Targeted “bone-seeking” radiopharmaceuticals for palliative treatment of bone metastases: A systematic review and meta-analysis
Nuclear Medicine, Catholic University, Rome, Italy:2 Nuclear Medicine, "Regina Elena" National Cancer Institute, Rome, Italy - .The quarterly journal of nuclear medicine and molecular imaging: official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of... (Impact Factor: 2.03). 12/2012; 56(6):538-43.
Aim: The aim of the study was to assess the state of the art of the use of bone-seeking radiopharmaceuticals for palliation therapy of pain from bone metastases. Methods: A systematic literature search was conducted about therapy with 89Sr-chloride and 153Sm-EDTMP between 2001-2011. The primary outcomes were efficacy and toxicity. Descriptive and quantitative data were extracted from each study, calculating event rates and odds ratio (OR) with 95% confidence intervals (CI) for pooled analysis. Subgroup analyses were performed. Results: Fifty-seven studies contributed to the systematic review. Forty-six studies used radiopharmaceuticals as a single agent, 15 investigated therapeutic combinations. Most of the studies included patients with prostate cancer. The overall efficacy of bone-seeking radiopharmaceuticals as single agents was 70%, whereas it was 74% when used in combination with other therapies. Complete response was reported in 27% of patients. Efficacy resulted to be 70% for prostate cancer and 79% for breast cancer. The overall toxicity of radiopharmaceuticals was 15%: the toxicity was 11% selecting only studies reporting on the use of radiopharmaceuticals as a single agent. No significant difference was found between bone-seeking radiopharmaceuticals and other oncological treatments regarding efficacy or toxicity. Reports of objective response outcomes suggest that bone-seeking radiopharmaceuticals have some cytotoxic activity, either alone or combination with chemotherapy. Conclusion: This literature analysis emphasizes multiple evidences of high efficacy and low toxicity of bone seeking radiopharmaceuticals; moreover, this therapy may have a therapeutic potential beyond simple palliation of bone pain.
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ABSTRACT: Approximately 85% of patients with cancer suffer severe metastatic bone pain for which radionuclide therapy has been employed for pain palliation. We undertook this study to evaluate the pain relief effect of (153)Sm-EDTMP in Mexican patients with severe and painful bone metastases from mainly prostate, breast, and renal cancer and other malignancies. Patients (277) with intense sustained pain caused by bone metastases were referred to the Nuclear Medicine Department of the Oncology Hospital of the Mexican Social Security Institute. The patients had to have acceptable physical conditions, a previous positive (99m)Tc-MDP scan and blood values within normal range. (153)Sm-EDTMP was prepared at the Instituto Nacional de Investigaciones Nucleares (ININ) and 37 MBq/kg of body weight was injected intravenously. Pain palliation was evaluated with a visual analogue scale (VAS) and a verbal rating scale (VRS) before treatment and 3 and 12 weeks after treatment was started. The age interval of the patients was 24-92 years with a mean age of 64 ± 12 years. Mean values for hemoglobin, leukocyte and platelet counts did not statistically differ at zero time, 3 and 12 weeks after treatment. Pain intensity and relief assessment were statistically different: 9.1 ± 0.61 units initially; 4.2 ± 1.3 units 3 weeks later (54%) and after 12 weeks the pain diminished to 2.4 ± 1.4 units (74%) in the pain relief score scales. (153)Sm-EDTMP was readily available, safe and well tolerated. We conclude that (153)Sm-EDTMP was an adequate palliative agent and was the best option for our Mexican patients to relieve their severe metastatic bone pain.
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ABSTRACT: Samarium-153 (Sm-153)-EDTMP is routinely used for pain palliation in skeletal metastasis, however most patients report partial response. Many strategies have been contemplated to make radiation therapy for pain more effective, one of them being the use of radiosensitizers. Capecitabine is a chemotherapeutic drug and is routinely combined with external beam radiation to make the target more radio-sensitive. Aim of the study was to evaluate whether combining capecitabine in radiosensitizing dose with Sm-153-EDTMP produces superior analgesia compared to Sm alone. Forty-four patients with skeletal metastases from various primaries were randomized into two groups: The study group received 1 mCi/kg Sm-153-EDTMP plus capecitabine (1,650 mg/m(2)) orally for 8 days (equivalent to four t ½ of (153)Sm-EDTMP) and the control arm received 1 mCi/kg Sm-153-EDTMP plus placebo for the 8 days. After treatment, the patients were followed up for 12 weeks to evaluate the degree and duration of pain palliation and hematologic toxicity. All 44 patients reported different degrees of pain relief with none reporting complete pain relief for the entire duration of 12 weeks posttherapy observation period. However the level of pain relief obtained in study arm was significantly better than the control arm with mean posttherapy pain score being 1.29 ± 1.05 and 3.59 ± 2.77 respectively with P of 0.001. Transient and mild hematologic toxicity, as determined by World Health Organization criteria, was apparent in both arms without significant differences. The addition of a low-dose of capecitabine significantly enhances the analgesic effect of Sm-153 without any additional side effects.
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ABSTRACT: Between 60 and 84 % of patients with solid cancers develop bone metastases, the main complication that severely impairs quality of life and performance status and constitutes one of the major challenges of oncological practice. Among other palliative treatments, therapy with bone-seeking radiopharmaceuticals is part of the armamentarium available in the clinical setting to treat bone pain caused by skeletal metastases. Although several radionuclides have been proposed to this purpose, the most widely used radiopharmaceuticals are the β− emitters 89Sr-chloride and 153Sm-ethylenediamine-tetra-methylene phosphonate (153Sm-EDTMP), while the more recently approved α++ emitter 223Ra-chloride plays an increasing role in this scenario.Based on clinical experience acquired for over two decades, 153Sm-EDTMP has an excellent profile in terms of both efficacy and toxicity, as confirmed by a recent systematic review and meta-analysis of literature on therapy with 89Sr-chloride and 153Sm-EDTMP publi ...
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