Adjuvant chemotherapy in curatively resected rectal cancer: How valid are the data?

• 作者: Doris Henne-Bruns Fabius Hapke Giulia Manzini Ian N Hines Michael Kremer
• 来源期刊: 世界胃肠肿瘤学杂志:英文版(电子版)
• 学科: 医学
• 关键词: RECTAL cancer Validity Meta-analysis CONSORT CHECKLIST POSTOPERATIVE CHEMOTHERAPY Overall survival
• 年，卷（期）: 2020,（4）
• 页码范围: 503-513
• 页数: 11页
• 分类号: R735.37

摘要

BACKGROUND According to the result of the Cochrane review published in 2012,postoperative adjuvant chemotherapy(CTx)is associated with a survival benefit for rectal cancer patients operated for cure in comparison to patients who underwent only the surgical resection.AIM To analyze the quality of the data supporting the advantage of adjuvant CTx after surgery for rectal cancer.In the times of increasing health care costs,it is imperative to offer the patient an evidence-based therapy that justifies potential side effects as well as costs.METHODS Overall survival was selected as endpoint of interest.Among the 21 included papers which analyzed this endpoint,we identified those three publications which have the highest weights to influence the final result.The validity of these papers was analyzed using the CONSORT checklist for randomized controlled trials.We performed a second meta-analysis excluding the three analyzed studies(n=18)in order to assess their impact on the overall result of the original metaanalysis.Finally,we performed a third meta-analysis excluding all studies(n=16)which showed a statistically improved overall survival.RESULTS The detailed analysis of the three most relevant RCTs according to the items of the CONSORT checklist showed several pitfalls.In up to 47%of the items,inappropriate answers were found.Generally,a lack of information regarding therandomization procedure as well as the absence of allocation concealment,blinded set-up,of intention-to-treat analysis and omission of sample size calculation were common problems of the analyzed studies.The exclusion of these three studies from the meta-analysis did not affect the general result of the meta-analysis,still confirming a survival advantage after adjuvant chemotherapy.After exclusion of single studies with a statistically significant outcome improvement,the meta-analysis of the remaining 16 studies again shows a statistically significant result due in part to a large remaining sample size.CONCLUSION The three most powerful publications s