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结直肠癌肺转移切除术:93 例随机对照患者的更新分析-对照生存率比之前预期的要好得多。

Pulmonary Metastasectomy in Colorectal Cancer: updated analysis of 93 randomized patients - control survival is much better than previously assumed.

机构信息

Institute for Lung Diseases of Vojvodina, Thoracic Surgery Clinic, Sremska Kamenica, Serbia.

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

出版信息

Colorectal Dis. 2020 Oct;22(10):1314-1324. doi: 10.1111/codi.15113. Epub 2020 Jun 14.

Abstract

AIM

Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the 5-year survival of these patients would be near zero without metastasectomy. We tested the clinical effectiveness of this practice in Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC), a randomized, controlled noninferiority trial.

METHOD

Multidisciplinary teams in 14 hospitals recruited patients with resectable lung metastases into a two-arm trial. Randomization was remote and stratified according to site, with minimization for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, number of metastases and carcinoembryonic antigen level. The trial management group was blind to patient allocation until after intention-to-treat analysis.

RESULTS

From 2010 to 2016, 93 participants were randomized. These patients were 35-86 years of age and had between one and six lung metastases at a median of 2.7 years after colorectal cancer resection; 29% had prior liver metastasectomy. The patient groups were well matched and the characteristics of these groups were similar to those of observational studies. The median survival after metastasectomy was 3.5 (95% CI: 3.1-6.6) years compared with 3.8 (95% CI: 3.1-4.6) years for controls. The estimated unadjusted hazard ratio for death within 5 years, comparing the metastasectomy group with the control group, was 0.93 (95% CI: 0.56-1.56). Use of chemotherapy or local ablation was infrequent and similar in each group.

CONCLUSION

Patients in the control group (who did not undergo lung metastasectomy) have better survival than is assumed. Survival in the metastasectomy group is comparable with the many single-arm follow-up studies. The groups were well matched with features similar to those reported in case series.

摘要

目的

在选定的患者中切除结直肠癌肺转移灶,因为人们认为这能显著提高生存优势。一般认为,如果不进行转移灶切除术,这些患者的 5 年生存率几乎为零。我们在一项名为“结直肠癌肺转移切除术(PulMiCC)”的随机、对照非劣效性试验中检验了这种做法的临床效果。

方法

14 家医院的多学科团队将可切除肺转移灶的患者纳入一项双臂试验。采用远程随机化,根据部位进行分层,同时最小化年龄、性别、原发癌分期、原发切除术后时间间隔、肝转移既往史、转移灶数量和癌胚抗原水平等因素。直到意向治疗分析后,试验管理小组才对患者分组情况进行盲法处理。

结果

2010 年至 2016 年,共有 93 名患者参与了随机分组。这些患者年龄在 35-86 岁之间,在结直肠癌切除后中位时间 2.7 年内存在 1-6 个肺转移灶;29%的患者曾行肝转移灶切除术。两组患者匹配良好,且这些组的特征与观察性研究相似。转移灶切除术组的中位生存时间为 3.5 年(95%CI:3.1-6.6 年),对照组为 3.8 年(95%CI:3.1-4.6 年)。在未经调整的情况下,5 年内死亡风险的估计比值比(hazard ratio,HR),比较转移灶切除术组和对照组,为 0.93(95%CI:0.56-1.56)。两组患者化疗或局部消融治疗的应用均较少,且组间相似。

结论

与假设不同,对照组(未行肺转移灶切除术)患者的生存情况更好。转移灶切除术组的生存情况与许多单臂随访研究结果相似。两组患者匹配良好,且特征与病例系列报告相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/322b/8425329/87f8bdd06d48/CODI-22-1314-g002.jpg

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