Lutgens Ludy, van der Zee Jacoba, Pijls-Johannesma Madelon, De Haas-Kock Danielle Fm, Buijsen Jeroen, Mastrigt Ghislaine Apg van, Lammering Guido, De Ruysscher Dirk K M, Lambin Philippe
Radiation Oncology, Maastro Clinic, Dr. Tanslaan 12, 6229 ET Maastricht, Postbus 5800, Maastricht, Netherlands, 6202 AZ.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD006377. doi: 10.1002/14651858.CD006377.pub2.
Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures to damage and kill cancer cells. It was introduced into clinical oncology practice several decades ago. Positive clinical results, mostly obtained in single institutions, resulted in clinical implementation albeit in a limited number of cancer centres worldwide. Because large scale randomised clinical trials (RCTs) are lacking, firm conclusions cannot be drawn regarding its definitive role as an adjunct to radiotherapy in the treatment of locally advanced cervical carcinoma (LACC).
To assess whether adding hyperthermia to standard radiotherapy for LACC has an impact on (1) local tumour control, (2) survival and (3) treatment related morbidity.
The electronic databases of the Cochrane Central Register of Controlled Trials (CENTRAL), (Issue 1, 2009) and Cochrane Gynaecological Cancer Groups Specialised Register, MEDLINE, EMBASE, online databases for trial registration, handsearching of journals and conference abstracts, reviews, reference lists, and contacts with experts were used to identify potentially eligible trials, published and unpublished until January 2009.
RCTs comparing radiotherapy alone (RT) versus combined hyperthermia and radiotherapy (RHT) in patients with LACC.
Between 1987 and 2009 the results of six RCTs were published, these were used for the current analysis.
74% of patients had FIGO stage IIIB LACC. Treatment outcome was significantly better for patients receiving the combined treatment (Figures 1 to 3). The pooled data analysis yielded a significantly higher complete response rate (relative risk (RR) 0.56; 95% confidence interval (CI) 0.39 to 0.79; p < 0.001), a significantly reduced local recurrence rate at 3 years (hazard ratio (HR) 0.48; 95% CI 0.37 to 0.63; p < 0.001) and a significanly better overall survival (OS) at three years following the combined treatment with RHT(HR 0.67; 95% CI 0.45 to 0.99; p = 0.05). No significant difference was observed in treatment related acute (RR 0.99; 95% CI 0.30 to 3.31; p = 0.99) or late grade 3 to 4 toxicity (RR 1.01; CI 95% 0.44 to 2.30; p = 0.96) between both treatments.
AUTHORS' CONCLUSIONS: The limited number of patients available for analysis, methodological flaws and a significant over-representation of patients with FIGO stage IIIB prohibit drawing definite conclusions regarding the impact of adding hyperthermia to standard radiotherapy. However, available data do suggest that the addition of hyperthermia improves local tumour control and overall survival in patients with locally advanced cervical carcinoma without affecting treatment related grade 3 to 4 acute or late toxicity.
热疗是一种癌症治疗方法,通过将身体组织暴露于高温来损伤和杀死癌细胞。几十年前它被引入临床肿瘤学实践。尽管大多是在单一机构取得了积极的临床结果,但这使得热疗得以在全球范围内数量有限的癌症中心实施。由于缺乏大规模随机临床试验(RCT),关于热疗作为局部晚期宫颈癌(LACC)放疗辅助手段的确切作用,无法得出确凿结论。
评估在LACC的标准放疗中加入热疗是否对(1)局部肿瘤控制、(2)生存率和(3)治疗相关发病率有影响。
使用Cochrane对照试验中央注册库(CENTRAL,2009年第1期)、Cochrane妇科癌症组专业注册库、MEDLINE、EMBASE的电子数据库、试验注册在线数据库、期刊和会议摘要手工检索、综述、参考文献列表,并与专家联系,以识别截至2009年1月已发表和未发表的潜在合格试验。
比较LACC患者单纯放疗(RT)与热疗联合放疗(RHT)的RCT。
1987年至2009年间发表了6项RCT的结果,用于当前分析。
74%的患者为国际妇产科联盟(FIGO)IIIB期LACC。接受联合治疗的患者治疗结果明显更好(图1至3)。汇总数据分析得出,联合治疗组的完全缓解率显著更高(相对危险度(RR)0.56;95%置信区间(CI)0.39至0.79;p<0.001),3年局部复发率显著降低(风险比(HR)0.48;95%CI 0.37至0.63;p<0.001),且RHT联合治疗后3年总生存率显著更好(HR 0.67;95%CI 0.45至0.99;p = 0.05)。两种治疗在治疗相关急性毒性(RR 0.99;95%CI 0.30至3.31;p = 0.99)或3至4级晚期毒性(RR 1.01;95%CI 0.44至2.30;p = 0.96)方面未观察到显著差异。
可供分析的患者数量有限、方法学缺陷以及FIGO IIIB期患者比例过高,使得无法就标准放疗中加入热疗的影响得出明确结论。然而,现有数据确实表明,加入热疗可改善局部晚期宫颈癌患者的局部肿瘤控制和总生存率,且不影响3至4级治疗相关急性或晚期毒性。