Comparing the Effectiveness of Combined External Beam Radiation and Hyperthermia Versus External Beam Radiation Alone in Treating Patients With Painful Bony Metastases: A Phase 3 Prospective, Randomized, Controlled Trial
Comparing the Effectiveness of Combined External Beam Radiation and Hyperthermia Versus External Beam Radiation Alone in Treating Patients With Painful Bony Metastases: A Phase 3 Prospective, Randomized, Controlled Trial
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DOI：
10.1016/j.ijrobp.2017.09.030
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发表时间：
2018-01-01
影响因子：
7
通讯作者：
Chi, Kwan-Hwa
中科院分区：
文献类型：
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作者：
Chi, Mau-Shin;Yang, Kai-Lin;Chi, Kwan-Hwa
目的：比较骨转移癌患者在接受放射治疗(RT)和单纯热疗(HT)后的疗效、疼痛缓解时间和疼痛完全缓解时间。方法与材料：骨转移癌患者在简明疼痛问卷(BPI)中疼痛评分<4分，随机分为单纯放疗(RT+HT)和单纯放疗(RT+HT)，每组30 Gy10次。热疗采用RF-8型热加速器，放疗后2小时内维持目标体温40分钟/次，每周2次，共2周。根据病变数目(单发或多发)、BPI评分(4-6比7-10)和原发部位对患者进行分层。主要终点为治疗后3个月内完全缓解(CR)(BPI=0，无止痛药增加)。这项研究在ClinicalTrials.gov.Response上注册。结果：在首次登记(2013年11月至2016年11月)3年后，对57名患者进行中期分析后，该研究提前终止：RT+HT组29名患者，单纯RT组28名患者。治疗3个月后，单纯放疗组CR率为7.1%，单纯放疗组CR率为37.9%(P=0.006)。放疗+单纯放疗组治疗后3个月内累积CR率为58.6%，单纯RT组为32.1%(P=0.045)。单纯放疗组(n=9)CR患者疼痛进展的中位时间为55天，而单纯放疗组(n=9)在24周随访期间未达到终点(P
Purpose: To compare the response, duration of pain relief, and time to achieve complete pain relief after radiation therapy (RT) with or without hyperthermia (HT) in patients with painful bony metastases.Methods and Materials: Cancer patients with bony metastases and pain score >= 4 on the Brief Pain Inventory (BPI) were randomized to RT of 30 Gy in 10 fractions combined with HT (RT + HT) versus RT alone. Hyperthermia was performed by the Thermotron RF-8, with maintenance of the target temperature for 40 minutes per treatment within 2 hours after RT, twice weekly for 2 weeks. Patients were stratified by lesion number (solitary or multiple), BPI score (4-6 vs 7-10), and primary site. The primary endpoint was complete response (CR) (BPI = 0 with no increase of analgesics) within 3 months after treatment. This study was registered with ClinicalTrials.gov.Results: The study was terminated early after an interim analysis of 57 patients, 3 years after the first enrollment (November 2013 to November 2016): 29 patients in the RT + HT group and 28 patients in the RT-alone group. The CR rate at 3 months after treatment was 37.9% in the RT + HT group versus 7.1% in the RT-alone group (P=.006). The accumulated CR rate within 3 months after treatment was 58.6% in the RT + HT group versus 32.1% in the RT-alone group (P=.045). Median time to pain progression was 55 days in patients with CR (n=9) in the RT-alone group, whereas the endpoint was not reached during the 24-week follow-up in the RT + HT group (P