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2016年6月3-7日,一年一度的美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)年会在芝加哥举办。6月6日上午的消化系统(非结直肠)肿瘤口头报告专场上,一项摘要号为4008的PET-PANC试验,在疑似胰腺癌诊断和管理方面,对FDG PET/CT的诊断准确性和临床价值进行评估,医脉通整理如下:
胰腺癌的诊断和分期极具挑战性。FDG PET/CT之于功能性数据增加了解剖定位。PET-PANC试验的目的是在疑似胰腺癌患者中确定将FDG PET/CT增加至标准诊断检查的影响。
疑似胰腺癌患者在多排螺旋CT(MDCT)后接受FDG PET/CT。研究人员对FDG PET/CT扫描结果进行审查以保证质量。诊断,分期和计划管理在FDG PET/CT前后被记录。参考标准是组织学或临床预后。主要结局衡量是FDG PET/CT添加至MDCT的增量诊断价值。样本量在中期分析后有500例患者;80%P值以检出增加的灵敏度(81%增加至90%)和特异性(66%增加至80%)。次要结局衡量是诊断,分期,和管理的变化;并对成本效益进行评估。
2011年1月到2013年4月之间,589例疑似胰腺癌患者在英国18个中心接受MDCT和FDG PET/CT。550例患者提供完整数据和FDG PET/CT范围。261例患者(47%)出现胰腺导管腺癌(PDAC)。对于PDAC诊断来说,与MDCT相比较,FDG PET/CT的灵敏度(92.7%[95% CI 89.6%,95.9%]vs 88.5%[95% CI 84.6%,92.4%];P=0.010)和特异性(75.8%[95% CI 70.8%,80.7%]vs 70.6[95% CI 65.3%,75.8%];P=0.023)均显著较高。FDG PET/CT可以在56例患者(14%)中正确地改变PDAC分期(P=0.001)。FDG PET/CT会影响250例患者(45%)的管理。由于已经接受手术,FDG PET/CT在58例患者(20%)中停止了无用的切除术。FDG PET/CT会带来一个0.0157的QALY增益(95% CI -0.0101,0.0430)同时成本节约£645(95% CI -£1314,£2743)。在模型FDG PET/CT基本情况下,以MDCT为主导,很可能符合英国NHS成本效益。
综上所述,FDG PET/CT对胰腺癌诊断提供了显著的增量诊断性获益,同时对患者的分期和管理有显著影响。FDG PET/CT以目前的偿还率来看符合英国NHS的成本效益。临床试验信息:73852054。
会议专题》》》2016年ASCO年会专题报道
原文摘要:
PET-PANC: Multi-centre prospective diagnostic accuracy and clinical value trial of FDG PET/CT in the diagnosis and management of suspected pancreatic cancer.(Abstract4008)
Authors:Paula Ghaneh, Wai Lup Wong,et al.
Session Type:Oral Abstract Session
Background: Pancreatic cancer diagnosis and staging is challenging. FDG PET/CT adds anatomic localization to functional data. The aim of this study was to determine the impact of FDG PET/CT in addition to standard diagnostic workup in patients with suspected pancreatic cancer.
Methods: Patients with suspected pancreatic cancer underwent FDG PET/CT following multi-detector CT (MDCT). FDG PET/CT scans were reviewed and quality assured centrally. Diagnosis, staging and planned management were recorded before and after FDG PET/CT. Reference standard was histology or clinical outcome. Primary outcome measure was incremental diagnostic value of FDG PET/CT in addition to MDCT. Sample size was 500 patients, following interim analysis; 80% power to detect increase in sensitivity from 81% to 90% and specificity from 66% to 80%. Secondary outcome measures were changes in diagnosis, staging, and management; cost effectiveness was estimated.
Results: Between January 2011 and April 2013 589 patients with suspected pancreatic cancer underwent MDCT and FDG PET/CT in 18 UK centres. 550 patients had complete data and in range FDG PET/CT. 261 patients (47%) had pancreatic ductal adenocarcinoma (PDAC). For the diagnosis of PDAC, both sensitivity (92.7% [95% CI 89.6%, 95.9%] compared to 88.5% [95% CI 84.6%, 92.4%], p=0.010) and specificity (75.8% [95% CI 70.8%, 80.7%] compared to 70.6% [95% CI 65.3%, 75.8%] p=0.023) were significantly higher for FDG PET/CT than MDCT. FDG PET/CT correctly changed the staging of PDAC in 56 patients (14%) (p=0.001). FDG PET/CT influenced management in 250 (45%) of patients. FDG PET/CT stopped futile resection in 58 patients (20%) due to have surgery. FDG PET/CT was associated with a QALY gain of 0.0157 (95% CI -0.0101, 0.0430) and cost saving of £645 (95% CI -£1314, £2743). In the base case model FDG PET/CT dominated MDCT alone and is likely to be cost effective for the UK NHS.
Conclusions: FDG PET/CT provided significant incremental diagnostic benefit in the diagnosis of pancreatic cancer and had a significant influence on the staging and management of patients. FDG PET/CT was cost effective at current reimbursement rates for FDG PET/CT to the UK NHS. Clinical trial information: 73852054.
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