Abstract：
BACKGROUND: Stereotactic body radiotherapy (SBRT) has firmly established its role in stage I NSCLC. Clinical trial results may not fully apply to real-world scenarios. This study aimed to uncover the real-world incidence of acute toxicity and 90-day mortality in patients with SBRT-treated stage I NSCLC and develop prediction models for these outcomes.
METHODS: Prospective data from the Dutch Lung Cancer Audit for Radiotherapy (DLCA-R) were collected nationally. Patients with stage I NSCLC (cT1-2aN0M0) treated with SBRT in 2017 to 2021 were included. Acute toxicity was assessed, defined as grade greater than or equal to 2 radiation pneumonitis or grade greater than or equal to 3 non-hematologic toxicity less than or equal to 90 days after SBRT. Prediction models for acute toxicity and 90-day mortality were developed and internally validated.
RESULTS: Among 7279 patients, the mean age was 72.5 years, with 21.6% being above 80 years. Most were male (50.7%), had WHO scores 0 to 1 (73.3%), and had cT1a-b tumors (64.6%), predominantly in the upper lobes (65.2%). Acute toxicity was observed in 280 (3.8%) of patients and 90-day mortality in 122 (1.7%). Predictors for acute toxicity included WHO greater than or equal to 2, lower forced expiratory volume in 1 second and diffusion capacity for carbon monoxide, no pathology confirmation, middle or lower lobe tumor location, cT1c-cT2a stage, and higher mean lung dose (c-statistic 0.68). Male sex, WHO greater than or equal to 2, and acute toxicity predicted higher 90-day mortality (c-statistic 0.73).
CONCLUSIONS: This nationwide study revealed a low rate of acute toxicity and an acceptable 90-day mortality rate in patients with SBRT-treated stage I NSCLC. Notably, advanced age did not increase acute toxicity or mortality risk. Our predictive models, with satisfactory performance, offer valuable tools for identifying high-risk patients.
METHODS: Prospective data from the Dutch Lung Cancer Audit for Radiotherapy (DLCA-R) were collected nationally. Patients with stage I NSCLC (cT1-2aN0M0) treated with SBRT in 2017 to 2021 were included. Acute toxicity was assessed, defined as grade greater than or equal to 2 radiation pneumonitis or grade greater than or equal to 3 non-hematologic toxicity less than or equal to 90 days after SBRT. Prediction models for acute toxicity and 90-day mortality were developed and internally validated.
RESULTS: Among 7279 patients, the mean age was 72.5 years, with 21.6% being above 80 years. Most were male (50.7%), had WHO scores 0 to 1 (73.3%), and had cT1a-b tumors (64.6%), predominantly in the upper lobes (65.2%). Acute toxicity was observed in 280 (3.8%) of patients and 90-day mortality in 122 (1.7%). Predictors for acute toxicity included WHO greater than or equal to 2, lower forced expiratory volume in 1 second and diffusion capacity for carbon monoxide, no pathology confirmation, middle or lower lobe tumor location, cT1c-cT2a stage, and higher mean lung dose (c-statistic 0.68). Male sex, WHO greater than or equal to 2, and acute toxicity predicted higher 90-day mortality (c-statistic 0.73).
CONCLUSIONS: This nationwide study revealed a low rate of acute toxicity and an acceptable 90-day mortality rate in patients with SBRT-treated stage I NSCLC. Notably, advanced age did not increase acute toxicity or mortality risk. Our predictive models, with satisfactory performance, offer valuable tools for identifying high-risk patients.
摘要：
背景：立体定向放射治疗（SBRT）已牢固地确立了其在I期非小细胞肺癌（NSCLC）中的作用。临床试验结果可能并不完全适用于现实世界的情况。本研究旨在揭示SBRT治疗的I期NSCLC患者急性毒性和90天死亡率的实际发生率，并开发这些结果的预测模型。
方法：收集了荷兰肺癌放疗审核（DLCA-R）的全国前瞻性数据。纳入2017-2021年接受SBRT治疗的I期NSCLC（cT1-2aN0M0）患者。评估了急性毒性，定义为SBRT后≤90天≥2级放射性肺炎或≥3级非血液学毒性。建立并内部验证了急性毒性和90天死亡率的预测模型。
结果：在7279名患者中，平均年龄为72.5岁,21.6%>80岁。大多数是女性（50.7%），世卫组织评分为0-1（73.3%），和cT1a-b肿瘤（64.6%），主要在上叶（65.2％）。在280例患者中观察到急性毒性（3.8％），在122例患者中观察到90天死亡率（1.7％）。急性毒性的预测因子包括WHO≥2，较低的FEV1和DLCO，没有病理证实,中/下叶肿瘤位置，cT1c-cT2a阶段，和更高的平均肺剂量（c统计量0.68）。女性性别,WHO≥2和急性毒性预测90天死亡率更高(c统计量0.73)。
结论：这项全国性研究显示，在SBRT治疗的I期NSCLC患者中，急性毒性发生率低，90天死亡率可接受。值得注意的是,高龄并未增加急性毒性或死亡风险.我们的预测模型，以令人满意的性能，为识别高危患者提供有价值的工具。
方法：收集了荷兰肺癌放疗审核（DLCA-R）的全国前瞻性数据。纳入2017-2021年接受SBRT治疗的I期NSCLC（cT1-2aN0M0）患者。评估了急性毒性，定义为SBRT后≤90天≥2级放射性肺炎或≥3级非血液学毒性。建立并内部验证了急性毒性和90天死亡率的预测模型。
结果：在7279名患者中，平均年龄为72.5岁,21.6%>80岁。大多数是女性（50.7%），世卫组织评分为0-1（73.3%），和cT1a-b肿瘤（64.6%），主要在上叶（65.2％）。在280例患者中观察到急性毒性（3.8％），在122例患者中观察到90天死亡率（1.7％）。急性毒性的预测因子包括WHO≥2，较低的FEV1和DLCO，没有病理证实,中/下叶肿瘤位置，cT1c-cT2a阶段，和更高的平均肺剂量（c统计量0.68）。女性性别,WHO≥2和急性毒性预测90天死亡率更高(c统计量0.73)。
结论：这项全国性研究显示，在SBRT治疗的I期NSCLC患者中，急性毒性发生率低，90天死亡率可接受。值得注意的是,高龄并未增加急性毒性或死亡风险.我们的预测模型，以令人满意的性能，为识别高危患者提供有价值的工具。
