无法手术的 I 期非小细胞肺癌的立体定向放疗与低分次放疗对比

IF 22.5 1区医学 Q1 ONCOLOGY

JAMA Oncology Pub Date : 2024-09-19 DOI:10.1001/jamaoncol.2024.3089

Anand Swaminath, Sameer Parpia, Marcin Wierzbicki, Vijayananda Kundapur, Sergio Faria, Gordon S. Okawara, Theodoros K. Tsakiridis, Naseer Ahmed, Alexis Bujold, Khalid Hirmiz, Timothy Owen, Nelson Leong, Kevin Ramchandar, Edith Filion, Harold Lau, Zsolt Gabos, Robert Thompson, Brian Yaremko, Selma Mehiri, Alexander V. Louie, Kimmen Quan, Mark N. Levine, James R. Wright, Timothy J. Whelan

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引用次数: 0

摘要

重要性立体定向体放射治疗（SBRT）被广泛用于医学上无法手术的I期非小细胞肺癌（NSCLC），但随机临床试验（RCT）的结果不尽相同，治疗中心位置肿瘤的问题依然存在。目的研究与低分次常规放射治疗（CRT）相比，SBRT是否能改善局部控制（LC）。医学上无法手术的I期（≤5厘米）NSCLC患者按照2:1的比例随机接受48 Gy分4次（周边NSCLC）或60 Gy分8次（中心NSCLC）的SBRT与60 Gy分15次的CRT治疗。数据收集时间为2014年5月至2020年1月，数据分析时间为2022年7月至2023年7月。干预措施SBRT或CRT。主要结果和测量指标主要目的是根据3年后的LC确定SBRT与CRT相比的有效性。次要结果包括无事件生存期、总生存期和毒性反应。所有放射计划均接受实时/最终审查。局部失败由中央裁决。该研究旨在检测 SBRT 3 年生存率从 75% 提高到 87.5%。结果在233例纳入患者中，119例（51.1%）为男性，平均（SD）年龄为75.4（7.7）岁；中位（IQR）随访时间为36.1（26.4-52.8）个月。共有154名患者接受了SBRT治疗，79名患者接受了CRT治疗。SBRT的3年生存率为87.6%（95% CI，81.9%-93.4%），CRT为81.2%（95% CI，71.9%-90.5%）（危险比[HR]，0.61；95% CI，0.31-1.20；P = .15）。无事件生存率为 1.02 (95% CI, 0.72-1.45; P = .87)，总生存率为 1.18 (95% CI, 0.80-1.76; P = .40)。急性毒性反应极小。在随机接受SBRT治疗的患者中，45例中心型NSCLC患者中有5例（11%）出现了晚期3级或4级毒性反应，109例外周型NSCLC患者中有2例（1.8%）出现了晚期3级或4级毒性反应；在随机接受CRT治疗的患者中，19例中心型NSCLC患者中有1例（5%）出现了晚期3级或4级毒性反应，60例外周型NSCLC患者中有1例（2%）出现了晚期3级或4级毒性反应。一名接受SBRT治疗超中心病灶（靶点与近端支气管重叠）的患者可能发生了治疗相关的5级事件（咯血）。两组患者的低密度脂蛋白血症无差异。严重毒性反应有限，包括中心性肿瘤患者。该试验提供了评估SBRT的重要前瞻性数据；但是，要确定SBRT是否比CRT对周围和中心NSCLC更有效，还需要进一步的研究：NCT03924869

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Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non–Small Cell Lung Cancer

ImportanceStereotactic body radiotherapy (SBRT) is widely used for stage I medically inoperable non–small cell lung cancer (NSCLC), yet varied results from randomized clinical trials (RCTs) and concerns in treating centrally located tumors persist.ObjectiveTo examine whether SBRT would improve local control (LC) compared with hypofractionated conventional radiotherapy (CRT).Design, Setting, and ParticipantsThis phase 3 RCT was conducted in 16 Canadian centers. Patients with medically inoperable stage I (≤5 cm) NSCLC were randomized 2:1 to SBRT of 48 Gy in 4 fractions (peripheral NSCLC) or 60 Gy in 8 fractions (central NSCLC) vs CRT of 60 Gy in 15 fractions. Data were collected from May 2014 to January 2020, and data were analyzed from July 2022 to July 2023.InterventionsSBRT or CRT.Main Outcomes and MeasuresThe primary objective was to determine the effectiveness of SBRT compared with CRT based on LC at 3 years. Secondary outcomes included event-free survival, overall survival, and toxic effects. All radiation plans were subject to real-time/final review. Local failures were centrally adjudicated. The study was designed to detect a 3-year LC improvement of SBRT from 75% to 87.5%. The target sample size was 324 patients.ResultsOf 233 included patients, 119 (51.1%) were male, and the mean (SD) age was 75.4 (7.7) years; the median (IQR) follow-up was 36.1 (26.4-52.8) months. A total of 154 patients received SBRT and 79 received CRT. The 3-year LC was 87.6% (95% CI, 81.9%-93.4%) for SBRT and 81.2% (95% CI, 71.9%-90.5%) for CRT (hazard ratio [HR], 0.61; 95% CI, 0.31-1.20; P = .15). The HR was 1.02 (95% CI, 0.72-1.45; P = .87) for event-free survival and 1.18 (95% CI, 0.80-1.76; P = .40) for overall survival. Minimal acute toxic effects were observed. Among those randomized to SBRT, late grade 3 or 4 toxic effects occurred in 5 of 45 (11%) with central NSCLC and 2 of 109 (1.8%) with peripheral NSCLC; among those randomized to CRT, in 1 of 19 (5%) with central NSCLC and 1 of 60 (2%) with peripheral NSCLC. One patient who received SBRT for an ultracentral lesion (target overlapping proximal bronchus) experienced a possible treatment-related grade 5 event (hemoptysis).Conclusions and RelevanceThis RCT compared lung SBRT with hypofractionated CRT that included central/ultracentral tumors. No difference was detected in LC between groups. Severe toxic effects were limited, including patients with central tumors. The trial provides important prospective data evaluating SBRT; however, further research is necessary to determine if SBRT is more effective than CRT for peripheral and central NSCLC.Trial RegistrationClinicalTrials.gov Identifier: NCT03924869

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来源期刊

JAMA Oncology Medicine-Oncology

自引率

1.80%

发文量

423

期刊介绍： JAMA Oncology is an international peer-reviewed journal that serves as the leading publication for scientists, clinicians, and trainees working in the field of oncology. It is part of the JAMA Network, a collection of peer-reviewed medical and specialty publications.