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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >HDR brachytherapy combined with interstitial hyperthermia in locally advanced cervical cancer patients initially treated with concomitant radiochemotherapy - A phase III study
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HDR brachytherapy combined with interstitial hyperthermia in locally advanced cervical cancer patients initially treated with concomitant radiochemotherapy - A phase III study

机译：HDR近距离放射疗法结合间质性热疗法在局部晚期宫颈癌患者中最初接受放射化学疗法治疗-III期研究

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Background and purpose The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Materials and methods After radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II-III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5 C, was administered for 45 min before and during the HDR BT. Results The median follow-up time was 45 months (range 3-72 months). An effect of hyperthermia was not detected for disease-free survival (DFS) (log-rank test: p = 0.178) or for local control (LC) (p = 0.991). According to Cox's analysis, HT did not significantly influence failure or interactions with potential prognostic factors for LC or DFS. Statistical differences were not observed for the distribution of early and late complications between the HT and non HT groups. Conclusions ISHT is well-tolerated and does not affect treatment-related early or late complications. Improvements in DFS and LC were not observed following the addition of ISHT to ISBT.
机译：背景和目的这项随机试验的目的是研究热疗（HT）与间质近距离放射治疗（ISBT）结合对患者的局部控制（LC），无病生存期（DFS）或急性和晚期副作用是否有影响患有晚期宫颈癌。材料和方法放化疗后，将连续患宫颈癌的患者（FIGO II-III期）随机分为两个治疗组，分别为ISBT或ISBT联合间质热疗（ISHT）。统计分析共包括205例患者。在HDR BT之前和期间，每周一次在温度高于42.5 C的条件下施用HT，持续45分钟。结果中位随访时间为45个月（范围3-72个月）。未检测到无病生存期（DFS）（对数秩检验：p = 0.178）或局部对照（LC）（p = 0.991）的热疗效果。根据Cox的分析，HT对LC或DFS的失败或与潜在预后因素的相互作用没有显着影响。 HT组和非HT组之间早期和晚期并发症的分布没有观察到统计学差异。结论ISHT具有良好的耐受性，不会影响与治疗相关的早期或晚期并发症。将ISHT加入ISBT后，未观察到DFS和LC的改善。

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