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III 期 A/B 期非小细胞肺癌的治疗前代谢肿瘤体积揭示了确定性放化疗方案疗效的差异:ESPATUE 随机 3 期试验分析。

Pretreatment metabolic tumour volume in stage IIIA/B non-small-cell lung cancer uncovers differences in effectiveness of definitive radiochemotherapy schedules: analysis of the ESPATUE randomized phase 3 trial.

机构信息

Department of Radiation Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, Hufelandstr. 55, 45122, Essen, Germany.

Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen Medical School, 45122, Essen, Germany.

出版信息

Eur J Nucl Med Mol Imaging. 2019 Jul;46(7):1439-1447. doi: 10.1007/s00259-019-4270-x. Epub 2019 Feb 1.

DOI:10.1007/s00259-019-4270-x
PMID:30710323
Abstract

PURPOSE

According to the ACRIN 6668/RTOG 0235 trial, pretreatment metabolic tumour volume (MTV) as detected by F-fluorodeoxyglucose PET/CT is a prognostic factor in patients with stage III non-small-cell lung cancer (NSCLC) after definitive radiochemotherapy (RCT). To validate the prognostic value of MTV in patients with stage III NSCLC after RCT, we analysed mature survival data from the German phase III trial ESPATUE.

METHODS

This analysis included patients who were staged by PET/CT and who were enrolled in the ESPATUE trial, a randomized study comparing definitive RCT (arm A) with surgery (arm B) after induction chemotherapy and RCT in patients with resectable stage IIIA/IIIB NSCLC. Patients refusing surgery and those with nonresectable disease were scheduled to receive definitive RCT. MTV was measured using a fixed threshold-based approach and a model-based iterative volume thresholding approach. Data were analysed using proportional hazards models and Kaplan-Meier survival functions.

RESULTS

MTV as a continuous variable did not reveal differences in survival between the 117 patients scheduled to receive definitive RCT and all 169 enrolled patients who underwent pretreatment PET/CT (p > 0.5). Five-year survival rates were 33% (95% CI 17-49%) in patients scheduled for definitive RCT with a high MTV (>95.4 ml) and 32% (95% CI: 22-42%) in those with a low MTV. The hazard ratio for survival was 0.997 (95% CI 0.973-1.022) per 10-ml increase in MTV and the slope was significantly shallower than that in the ACRIN 6668/RTOG 0235 trial (random effects model, p = 0.002). There were no differences in MTV size distributions between the ACRIN and ESPATUE trials (p = 0.97).

CONCLUSION

Patients with stage III NSCLC and a large MTV in whom definitive RCT had a particularly good survival in the ESPATUE trial. Treatment individualization according to MTV is not supported by this study. The ESPATUE and ACRIN trials differed by the use of cisplatin-containing induction chemotherapy and an intensified radiotherapy regimen that were particularly effective in patients with large MTV disease.

摘要

目的

根据 ACRIN 6668/RTOG 0235 试验,通过 F-氟代脱氧葡萄糖 PET/CT 检测的预处理肿瘤代谢体积(MTV)是接受根治性放化疗(RCT)的 III 期非小细胞肺癌(NSCLC)患者的预后因素。为了验证 MTV 在 RCT 后 III 期 NSCLC 患者中的预后价值,我们分析了德国 III 期 ESPATUE 试验的成熟生存数据。

方法

这项分析包括通过 PET/CT 分期并纳入 ESPATUE 试验的患者,该试验是一项比较诱导化疗后根治性 RCT(A 臂)与手术(B 臂)的随机研究,适用于可切除的 IIIA/IIIB 期 NSCLC 患者。拒绝手术和不可切除疾病的患者计划接受根治性 RCT。使用基于固定阈值的方法和基于模型的迭代体积阈值方法测量 MTV。使用比例风险模型和 Kaplan-Meier 生存函数进行数据分析。

结果

作为连续变量,117 例计划接受根治性 RCT 的患者和所有接受预处理 PET/CT 的 169 例入组患者之间的 MTV 无生存差异(p>0.5)。高 MTV(>95.4ml)患者的 5 年生存率为 33%(95%CI 17-49%),低 MTV 患者的 5 年生存率为 32%(95%CI:22-42%)。MTV 每增加 10ml,生存的风险比为 0.997(95%CI 0.973-1.022),斜率明显小于 ACRIN 6668/RTOG 0235 试验(随机效应模型,p=0.002)。ACRIN 和 ESPATUE 试验之间 MTV 大小分布无差异(p=0.97)。

结论

在 ESPATUE 试验中,接受根治性 RCT 的 III 期 NSCLC 患者 MTV 较大,生存特别好。这项研究不支持根据 MTV 进行个体化治疗。ESPATUE 和 ACRIN 试验的区别在于使用含顺铂的诱导化疗和强化放疗方案,这些方案对 MTV 疾病较大的患者特别有效。

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