Di Staso Mario, Gravina Giovanni Luca, Zugaro Luigi, Bonfili Pierluigi, Gregori Lorenzo, Franzese Pietro, Marampon Francesco, Vittorini Francesca, Moro Roberto, Tombolini Vincenzo, Di Cesare Ernesto, Masciocchi Carlo
Department of Biotechnological and Applied Clinical Sciences, Division of Radiation Oncology and Radiobiology, S. Salvatore Hospital, University of L'Aquila, Medical School, L'Aquila, Italy.
Department of Biotechnological and Applied Clinical Sciences, Division of Radiology, S. Salvatore Hospital, University of L'Aquila, Medical School, L'Aquila, Italy.
PLoS One. 2015 Jun 23;10(6):e0129021. doi: 10.1371/journal.pone.0129021. eCollection 2015.
aim of this study was to identify outcomes in pain relief and quality of life in patients with a solitary painful osseous metastasis treated by radiotherapy, cryoablation or the combination using a propensity score matching study design.
175 patients with painful bone metastases were included in the study. Twenty-five of them underwent a radiation course (20 Gy in five daily fractions) 15 days after the cryoablation. These subjects were retrospectively matched by propensity analysis with a group of subjects treated by radiotherapy (125 subjects) and with a group treated byCryoablation (25 subjects). The pain relief in terms of complete response, rate of subjects requiring analgesics after treatments and the changes in self-rated quality of life were measured. Informed consent was obtained from the subject and the study was approved by the local Ethical Committee.
An higher proportion of subjects treated by cryoablation (32%) or cryoablation followed by RT (72%;) experienced a complete response compared with patients treated by radiotherapy alone (11.2%). After Bonferroni correction strategy, the addition of radiotherapy to cryoablation significantly improved the rate of complete response compared with cryoablation alone (p = 0.011) and this paralleled with an improved self-rated quality of life. Seventeen subjects (13.6%) of patients in the radiotherapy group, 9 (36%) in the cryoablation group, and 19 (76)% in the cryoablation- radiotherapy group did not require narcotic medications.
The addition of radiotherapy to cryoablation favorably impacts on perceived pain, with a favorable toxicity profile. However, our data should be interpreted with caution and could serve as a framework around which to design future trials.
本研究旨在通过倾向评分匹配研究设计，确定接受放射治疗、冷冻消融或联合治疗的孤立性疼痛性骨转移患者在疼痛缓解和生活质量方面的结果。
175例伴有疼痛性骨转移的患者纳入本研究。其中25例在冷冻消融术后15天接受了一个疗程的放射治疗（20 Gy，分5天给予）。通过倾向分析将这些受试者与一组接受放射治疗的受试者（125例）和一组接受冷冻消融治疗的受试者（25例）进行回顾性匹配。测量了完全缓解方面的疼痛缓解情况、治疗后需要镇痛药的受试者比例以及自评生活质量的变化。获得了受试者的知情同意，本研究得到了当地伦理委员会的批准。
与单纯接受放射治疗的患者（11.2%）相比，接受冷冻消融治疗（32%）或冷冻消融后再行放疗的患者（72%）完全缓解的比例更高。采用Bonferroni校正策略后，与单纯冷冻消融相比，冷冻消融联合放射治疗显著提高了完全缓解率（p = 0.011），这与自评生活质量的改善相平行。放射治疗组有17例患者（13.6%）、冷冻消融组有9例患者（36%）、冷冻消融 - 放射治疗组有19例患者（76%）不需要使用麻醉药物。
冷冻消融联合放射治疗对疼痛感受有积极影响，且毒性特征良好。然而，我们的数据应谨慎解读，可为未来试验设计提供一个框架。
