肺段或亚肺叶切除术治疗外周型ⅠA 期非小细胞肺癌。
Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer.
机构信息
From Weill Cornell Medicine, New York-Presbyterian Hospital (N.A., J.P.), Memorial Sloan Kettering Cancer Center (D.R.J.), and New York University Grossman School of Medicine (H.P.), New York, and SUNY Upstate Medical University, Syracuse (L.J.K.) - all in New York; the Alliance Statistics and Data Management Center and the Department of Biostatistics and Bioinformatics, Duke University (X.W.), and Duke Cancer Institute, Duke University Medical Center (T.E.S.) - both in Durham, NC; Alliance Protocol Operations Office (D.K., C.W.) and the University of Chicago Comprehensive Cancer Center (E.V.) - both in Chicago; University of Pittsburgh Medical Center, Pittsburgh (R.L.); Mayo Clinic, Rochester, MN (D.W.); Institut Universitaire de Cardiologie et Pneumologie de Québec, Quebec (M.C.), and Centre Hospitalier de l'Université de Montréal, Montreal (M.L.), QC, Surrey Memorial Hospital Thoracic Group Fraser Valley Health Authority, Surrey, BC (A.S.A.), and the University of Toronto, Toronto (K.Y.) - all in Canada; Johns Hopkins University, Baltimore (S.Y.); University of Colorado Hospital School of Medicine, Aurora (J.D.M.); Moffitt Cancer Center, Tampa, FL (R.K.); Hackensack Meridian Health System, Edison, NJ (T.B.); and Emory University School of Medicine, Atlanta (D.M.).
出版信息
N Engl J Med. 2023 Feb 9;388(6):489-498. doi: 10.1056/NEJMoa2212083.
BACKGROUND
The increased detection of small-sized peripheral non-small-cell lung cancer (NSCLC) has renewed interest in sublobar resection in lieu of lobectomy.
METHODS
We conducted a multicenter, noninferiority, phase 3 trial in which patients with NSCLC clinically staged as T1aN0 (tumor size, ≤2 cm) were randomly assigned to undergo sublobar resection or lobar resection after intraoperative confirmation of node-negative disease. The primary end point was disease-free survival, defined as the time between randomization and disease recurrence or death from any cause. Secondary end points were overall survival, locoregional and systemic recurrence, and pulmonary functions.
RESULTS
From June 2007 through March 2017, a total of 697 patients were assigned to undergo sublobar resection (340 patients) or lobar resection (357 patients). After a median follow-up of 7 years, sublobar resection was noninferior to lobar resection for disease-free survival (hazard ratio for disease recurrence or death, 1.01; 90% confidence interval [CI], 0.83 to 1.24). In addition, overall survival after sublobar resection was similar to that after lobar resection (hazard ratio for death, 0.95; 95% CI, 0.72 to 1.26). The 5-year disease-free survival was 63.6% (95% CI, 57.9 to 68.8) after sublobar resection and 64.1% (95% CI, 58.5 to 69.0) after lobar resection. The 5-year overall survival was 80.3% (95% CI, 75.5 to 84.3) after sublobar resection and 78.9% (95% CI, 74.1 to 82.9) after lobar resection. No substantial difference was seen between the two groups in the incidence of locoregional or distant recurrence. At 6 months postoperatively, a between-group difference of 2 percentage points was measured in the median percentage of predicted forced expiratory volume in 1 second, favoring the sublobar-resection group.
CONCLUSIONS
In patients with peripheral NSCLC with a tumor size of 2 cm or less and pathologically confirmed node-negative disease in the hilar and mediastinal lymph nodes, sublobar resection was not inferior to lobectomy with respect to disease-free survival. Overall survival was similar with the two procedures. (Funded by the National Cancer Institute and others; CALGB 140503 ClinicalTrials.gov number, NCT00499330.).
背景
随着小尺寸周围非小细胞肺癌（NSCLC）的检出率增加，亚肺叶切除术代替肺叶切除术再次受到关注。
方法
我们进行了一项多中心、非劣效性、3 期临床试验，将临床分期为 T1aN0（肿瘤大小，≤2cm）的 NSCLC 患者随机分配接受亚肺叶切除术或肺叶切除术，术中确认无淋巴结转移疾病后进行。主要终点是无病生存，定义为随机分组至疾病复发或任何原因死亡的时间。次要终点是总生存、局部和远处复发以及肺功能。
结果
从 2007 年 6 月至 2017 年 3 月，共 697 例患者被分配接受亚肺叶切除术（340 例）或肺叶切除术（357 例）。中位随访 7 年后，亚肺叶切除术在无病生存方面不劣于肺叶切除术（疾病复发或死亡的风险比，1.01；90%置信区间[CI]，0.83 至 1.24）。此外，亚肺叶切除术后的总生存率与肺叶切除术后相似（死亡风险比，0.95；95%CI，0.72 至 1.26）。亚肺叶切除术后 5 年无病生存率为 63.6%（95%CI，57.9 至 68.8），肺叶切除术后为 64.1%（95%CI，58.5 至 69.0）。亚肺叶切除术后 5 年总生存率为 80.3%（95%CI，75.5 至 84.3），肺叶切除术后为 78.9%（95%CI，74.1 至 82.9）。两组间局部或远处复发的发生率无显著差异。术后 6 个月，用力呼气量 1 秒率预测值的中位数两组间有 2 个百分点的差异，亚肺叶切除术组更优。
结论
对于肿瘤大小为 2cm 或更小且肺门和纵隔淋巴结病理证实无淋巴结转移的周围性 NSCLC 患者，亚肺叶切除术在无病生存率方面不劣于肺叶切除术。两种手术的总生存率相似。（由美国国立癌症研究所等资助；CALGB 140503 ClinicalTrials.gov 编号，NCT00499330。）
Zotero 插件