. Bone metastases disrupt skeletal metabolism and result in considerable skeletal morbidity, including intractable, chronic bone pain, hypercalcemia of malignancy, pathologic fracture and spinal-cord compression. In addition to the chronic pain caused by bone metastases, skeletal-related events (SREs) such as pathologic fractures and spinal-cord compression can result in acute increases in pain. These effects can severely impair mobility and contribute to a general decrease in quality of life. Palliative options to treat bone metastases include radiotherapy, analgesics, surgery and bisphosphonates. These drugs bind to the surface of the bone and impair osteoclast-mediated bone resorption, and reduce the tumor-associated osteolysis that is initiated by the development of skeletal metastases. In addition to preventing SREs, bisphosphonates can palliate bone pain caused by a variety of solid tumors. This Review summarizes the clinical trial data of bisphosphonates for the prevention of SREs and the palliation of bone pain. Among these agents, nitrogen-containing bisphosphonates are recognized as the most effective, and zoledronic acid has demonstrated the broadest clinical utility.

Randomized, open label, prospective study on the effect of zoledronic acid on the prevention of bone metastases in patients with recurrent solid tumors that did not present with bone metastases at baseline

Medical oncology (Northwood, London, England), 2005

Bisphosphonates have been used successfully in the treatment of hypercalcemia and to reduce skeletal-related complications of bone metastases. Recent in vitro and in vivo evidence suggest that they may also have direct antitumor effects via induction of apoptosis, inhibition of the invasive potential of tumor cell lines in vitro, inhibition of angiogenesis, and reduction in tumor growth indirectly via effects on accessory cells. This is a randomized, open label, prospective study that examined the effect of preventive zoledronic acid treatment on the development of bone metastases in patients with recurrent solid tumors, without bone metastases at the time of randomization. Forty patients with recurrent or metastatic advanced cancer, without bone metastases, were randomized into the trial to either receive zoledronic acid or no treatment. Patients were followed up until bone metastases were established. The percentage of patients being bone metastases free at 12 mo was 60% in the zo...

The Effectiveness of Bisphosphonate to Reduce Pain in Lung Cancer Patients with Bone Metastasis

Open Access Macedonian Journal of Medical Sciences

Background: Bisphosphonates (BPs) are commonly used as supportive therapy to prevent skeletal-related events in lung cancer patients with bone metastasis, including severe bone pain, hypercalcemia, and pathological fractures. The purpose of this study was to assess the effectiveness of bisphosphonate therapy to reduce pain in non-small cell lung cancer (NSCLC) patients with bone metastasis. Methods: This was a cross-sectional study carried on 38 patients diagnosed with lung cancer based on cytology or histopathology findings. Radiological examination such as thoracic CT scan, bone survey, and bone scan was performed to determine bone metastasis. Multimodality therapy is carried out for lung cancer palliative therapy including chemotherapy, radiotherapy, and bisphosphonate therapy (zoledronic acid and ibandronate) as supportive therapy to reducing cancer pain. Pain was assessed using the Visual Analog Scale (VAS) determined by patients themselves. Statistical tests were performed by...

Management of pain in elderly patients receiving infusion of zoledronic acid for bone metastasis: a single-institution report

Supportive Care in Cancer, 2008

Goals of work Bone metastases are a common cause of morbidity in elderly patients with solid tumors and myeloma. We studied the safety and the effect of a new bisphosphonate, zoledronic acid (ZA), on pain and on quality of life (QoL) in elderly patients with bone metastases. Materials and methods From January 2004 to December 2005, we have enrolled elderly patients with bone metastasis for receiving ZA administration. Visual analog scale (VAS) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire were used to assess potential benefits of ZA therapy. Results Eighty-six patients were included; the median age was 75.5 years. Before starting treatment, the mean VAS was 6.8 (±0.24), after three infusions 5.4 (±0.3), and after six courses 4.5 (±0.3) with a significant improvement of bone pain. Moreover, we found a statistically significant improvement of QoL measured by FACT-G questionnaire after six courses (p=0.010). Median baseline and final value of serum creatinine were 0.73 and 0.72 mg/dl, respectively (p=0.11); creatinine clearance was also normal for most patients. Osteonecrosis of the jaw was diagnosed in one patient who received a prolonged ZA treatment. Conclusions These data confirm the benefits of ZA on pain and QoL also in elderly patients with bone metastasis from solid tumors.

Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion

Cancer, 2004

In women who develop bone metastases from breast cancer (BC), interactions between tumor cells and osteoclasts within the bone lead to localized bone destruction and increase the risk of skeletal-related events (SREs). Bisphosphonates inhibit osteoclast-mediated bone resorption, and have been used extensively for treating post-menopausal osteoporosis and reducing the risk of SREs in patients with bone metastases. A number of clinical trials in women with early stage BC have demonstrated that adding bisphosphonates to adjuvant endocrine therapy can prevent bone loss and may prevent disease recurrence and improve disease-free survival. In women with bone metastases from BC, bisphosphonates have demonstrated efficacy for reducing skeletal morbidity and pain and improving quality of life. Recent economic analyses have demonstrated that bisphosphonate therapy is a cost-effective use of healthcare resources. This review summarizes the available data for bisphosphonate benefits in both the adjuvant and metastatic settings in the context of evolving clinical practice.

Efficacy and Safety of Zoledronic Acid in Patients with Breast Cancer Metastatic to Bone: A Multicenter Clinical Trial

The Oncologist, 2006

Materials and Methods. Patients diagnosed with bone metastases ≤6 weeks prior to first visit were enrolled. Zoledronic acid (4 mg) was administered via a 15-minute infusion every 3 or 4 weeks for 12 infusions. Skeletal-related events (SREs) were defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy. Primary efficacy end points were the proportion of patients with at least one SRE and the time to first SRE. Secondary end points included pain, analgesic use, and quality of life.

Clinical Endpoints for Assessing Bisphosphonate Efficacy in the Prevention of Skeletal Complications of Bone Metastases

European Urology Supplements, 2004

Objective: To evaluate the relative benefits and limitations of statistical analysis techniques for assessing the efficacy of bisphoshonate therapy in patients with bone metastases from prostate cancer. Methods: The results from a recent long-term phase III clinical trial of zoledronic acid in patients with bone metastases from hormone-refractory prostate cancer were analyzed using common statistical techniques including Andersen-Gill multiple event analysis (a Cox regression-based methodology) and a new nonparametric method for determining survival-adjusted cumulative incidence of skeletal morbidity (based on the models of Ghosh and Lin, 2000 and Cook and Lawless, 1997). Results: The pattern of skeletal complications in patients with bone metastases is complex. Simple statistical endpoints assess treatment benefits in a traditional manner that is generally straightforward. However, these methods may not capture all therapeutic benefits. For example, conservative first-event analyses do not capture ongoing benefits. Simple skeletal morbidity rate calculations capture some ongoing benefits of therapy but cannot accommodate variations in skeletal morbidity rates. Statistical models that provide robust assessments of treatment benefits are discussed. The Andersen-Gill multiple event analysis captures data from all events and can adjust for inter-and intrapatient variations in event rates. The newer method of Cook and Lawless can also be adjusted for survival. All analyses detected significant benefits for 4 mg zoledronic acid compared with placebo. Survivaladjusted cumulative incidence analysis confirmed and extended the results obtained with the Andersen-Gill model. Conclusion: The new survival-adjusted cumulative risk model is an excellent method for analyzing the ongoing risk of skeletal morbidity in bisphosphonate trials in patients with advanced cancer and bone metastases.