各位好！今天与大家分享一篇近期发表在Annals of surgery上的一篇文献。研究对所在中心可切除NSCLC的队列进行了回顾分析，对选择手术和推荐SBRT的患者进行了析因分析、决策模型构建和生存分析。在这个老生常谈、备受争议的话题上，究竟什么样的患者做手术和做SBRT具有可比性，后续的诊疗模式又有哪些地方可以进一步优化？一起看看。
Real-world Decision-making Process for Stereotactic Body Radiotherapy Versus Minimally Invasive Surgery in Early-stage Lung Cancer Patients
Vanstraelen, Stijn MD*; Tan, Kay See PhD†; Adusumilli, Prasad S. MD*; Bains, Manjit S. MD*; Bott, Matthew J. MD*; Downey, Robert J. MD*; Gomez, Daniel R. MD‡; Gray, Katherine D. MD*; Huang, James MD*; Isbell, James M. MD*; Molena, Daniela MD*; Park, Bernard J. MD*; Rimner, Andreas MD‡; Rusch, Valerie W. MD*; Shaverdian, Narek MD‡; Sihag, Smita MD*; Wu, Abraham J. MD‡; Jones, David R. MD*,§; Rocco, Gaetano MD*,§
Annals of Surgery 2 October 2024
Objective: To generate a prediction model for selection of treatment modality for early-stage non-small cell lung cancer (NSCLC).
目的：建立早期非小细胞肺癌治疗方式选择的预测模型。
Summary Background Data: Stereotactic body radiotherapy (SBRT) and minimally invasive surgery (MIS) are used in the local treatment of early-stage NSCLC. However, selection of patients for either SBRT or MIS remains challenging, due to the multitude of factors influencing the decision-making process.
背景：立体定向体部放射治疗（SBRT）和微创手术（MIS）用于早期非小细胞肺癌的局部治疗。然而，由于影响决策过程的因素众多，为SBRT或MIS选择患者仍然具有挑战性。
Methods: We analyzed 1291 patients with clinical stage I NSCLC treated with intended MIS or SBRT from January 2020 to July 2023. A prediction model for selection for SBRT was created based on multivariable logistic regression analysis. The receiver operating characteristic curve analysis stratified the cohort into 3 treatment-related risk categories. Post-procedural outcomes, recurrence and overall survival (OS) were investigated to assess the performance of the model.
方法：我们分析了2020年1月至2023年7月期间接受预期MIS或SBRT治疗的1291名临床I期非小细胞肺癌患者。基于多因素逻辑回归分析创建了SBRT选择的预测模型。受试者操作特征曲线分析将队列分层为3个治疗相关风险类别。研究了术后结局、复发和总生存期（OS）以评估模型的性能。
Results: In total, 1116 patients underwent MIS and 175 SBRT. The prediction model included age, performance status, previous pulmonary resection, MSK-Frailty score, FEV1 and DLCO, and demonstrated an area-under-the-curve of 0.908 (95%CI, 0.876–0.938). Based on the probability scores (n=1197), patients were stratified into a low-risk (MIS, n=970 and SBRT, n=28), intermediate-risk (MIS, n=96 and SBRT, n=53) and high-risk category (MIS, n=10 and SBRT, n=40). Treatment modality was not associated with OS (HR of SBRT, 1.67 [95%CI: 0.80-3.48]; P=0.20).
结果：总共有1116名患者接受了MIS和175名SBRT。预测模型包括年龄、体能状态、既往肺切除术、MSK-Frailty评分、FEV 1和DLCO，并显示曲线下面积为0.908（95%CI，0.876-0.938）。根据概率评分（n=1197），将患者分为低风险（MIS，n=970和SBRT，n=28）、中风险（MIS，n=96和SBRT，n=53）和高风险类别（MIS，n=10和SBRT，n=40）。治疗方式与OS无关（SBRT HR，1.67 [95%CI：0.80-3.48]; P=0.20）。
Conclusions: Clinical expertise can be translated into a robust predictive model, guiding the selection of stage I NSCLC patients for MIS versus SBRT and effectively categorizing them into three distinct risk groups. Patients in the intermediate category could benefit most from multidisciplinary evaluation.
