Video-Assisted Thoracoscopic or Open Lobectomy in Early-Stage Lung Cancer.
Video-Assisted Thoracoscopic or Open Lobectomy in Early-Stage Lung Cancer.
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DOI：
10.1056/evidoa2100016
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发表时间：
2022-03-01
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影响因子：
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通讯作者：
Rogers, Chris A
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作者：
Lim, Eric;Batchelor, Tim J P;Rogers, Chris A
背景：电视胸腔镜术(VATS)与开腹手术治疗早期肺癌的疗效比较，随机证据有限。方法：我们进行了一项平行分组的多中心随机试验，招募了已知或疑似早期肺癌的参与者，并随机分配他们接受开放手术或电视胸腔切除术。使用欧洲癌症研究和治疗组织健康相关生活质量问卷(QLQ-C30)，主要结果是5周后的身体功能作为恢复的指标(得分范围从0到100，得分越高表明功能更好；临床上最小的改善重要性差异为5分)。我们又对患者进行了47周的跟踪观察，以了解其他结果。结果：共有503名参与者被随机分配(247名接受VATS，256名接受开放肺叶切除术)。5周时，VATS组和开放手术组的平均身体功能评分分别为73和67，平均相差4.65分(95%可信区间为1.69~7.61)。在分配到VATS的参与者中，30.7%的患者在出院后发生严重不良事件，而分配给开放手术的参与者中这一比例为37.8%(风险比为0.81[95%可信区间0.66至1.00])。在52周时，癌症无进展生存率(风险比0.74[0.43比1.27])或总生存率(风险比0.67[0.32比1.40])没有差异。结论：与开放手术相比，随机分配后5周内接受胸廓叶切除术的肺癌患者的身体功能恢复较好。长期的肿瘤学结果将需要持续的随访来评估。(由国家卫生研究所卫生技术评估方案资助[参考号13/04/03]；ISRCTN编号，ISRCTN13472721。)
BACKGROUND: There is limited randomized evidence on the comparative outcomes of early-stage lung cancer resection by video-assisted thoracoscopic surgery (VATS) versus open resection. METHODS: We conducted a parallel-group multicenter randomized trial that recruited participants with known or suspected early-stage lung cancer and randomly assigned them to open or VATS resection of their lesions. The primary outcome was physical function at 5 weeks as a measure of recovery using the European Organisation for Research and Treatment of Cancercore health-related quality of life questionnaire (QLQ-C30) (scores range from 0 to 100, with higher scores indicating better function; the clinical minimally important difference for improvement is 5 points). We followed the patients for an additional 47 weeks for other outcomes. RESULTS: A total of 503 participants were randomly assigned (247 to VATS and 256 to open lobectomy). At 5 weeks, median physical function was 73 in the VATS group and 67 in the open surgery group, with a mean difference of 4.65 points (95% confidence interval, 1.69 to 7.61). Of the participants allocated to VATS, 30.7% had serious adverse events after discharge compared with 37.8% of those allocated to open surgery (risk ratio, 0.81 [95% confidence interval, 0.66 to 1.00]). At 52 weeks, there were no differences in cancer progression-free survival (hazard ratio, 0.74 [0.43 to 1.27]) or overall survival (hazard ratio, 0.67 [0.32 to 1.40]). CONCLUSIONS: VATS lobectomy for lung cancer is associated with a better recovery of physical function in the 5 weeks after random assignment compared with open surgery. Long-term oncologic outcomes will require continued follow-up to assess. (Funded by the National Institute for Health Research Health Technology Assessment programme [reference number 13/04/03]; ISRCTN number, ISRCTN13472721.)