Weber W A, Dietlein M, Hellwig D, Kirsch C-M, Schicha H, Schwaiger M
Nuklearmedizinische Klinik und Poliklinik, Technische Universität München, Ismaningerstrasse 22, 81675 München, Deutschland.
Nuklearmedizin. 2003 Aug;42(4):135-44.
To evaluate studies on the use of positron emission tomography with the glucose analog (18)F-fluoro-deoxyglucose (FDG-PET) for the preoperative staging of patients with non-small cell lung cancer (NSCLC) according to the criteria of evidence based medicine and to discuss the cost-effectiveness of the technique.
Clinical studies published between 1995 and 2002 on the preoperative staging of non-small cell lung cancer were used for this analysis. Studies that did not meet the criteria published by the European Agency for the Evaluation of Medicinal Products (EMEA) were excluded. The validity of the studies was evaluated by a standardized rating system developed by the Agency for Health Care Policy and Research (AHCPR).
For the detection of mediastinal lymph node metastases the mean sensitivity and specificity of FDG-PET on a patient basis is 85% and 87% (16 studies, 1355 patients). In studies that compared FDG-PET and computed tomography (CT) the mean sensitivity of CT was 66% at a specificity of 71%. In the detection of distant metastases FDG-PET correctly changed the tumor stage in 18% of the patients when compared to CT based staging (10 studies, 1073 patients). Five cost effectiveness analyses from the USA, Japan, and Germany concluded that FDG-PET improves the outcome of treatment at reduced or only slightly increased overall costs. Improvement of patient outcome was also demonstrated in a randomized trial, which found that the risk of a futile thoracotomy was reduced by 51% (p=0.003) when FDG-PET was added to the preoperative staging.
According to the criteria of the AHCPR the use of FDG-PET for detection of mediastinal lymph node and distant metastases is documented at a level of evidence Ia and Ib, respectively. Since systematic analyses also indicate a favorable cost-effectiveness ratio FDG-PET has to be considered as "strictly indicated" for the preoperative staging of non-small cell lung cancer.
根据循证医学标准评估使用葡萄糖类似物(18)F-氟脱氧葡萄糖正电子发射断层扫描(FDG-PET)对非小细胞肺癌(NSCLC)患者进行术前分期的研究,并探讨该技术的成本效益。
本分析采用1995年至2002年间发表的关于非小细胞肺癌术前分期的临床研究。不符合欧洲药品评估局(EMEA)发布标准的研究被排除。研究的有效性通过医疗保健政策与研究局(AHCPR)制定的标准化评分系统进行评估。
对于纵隔淋巴结转移的检测,基于患者的FDG-PET平均敏感性和特异性分别为85%和87%(16项研究,1355例患者)。在比较FDG-PET和计算机断层扫描(CT)的研究中,CT的平均敏感性为66%,特异性为71%。在远处转移的检测中,与基于CT的分期相比,FDG-PET在18%的患者中正确改变了肿瘤分期(10项研究,1073例患者)。来自美国、日本和德国的五项成本效益分析得出结论,FDG-PET在降低或仅略微增加总体成本的情况下改善了治疗结果。一项随机试验也证明了患者预后的改善,该试验发现,术前分期加入FDG-PET时,无意义开胸手术的风险降低了51%(p=0.003)。
根据AHCPR标准,使用FDG-PET检测纵隔淋巴结和远处转移分别被记录为证据等级Ia和Ib。由于系统分析也表明成本效益比良好,因此FDG-PET必须被视为非小细胞肺癌术前分期的“严格指征”。