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非转移性结直肠癌患者的随访策略

Follow-up strategies for patients treated for non-metastatic colorectal cancer.

作者信息

Jeffery Mark, Hickey Brigid E, Hider Phillip N

机构信息

Canterbury Regional Cancer and Haematology Service, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand, 8140.

出版信息

Cochrane Database Syst Rev. 2019 Sep 4;9(9):CD002200. doi: 10.1002/14651858.CD002200.pub4.

Abstract

BACKGROUND

This is the fourth update of a Cochrane Review first published in 2002 and last updated in 2016.It is common clinical practice to follow patients with colorectal cancer for several years following their curative surgery or adjuvant therapy, or both. Despite this widespread practice, there is considerable controversy about how often patients should be seen, what tests should be performed, and whether these varying strategies have any significant impact on patient outcomes.

OBJECTIVES

To assess the effect of follow-up programmes (follow-up versus no follow-up, follow-up strategies of varying intensity, and follow-up in different healthcare settings) on overall survival for patients with colorectal cancer treated with curative intent. Secondary objectives are to assess relapse-free survival, salvage surgery, interval recurrences, quality of life, and the harms and costs of surveillance and investigations.

SEARCH METHODS

For this update, on 5 April 2109 we searched CENTRAL, MEDLINE, Embase, CINAHL, and Science Citation Index. We also searched reference lists of articles, and handsearched the Proceedings of the American Society for Radiation Oncology. In addition, we searched the following trials registries: ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We contacted study authors. We applied no language or publication restrictions to the search strategies.

SELECTION CRITERIA

We included only randomised controlled trials comparing different follow-up strategies for participants with non-metastatic colorectal cancer treated with curative intent.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane. Two review authors independently determined study eligibility, performed data extraction, and assessed risk of bias and methodological quality. We used GRADE to assess evidence quality.

MAIN RESULTS

We identified 19 studies, which enrolled 13,216 participants (we included four new studies in this second update). Sixteen out of the 19 studies were eligible for quantitative synthesis. Although the studies varied in setting (general practitioner (GP)-led, nurse-led, or surgeon-led) and 'intensity' of follow-up, there was very little inconsistency in the results.Overall survival: we found intensive follow-up made little or no difference (hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.80 to 1.04: I² = 18%; high-quality evidence). There were 1453 deaths among 12,528 participants in 15 studies. In absolute terms, the average effect of intensive follow-up on overall survival was 24 fewer deaths per 1000 patients, but the true effect could lie between 60 fewer to 9 more per 1000 patients.Colorectal cancer-specific survival: we found intensive follow-up probably made little or no difference (HR 0.93, 95% CI 0.81 to 1.07: I² = 0%; moderate-quality evidence). There were 925 colorectal cancer deaths among 11,771 participants enrolled in 11 studies. In absolute terms, the average effect of intensive follow-up on colorectal cancer-specific survival was 15 fewer colorectal cancer-specific survival deaths per 1000 patients, but the true effect could lie between 47 fewer to 12 more per 1000 patients.Relapse-free survival: we found intensive follow-up made little or no difference (HR 1.05, 95% CI 0.92 to 1.21; I² = 41%; high-quality evidence). There were 2254 relapses among 8047 participants enrolled in 16 studies. The average effect of intensive follow-up on relapse-free survival was 17 more relapses per 1000 patients, but the true effect could lie between 30 fewer and 66 more per 1000 patients.Salvage surgery with curative intent: this was more frequent with intensive follow-up (risk ratio (RR) 1.98, 95% CI 1.53 to 2.56; I² = 31%; high-quality evidence). There were 457 episodes of salvage surgery in 5157 participants enrolled in 13 studies. In absolute terms, the effect of intensive follow-up on salvage surgery was 60 more episodes of salvage surgery per 1000 patients, but the true effect could lie between 33 to 96 more episodes per 1000 patients.Interval (symptomatic) recurrences: these were less frequent with intensive follow-up (RR 0.59, 95% CI 0.41 to 0.86; I² = 66%; moderate-quality evidence). There were 376 interval recurrences reported in 3933 participants enrolled in seven studies. Intensive follow-up was associated with fewer interval recurrences (52 fewer per 1000 patients); the true effect is between 18 and 75 fewer per 1000 patients.Intensive follow-up probably makes little or no difference to quality of life, anxiety, or depression (reported in 7 studies; moderate-quality evidence). The data were not available in a form that allowed analysis.Intensive follow-up may increase the complications (perforation or haemorrhage) from colonoscopies (OR 7.30, 95% CI 0.75 to 70.69; 1 study, 326 participants; very low-quality evidence). Two studies reported seven colonoscopic complications in 2292 colonoscopies, three perforations and four gastrointestinal haemorrhages requiring transfusion. We could not combine the data, as they were not reported by study arm in one study.The limited data on costs suggests that the cost of more intensive follow-up may be increased in comparison with less intense follow-up (low-quality evidence). The data were not available in a form that allowed analysis.

