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术后房颤对胸段食管癌患者食管癌切除术后的总生存期无影响:一项随机、双盲、安慰剂对照试验的结果

Postoperative atrial fibrillation does not impact on overall survival after esophagectomy in patients with thoracic esophageal cancer: results from a randomized, double-blind, placebo-controlled trial.

作者信息

Ojima Toshiyasu, Nakamura Masaki, Hayata Keiji, Kitadani Junya, Katsuda Masahiro, Nakamori Mikihito, Takeuchi Akihiro, Maruoka Shimpei, Fukuda Naoki, Tominaga Shinta, Motobayashi Hideki, Yamaue Hiroki

机构信息

Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.

出版信息

Oncotarget. 2020 Jun 23;11(25):2414-2423. doi: 10.18632/oncotarget.27643.

Abstract

BACKGROUND

Administration of landiolol hydrochloride was found to be associated with reduced incidence of atrial fibrillation (AF) after esophagectomy for esophageal cancer in our previous randomized controlled trial (RCT). In addition, reduced incidence of AF was associated with reduction of other complications. Meanwhile, the effects of postoperative AF and other complications on long-term survival following esophagectomy are not well understood.

MATERIALS AND METHODS

Between March 2014 and January 2016, 100 patients with esophageal cancer were registered in an RCT trial and randomly allocated to receive either administration of landiolol or a placebo. We analyzed data from this RCT to better understand the effect of postoperative AF and severe associated complications on overall survival (OS) after esophagectomy for cancer. We also examined whether prophylactic administration of landiolol hydrochloride directly affects prolonged survival in patients with esophageal cancer.

RESULTS

The five-year rates of OS in the patients with and without AF were 60%, and 68.6%, respectively, there was no significant difference ( = 0.328). Five-year rates of OS of the patients with and without severe complications were 64.6%, and 67.5%, respectively ( = 0.995). The five-year rates of OS in the placebo and landiolol groups were 65.8% and 68%, respectively ( = 0.809). In multivariate analysis, high stage (stage III/IV) alone was an independent prognostic factor for esophageal cancer patients following esophagectomy.

CONCLUSIONS

New-onset AF and the other severe complications were not associated with poorer long-term survival following esophagectomy. In addition, administration of landiolol hydrochloride after esophagectomy did not contribute to prolonging the OS.

摘要

背景

在我们之前的一项随机对照试验(RCT)中,发现盐酸兰地洛尔的应用与食管癌食管切除术后房颤(AF)发生率降低相关。此外,房颤发生率降低与其他并发症的减少相关。同时,术后房颤和其他并发症对食管切除术后长期生存的影响尚不清楚。

材料与方法

2014年3月至2016年1月期间,100例食管癌患者登记参加一项RCT试验,并随机分配接受兰地洛尔或安慰剂治疗。我们分析了该RCT的数据,以更好地了解术后房颤和严重相关并发症对癌症食管切除术后总生存(OS)的影响。我们还研究了预防性应用盐酸兰地洛尔是否直接影响食管癌患者的生存期延长。

结果

有房颤和无房颤患者的5年总生存率分别为60%和68.6%,差异无统计学意义(P = 0.328)。有严重并发症和无严重并发症患者的5年总生存率分别为64.6%和67.5%(P = 0.995)。安慰剂组和兰地洛尔组的5年总生存率分别为65.8%和68%(P = 0.809)。多因素分析显示,仅高分期(III/IV期)是食管癌患者食管切除术后的独立预后因素。

结论

新发房颤和其他严重并发症与食管切除术后较差的长期生存无关。此外,食管切除术后应用盐酸兰地洛尔无助于延长总生存期。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b78/7321699/a13f78023098/oncotarget-11-2414-g001.jpg

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