磁共振成像联合淋巴结特异性造影剂替代计算机断层扫描及淋巴结清扫术用于前列腺癌患者：一项前瞻性多队列研究
MRI with a lymph-node-specific contrast agent as an alternative to CT scan and lymph-node dissection in patients with prostate cancer: a prospective multicohort study.
作者信息
Heesakkers Roel A M, Hövels Anke M, Jager Gerrit J, van den Bosch Harrie C M, Witjes J Alfred, Raat Hein P J, Severens Johan L, Adang Eddy M M, van der Kaa Christina Hulsbergen, Fütterer Jurgen J, Barentsz Jelle
机构信息
Department of Radiology, Radboud University Medical Centre, Nijmegen, Netherlands.
出版信息
Lancet Oncol. 2008 Sep;9(9):850-6. doi: 10.1016/S1470-2045(08)70203-1. Epub 2008 Aug 15.
BACKGROUND
In patients with prostate cancer who are deemed to be at intermediate or high risk of having nodal metastases, invasive diagnostic pelvic lymph-node dissection (PLND) is the gold standard for the detection of nodal disease. However, a new lymph-node-specific MR-contrast agent ferumoxtran-10 can detect metastases in normal-sized nodes (ie, <8 mm in size) by use of MR lymphoangiography (MRL). In this prospective, multicentre cohort study, we aimed to compare the diagnostic accuracy of MRL with up-to-date multidetector CT (MDCT), and test the hypothesis that a negative MRL finding obviates the need for a PLND.
METHODS
We included consecutive patients with prostate cancer who had an intermediate or high risk (risk of >5% according to routinely used nomograms) of having lymph-node metastases. All patients were assessed by MDCT and MRL, and underwent PLND or fine-needle aspiration biopsy. Imaging results were correlated with histopathology. The primary outcomes were sensitivity, specificity, accuracy, NPV, and PPV of MRL and MDCT. This study is registered with ClinicalTrials.gov, number NCT00185029.
FINDINGS
The study was done in 11 hospitals in the Netherlands between April 8, 2003, and April 19, 2005. 375 consecutive patients were included. 61 of 375 (16%) patients had lymph-node metastases. Sensitivity was 34% (21 of 61; 95% CI 23-48) for MDCT and 82% (50 of 61; 70-90) for MRL (McNemar's test p<0.05). Specificity was 97% (303 of 314; 94-98) for MDCT and 93% (291 of 314; 89-95) for MRL. Positive predictive value (PPV) was 66% (21 of 32; 47-81) for MDCT and 69% (50 of 73; 56-79) for MRL. Negative predictive value (NPV) was 88% (303 of 343; 84-91) for MDCT and 96% (291 of 302; 93-98) for MRL (McNemar's test p<0.05). Of the 61 patients with lymph-node metastases, 50 were detected by MRL, of which 40 (80%) had metastases in normal-sized lymph nodes. The high sensitivity and NPV of MRL imply that in patients with a negative MRL, the chance of positive lymph nodes is less than 11/302 (4%).
INTERPRETATION
MRL had significantly higher sensitivity and NPV than MDCT for patients with prostate cancer who had intermediate or high risk of having lymph-node metastases. In such patients, after a negative MRL, the post-test probability of having lymph-node metastases is low enough to omit a PLND.
背景
对于被认为有淋巴结转移中高风险的前列腺癌患者，侵入性诊断性盆腔淋巴结清扫术（PLND）是检测淋巴结疾病的金标准。然而，一种新型淋巴结特异性磁共振造影剂ferumoxtran - 10可通过磁共振淋巴造影（MRL）检测正常大小淋巴结（即直径<8 mm）中的转移灶。在这项前瞻性多中心队列研究中，我们旨在比较MRL与最新的多排螺旋CT（MDCT）的诊断准确性，并检验MRL检查结果为阴性可避免进行PLND这一假设。
方法
我们纳入了连续的前列腺癌患者，这些患者有淋巴结转移的中高风险（根据常规使用的列线图，风险>5%）。所有患者均接受MDCT和MRL检查，并接受PLND或细针穿刺活检。影像学检查结果与组织病理学结果进行对照。主要结局指标为MRL和MDCT的敏感性、特异性、准确性、阴性预测值（NPV）和阳性预测值（PPV）。本研究已在ClinicalTrials.gov注册，注册号为NCT00185029。
研究结果
该研究于2003年4月8日至2005年4月19日在荷兰的11家医院进行。共纳入375例连续患者。375例患者中有61例（16%）有淋巴结转移。MDCT的敏感性为34%（61例中的21例；95%CI 23 - 48），MRL的敏感性为82%（61例中的50例；70 - 90）（McNemar检验p<0.05）。MDCT的特异性为97%（314例中的303例；94 - 98），MRL的特异性为93%（314例中的291例；89 - 95）。MDCT的阳性预测值（PPV）为66%（32例中的21例；47 - 81），MRL的阳性预测值为69%（73例中的50例；56 - 79）。MDCT的阴性预测值（NPV）为88%（343例中的303例；84 - 91），MRL的阴性预测值为96%（302例中的291例；93 - 98）（McNemar检验p<0.05）。在61例有淋巴结转移的患者中，MRL检测出50例，其中40例（80%）在正常大小的淋巴结中有转移灶。MRL的高敏感性和NPV表明，MRL检查结果为阴性的患者，淋巴结阳性的几率小于11/302（4%）。
解读
对于有淋巴结转移中高风险的前列腺癌患者，MRL的敏感性和NPV显著高于MDCT。在此类患者中，MRL检查结果为阴性后，有淋巴结转移的检测后概率低至足以省略PLND。
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