AUTHORS' CONCLUSIONS: The results of our review suggest that there is no overall survival benefit for intensifying the follow-up of patients after curative surgery for colorectal cancer. Although more participants were treated with salvage surgery with curative intent in the intensive follow-up groups, this was not associated with improved survival. Harms related to intensive follow-up and salvage therapy were not well reported.

摘要

背景

这是一篇Cochrane系统评价的第四次更新,该评价首次发表于2002年,上一次更新是在2016年。对接受根治性手术或辅助治疗或两者兼有的结直肠癌患者进行数年随访是常见的临床实践。尽管这种做法很普遍,但对于患者应多久接受一次检查、应进行哪些检查以及这些不同的策略是否对患者预后有任何重大影响,仍存在相当大的争议。

目的

评估随访计划(随访与不随访、不同强度的随访策略以及在不同医疗环境中的随访)对接受根治性治疗的结直肠癌患者总生存的影响。次要目的是评估无复发生存率、挽救性手术、间期复发、生活质量以及监测和检查的危害及成本。

检索方法

本次更新中,我们于2019年4月5日检索了Cochrane中心对照试验注册库(CENTRAL)、MEDLINE、Embase、护理学与健康领域数据库(CINAHL)以及科学引文索引。我们还检索了文章的参考文献列表,并手工检索了美国放射肿瘤学会会议论文集。此外,我们检索了以下试验注册库:美国国立医学图书馆临床试验数据库(ClinicalTrials.gov)和世界卫生组织国际临床试验注册平台。我们联系了研究作者。我们对检索策略未设置语言或发表限制。

入选标准

我们仅纳入了比较不同随访策略的随机对照试验,这些试验的参与者为接受根治性治疗的非转移性结直肠癌患者。

数据收集与分析

我们采用了Cochrane期望的标准方法程序。两位综述作者独立确定研究的纳入资格、进行数据提取,并评估偏倚风险和方法学质量。我们使用GRADE评估证据质量。

主要结果

我们共识别出19项研究,纳入了13216名参与者(本次第二次更新纳入了4项新研究)。19项研究中有16项符合定量合成的条件。尽管这些研究在随访的设置(由全科医生、护士或外科医生主导)和“强度”方面存在差异,但结果的不一致性很小。

总生存

我们发现强化随访几乎没有差异(风险比(HR)0.91,95%置信区间(CI)0.80至1.04:I² = 18%;高质量证据)。15项研究中的12528名参与者中有1453人死亡。从绝对数值来看,强化随访对总生存的平均影响是每千名患者死亡人数减少24例,但真实影响可能在每千名患者减少60例至增加9例之间。

结直肠癌特异性生存

我们发现强化随访可能几乎没有差异(HR 0.93,95% CI 0.81至1.07:I² = 0%;中等质量证据)。11项研究中的11771名参与者中有925人死于结直肠癌。从绝对数值来看,强化随访对结直肠癌特异性生存的平均影响是每千名患者结直肠癌特异性生存死亡人数减少15例,但真实影响可能在每千名患者减少47例至增加12例之间。

无复发生存

我们发现强化随访几乎没有差异(HR 1.05,95% CI 0.92至1.21;I² = 41%;高质量证据)。16项研究中的8047名参与者中有2254例复发。强化随访对无复发生存的平均影响是每千名患者复发人数增加17例,但真实影响可能在每千名患者减少30例至增加66例之间。

根治性挽救性手术

强化随访时更为常见(风险比(RR)1.98,95% CI 1.53至2.56;I² = 31%;高质量证据)。13项研究中的5157名参与者中有457例进行了挽救性手术。从绝对数值来看,强化随访对挽救性手术的影响是每千名患者挽救性手术增加60例,但真实影响可能在每千名患者增加33例至96例之间。

间期(有症状)复发:强化随访时较少见(RR 0.59,95% CI 0.41至0.86;I² = 66%;中等质量证据)。7项研究中的3933名参与者报告了376例间期复发。强化随访与间期复发减少相关(每千名患者减少52例);真实影响在每千名患者减少18例至75例之间。

强化随访可能对生活质量、焦虑或抑郁几乎没有影响(7项研究报告;中等质量证据)。数据无法以可分析的形式获取。

强化随访可能会增加结肠镜检查的并发症(穿孔或出血)(比值比(OR)为7.30,95% CI 0.75至70.69;1项研究,326名参与者;极低质量证据)。两项研究报告在2292次结肠镜检查中有7例并发症,3例穿孔和4例需要输血治疗的胃肠道出血。由于一项研究未按研究组报告数据,我们无法合并这些数据。

关于成本的有限数据表明,与较少强化的随访相比,强化随访的成本可能会增加(低质量证据)。数据无法以可分析的形式获取。

作者结论

我们的综述结果表明,结直肠癌根治性手术后强化患者随访对总生存没有益处。尽管强化随访组中有更多参与者接受了根治性挽救性手术,但这与生存改善无关。与强化随访和挽救性治疗相关的危害报告不足。

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