Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, USA.
Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, USA.
Radiother Oncol. 2019 May;134:44-49. doi: 10.1016/j.radonc.2019.01.027. Epub 2019 Feb 1.
Although stereotactic body radiation therapy (SBRT) is the standard of care for inoperable early-stage non-small cell lung carcinoma (NSCLC), its role for medically operable patients remains controversial. To address this knowledge gap, we conducted a multi-institutional study to assess post-SBRT disease control and survival outcomes in medically operable patients.
We conducted a retrospective cohort study including patients with biopsy-proven cT1-2N0M0 NSCLC treated with definitive SBRT (2006-2015). Per patient charts, inoperability referred to documentation of poor surgical candidacy with a given rationale for lack of resection. Charts of operable patients contained documentation of patients refusing surgery or choosing SBRT, without a documented rationale for inoperability. Subjects were excluded in cases of ambiguity regarding the aforementioned definitions and/or lack of clearly documented operability status. Endpoints included local failure (LF) and regional-distant failure, both evaluated with Fine and Gray competing risks regression; Kaplan-Meier methodology analyzed overall survival (OS) and progression-free survival (PFS).
Of 952 patients, 408 (42.9%) were operable, and 544 (57.1%) were inoperable. Median follow-up was 22 months. Two-year LF was 9.7% in operable patients and 8.2% in inoperable patients (p = 0.36). There was no statistical difference in regional-distant failure (p = 0.55) between cohorts. Operable patients experienced statistically higher OS (p = 0.04), but not PFS (p = 0.11). Respective 1-, 2-, and 3-year OS in operable patients were 85.4%, 66.2%, and 51.2%.
Although patients with operable NSCLC experience higher OS than their inoperable counterparts, disease-related outcomes are similar. These results may better inform shared decision-making between medically operable patients and their multidisciplinary providers.
尽管立体定向体部放射治疗（SBRT）是不可手术的早期非小细胞肺癌（NSCLC）的标准治疗方法，但对于有手术适应证的患者，其作用仍存在争议。为了解决这一知识空白，我们进行了一项多机构研究，以评估有手术适应证的患者接受 SBRT 后的疾病控制和生存结果。
我们进行了一项回顾性队列研究，纳入了 2006 年至 2015 年间接受根治性 SBRT 治疗的经活检证实的 cT1-2N0M0 NSCLC 患者。根据患者病历，无法手术是指有明确的手术禁忌证且无切除适应证的记录。有手术适应证的患者病历中记录了拒绝手术或选择 SBRT 的患者，但无明确的无法手术的记录。如果上述定义存在歧义或无法明确记录手术适应证，则将患者排除在外。终点包括局部失败（LF）和区域远处失败，均采用 Fine 和 Gray 竞争风险回归进行评估；Kaplan-Meier 方法分析总生存（OS）和无进展生存（PFS）。
在 952 名患者中，408 名（42.9%）有手术适应证，544 名（57.1%）无手术适应证。中位随访时间为 22 个月。有手术适应证的患者 2 年 LF 为 9.7%，无手术适应证的患者为 8.2%（p=0.36）。两组间区域远处失败无统计学差异（p=0.55）。有手术适应证的患者 OS 更高（p=0.04），但 PFS 无统计学差异（p=0.11）。有手术适应证的患者 1、2、3 年 OS 分别为 85.4%、66.2%和 51.2%。
尽管有手术适应证的 NSCLC 患者的 OS 高于无手术适应证的患者，但疾病相关结局相似。这些结果可能为有手术适应证的患者及其多学科提供者之间的共同决策提供更好的信息。
