RANDOMIZED TRIAL OF LOBECTOMY VERSUS LIMITED RESECTION FOR T1 N0 NON-SMALL-CELL LUNG-CANCER
RANDOMIZED TRIAL OF LOBECTOMY VERSUS LIMITED RESECTION FOR T1 N0 NON-SMALL-CELL LUNG-CANCER
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DOI：
10.1016/0003-4975(95)00537-u
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发表时间：
1995-09-01
影响因子：
4.6
通讯作者：
LONG, S
中科院分区：
文献类型：
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作者：
HOLMES, CE;RUCKDESCHEL, JC;LONG, S
背景据报道，在早期（T1-2 NO）非小细胞肺癌的治疗中，有限切除（肺段或楔形）与肺叶切除相当。一项前瞻性的多机构随机试验比较了手术时记录的周围型TI NO非小细胞肺癌患者的局限性切除术与肺叶切除术。分析包括局部和远处复发率、5年生存率、围手术期发病率和死亡率以及晚期肺功能评估。276例患者接受了随机化，247例患者符合分析条件。所有分层变量、选定的预后因素、围手术期发病率、死亡率或晚期肺功能无显著差异。在接受有限切除术的患者中，观察到复发率增加了75（p = 0.02，单侧）归因于观察到的局部复发率的三倍（双侧p = 0.008），观察到总死亡率增加30%（p = 0.08，单侧），并且与接受肺叶切除术的患者相比，观察到癌症死亡率增加50%（p = 0.09，单侧）（p = 0.10，单侧是该等效性研究的统计学显著性的预定义阈值）。与肺叶切除术相比，限制性肺切除术并不能改善围手术期发病率、死亡率或术后晚期肺功能。由于与有限切除相关的较高的死亡率和局部复发率，肺叶切除术仍然必须被认为是周围型T1 NO非小细胞肺癌患者的外科手术选择。
Background. It has been reported that limited resection (segment or wedge) is equivalent to lobectomy in the management of early stage (T1-2 NO) non-small cell lung cancer.Methods. A prospective, multiinstitutional randomized trial was instituted comparing limited resection with lobectomy for patients with peripheral TI NO 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 NO nonsmall cell lung cancer.