放射治疗联合热疗与顺铂治疗局部晚期宫颈癌：随机RADCHOC试验结果
Radiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial.
作者信息
Lutgens Ludy C H W, Koper Peter C M, Jobsen Jan J, van der Steen-Banasik Elzbieta M, Creutzberg Carien L, van den Berg Hetty A, Ottevanger Petronella B, van Rhoon Gerard C, van Doorn Helena C, Houben Ruud, van der Zee Jacoba
机构信息
Maastricht Radiation Oncology (MAASTRO) Clinic, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.
Department of Radiotherapy, Medical Center Haaglanden, The Hague, The Netherlands.
出版信息
Radiother Oncol. 2016 Sep;120(3):378-382. doi: 10.1016/j.radonc.2016.02.010. Epub 2016 Feb 17.
BACKGROUND
Chemoradiation (RT-CT) is standard treatment for locally advanced cervical cancer (LACC). This study tried to establish if radiotherapy combined with hyperthermia (RT-HT) should be preferred in bulky and/or FIGO-stage ⩾III.
METHODS
In this open-label, multicenter randomized trial, patients with LACC were randomly assigned by a computer-generated, biased coin minimization technique to RT-CT or RT-HT. Central randomization was done with stratification by FIGO-stage, tumour diameter and nodal status. Primary endpoint was event free survival (EFS). Secondary endpoints were pelvic recurrence free survival (PRFS), overall survival (OS) and treatment related toxicity. Analysis was done by intention to treat.
RESULTS
The trial was closed prematurely (87 of 376 planned patients enrolled: 43 RT-CT; 44 RT-HT). Median follow-up time was 7.1 years. The cumulative incidence of an event was 33% in the RT-CT group and 35% in the RT-HT group. The corresponding hazard rate (HR) for EFS was 1.15 (CI: 0.56-2.36, p=0.7). Also the hazards for PRFS (0.94; CI 0.36-2.44) and OS (1.04; CI 0.48-2.23) at 5 years were comparable between both treatment arms as was grade ⩾3 radiation related late toxicity (6 RT-CT and 5 RT-HT patients).
CONCLUSION
After 25% of intended accrual, data suggest comparable outcome for RT-CT and RT-HT.
背景
放化疗（RT-CT）是局部晚期宫颈癌（LACC）的标准治疗方法。本研究试图确定在肿瘤体积较大和/或国际妇产科联盟（FIGO）分期≥III期的患者中，放疗联合热疗（RT-HT）是否更具优势。
方法
在这项开放标签、多中心随机试验中，LACC患者通过计算机生成的偏倚硬币最小化技术随机分配接受RT-CT或RT-HT治疗。根据FIGO分期、肿瘤直径和淋巴结状态进行分层的中央随机分组。主要终点是无事件生存期（EFS）。次要终点是无盆腔复发生存期（PRFS）、总生存期（OS）和治疗相关毒性。采用意向性分析。
结果
该试验提前终止（计划入组的376例患者中有87例入组：43例接受RT-CT治疗；44例接受RT-HT治疗）。中位随访时间为7.1年。RT-CT组事件累积发生率为33%，RT-HT组为35%。EFS的相应风险比（HR）为1.15（95%置信区间：0.56 - 2.36，p = 0.7）。在5年时，两个治疗组的PRFS（0.94；95%置信区间0.36 - 2.44）和OS（1.04；95%置信区间0.48 - 2.23）风险以及≥3级放射性晚期毒性（RT-CT组6例患者，RT-HT组5例患者）均具有可比性。
结论
在完成预期入组人数的25%后，数据表明RT-CT和RT-HT的治疗效果相当。
Zotero 插件