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早期肺癌电视辅助胸腔镜手术与开胸肺叶切除术随机对照试验的长期生存率

Long-term survival from a randomized controlled trial of lobectomy by video-assisted thoracoscopic surgery versus thoracotomy for early-stage lung cancer.

作者信息

Dittberner Finn Amundsen, Bendixen Morten, Licht Peter Bjørn

机构信息

Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.

出版信息

Eur J Cardiothorac Surg. 2025 Jul 1;67(7). doi: 10.1093/ejcts/ezaf017.

DOI:10.1093/ejcts/ezaf017
PMID:39873729
Abstract

OBJECTIVES

We previously did a randomized clinical trial of lobectomy by video-assisted thoracoscopic surgery (VATS) or thoracotomy for early-stage lung cancer and found that patients who underwent VATS had less postoperative pain and better quality of life compared with thoracotomy. VATS has since been regarded the preferred surgical method for early-stage lung cancer. It is assumed that long-term survival is not influenced by surgical approach, but this assumption primarily rests on non-randomized comparative studies. We decided to do a long-term follow-up of patients who entered our previous randomized trial.

METHODS

Between 2008 and 2014, we randomly assigned 206 patients to VATS (n = 103) or anterolateral thoracotomy (n = 103) for proven or suspected early-stage non-small-cell lung cancer (NSCLC). Records from patients with NSCLC on final pathology were identified in the national electronic patient-record system and the Danish Lung Cancer Registry. Overall, disease-free and cancer-specific survival (CSS) were estimated using the Kaplan-Meier method and log-rank test was used to compare the 2 interventions.

RESULTS

A total of 196 patients had NSCLC on final histopathology. Four patients were lost to follow-up and the remaining 192 were included in this follow-up study with 128 events used for overall survival analysis, 100 events for disease-free survival analysis and 79 events for CSS analysis. VATS was used in 99 patients versus 93 by thoracotomy. Median age at time of surgery was 66 years (range 41-85 years). After a median follow-up time of 12.8 years (range 9.9-15.8 years), 33% of patients were alive. Overall, disease-free and CSS were not significantly different between VATS and thoracotomy: overall survival (P = 0.29), disease-free survival (P = 0.17) and CSS (P = 0.31).

CONCLUSIONS

We did not find any statistically significant differences in overall, disease-free or CSS between VATS and thoracotomy. However, larger trials with better power for survival analysis are needed to fully explore if there are differences. Alternatively, differences in survival between thoracotomy and VATS for early-stage NSCLC could be investigated by pooling survival data from 2 similar randomized trials that have since been published.

摘要

目的

我们之前进行了一项关于电视辅助胸腔镜手术(VATS)或开胸手术治疗早期肺癌的随机临床试验,发现与开胸手术相比,接受VATS的患者术后疼痛较轻,生活质量更高。自那以后,VATS被视为早期肺癌的首选手术方法。据推测,手术方式不会影响长期生存率,但这一推测主要基于非随机对照研究。我们决定对之前参与随机试验的患者进行长期随访。

方法

在2008年至2014年期间,我们将206例经证实或疑似早期非小细胞肺癌(NSCLC)的患者随机分为VATS组(n = 103)或前外侧开胸手术组(n = 103)。在国家电子病历系统和丹麦肺癌登记处中识别出NSCLC患者的最终病理记录。总体而言,采用Kaplan-Meier方法估计无病生存率和癌症特异性生存率(CSS),并使用对数秩检验比较两种干预措施。

结果

共有196例患者最终组织病理学诊断为NSCLC。4例患者失访,其余192例纳入本随访研究,其中128例事件用于总生存分析,100例事件用于无病生存分析,79例事件用于CSS分析。99例患者采用VATS,93例采用开胸手术。手术时的中位年龄为66岁(范围41 - 85岁)。中位随访时间为12.8年(范围9.9 - 15.8年)后,33%的患者存活。总体而言,VATS和开胸手术之间的无病生存率和CSS无显著差异:总生存率(P = 0.29)、无病生存率(P = 0.17)和CSS(P = 0.31)。

结论

我们未发现VATS和开胸手术在总生存率、无病生存率或CSS方面存在任何统计学显著差异。然而,需要进行更大规模、具有更好生存分析效能的试验,以充分探究是否存在差异。或者,可以通过汇总此后发表的两项类似随机试验的生存数据,来研究早期NSCLC开胸手术和VATS在生存率上的差异。

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