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非转移性结直肠癌患者辅助化疗的疗程

Duration of adjuvant chemotherapy for patients with non-metastatic colorectal cancer.

作者信息

Des Guetz Gaëtan, Uzzan Bernard, Morere Jean-Francois, Perret Gerard, Nicolas Patrick

机构信息

Oncology, Hospital Avicenne, 125 Rue de Stalingrad, Bobigny, France, 93009.

出版信息

Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD007046. doi: 10.1002/14651858.CD007046.pub2.


DOI:10.1002/14651858.CD007046.pub2
PMID:20091614
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10632948/
Abstract

BACKGROUND: Surgery of primary tumour is the backbone of colorectal cancer treatment (CRC). But in stage III cancer, metastatic or local relapse is often observed (50%). So, adjuvant treatment is always considered in this setting. The best treatment duration of hypothetic disease is not easy to define. Adjuvant chemotherapy for CRC actually lasts 6 months. The choice of optimal duration is based upon old studies using 5-fluorouracil (5FU). During the last ten years, results of major randomized controlled studies (RCTs) comparing different durations of treatments and different schedules in adjuvant setting were published. Several studies compared a 6-month chemotherapy with a longer treatment. Conversely, a single study by Chau et al compared a 6 month chemotherapy with continuous treatment lasting 3 months. But the optimal duration of these chemotherapies could be challenged. Even though the optimal duration of chemotherapy in CRC is a major issue, it has never been answered adequately. OBJECTIVES: To evaluate the optimal duration of adjuvant treatment, we performed a meta-analysis of all RCTs comparing two durations of adjuvant treatment, 6 months versus 9 to 12 months. SEARCH STRATEGY: Publications were identified from PubMed (February 28th, 2009), Embase, and the Cochrane Database of Clinical Controlled Trials (CENTRAL) in the Cochrane Library 2009 issue 1. Reviews and books were also scrutinized. Abstracts were reviewed from ASCO annual meetings proceedings from 1998 to 2009. SELECTION CRITERIA: Patients with surgically resected colorectal cancer with high risk of recurrence. DATA COLLECTION AND ANALYSIS: Several RCTs compared shorter versus longer durations of chemotherapy, 6 studies for overall survival (OS) and 7 studies for relapse free survival (RFS), for a total of 10326 patients, mean age 63.1 years, including 9826 colon and 500 rectum cancers. MAIN RESULTS: Treatments were always based on 5-FU. Two studies were excluded, an epidemiological study and a study comparing continuous treatment during 3 months with conventional chemotherapy during 6 months. The later because it compared 2 durations less than or equal to 6 months. Shorter duration of chemotherapy (3-6 months) compared with longer duration (9-12 months) was not associated to poorer RFS (RR =0.96, 95% CI : 0.90-1.02) and OS (RR = 0.96 ; 95% CI : 0.91-1.02). AUTHORS' CONCLUSIONS: The present meta-analysis confirmed that adjuvant chemotherapy of CRC should not last for more than 6 months. Prolonged duration would result in lower benefit to risk ratio. However, the results do not make it possible to favour either 3 or 6 month durations. They should help design a future RCT comparing different durations of continuous treatment.

摘要

背景:原发性肿瘤手术是结直肠癌(CRC)治疗的核心。但在III期癌症中,常观察到转移或局部复发(50%)。因此,在此情况下总是考虑辅助治疗。假设疾病的最佳治疗持续时间不易确定。CRC的辅助化疗实际持续6个月。最佳持续时间的选择基于使用5-氟尿嘧啶(5FU)的旧研究。在过去十年中,发表了主要的随机对照研究(RCT)结果,比较了辅助治疗中不同持续时间和不同方案。几项研究将6个月化疗与更长疗程的治疗进行了比较。相反,Chau等人的一项单一研究将6个月化疗与持续3个月的连续治疗进行了比较。但这些化疗的最佳持续时间可能受到质疑。尽管CRC化疗的最佳持续时间是一个主要问题,但从未得到充分解答。 目的:为评估辅助治疗的最佳持续时间,我们对所有比较两种辅助治疗持续时间(6个月与9至12个月)的RCT进行了荟萃分析。 检索策略:从PubMed(2009年2月28日)、Embase和Cochrane图书馆2009年第1期的Cochrane临床对照试验数据库(CENTRAL)中识别出版物。还仔细审查了综述和书籍。审查了1998年至2009年美国临床肿瘤学会年会会议记录的摘要。 选择标准:手术切除的结直肠癌且复发风险高的患者。 数据收集与分析:几项RCT比较了化疗持续时间较短与较长的情况,6项研究涉及总生存期(OS),7项研究涉及无复发生存期(RFS),共10326例患者,平均年龄63.1岁,包括9826例结肠癌和500例直肠癌。 主要结果:治疗始终基于5-FU。两项研究被排除,一项流行病学研究和一项比较3个月连续治疗与6个月传统化疗的研究。后者是因为它比较的两个持续时间均小于或等于6个月。与较长疗程(9至12个月)相比,较短疗程(3至6个月)的化疗与较差的RFS(RR = 0.96,95%CI:0.90 - 1.02)和OS(RR = 0.96;95%CI:0.91 - 1.02)无关。 作者结论:本荟萃分析证实,CRC的辅助化疗不应持续超过6个月。延长疗程会导致效益风险比降低。然而,结果无法支持3个月或6个月的疗程。它们应有助于设计未来比较不同持续时间连续治疗的RCT。

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