结论：临床专业知识可以转化为强大的预测模型，指导选择I期非小细胞肺癌患者进行MIS与SBRT，并有效地将他们分为三个不同的风险组。中间类别的患者可以从多学科评估中受益最多。
1.众所周知，早期肺癌的治疗策略较为多样，手术、SBRT、消融治疗、观察随访。目前针对淋巴结阴性的早期NSCLC指南中推荐对于不可手术或拒绝手术的患者进行SBRT治疗。目前学术界的争议在于哪些人群中进行SBRT不劣于外科手术，怎样更好的进行治疗选择？
10.1016/j.thorsurg.2023.01.003
2.上细节：
首先本文是基于韩国单个医疗中心的回顾性数据，针对手术或SBRT具体临床决策中，哪些因素主要影响了治疗决策进行了分析，并构建了nomogram，然后根据不同治疗后并发症与毒性进行人群分层。对不同分层的人群进行预后分析。
其次，文章之所以根据治疗前概率模型找2个cutoff值，是因为想找到SBRT与手术的可比人群。超高概率做手术推荐的患者和超高概率推荐做SBRT的患者肯定有潜在的临床特征差异，那么在这种临床差异并不是那么明显的intermediate-risk group中评估预后差异具有一定的可比性。
第三，在临床实践需要进行治疗决策的选择中，肿瘤的长期控制情况某种程度上是要让位于短期90天内死亡/严重并发症。多学科诊疗和共同决策工具可能也只能将哪些不容易细化的合并症死亡风险进行相对量化。
10.1016/j.athoracsur.2022.07.019
3. 可手术I期NSCLC多样化的治疗手段，有待于更丰富的数据进一步验证。
https://www.drericlim.com/grand-rounds-2023
目录
1. INTRODUCTION
2. Material and Methods
2.1 Study population and data collection (Supplemental Figure 1)
2.2 Statistical analysis
3. Results
3.1 Patient cohort and treatment (Table 1 and Supplemental Table 1)
3.2 Factors associated with selection for SBRT and construction of a decision-making model (Table 2)(Figure 1-2)(Supplemental Table 2-4)(Supplemental Figure 2)
3.3 Outcome after MIS and SBRT (Supplemental Figure 3A-C)(Table 3 and Supplemental Figure 3D)(Figure 3)(Supplemental Table 5)
4. Discussion
— 图表汇总—
2. Material and Methods
2.1 Study population and data collection
Supplemental Figure 1. Consort diagram
2.2 Statistical analysis
3. Results
3.1 Patient cohort and treatment
Table 1. patient demographics and characteristics
Supplemental Table 1. Distribution of the variables included in the MSK-Frailty score stratified by treatment modality
3.2 Factors associated with selection for SBRT and construction of a decision-making model
Table 2. Univariable and multivariable logistic regression for selection for SBRT
Figure 1. Nomogram for calculating the probability of selection for stereotactic body radiotherapy. FEV1, forced expiratory volume in 1 second; SBRT, stereotactic body radiotherapy.
Figure2. Distribution of the probabilities stratified by treatment modality (A) and calibration curve analysis for the prediction model (B). MIS, minimally invasive surgery; SBRT, stereotactic body radiotherapy.
Supplemental Table 2. Univariable and multivariable logistic regression model for selection of SBRT for the intermediate-risk category
Supplemental Table 3. Univariable and multivariable Cox regression model for overall survival for the intermediate-risk category
Supplemental Table 4. Sensitivity and specificity in relation to different cutoff probabilities for SBRT
Supplemental Figure 2. Sensitivity and specificity in relation to the probability score from the prediction model. FPR, false-positive rate; SBRT, stereotactic body radiotherapy; TPR, true-positive rate
3.3 Outcome after MIS and SBRT
Supplemental Figure 3. Cumulative incidence of recurrence for all recurrences (A), locoregional recurrences (B) and distant recurrences (C) stratified by treatment modality. Overall survival analysis stratified by treatment modality (D).
CI, confidence interval; MIS, minimally invasive surgery; SBRT, stereotactic body radiotherapy.
Table 3. Overall survival for MIS and SBRT
Figure 3. Overall survival of the intermediate-risk group stratified by treatment modality.
MIS, minimally invasive surgery; SBRT, stereotactic body radiotherapy.
Supplemental Table 5. Univariable and multivariable Cox regression model for overall survival
