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为了比较肺叶切除与局限性肺切除的治疗效果，北美肺癌研究组于1982年设计、实施了一个前瞻性多中心临床研究，1995年报告了最终结果：发现与肺叶切除术相比，局限性肺切除并不能减少围手术期并发症和死亡的发生，亦不能保留更多的手术后肺功能；但手术后局部复发率较对照组增加3倍，局部复发和远处转移合计增加75％，肺癌特异性死亡率增加50％。因此认为肺叶切除术仍是肺癌的标准手术方式。
CT的出现促使北美肺癌研究组（Lung Cancer Study Group，LCSG) [Ginsberg RJ. 1995]于1982年进行了一项外科前瞻性随机对照临床试验以明确局限性切除术与肺叶切除术治疗早期NSCLC（周围型、T1 N0）是否有相同的长期生存率和无瘤生存期。这项二十余年前的随机对照临床试验也是至今为止已完成的唯一大样本研究，研究设计严谨，其设计原则至今仍适用。该研究共247例入组，125例接受肺叶切除术，122例接受局限性切除术（40例接受楔形切除术，82例接受肺段切除术）。结果显示，两组的围术期并发症和死亡率，术后肺功能等均无统计学差异。但是接受局限性切除的患者复发转移率增加了75%（p = 0.02），这主要是由于局部复发率增加了三倍（楔形切除术增加3倍，肺段切除术增加2.4倍，p = 0.008）；总死亡率增加了30%（p = 0.08）；肿瘤相关死亡率增加了50%（p = 0.09）。肺叶切除组的死亡率和肿瘤相关死亡率皆低于局限性切除组，但统计学差异均很小。局限性切除组总死亡率增加了30%，肿瘤相关死亡率增加了50%。局限性切除组仅在术后6个月肺功能检测中有统计学差异，但在12至18个月的肺功能检测中则无统计学差异（除FEV1外）。
虽然研究显示局限性切除组总生存率和无瘤生存率与肺叶切除组差异很小，但局部复发则明显增多，而局部复发势必影响患者的生存质量。鉴于pT1N0M0的5年生存率在80%以上，还需要更长时间的随访才能最后评价患者的在长期生存率上的差异。来自Memorial Sloan-Kettering Cancer Center[Martini N, 1995]的回顾性资料显示，接受局限性切除的Ⅰ期NSCLC患者（61例）5年和10年生存率分别为59%和35%，而解剖性肺叶切除术或全肺切除术（511例）则分别为77%和70%。在10年生存率上，肺叶切除术较局限性切除术更优，很可能这一趋势随着生存时间的延长而更加明显。
Ann Thorac Surg 1995;60:615-623
Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer
Lung Cancer Study Group, Robert J. Ginsberg, MD*, Lawrence V. Rubinstein, PhD
Accepted for publication April 1, 1995.
* Address reprint requests to Dr Ginsberg, Thoracic Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021.
Background.: It has been reported that limited resection (segment or wedge) is equivalent to lobectomy in the management of early stage (T1–2 N0) non-small cell lung cancer.
Methods.: A prospective, multiinstitutional randomized trial was instituted comparing limited resection with lobectomy for patients with peripheral T1 N0 non-small cell lung cancer documented at operation. Analysis included locoregional and distant recurrence rates, 5-year survival rates, perioperative morbidity and mortality, and late pulmonary function assessment.
Results.: There were 276 patients randomized, with 247 patients eligible for analysis. There were no significant differences for all stratification variables, selected prognostic factors, perioperative morbidity, mortality, or late pulmonary function. In patients undergoing limited resection, there was an observed 75% increase in recurrence rates (p = 0.02, one-sided) attributable to an observed tripling of the local recurrence rate (p = 0.008 two-sided), an observed 30% increase in overall death rate (p = 0.08, one-sided), and an observed 50% increase in death with cancer rate (p = 0.09, one-sided) compared to patients undergoing lobectomy (p = 0.10, one-sided was the predefined threshold for statistical significance for this equivalency study).
Conclusions.: Compared with lobectomy, limited pulmonary resection does not confer improved perioperative morbidity, mortality, or late postoperative pulmonary function. Because of the higher death rate and locoregional recurrence rate associated with limited resection, lobectomy still must be considered the surgical procedure of choice for patients with peripheral T1 N0 non-small cell lung cancer.
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JCOG 0802 VS CALGB 140503 VS LCSG
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