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The radiation dose schedules permitted in the study were those administering 8 to 20 Gy in 1 to 5 daily fractions. Criteria for patient eligibility were: age 18 years or older with radiological evidence of bone metastases from a solid tumor, single lesion or multiple metastases were both accepted, pain intensity attributable to the bone lesion measured by Visual Analogue Scale (VAS) of 0–10 and patients capability and willingness to sign informed consent and complete the daily diary. Subjects eligible for the study were patients with bone metastases treated with External Beam RT. Therefore, the objectives of this prospective multi-center observational study were to determine the incidence of pain flare after palliative radiation for painful bone metastases and to evaluate the impact of the pain flare on the pain control and the functionality of the patients. These studies have also demonstrated that pain flare associated with RT negatively impacts on the functionality and the mood of the patients. Few prospective observational studies, with a low number of patients, have explored the incidence of pain flare. To date, the evidence in the literature evaluating prospectively the incidence of pain flare is scarce. Several randomized controlled trials (RCT) and three meta-analysis have shown equivalent pain response rates for single- and multiple-fraction radiotherapy treatments in the palliation of painful bone metastases.Īlthough RT for bone metastases is associated with limited side effects, a transitory aggravation of bone pain after treatment in the irradiated site has been recognized in several published reports, with published incidence rates of this phenomenon varying between 2 % and 40 %. Depending on the criteria used, complete response of the pain could be achieved from 10 % to 35 % of patients, with overall pain response rates approaching 70 %. Palliative radiotherapy (RT) is a well-established and effective treatment alternative for symptomatic bone metastases. It is the most common cause of cancer-related pain and the most frequent symptom that requires treatment in cancer patients. This phenomenon is not a predictor for pain response.īone metastases are a common distance manifestation in advanced oncologic patients with a rising incidence due to longer survival of cancer patients. Pain flare is a common event, occurring in nearly 40 % of the patients that receive palliative RT for symptomatic bone metastases. No significant differences in BPI time trends were found between patients with and without flare pain. There were no significant relationships between the occurrence of pain flare and collected variables.Īll BPI items measured four weeks after end of RT showed significant improvement as compared with pretreatment scores (p < 0.001). The mean duration of the pain flare was 3 days (SD: 3).
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The majority of pain flares occurred on days 1–5 (88.2 %). The overall pain flare incidence across all centers was 51/135 (37.7 %). Forty-two patients (31.1 %) patients received a single fraction of 8 Gy and 83 (61.5 %) received 20 Gy in five fractions. The most common primary cancer site was lung in 42 patients (31.1 %), followed by prostate in 27 patients (20.0 %).
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The Brief Pain Inventory (BPI) was filled out on the pretreatment and at the 4 weeks follow-up visit. All pain medications and worst pain scores were collected before, daily during, and for 10 days after RT. Pain flare was defined as a 2- point increase in worst pain score as compared with baseline with no decrease in analgesic intake or a 25 % increase in analgesic intake as compared with baseline with no decrease in worst pain score. Methodsīetween June 2010 and June 2014, 204 patients were enrolled in this study and 135 patients with complete data were evaluable. The aim of the study was to prospectively evaluate the incidence of pain flare following RT for painful bone metastases and evaluate its effects on pain control and functionality of the patients. Pain flare, a transient worsening of the bone pain after RT, has been described in previous reports with different incidence rates. Palliative radiotherapy (RT) is an effective treatment for symptomatic bone metastases.