撤回。局部食管癌单纯放疗与放化疗联合(不放疗)的比较。

WITHDRAWN. Combined chemotherapy and radiotherapy (without surgery) compared with radiotherapy alone in localized carcinoma of the esophagus.

作者信息

Wong Rebecca Ks, Malthaner Richard

机构信息

Department of Radiation Oncology, The Princess Margaret Hospital, 5th Floor, 610 University Avenue, Toronto, Ontario, Canada, M5G 2M9.

出版信息

Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002092. doi: 10.1002/14651858.CD002092.pub3.

Abstract

BACKGROUND

Esophageal carcinoma can be managed primarily with either a surgical or non-surgical radiotherapeutic approach. Combination chemotherapy (CT) and radiotherapy (RT) has been incorporated into clinical practice and applied increasingly, especially in North America.

OBJECTIVES

To evaluate combined CT and RT (CTRT) versus RT alone in patients with localized esophageal carcinoma. Outcomes included overall survival, cause-specific survival, local recurrence, dysphagia relief, quality of life, acute and chronic toxicities.

SEARCH STRATEGY

The Cochrane strategy for identifying randomized trials was combined with relevant MeSH headings. The Cochrane Library, MEDLINE, CancerLIT and EMBASE were last searched in April 2005. References from relevant articles and personal files were included.

SELECTION CRITERIA

Randomized controlled trials in patients with localized esophageal cancer comparing RT alone with combined CTRT were included. Studies comparing non-chemotherapy agents such as pure radiotherapy sensitisers, immunostimulants, planned esophagectomy, were excluded.

DATA COLLECTION AND ANALYSIS

Two reviewers extracted data independently. Trial quality was assessed using the Jadad scale and Detsky checklist. Sensitivity analyses were planned to examine the effect of concomitant versus sequential treatment, study quality, radiotherapy dose, and whether the drug regimen contained cisplatin or 5-fluorouracil were performed.

MAIN RESULTS

Nineteen randomized trials were included, with eleven concomitant and eight sequential RTCT studies. Concomitant RTCT provided significant reduction in mortality with a harms ratio (HR) of 0.73 (95% confidence interval (CI) 0.64 to 0.84). Using an estimated mortality rate for the control group of 62% at year one and 83% at year two, the absolute survival benefit for RTCT was 9% (95% CI 5 to 12%) and 4% (95% CI 3 to 6%]) respectively. There was an absolute reduction of local recurrence rate of 12% (95% CI 3 to 22%), number needed to treat (NNT) of 9, when the local recurrence rate for the RT alone arm was 68%. This was associated with a significant risk of severe and life-threatening toxicities (number needed to harm (NNH)of 6). Sensitivity analyses did not identify any factors that interacted with the results. The results from sequential RTCT studies showed no significant benefit in survival or local control but significant toxicities.

AUTHORS' CONCLUSIONS: Based on the available data, when a non-operative approach is selected then concomitant RTCT is superior to RT alone for patients with localized esophageal cancer but with significant toxicities. In patients who are in good general condition, and the risk benefit has been thoroughly discussed with the patient, concomitant RTCT should be considered for the management of esophageal cancer compared with radiotherapy alone.

摘要

背景

食管癌的主要治疗方法可以是手术或非手术放射治疗。联合化疗(CT)和放疗(RT)已被纳入临床实践并越来越多地应用,尤其是在北美。

目的

评估局部食管癌患者联合CT与RT(CTRT)对比单纯RT的疗效。结局指标包括总生存期、病因特异性生存期、局部复发、吞咽困难缓解情况、生活质量、急性和慢性毒性反应。

检索策略

将Cochrane协作网识别随机试验的策略与相关医学主题词相结合。Cochrane图书馆、MEDLINE、CancerLIT和EMBASE数据库最近一次检索时间为2005年4月。纳入相关文章和个人文件中的参考文献。

选择标准

纳入局部食管癌患者中比较单纯RT与联合CTRT的随机对照试验。排除比较非化疗药物如单纯放疗增敏剂、免疫刺激剂、计划性食管切除术的研究。

数据收集与分析

两名研究者独立提取数据。采用Jadad量表和Detsky清单评估试验质量。计划进行敏感性分析以检验同步治疗与序贯治疗的效果、研究质量、放疗剂量,以及药物方案是否包含顺铂或5-氟尿嘧啶。

主要结果

共纳入19项随机试验,其中11项同步RTCT研究和8项序贯RTCT研究。同步RTCT显著降低死亡率,危害比(HR)为0.73(95%置信区间(CI)0.64至0.84)。以对照组第1年估计死亡率62%和第2年83%计算,RTCT的绝对生存获益分别为9%(95%CI 5至12%)和4%(95%CI 3至6%)。当单纯RT组局部复发率为68%时,局部复发率绝对降低12%(95%CI 3至22%),需治疗人数(NNT)为9。这与严重及危及生命毒性反应的显著风险相关(危害需治疗人数(NNH)为6)。敏感性分析未发现与结果相互作用的任何因素。序贯RTCT研究结果显示在生存或局部控制方面无显著获益,但毒性反应显著。

作者结论

基于现有数据,当选择非手术治疗方法时,同步RTCT对于局部食管癌患者优于单纯RT,但毒性反应显著。对于一般状况良好且已与患者充分讨论风险获益的患者,与单纯放疗相比,同步RTCT应考虑用于食管癌的治疗。

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