NRG-RTOG1106/ECOG-ACRIN6697 的主要结果：使用治疗中 F-氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描对 III 期非小细胞肺癌进行个体化适应性（化）放疗的随机 II 期试验。
Primary Results of NRG-RTOG1106/ECOG-ACRIN 6697: A Randomized Phase II Trial of Individualized Adaptive (chemo)Radiotherapy Using Midtreatment F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Stage III Non-Small Cell Lung Cancer.
机构信息
University of Hong Kong Shenzhen Hospital, The University of Hong Kong, Shenzhen/Hong Kong SAR, China.
NRG Oncology Statistics and Data Management Center, Philadelphia, PA.
出版信息
J Clin Oncol. 2024 Nov 20;42(33):3935-3946. doi: 10.1200/JCO.24.00022. Epub 2024 Oct 4.
PURPOSE
NRG-RTOG0617 demonstrated a detrimental effect of uniform high-dose radiation in stage III non-small cell lung cancer. NRG-RTOG1106/ECOG-ACRIN6697 (ClinicalTrials.gov identifier: NCT01507428), a randomized phase II trial, studied whether midtreatment F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) can guide individualized/adaptive dose-intensified radiotherapy (RT) to improve and predict outcomes in patients with this disease.
MATERIALS AND METHODS
Patients fit for concurrent chemoradiation were randomly assigned (1:2) to standard (60 Gy/30 fractions) or FDG-PET-guided adaptive treatment, stratified by substage, primary tumor size, and histology. All patients had midtreatment FDG-PET/CT; adaptive arm patients had an individualized, intensified boost RT dose to residual metabolically active areas. The primary therapeutic end point was 2-year centrally reviewed freedom from local-regional progression (FFLP), defined as no progression in or near the planning target volume and/or regional nodes. FFLP was analyzed on a modified intent-to-treat population at a one-sided -test significance level of 0.15. The primary imaging end point was centrally reviewed change in SUV from baseline to midtreatment; its association with FFLP was assessed using the two-sided Wald test on the basis of Cox regression.
RESULTS
Of 138 patients enrolled, 127 were eligible. Adaptive-arm patients received a mean 71 Gy in 30 fractions, with mean lung dose 17.9 Gy. There was no significant difference in centrally reviewed 2-year FFLP (59.5% and 54.6% in standard and adaptive arms; = .66). There were no significant differences in protocol-specified grade 3 toxicities, survival, or progression-free survival ( > .4). Median SUV and metabolic tumor volume (MTV) in the adaptive arm decreased 49% and 54%, from pre-RT to mid-RT PET. However, ΔSUV and ΔMTV were not associated with FFLP (hazard ratios, 0.997; = .395 and .461).
CONCLUSION
Midtreatment PET-adapted RT dose escalation as given in this study was safe and feasible but did not improve efficacy outcomes.
目的
NRG-RTOG0617 研究表明，在 III 期非小细胞肺癌中，采用均匀高剂量放疗会产生不良影响。NRG-RTOG1106/ECOG-ACRIN6697（ClinicalTrials.gov 标识符：NCT01507428）是一项随机的 II 期试验，旨在研究在疾病治疗过程中，中期 F-氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描（FDG-PET/CT）是否可以指导个体化/适应性剂量递增放疗（RT），以改善和预测患者的预后。
材料和方法
适合同步放化疗的患者按 1:2 比例随机分配（分层因素包括亚分期、原发肿瘤大小和组织学）至标准（60 Gy/30 个分次）或 FDG-PET 指导的适应性治疗组。所有患者均在治疗中期接受 FDG-PET/CT 检查；适应性治疗组的患者将对残留代谢活跃区域进行个体化、强化的推量放疗。主要治疗终点为中央审查的 2 年局部区域无进展率（FFLP），定义为计划靶区和/或区域淋巴结内或附近无进展。FFLP 在单侧检验显著性水平为 0.15 的改良意向治疗人群中进行分析。主要影像学终点为基线至治疗中期 SUV 变化的中央审查结果；基于 Cox 回归的双侧 Wald 检验评估其与 FFLP 的关系。
结果
在入组的 138 例患者中，127 例符合条件。适应性治疗组患者接受了 30 个分次、平均 71 Gy 的放疗，平均肺剂量为 17.9 Gy。标准治疗组和适应性治疗组的 2 年中央审查 FFLP 无显著差异（分别为 59.5%和 54.6%， =.66）。无 3 级规定毒性、生存或无进展生存期的显著差异（ >.4）。在适应性治疗组中，治疗中期的 FDG-PET 显示 SUV 中位数和代谢肿瘤体积（MTV）分别下降了 49%和 54%。然而，SUV 和 MTV 的变化与 FFLP 无显著关联（风险比，0.997； =.395 和.461）。
结论
在这项研究中，给予的治疗中期 PET 指导的自适应 RT 剂量递增是安全可行的，但并未改善疗效结果。
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