Weill Cornell Medicine, New York-Presbyterian Hospital, New York.
Alliance Statistics and Data Management Center, and Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.
JAMA Oncol. 2024 Sep 1;10(9):1179-1186. doi: 10.1001/jamaoncol.2024.2491.
The 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.
To 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 SETTING: CALGB 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.
Lobar or sublobar resection.
Survival end points were estimated by the Kaplan-Meier estimator. Hazard ratios and 95% CIs were estimated using stratified Cox proportional hazard models.
Of 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.
The 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.
ClinicalTrials.gov Identifier: NCT0049933.
CALGB 140503 随机临床试验表明，对于临床分期为 T1N0 非小细胞肺癌（NSCLC；≤2cm）的患者，亚肺叶切除术与肺叶切除术的肿瘤学结果相似。对于基于脏层胸膜侵犯（VPI）病理升级为 T2 的肿瘤患者，肺实质切除范围与复发和生存的关系存在争议。
确定在 CALGB 140503 中，接受肺叶或亚肺叶切除术治疗的小外周性 pT2 NSCLC（≤2cm）患者的生存和复发率。
设计、参与者和设置：CALGB 140503 是一项随机多中心非劣效性试验，纳入了 697 例临床分期为 T1N0 的小外周性 NSCLC 患者。招募时间为 2007 年 6 月至 2017 年 3 月，在 83 家参与机构进行，中位随访 7 年后，亚肺叶切除术后无病生存的主要结局是非劣效于肺叶切除术后。
肺叶或亚肺叶切除术。
采用 Kaplan-Meier 估计器估计生存终点。使用分层 Cox 比例风险模型估计风险比和 95%置信区间。
在 679 名参与者中，390 名（57.4%）为女性，中位（范围）年龄为 67.8（37.8-89.7）岁。在随机分组的 697 例患者中，566 例（81.2%）为 pT1 肿瘤（无 VPI），113 例（16.2%）为 pT2 肿瘤（VPI）。pT1 肿瘤患者的 5 年无病生存率为 65.9%（95%CI，61.9%-70.2%），而 pT2 肿瘤患者为 53.3%（95%CI，44.3%-64.1%）（分层对数秩检验：P=0.02）。pT1 肿瘤患者中有 27.6%（局部区域仅：60[10.8%]；远处仅：81[14.6%]）和 pT2 肿瘤患者中有 41.6%（局部区域仅：17[15.0%]；远处仅：27[23.9%]）发生疾病复发。pT1 肿瘤患者的 5 年无复发生存率为 73.1%（95%CI，69.2%-77.1%），pT2 肿瘤患者为 58.2%（95%CI，49.2%-68.8%）（分层对数秩检验：P=0.01）。基于实质切除范围，两组之间在无病生存或无复发生存方面无差异。
本二次分析结果表明，与无 VPI 肿瘤患者相比，有 VPI 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范围无关，这些数据支持将这些患者纳入辅助治疗试验。
ClinicalTrials.gov 标识符：NCT0049933。
