Jánváry Zsolt Levente, Bajcsay András, Stelczer Gábor, Kontra Gábor, Pócza Tamás, Gerdán Mercédesz, Lövey József, Kocsis Zsuzsa S, Ladányi Katalin, Pap Éva, Major Tibor, Polgár Csaba
Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
National Tumor Biology Laboratory, National Institute of Oncology, Budapest, Hungary.
Strahlenther Onkol. 2025 Aug 25. doi: 10.1007/s00066-025-02455-3.
The aim of the study was to evaluate the clinical efficacy and side effects of stereotactic body radiotherapy (SBRT) using a gantry-based linear accelerator (LINAC) or robotic technique in a large cohort of consecutively treated medically inoperable early-stage lung cancer patients.
Between March 2015 and February 2023, 401 early-stage (T1-2 N0 M0) primary lung cancer patients were treated using either LINACs (Varian VitalBeam® and TrueBeam®; Varian, Palo Alto, CA, USA) or CyberKnife® (Accuray, Madison, WI, USA). Median age was 70 years (range 44-90). Diagnosis was based on biopsy for 37.4% of patients, while pathological confirmation was unavailable due to high risk for 62.6%. F‑fluorodeoxyglucose positron-emission tomography (18-FDG-PET) was part of the pretreatment diagnostic workup in 96% (n = 386) of the total cohort. Tumor stage distribution was T1a in 32 (8%), T1b in 179 (44.6%), T1c in 112 (27.9%), T2a in 67 (16.7%), and T2b in 11 (2.7%) patients. Applied dose schemes were identical for both LINAC and CyberKnife treatments, using risk-adapted doses of 45-60 Gy in 3 to 8 fractions, (biologically effective dose ranging from 86 to 151.2 Gy BED).
At a median follow-up of 32 months (range 2-104), the crude survival rate was 58%. Median overall survival (OS) was 63 months (95% CI: 51.1-74.8) the 2‑, 3‑, and 4‑year OS rates were 79, 68, and 56%, respectively. Actuarial local control (LC) rates were 94% at 2 years, 90% at 3 years, and 87% at 4 years. Median LC was not reached. Median local progression-free survival (LPFS) and progression-free survival (PFS) rates were 49.5 months (95% CI: 42.8-56.3) and 37 months (95% CI: 31.2.-42.8), respectively. Actuarial 2‑, 3‑, and 4‑year LPFS and PFS rates were 75, 60, and 51% and 66, 51, and 42%, respectively. On multivariate analysis, BED ≥ 132 Gy predicted improved LPFS, while earlier tumor stage and better ECOG performance status were associated with improved OS. No grade 3 or higher acute side effects were observed. Grade 3 late side effects occurred in 4 patients (1%), including grade 3 late pulmonary fibrosis in 3 cases and potentially treatment-related grade 3 pneumothorax in 1 patient. Rib fracture was observed in 14 cases (3%).
Clinical results after SBRT at a national comprehensive cancer center demonstrate high LC and LPFS rates and favorable PFS and OS, comparable to published studies. Application of a BED of 132 Gy or higher shows a potential benefit in terms of LPFS and may thus be recommended in the absence of conflict with organ at risk constraints. SBRT with either LINAC or CK is proven to be a well-tolerated but still highly effective treatment for the elderly, medically inoperable early-stage lung cancer population.
本研究旨在评估在一大群连续接受治疗的医学上无法手术的早期肺癌患者中,使用基于龙门架的直线加速器(LINAC)或机器人技术进行立体定向体部放射治疗(SBRT)的临床疗效和副作用。
2015年3月至2023年2月期间,401例早期(T1-2 N0 M0)原发性肺癌患者接受了LINAC(瓦里安VitalBeam®和TrueBeam®;美国加利福尼亚州帕洛阿尔托的瓦里安公司)或赛博刀®(Accuray,美国威斯康星州麦迪逊)治疗。中位年龄为70岁(范围44-90岁)。37.4%的患者诊断基于活检,而62.6%的患者因风险高无法获得病理确诊。96%(n = 386)的总队列患者在预处理诊断检查中进行了氟脱氧葡萄糖正电子发射断层扫描(18-FDG-PET)。肿瘤分期分布为:T1a 32例(8%),T1b 179例(44.6%),T1c 112例(27.9%),T2a 67例(16.7%),T2b 11例(2.7%)。LINAC和赛博刀治疗的应用剂量方案相同,采用风险适应剂量45-60 Gy,分3至8次照射,(生物等效剂量范围为86至151.2 Gy BED)。
中位随访32个月(范围2-104个月),粗生存率为58%。中位总生存期(OS)为63个月(95%CI:51.1-74.8),2年、3年和4年OS率分别为79%、68%和56%。精算局部控制(LC)率2年时为94%,3年时为90%,4年时为87%。未达到中位LC。中位局部无进展生存期(LPFS)和无进展生存期(PFS)分别为49.5个月(95%CI:42.8-56.3)和37个月(95%CI:31.2-42.8)。精算2年、3年和4年LPFS和PFS率分别为75%、60%和51%以及66%、51%和42%。多因素分析显示,BED≥132 Gy预测LPFS改善,而较早的肿瘤分期和较好的ECOG体能状态与OS改善相关。未观察到3级或更高的急性副作用。4例患者(1%)出现3级晚期副作用,包括3例患者出现3级晚期肺纤维化和1例患者可能与治疗相关的3级气胸。观察到14例(3%)肋骨骨折。
在国家综合癌症中心进行SBRT后的临床结果显示,LC和LPFS率高,PFS和OS良好,与已发表的研究相当。应用132 Gy或更高的BED在LPFS方面显示出潜在益处,因此在不与危及器官的限制条件冲突的情况下可能被推荐。已证明使用LINAC或CK进行SBRT对老年、医学上无法手术的早期肺癌患者是一种耐受性良好但仍然高效的治疗方法。