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结直肠癌肝转移切除术后单药辅助化疗:随机试验的荟萃分析

Postoperative chemotherapy with single-agent after resection of colorectal cancer liver metastases: a meta-analysis of randomised trials.

作者信息

Mauri Davide, Zarkavelis George, Filis Panagiotis, Tsali Lampriani, Zafeiri Georgia, Papadaki Alexandra, Vassou Amalia, Georgopoulos Christos, Pentheroudakis George

机构信息

Department of Medical Oncology, Medical School, University of Ioannina, Ioannina, Greece.

Society for Study of Clonal Heterogeneity of Neoplasia (EMEKEN).

出版信息

ESMO Open. 2018 Jun 23;3(4):e000343. doi: 10.1136/esmoopen-2018-000343. eCollection 2018.

DOI:10.1136/esmoopen-2018-000343
PMID:30018809
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6045754/
Abstract

UNLABELLED

Surgical resection is the only option of cure for patients with metastatic colorectal cancer. Risk of recurrence after metastasectomy is around 75%. Use of adjuvant chemotherapy after metastasectomy is controversial.

AIM

To address whether adjuvant systemic therapy after colorectal cancer metastasectomy offers any survival benefit compared with surgery alone.

METHODS

Systematic review of literature and meta-analysis of all available randomised evidence. Relative hazards (RHs) were summarised across trials and heterogeneity was assessed with the Q and I2 statistics.

RESULTS

Five trials were eligible. Three trials, all using single-agent fluoropyrimidine chemotherapy, presented data valuable for analyses. 482 patients were included in the meta-analysis: 238 randomly assigned to receive postoperative chemotherapy and 244 to metastasectomy only. We found no overall survival (OS) benefit with the use of postoperative single-agent fluoropyrimidines compared with surgery alone, even if a trend for benefit was observed (relative hazard (RH)=0.781, 95% CI 0.593 to 1.030, p=0.080). Significant disease-free survival benefit with the use of postoperative chemotherapy was observed (RH=0.645, 95% CI 0.509 to 0.818, p=0.001). No quality of life (QL) data were available. All trials showed accrual delay, two stopped and one recruiting after 10 years. Long follow-up needs were evidenced since OS curves split only after 3.5 years.

CONCLUSIONS

No OS benefit was documented from the use of postoperative monochemotherapy. Metastasectomy alone continues to be the standard of care. Combination chemotherapy regimens should be evaluated along with QL assessment in future trials appropriately designed for long-term accrual and follow-up.

摘要

未标注

手术切除是转移性结直肠癌患者唯一的治愈选择。转移灶切除术后复发风险约为75%。转移灶切除术后辅助化疗的应用存在争议。

目的

探讨结直肠癌转移灶切除术后辅助全身治疗与单纯手术相比是否能带来生存获益。

方法

对文献进行系统回顾并对所有可用的随机证据进行荟萃分析。汇总各试验的相对风险(RHs),并用Q和I²统计量评估异质性。

结果

五项试验符合条件。三项试验均使用单药氟嘧啶化疗,提供了有价值的分析数据。荟萃分析纳入482例患者:238例随机分配接受术后化疗,244例仅接受转移灶切除术。我们发现,与单纯手术相比,术后使用单药氟嘧啶并无总体生存(OS)获益,尽管观察到有获益趋势(相对风险(RH)=0.781,95%置信区间0.593至1.030,p=0.080)。观察到术后化疗有显著的无病生存获益(RH=0.645,95%置信区间0.509至0.818,p=0.001)。无生活质量(QL)数据。所有试验均显示入组延迟,两项试验停止,一项试验在10年后仍在招募。由于OS曲线仅在3.5年后才分开,因此证明需要长期随访。

结论

术后单药化疗未显示出OS获益。单纯转移灶切除术仍是治疗标准。在未来为长期入组和随访而适当设计的试验中,应评估联合化疗方案并进行QL评估。

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