ImportanceThe randomized clinical trial Cancer and Leukemia Group B (CALGB) 140503 showed that for patients with clinically staged T1N0 non–small cell lung cancer (NSCLC; ≤2 cm), sublobar resections were associated with similar oncological outcomes to those after lobar resection. The association of the extent of parenchymal resection with recurrence and survival in patients with tumors pathologically upstaged to T2 based on visceral pleural invasion (VPI) is controversial.ObjectiveTo determine survival and recurrence rates in patients with small peripheral pT2 NSCLC (≤2 cm) that was treated by either lobar or sublobar resection in CALGB 140503.Design, Participants, and SettingCALGB 140503, a randomized multicenter noninferiority trial, included 697 patients with small peripheral NSCLC that was clinically staged as T1N0. Enrollment was from June 2007 through March 2017 at 83 participating institutions, and after a median follow-up of 7 years, the primary outcome of disease-free survival after sublobar resection was noninferior to that after lobar resection.InterventionLobar or sublobar resection.Main Outcomes and MeasuresSurvival end points were estimated by the Kaplan-Meier estimator. Hazard ratios and 95% CIs were estimated using stratified Cox proportional hazard models.ResultsOf 679 participants, 390 (57.4%) were female, and the median (range) age was 67.8 (37.8-89.7) years. Among 697 patients randomized, 566 (81.2%) had pT1 tumors (no VPI) and 113 (16.2%) had pT2 tumors (VPI). Five-year disease-free survival was 65.9% (95% CI, 61.9%-70.2%) in patients with pT1 compared with 53.3% (95% CI, 44.3%-64.1%) in patients with pT2 tumors (stratified log-rank: P = .02). Disease recurrence developed in 27.6% of patients with pT1 (locoregional only: 60 [10.8%]; distant only: 81 [14.6%]) and 41.6% of those with pT2 (locoregional only: 17 [15.0%]; distant only: 27 [23.9%]). Five-year recurrence-free survival was 73.1% (95% CI, 69.2%-77.1%) for pT1 tumors and 58.2% (95% CI, 49.2%-68.8%) for pT2 tumors (stratified log-rank: P = .01). There were no intergroup differences in disease-free or recurrence-free survival based on the extent of parenchymal resection.Conclusions and RelevanceThe results of this secondary analysis suggest that compared with patients with tumors without VPI, patients who had tumors with VPI had worse disease-free and recurrence-free survival and a higher rate of local and distant disease recurrence. These high rates of recurrence were independent of the extent of parenchymal resection, and these data support the inclusion of these patients in adjuvant therapy trials.Trial RegistrationClinicalTrials.gov Identifier: NCT0049933

中文翻译：

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非小细胞肺癌伴内脏胸膜浸润的复发


重要性随机临床试验癌症和白血病 B 组 （CALGB） 140503 显示，对于临床分期 T1N0 非小细胞肺癌 （NSCLC;≤2 cm） 患者，亚肺叶切除术与肺叶切除术后的肿瘤学结局相似。实质切除范围与基于内脏胸膜浸润 （VPI） 的病理分期至 T2 的肿瘤患者的复发和生存率的相关性是有争议的。目的为了确定在 CALGB 140503.Design 中接受肺叶或亚肺叶切除术治疗的小外周 pT2 NSCLC （≤2 cm） 患者的生存率和复发率，参与者和 SettingCALGB 140503是一项随机多中心非劣效性试验，包括 697 例临床分期为 T1N0 的小外周 NSCLC 患者。从 2007 年 6 月到 2017年3月，在 83 个参与机构入组，中位随访 7 年后，亚肺叶切除术后无病生存的主要结局不劣于肺叶切除术后。干预 肺叶或亚肺叶切除术。主要结局和测量生存终点由 Kaplan-Meier 估计器估计。使用分层 Cox 比例风险模型估计风险比和 95% CI。结果在 679 名参与者中，390 名 （57.4%） 为女性，中位 （range） 年龄为 67.8 （37.8-89.7） 岁。在随机分配的 697 例患者中，566 例 （81.2%） 患有 pT1 肿瘤 （无 VPI），113 例 （16.2%） 患有 pT2 肿瘤 （VPI）。pT1 患者的 5 年无病生存率为 65.9% （95% CI，61.9%-70.2%），而 pT2 肿瘤患者的 53.3% （95% CI，44.3%-64.1%） （分层对数秩： P = .02）。27.6% 的 pT1 患者（仅局部区域：60 [10.8%];仅远处：81 [14.6%]）和 41.6% 的 pT2 患者（仅局部区域：17 [15.0%];仅远处：27 [23.9%]）。pT1 肿瘤的 5 年无复发生存率为 73.1% （95% CI，69.2%-77.1%），pT2 肿瘤的 58.2% （95% CI，49.2%-68.8%） （分层对数秩：P = .01）。基于实质切除范围的无病生存期或无复发生存期无组间差异。结论和相关性该二次分析的结果表明，与无 VPI 的肿瘤患者相比，有 VPI 的肿瘤患者的无病和无复发生存率更差，局部和远处疾病复发率更高。这些高复发率与实质切除的范围无关，这些数据支持将这些患者纳入辅助治疗试验。试验注册临床试验。gov 标识符： NCT0049933