Lamuraglia M, Raslan S, Elaidi R, Oudard S, Escudier B, Slimane K, Penna R Renard, Wagner M, Lucidarme O
Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Laboratoire d'Imagerie Biomédicale, F-75013, Paris, France.
Service de Radiologie Polyvalente et Oncologique, Groupe Hospitalier Pitié-Salpêtrière, APHP UPMC, 47-83, Bd de l'Hôpital, 75651, Paris Cedex 13, France.
Eur Radiol. 2016 Jan;26(1):278-85. doi: 10.1007/s00330-015-3828-7. Epub 2015 May 8.
To determine whether 2D or 3D Choi and modified Choi (mChoi) criteria could assess the efficacy of everolimus against metastatic renal cell carcinoma (mRCC).
RECIST-1.1, Choi, and mChoi criteria were applied retrospectively to analyse baseline and 2-month contrast-enhanced computed tomography (CECT) images in 48 patients with mRCC enrolled in the everolimus arm of the French randomized double-blind multicentre phase III trial comparing everolimus versus placebo (RECORD-1). The primary endpoint was centrally reviewed progression-free survival (PFS) calculated from the initial RECORD-1 analysis. Mean attenuation was determined for 2D target lesion regions of interest drawn on CECT sections whose largest diameters had been measured, and for the 3D whole target lesion.
The median PFS was 5.5 months. The median PFS for everolimus responders defined using 3D mChoi criteria was significantly longer than for non-responders (7.6 versus 5.4 months, respectively), corresponding to a hazard ratio for progression of 0.45 (95 % CI: 0.22-0.92), with respective 1-year survival rates of 31 % and 9 %. No other 2D or 3D imaging criteria at 2 months identified patients who would benefit from everolimus.
At 2 months, only 3D mChoi criteria were able to identify mRCC patients with a PFS benefit from everolimus.
Choi criteria could not identify everolimus-treated patients with significantly prolonged PFS. mCHOI enabled identification of everolimus-treated mRCC patients with a PFS benefit. 3D attenuation measurement criteria appeared to perform better than single-slice measurement.
确定二维或三维Choi标准以及改良Choi(mChoi)标准能否评估依维莫司治疗转移性肾细胞癌(mRCC)的疗效。
回顾性应用RECIST-1.1、Choi标准和mChoi标准,分析48例参加比较依维莫司与安慰剂的法国随机双盲多中心III期试验(RECORD-1)依维莫司组的mRCC患者的基线和2个月时的对比增强计算机断层扫描(CECT)图像。主要终点是根据最初的RECORD-1分析集中评估的无进展生存期(PFS)。在已测量最大直径的CECT切片上绘制二维感兴趣目标病变区域,并对三维整个目标病变确定平均衰减值。
中位PFS为5.5个月。使用三维mChoi标准定义的依维莫司反应者的中位PFS显著长于无反应者(分别为7.6个月和5.4个月),进展风险比为0.45(95%CI:0.22 - 0.92),1年生存率分别为31%和9%。2个月时的其他二维或三维成像标准均未识别出可从依维莫司治疗中获益的患者。
在2个月时,只有三维mChoi标准能够识别出PFS可从依维莫司治疗中获益的mRCC患者。
Choi标准无法识别PFS显著延长的接受依维莫司治疗的患者。mChoi标准能够识别PFS可从依维莫司治疗中获益的mRCC患者。三维衰减测量标准似乎比单层面测量表现更好。