Recurrence of Non-Small Cell Lung Cancer With Visceral Pleural Invasion: A Secondary Analysis of a Randomized Clinical Trial.

IF 28.4 1区 医学 Q1 Biochemistry, Genetics and Molecular Biology Jama Oncology Pub Date : 2024-09-01 DOI:10.1001/jamaoncol.2024.2491
Nasser Altorki, Xiaofei Wang, Bryce Damman, David R Jones, Dennis Wigle, Jeffrey Port, Massimo Conti, Ahmad S Ashrafi, Moishe Liberman, Rodney Landreneau, Kazuhiro Yasufuku, Stephen Yang, John D Mitchell, Robert Keenan, Thomas Bauer, Daniel Miller, David Kozono, Jennifer Mentlick, Everett Vokes, Thomas E Stinchcombe
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Abstract

Importance: 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.

Objective: 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.

Intervention: Lobar or sublobar resection.

Main outcomes and measures: Survival end points were estimated by the Kaplan-Meier estimator. Hazard ratios and 95% CIs were estimated using stratified Cox proportional hazard models.

Results: 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.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT0049933.

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内脏胸膜受侵的非小细胞肺癌复发:随机临床试验的二次分析》。
重要性:癌症和白血病B组(CALGB)140503随机临床试验显示,对于临床分期为T1N0的非小细胞肺癌(NSCLC;≤2厘米)患者,肺叶下切除术与肺叶切除术的肿瘤预后相似。对于根据内脏胸膜侵犯(VPI)将肿瘤病理分期上调至T2的患者,实质切除范围与复发和生存的关系尚存争议:目的:确定在CALGB 140503中采用肺叶或肺下叶切除术治疗的小周围pT2 NSCLC(≤2厘米)患者的生存率和复发率:CALGB 140503是一项随机多中心非劣效性试验,共纳入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,83家参与机构进行了登记,经过7年的中位随访,叶下切除术后的无病生存率这一主要结果不优于叶状切除术后的无病生存率:主要结果和测量指标:主要结果和测量方法:生存期终点用Kaplan-Meier估计法估算。使用分层考克斯比例危险模型估算危险比和 95% CI:在 679 名参与者中,390 人(57.4%)为女性,年龄中位数(范围)为 67.8(37.8-89.7)岁。在697名随机患者中,566人(81.2%)患有pT1肿瘤(无VPI),113人(16.2%)患有pT2肿瘤(VPI)。pT1 肿瘤患者的五年无病生存率为 65.9%(95% CI,61.9%-70.2%),而 pT2 肿瘤患者的五年无病生存率为 53.3%(95% CI,44.3%-64.1%)(分层对数秩:P = .02)。27.6%的pT1患者(仅局部:60 [10.8%];仅远处:81 [14.6%])和41.6%的pT2患者(仅局部:17 [15.0%];仅远处:27 [23.9%])出现疾病复发。pT1肿瘤的五年无复发生存率为73.1%(95% CI,69.2%-77.1%),pT2肿瘤为58.2%(95% CI,49.2%-68.8%)(分层对数秩:P = .01)。根据实质切除的程度,无病或无复发生存率没有组间差异:这项二次分析的结果表明,与没有VPI的肿瘤患者相比,有VPI的肿瘤患者的无病生存率和无复发生存率更低,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:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT0049933。
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来源期刊
Jama Oncology
Jama Oncology Medicine-Oncology
CiteScore
37.50
自引率
1.80%
发文量
423
期刊介绍: At JAMA Oncology, our primary goal is to contribute to the advancement of oncology research and enhance patient care. As a leading journal in the field, we strive to publish influential original research, opinions, and reviews that push the boundaries of oncology science. Our mission is to serve as the definitive resource for scientists, clinicians, and trainees in oncology globally. Through our innovative and timely scientific and educational content, we aim to provide a comprehensive understanding of cancer pathogenesis and the latest treatment advancements to our readers. We are dedicated to effectively disseminating the findings of significant clinical research, major scientific breakthroughs, actionable discoveries, and state-of-the-art treatment pathways to the oncology community. Our ultimate objective is to facilitate the translation of new knowledge into tangible clinical benefits for individuals living with and surviving cancer.
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