全国肺癌“高危”患者合作组临床试验：他们真的是“高危”吗？
National cooperative group trials of "high-risk" patients with lung cancer: are they truly "high-risk"?
机构信息
Department of Surgery, Washington University, St. Louis, St. Louis, Missouri.
Department of Surgery, Washington University, St. Louis, St. Louis, Missouri.
出版信息
Ann Thorac Surg. 2014 May;97(5):1678-83; discussion 1683-5. doi: 10.1016/j.athoracsur.2013.12.028. Epub 2014 Feb 16.
BACKGROUND
The American College of Surgery Oncology Group (ACOSOG) trials z4032 and z4033 prospectively characterized lung cancer patients as "high-risk" for surgical intervention, and these results have appeared frequently in the literature. We hypothesized that many patients who meet the objective enrollment criteria for these trials ("high-risk") have similar perioperative outcomes as "normal-risk" patients.
METHODS
We reviewed a prospective institutional database and classified patients undergoing resection for clinical stage I lung cancer as "high-risk" and "normal-risk" by ACOSOG major criteria.
RESULTS
From 2000 to 2010, 1,066 patients underwent resection for clinical stage I lung cancer. Of these, 194 (18%) met ACOSOG major criteria for risk (preoperative forced expiratory volume in 1 second or diffusion capacity of the lung for carbon monoxide≤50% predicted). "High-risk" patients were older (66.4 vs 64.6 years, p=0.02) but similar to controls in sex, prevalence of hypertension, diabetes, and coronary artery disease. "High-risk" patients were less likely than "normal-risk" patients to undergo a lobectomy (117 of 194 [60%] vs 665 of 872 [76%], p<0.001). "High-risk" and control patients experienced similar morbidity (any complication: 55 of 194 [28%] vs 230 of 872 [26%], p=0.59) and 30-day mortality (2 of 194 [1%] vs 14 of 872 [ 2%], p=0.75). A regression analysis showed age (hazard risk, 1.04; 95% confidence interval, 1.02 to 1.06) and coronary artery disease (hazard risk, 1.58; 95% confidence interval, 1.05 to 2.40) were associated with an elevated risk of complications in those undergoing lobectomy, whereas female sex (hazard ratio, 0.63; 95% confidence interval, 0.44 to 0.91) was protective. ACOSOG "high-risk" status was not associated with perioperative morbidity.
CONCLUSIONS
There are no important differences in early postsurgical outcomes between lung cancer patients characterized as "high-risk" and "normal-risk" by ACOSOG trial enrollment criteria, despite a significant proportion of "high-risk" patients undergoing lobectomy.
背景
美国外科医师学院肿瘤学组（ACOSOG）的 z4032 和 z4033 试验前瞻性地将肺癌患者归类为手术干预的“高危”，这些结果经常出现在文献中。我们假设，许多符合这些试验的客观入组标准（“高危”）的患者与“低危”患者具有相似的围手术期结局。
方法
我们回顾了一个前瞻性的机构数据库，并根据 ACOSOG 主要标准将接受手术治疗的 I 期肺癌患者分为“高危”和“低危”。
结果
2000 年至 2010 年，1066 例临床 I 期肺癌患者接受了手术治疗。其中，194 例（18%）符合 ACOSOG 主要风险标准（术前用力呼气量或一氧化碳弥散量预测值≤50%）。“高危”患者比对照组年龄更大（66.4 岁比 64.6 岁，p=0.02），但在性别、高血压、糖尿病和冠心病的患病率方面与对照组相似。“高危”患者行肺叶切除术的可能性低于“低危”患者（194 例中的 117 例[60%]比 872 例中的 665 例[76%]，p<0.001）。“高危”和对照组患者的发病率（任何并发症：194 例中的 55 例[28%]比 872 例中的 230 例[26%]，p=0.59）和 30 天死亡率（194 例中的 2 例[1%]比 872 例中的 14 例[2%]，p=0.75）相似。回归分析显示，年龄（危险比，1.04；95%置信区间，1.02 至 1.06）和冠心病（危险比，1.58；95%置信区间，1.05 至 2.40）与行肺叶切除术患者的并发症风险升高相关，而女性（危险比，0.63；95%置信区间，0.44 至 0.91）则具有保护作用。ACOSOG 的“高危”状态与围手术期发病率无关。
结论
尽管“高危”患者中相当一部分行肺叶切除术，但根据 ACOSOG 试验入组标准将肺癌患者归类为“高危”和“低危”，两组患者的早期术后结局并无显著差异。
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