The effect of modulated electro-hyperthermia on local disease control in HIV-positive and -negative cervical cancer women in South Africa: Early results from a phase III randomised controlled trial
The effect of modulated electro-hyperthermia on local disease control in HIV-positive and -negative cervical cancer women in South Africa: Early results from a phase III randomised controlled trial
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南非 HIV 阳性和阴性宫颈癌妇女接受调节性电热疗对局部疾病控制的影响： 第三阶段随机对照试验的早期结果
DOI：
10.1371/journal.pone.0217894
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发表时间：
2019-06-19
期刊：
影响因子：
3.7
通讯作者：
Baeyens, Ans
中科院分区：
文献类型：
--
作者：
Minnaar, Carrie Anne;Kotzen, Jeffrey Allan;Baeyens, Ans
背景宫颈癌的全球负担仍然很高，据报道，发展中国家的发病率和死亡率最高。热疗作为化疗和放射增敏剂已被证明可以改善治疗结果。这是一项正在进行的研究，研究在低资源环境下，在放化疗中加入调制电热疗法（mEHT）治疗hiv阳性和阴性宫颈癌患者的效果，对患者治疗后6个月的局部对照结果进行分析。方法：这项正在进行的III期随机对照试验，在南非约翰内斯堡的一家州立医院进行，已在相应的伦理委员会注册。在签署知情同意书后，FIGO IIB至IIIB期宫颈鳞状细胞癌的参与者使用安全的在线随机抽样工具（分层：HIV状态），根据年龄和分期，随机接受含/不含mEHT的放化疗。报告医生对治疗分配不知情。接受抗逆转录病毒治疗的hiv阳性参与者，或CD4细胞计数为200个/ μ L的参与者。mEHT每周2次，紧接着外束放疗。主要终点是局部疾病控制（LDC），次要终点是毒性；生活质量分析；存活时间为两年。我们报告了6个月的LDFS，包括在F-18-FDG PET/CT上在辐射场中显示的淋巴结（6个月的生存期）和6个月的局部无病生存期（LDFS）（基于治疗意向）。试验状态：招募结束（临床试验）。政府:NCT03332069)。结果在2014年1月至2017年11月期间招募了271名参与者，其中210名被随机分配参加试验，202名在治疗后6个月可供分析（mEHT: n = 101; Control: n = 101）。mEHT组6个月LDFS （n = 39[38.6%]）高于对照组（n = 20[19.8%]）；P = 0.003)。mEHT组LDC （n = 40[45.5%]）高于对照组（n = 20[24.1%]）；（p = 0.003）。结论mEHT作为一种化疗放射增敏剂对宫颈癌有效，即使在高危患者和资源受限的情况下也是如此。
BackgroundThe global burden of cervical cancer remains high with the highest morbidity and mortality rates reported in developing countries. Hyperthermia as a chemo- and radiosensitiser has shown to improve treatment outcomes. This is an analysis of the local control results at six months post-treatment of patients enrolled in an ongoing study investigating the effects of the addition of modulated electro-hyperthermia (mEHT) to chemoradiotherapy for the treatment of HIV-positive and -negative cervical cancer patients in a low-resource setting.MethodsThis ongoing Phase III randomised controlled trial, conducted at a state hospital in Johannesburg, South Africa, was registered with the appropriate ethics committee. After signing an informed consent, participants with FIGO stages IIB to IIIB squamous cell carcinoma of the cervix were randomised to receive chemoradiotherapy with/without mEHT using a secure online random-sampling tool (stratum: HIV status) accounting for age and stage. Reporting physicians were blind to treatment allocation. HIV-positive participants on antiretroviral treatment, or with a CD4 count >200cell/mu L were included. mEHT was administered 2/weekly immediately before external beam radiation. The primary end point is local disease control (LDC) and secondary endpoints are toxicity; quality of life analysis; and two year survival. We report on six month LDC, including nodes visualised in the radiation field on F-18-FDG PET/CT (censored for six month survival), and six month local disease free survival (LDFS) (based on intention to treat). Trial status: Recruitment closed (ClinicalTrials. gov: NCT03332069).Results271 participants were recruited between January 2014 and November 2017, of which 210 were randomised for trial and 202 were available for analysis at six months post-treatment (mEHT: n = 101; Control: n = 101). Six month LDFS was higher in the mEHT Group (n = 39 [38.6%]), than in the Control Group (n = 20[19.8%]); p = 0.003). LDC was also higher in the mEHT Group (n = 40[45.5%]) than the Control Group (n = 20[24.1%]); (p = 0.003).ConclusionOur results show that mEHT is effective as a chemo-radiosensitiser for cervical cancer, even in high risk a patients and resource-constrained settings.