Wagner Jeffrey D, Schauwecker Donald, Davidson Darrell, Logan Theodore, Coleman John J, Hutchins Gary, Love Charlene, Wenck Stacie, Daggy Joanne
Department of Surgery, Indiana University School of Medicine, Indiana University-Purdue University at Indianapolis, Suite 570 Clearvista Parkway, Indianapolis, IN 46556, USA.
Cancer. 2005 Aug 1;104(3):570-9. doi: 10.1002/cncr.21189.
The purpose of the current study was to determine the sensitivity and specificity of initial F-18 fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) scanning for detection of occult lymph node and distant metastases in patients with early-stage cutaneous melanoma.
The authors conducted a prospective nonrandomized clinical trial. Inclusion criteria were patients with cutaneous melanoma tumors > 1.0 mm Breslow thickness, local disease recurrence, or solitary intransit metastases without regional lymph or distant metastases by standard clinical evaluation. All patients underwent whole-body FDG-PET scanning before surgical therapy. