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首页> 美国卫生研究院文献>Radiation Oncology (London England) >Short report: interim safety results for a phase II trial measuring the integration of stereotactic ablative radiotherapy (SABR) plus surgery for early stage non-small cell lung cancer (MISSILE-NSCLC)
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Short report: interim safety results for a phase II trial measuring the integration of stereotactic ablative radiotherapy (SABR) plus surgery for early stage non-small cell lung cancer (MISSILE-NSCLC)

机译：简短报告：一项II期临床试验的临时安全性结果该试验测量了立体定向消融放射疗法（SABR）与早期非小细胞肺癌（MISSILE-NSCLC）手术的结合

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AbstractA phase II trial was launched to evaluate if neoadjuvant stereotactic ablative radiotherapy (SABR) before surgery improves oncologic outcomes in patients with stage I non-small cell lung cancer (NSCLC). We report a mandated interim safety analysis for the first 10 patients who completed protocol treatment. Operable patients with biopsy-proven T1-2 N0 NSCLC were eligible. SABR was delivered using a risk-adapted fractionation (54Gy/3 fractions, 55/5 or 60/8). Surgical resection was planned 10 weeks later at a high-volume center (>200 lung cancer resections annually). Patients were imaged with dynamic positron emission tomography-computed tomography scans using 18F-fludeoxyglucose (18F-FDG-PET CT) and dynamic contrast-enhanced CT before SABR and again before surgery. Toxicity was recorded using CTCAE version 4.0. Twelve patients were enrolled between 09/2014 and 09/2015. Two did not undergo surgery, due to patient or surgeon preference; neither patient has developed toxicity or recurrence. For the 10 patients completing both treatments, median age was 70 (range: 54–76), 60% had T1 disease, and 60% had adenocarcinoma. Median FEV1 was 73% predicted (range: 54–87%). Median time to surgery post-SABR was 10.1 weeks (range: 9.3–15.6 weeks). Surgery consisted of lobectomy (n = 8) or wedge resection (n = 2). Median follow-up post-SABR was 6.3 months. After combined treatment, the rate of acute grade 3–4 toxicity was 10%. There was no post-operative mortality at 90 days. The small sample size included herein precludes any definitive conclusions regarding overall toxicity rates until larger datasets are available. However, these data may inform others who are designing or conducting similar trials.
机译：摘要开展了一项II期临床试验，以评估手术前新辅助立体定向消融放疗（SABR）是否能改善I期非小细胞肺癌（NSCLC）患者的肿瘤学结局。我们报告了完成方案治疗的前10名患者的强制性中期安全性分析。经活检证实为T1-2 N0 NSCLC的可手术患者符合条件。使用适应风险的分馏方式（54Gy / 3分数，55/5或60/8）递送SABR。计划在10周后在一个高容量的中心进行手术切除（每年> 200例肺癌切除）。患者在SABR之前使用 18 F-脱氧葡萄糖（ 18 F-FDG-PET CT）和动态对比增强CT对动态正电子发射断层计算机断层扫描进行成像手术前。使用CTCAE 4.0版记录了毒性。在09/2014至09/2015之间招募了12名患者。由于患者或外科医生的偏爱，有两名未接受手术；患者均未出现毒性反应或复发。对于完成两种治疗的10位患者，中位年龄为70岁（范围：54-76岁），其中60％患有T1病，60％患有腺癌。 FEV1中位数为预测的73％（范围：54–87％）。 SABR后的中位手术时间为10.1周（范围：9.3-15.6周）。手术包括肺叶切除术（n = 8）或楔形切除术（n = 2）。 SABR后的中位随访时间为6.3个月。联合治疗后，急性3-4级毒性反应率为10％。 90天无术后死亡率。除非有较大的数据集，否则此处包含的小样本量无法得出关于总毒性率的任何明确结论。但是，这些数据可能会通知正在设计或进行类似试验的其他人。

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