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撤回:新辅助化疗与不进行新辅助化疗治疗可切除胃癌的对比

WITHDRAWN: Neoadjuvant chemotherapy versus none for resectable gastric cancer.

作者信息

Wu A W, Xu G W, Wang H Y, Ji J F, Tang J L

机构信息

Peking University, Surgical Oncology, Fucheng Road, No.52, Haidian District, Beijing, China, 100036.

出版信息

Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005047. doi: 10.1002/14651858.CD005047.pub3.

Abstract

BACKGROUND

Gastric cancer is a major cause of cancer death, and many patients are only diagnosed when the cancer has reached an advanced stage. Neoadjuvant chemotherapy (NAC), that is, chemotherapy administered shortly before surgical treatment, could provide a method of increasing the possibility of complete resection and survival.

OBJECTIVES

To evaluate the effect of neoadjuvant chemotherapy versus none for patients with resectable gastric cancer in terms of efficacy and toxicity.

SEARCH STRATEGY

Electronic databases including Cochrane Library, MEDLINE, EMBASE, CancerLit, Chinese Biomedical Literature Database (CBMDISC) and ongoing clinical trials as well as handsearching of conference proceedings, were searched to retrieve relevant data.

SELECTION CRITERIA

Randomized controlled clinical trials of neoadjuvant chemotherapy on resectable gastric cancer.

DATA COLLECTION AND ANALYSIS

We identified a total of 36 published citations or meeting abstracts. Thirty-two items were excluded. Of the four remaining studies, three stated random allocation but the method of randomization was unclear. Two of these employed allocation concealment by sealed envelope which was controlled by an independent party. None of the trials was double blind. All trials presented a detailed description of the number of withdrawals, dropouts and losses to follow-up.

MAIN RESULTS

Of the four clinical trials enrolled, there were 250 and 332 cases in total, with 106 and 126 deaths at the end of follow-up in the NAC and control group, respectively. The OR (odds ratio) was 1.05 (95%CI: 0.73-1.50), which was not statistically significant. Of the evaluable 129 patients receiving NAC, 28.7% demonstrated either a complete or a partial response. Two studies of NAC in resectable gastric cancer had resection rate data available for analysis The R0 resection rate in the NAC group was comparable to that in the control (OR: 0.96 (95%CI: 0.51-1.83)). The morbidity and mortality of NAC varied with the regimens used preoperatively. Of the 129 patients included in the analyzed studies, some acceptable toxicity was observed.

AUTHORS' CONCLUSIONS: There is no definite evidence of the effectiveness of NAC in resectable gastric cancer, in terms of improvements in patient survival, in the trials we reviewed. Neoadjuvant chemotherapy should not be used routinely in clinical setting until further results from randomized clinical are available. Neoadjuvant chemotherapy of gastric cancer should be applied under the framework of clinical trials.

摘要

背景

胃癌是癌症死亡的主要原因之一,许多患者在癌症发展到晚期时才被诊断出来。新辅助化疗,即在手术治疗前不久进行的化疗,可能提供一种提高完全切除率和生存率的方法。

目的

评估新辅助化疗与不进行化疗相比,对可切除胃癌患者的疗效和毒性。

检索策略

检索电子数据库,包括Cochrane图书馆、MEDLINE、EMBASE、CancerLit、中国生物医学文献数据库(CBMDISC)以及正在进行的临床试验,并手工检索会议论文集,以获取相关数据。

选择标准

关于可切除胃癌新辅助化疗的随机对照临床试验。

数据收集与分析

我们共识别出36篇已发表的文献或会议摘要。排除了32项。在其余四项研究中,三项表明采用随机分配,但随机化方法不明确。其中两项采用独立第三方控制的密封信封进行分配隐藏。所有试验均非双盲。所有试验都详细描述了退出、失访和随访丢失的人数。

主要结果

在纳入的四项临床试验中,共有250例和332例患者,新辅助化疗组和对照组在随访结束时分别有106例和126例死亡。比值比(OR)为1.05(95%可信区间:0.73 - 1.50),无统计学意义。在接受新辅助化疗的129例可评估患者中,28.7%表现出完全或部分缓解。两项关于可切除胃癌新辅助化疗的研究有可用于分析的切除率数据。新辅助化疗组的R0切除率与对照组相当(OR:0.96(95%可信区间:0.51 - 1.83))。新辅助化疗的发病率和死亡率因术前使用的方案而异。在所分析研究纳入的129例患者中,观察到了一些可接受的毒性反应。

作者结论

在我们所回顾的试验中,就改善患者生存而言,没有确凿证据表明新辅助化疗对可切除胃癌有效。在获得随机临床试验的进一步结果之前,新辅助化疗不应在临床中常规使用。胃癌的新辅助化疗应在临床试验框架下应用。

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