Intraoperative MRI-Guided Resection Is Not Superior to 5-Aminolevulinic Acid Guidance in Newly Diagnosed Glioblastoma: A Prospective Controlled Multicenter Clinical Trial

被引:33
作者
Roder, Constantin [1 ,22 ]
Stummer, Walter [2 ]
Coburger, Jan [3 ]
Scherer, Moritz [4 ]
Haas, Patrick [1 ]
von der Brelie, Christian [5 ,6 ]
Kamp, Marcel Alexander [7 ,8 ]
Loehr, Mario [9 ]
Hamisch, Christina A. [10 ]
Skardelly, Marco [1 ,11 ]
Scholz, Torben [12 ]
Schipmann, Stephanie [2 ,13 ]
Rathert, Julian [14 ]
Brand, Catrin Marlene [15 ]
Pala, Andrej [3 ]
Ernemann, Ulrike [16 ]
Stockhammer, Florian [15 ]
Gerlach, Rudiger [14 ]
Kremer, Paul [12 ]
Goldbrunner, Roland [10 ]
Ernestus, Ralf-Ingo [9 ]
Sabel, Michael [7 ]
Rohde, Veit [5 ]
Tabatabai, Ghazaleh [17 ,18 ]
Martus, Peter [19 ]
Bisdas, Sotirios [20 ]
Ganslandt, Oliver [21 ]
Unterberg, Andreas [4 ]
Wirtz, Christian Rainer [3 ]
Tatagiba, Marcos [1 ]
机构
[1] Eberhard Karls Univ Tubingen, Univ Hosp Tubingen, Ctr Neurooncol, Dept Neurosurg,Comprehens Canc Ctr Tubingen Stuttg, Tubingen, Germany
[2] Univ Hosp Munster, Westphalian Wilhelms Univ, Dept Neurosurg, Munster, Germany
[3] Univ Hosp Ulm Gunzburg, Univ Ulm, Dept Neurosurg, Gunzburg, Germany
[4] Univ Hosp Heidelberg, Rupprecht Karls Univ, Dept Neurosurg, Heidelberg, Germany
[5] Univ Hosp Gottingen, Georg August Univ, Dept Neurosurg, Gottingen, Germany
[6] Johanniter Hosp Bonn, Dept Neurosurg, Bonn, Germany
[7] Univ Hosp Dusseldorf, Heinrich Heine Univ, Dept Neurosurg, Dusseldorf, Germany
[8] Univ Hosp Jena, Friedrich Schiller Univ, Dept Neurosurg, Jena, Germany
[9] Univ Hosp Wurzburg, Julius Maximilians Univ, Dept Neurosurg, Wurzburg, Germany
[10] Univ Hosp Cologne, Univ Cologne, Dept Neurosurg, Cologne, Germany
[11] Municipal Hosp Reutlingen, Dept Neurosurg, Reutlingen, Germany
[12] Dept Neurosurg, Asklepios Klin Nord Heidberg, Hamburg, Germany
[13] Haukeland Univ Hosp Bergen, Dept Neurosurg, Bergen, Norway
[14] Helios Hosp Erfurt, Dept Neurosurg, Erfurt, Germany
[15] Municipal Hosp Dresden, Dept Neurosurg, Dresden, Germany
[16] Univ Hosp Tubingen, Eberhards Karls Univ, Dept Neuroradiol, Tubingen, Germany
[17] Eberhard Karls Univ Tubingen, Partner Site Tubingen Eberhard Karls Univ, Comprehens Canc Ctr Tubingen Stuttgart, Dept Neurol,Partner Site Tubingen,Univ Hosp Tubing, Tubingen, Germany
[18] Eberhard Karls Univ, Hertie Inst Clin Brain Res, Ctr Neurooncol, Univ Hosp Tubingen,Partner Site Tubingen,Comprehen, Stuttgart, Germany
[19] Eberhard Karls Univ Tubingen, Dept Clin Epidemiol & Appl Biostat, Tubingen, Germany
[20] Univ Coll London Hosp NHS Fdn Trust, Natl Hosp Neurol & Neurosurg, Lysholm Dept Neuroradiol, London, England
[21] Municipal Hosp Stuttgart, Dept Neurosurg, Stuttgart, Germany
[22] Eberhard Karls Univ Tubingen, Ctr Neurooncol, Comprehens Canc Ctr Tubingen Stuttgart, Dept Neurosurg, Hoppe Seyler Str 3, D-72076 Tubingen, Germany
关键词
CENTRAL-NERVOUS-SYSTEM; QUALITY-OF-LIFE; SURVIVAL; EXTENT; SURGERY; CLASSIFICATION; TEMOZOLOMIDE; GLIOMA; TUMORS;
D O I
10.1200/JCO.22.01862
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSEProspective data suggested a superiority of intraoperative MRI (iMRI) over 5-aminolevulinic acid (5-ALA) for achieving complete resections of contrast enhancement in glioblastoma surgery. We investigated this hypothesis in a prospective clinical trial and correlated residual disease volumes with clinical outcome in newly diagnosed glioblastoma.METHODSThis is a prospective controlled multicenter parallel-group trial with two center-specific treatment arms (5-ALA and iMRI) and blinded evaluation. The primary end point was complete resection of contrast enhancement on early postoperative MRI. We assessed resectability and extent of resection by an independent blinded centralized review of preoperative and postoperative MRI with 1-mm slices. Secondary end points included progression-free survival (PFS) and overall survival (OS), patient-reported quality of life, and clinical parameters.RESULTSWe recruited 314 patients with newly diagnosed glioblastomas at 11 German centers. A total of 127 patients in the 5-ALA and 150 in the iMRI arm were analyzed in the as-treated analysis. Complete resections, defined as a residual tumor <= 0.175 cm(3), were achieved in 90 patients (78%) in the 5-ALA and 115 (81%) in the iMRI arm (P = .79). Incision-suture times (P < .001) were significantly longer in the iMRI arm (316 v 215 [5-ALA] minutes). Median PFS and OS were comparable in both arms. The lack of any residual contrast enhancing tumor (0 cm(3)) was a significant favorable prognostic factor for PFS (P < .001) and OS (P = .048), especially in methylguanine-DNA-methyltransferase unmethylated tumors (P = .006).CONCLUSIONWe could not confirm superiority of iMRI over 5-ALA for achieving complete resections. Neurosurgical interventions in newly diagnosed glioblastoma shall aim for safe complete resections with 0 cm(3) contrast-enhancing residual disease, as any other residual tumor volume is a negative predictor for PFS and OS.
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收藏
页码:5512 / +
页数:15
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