ImportancePatients with interstitial lung disease (ILD) and early-stage non–small cell lung cancer (NSCLC) have been reported to be at high risk of toxic effects after stereotactic ablative radiotherapy (SABR), but for many patients, there are limited alternative treatment options.ObjectiveTo prospectively assess the benefits and toxic effects of SABR in this patient population.Design, Setting, and ParticipantsThis prospective cohort study was conducted at 6 academic radiation oncology institutions, 5 in Canada and 1 in Scotland, with accrual between March 7, 2019, and January 12, 2022. Patients aged 18 years or older with fibrotic ILD and a diagnosis of T1-2N0 NSCLC who were not candidates for surgical resection were enrolled.InterventionPatients were treated with SABR to a dose of 50 Gy in 5 fractions every other day.Main Outcomes and MeasuresThe study prespecified that SABR would be considered worthwhile if median overall survival—the primary end point—was longer than 1 year, with a grade 3 to 4 risk of toxic effects less than 35% and a grade 5 risk of toxic effects less than 15%. Secondary end points included toxic effects, progression-free survival (PFS), local control (LC), quality-of-life outcomes, and changes in pulmonary function. Intention-to-treat analysis was conducted.ResultsThirty-nine patients enrolled and received SABR. Median age was 78 (IQR, 67-83) years and 59% (n = 23) were male. At baseline, 70% (26 of 37) of patients reported dyspnea, median forced expiratory volume in first second of expiration was 80% (IQR, 66%-90%) predicted, median forced vital capacity was 84% (IQR, 69%-94%) predicted, and median diffusion capacity of the lung for carbon monoxide was 49% (IQR, 38%-61%) predicted. Median follow-up was 19 (IQR, 14-25) months. Overall survival at 1 year was 79% (95%, CI 62%-89%; P < .001 vs the unacceptable rate), and median overall survival was 25 months (95% CI, 14 months to not reached). Median PFS was 19 months (95% CI, 13-28 months), and 2-year LC was 92% (95% CI, 69%-98%). Adverse event rates (highest grade per patient) were grade 1 to 2: n = 12 (31%), grade 3: n = 4 (10%), grade 4: n = 0, and grade 5: n = 3 (7.7%, all due to respiratory deterioration).Conclusions and RelevanceIn this trial, use of SABR in patients with fibrotic ILD met the prespecified acceptability thresholds for both toxicity and efficacy, supporting the use of SABR for curative-intent treatment after a careful discussion of risks and benefits.Trial RegistrationClinicalTrials.gov Identifier: NCT03485378

中文翻译：

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早期非小细胞肺癌和间质性肺病的立体定向放射治疗

据报道，间质性肺疾病 (ILD) 和早期非小细胞肺癌 (NSCLC) 患者在立体定向消融放射治疗 (SABR) 后出现毒性反应的风险很高，但对于许多患者来说，替代治疗方法有限目的前瞻性评估 SABR 在此患者群体中的益处和毒性作用。设计、设置和参与者这项前瞻性队列研究在 6 个学术放射肿瘤学机构（其中 5 个在加拿大，1 个在苏格兰）进行，累计日期为 2019 年 3 月 7 日，以及2022年1月12日。纳入18岁或以上患有纤维化ILD且诊断为T1-2N0 NSCLC且不适合手术切除的患者。干预患者接受SABR治疗，剂量为50 Gy，每隔5次分次主要结果和措施该研究预先规定，如果中位总生存期（主要终点）超过 1 年，且 3 至 4 级毒性反应风险低于 35%，5 级风险为毒性作用小于15%。次要终点包括毒性作用、无进展生存期（PFS）、局部控制（LC）、生活质量结果和肺功能变化。进行意向治疗分析。结果 39 例患者入组并接受 SABR。中位年龄为 78（IQR，67-83）岁，其中 59%（n = 23）为男性。基线时，70%（37 名患者中的 26 名）报告呼吸困难，呼气第一秒的中位用力呼气量为预测值的 80%（IQR，66%-90%），中位用力肺活量为 84%（IQR，69%） -94%）预测，肺一氧化碳扩散能力中值预测为 49%（IQR，38%-61%）。中位随访时间为 19（IQR，14-25）个月。1 年总生存率为 79%（95%，CI 62%-89%；磷< .001 vs 不可接受率），中位总生存期为 25 个月（95% CI，14 个月未达到）。中位 PFS 为 19 个月（95% CI，13-28 个月），2 年 LC 为 92%（95% CI，69%-98%）。不良事件发生率（每位患者的最高等级）为 1 至 2 级：n = 12 (31%)，3 级：n = 4 (10%)，4 级：n = 0，5 级：n = 3 (7.7 ％，全部由于呼吸恶化）。结论和相关性在这项试验中，纤维化 ILD 患者使用 SABR 达到了预先设定的毒性和疗效可接受阈值，在仔细讨论风险后支持使用 SABR 进行治愈性治疗和好处。试验注册ClinicalTrials.gov 标识符：NCT03485378