SCI

8 June 2024

Stereotactic body radiotherapy for centrally located inoperable early-stage NSCLC: EORTC 22113-08113 LungTech phase II trial results

（IF: JTO., 20.4）

  • Levy A, Adebahr S, Hurkmans C, Ahmed M, Ahmad S, Guckenberger M, Geets X, Lievens Y, Lambrecht M, Pourel N, Lewitzki V, Konopa K, Franks K, Dziadziuszko R, McDonald F, Fortpied C, Clementel E, Fournier B, Rizzo S, Fink C, Riesterer O, Peulen H, Andratschke N, McWilliam A, Gkika E, Schimek-Jasch T, Grosu A-L, Le Pechoux C, Faivre-Finn C, Nestle U, Stereotactic body radiotherapy for centrally located inoperable early-stage NSCLC: EORTC 22113-08113 LungTech phase II trial results, Journal of Thoracic Oncology (2024),

  • Correspondence to: Prof Ursula Nestle, Department of Radiation Oncology, Kliniken Maria 55 Hilf, 41063, Mönchengladbach, Germany. ursula.nestle@mariahilf.de

Background 背景

The international EORTC phase II single-arm LungTech trial 22113-08113 assessed safety and efficacy of stereotactic body radiotherapy (SBRT) in patients with centrally located early-stage non-small cell lung cancer (NSCLC).

国际 EORTC II 期单臂 LungTech试验 22113-08113 评估了体部立体定向放疗 (SBRT) 对中央型早期非小细胞肺癌 (NSCLC) 患者的安全性和有效性。

 

Patients and Methods 患者与方法

Patients with inoperable non-metastatic central NSCLC (T1-T3 N0 M0, ≤7cm) were included. After prospective central imaging review and radiation therapy quality assurance (RTQA) for any eligible patient, SBRT (8x7.5 Gy, ICRU 83) was delivered. The primary endpoint was freedom from local progression probability at three years after start of SBRT. 

纳入了无法手术的非转移性中央型NSCLC（T1-T3 N0 M0，≤7cm）患者。对所有合格患者进行前瞻性中心影像学审查和放射治疗质量保证（RTQA）后，实施SBRT（8x7.5 Gy，ICRU 83）。主要终点是在SBRT开始后三年内无局部进展的概率。

 

Results 结果

The trial was closed earlier due to poor accrual related to repeated safety-related pauses in recruitment. Between 08/2015 and 12/2017, 39 patients from 6 European countries were included and 31 were treated per protocol and analyzed. Patients were mainly male (58%) with a median age of 75 years. Baseline comorbidities were mainly respiratory (68%) and cardiac (48%). Median tumor size was 2.6 cm (range, 1.2-5.5) and most cancers were T1 (51.6%) or T2a (38.7%) N0 M0 and of squamous cell origin (48.4%). Median follow-up was 3.6 years. The 3-year freedom from local progression and overall survival rates were 81.5% (90% CI: 62.7-91.4%) and 61.1% (90%CI: 44.1-74.4%), respectively. Cumulative incidence rates of local, regional and distant progression at 3 years were 6.7% (90% CI: 1.6-17.1%), 3.3% (90% CI: 0.4 – 12.4%) and 29.8% (90% CI: 16.8 – 44.1%), respectively. SBRT-related acute and late AEs ≥ G3 were reported in 6.5% (n=2, including one G5 pneumonitis in a patient with prior interstitial lung disease) and 19.4 % (n=6, including one lethal hemoptysis after a lung biopsy in a patient receiving anticoagulants), respectively. 

由于招募工作因安全问题屡屡暂停，导致招募效果不佳，该试验提前结束。2015年8月至2017年12月期间，来自6个欧洲国家的39名患者被纳入，其中31名按照方案接受了治疗并进行了分析。患者主要是男性（58%），中位年龄75岁。基线合并症主要是呼吸系统（68%）和心脏（48%）疾病。中位肿瘤大小为2.6厘米（范围1.2-5.5），大多数癌症为T1（51.6%）或T2a（38.7%）N0 M0，鳞状细胞起源（48.4%）。中位随访时间为3.6年。三年内局部进展和总生存率分别为81.5%（90% CI：62.7%-91.4%）和61.1%（90% CI：44.1%-74.4%）。三年局部、区域和远处进展的累积发病率分别为6.7%（90% CI：1.6%-17.1%）、3.3%（90% CI：0.4%-12.4%）和29.8%（90% CI：16.8%-44.1%）。SBRT相关急性和晚期 AE ≥ G3 的发生率分别为 6.5%（n=2，包括一名既往有间质性肺病的患者发生的 G5 肺炎）和19.4%（n=6，包括一名接受抗凝治疗的患者肺活检后发生的致死性咯血）。

 

Conclusion 结论

The LungTech trial suggests that SBRT with 8×7.5Gy for central lung tumors in inoperable patients is associated with acceptable local control rates. However, late severe adverse events may occur after completion of treatment. This SBRT regimen is a viable treatment option after thorough risk-benefit discussion with patients. To minimize potentially fatal toxicity, careful management of dose constraints and post-SBRT interventions is crucial.

LungTech试验表明，对于无法手术的中央型肺癌患者，采用8×7.5Gy的SBRT治疗具有可接受的局部控制率。然而，在治疗完成后可能发生晚期严重不良事件。在与患者进行充分的风险-收益讨论后，这种SBRT方案是一种可行的治疗选择。进行彻底的风险-收益讨论后，这种 SBRT 方案是一种可行的治疗选择。为了最大限度地减少潜在的致命毒性，仔细管理剂量限制和SBRT后的干预措施至关重要。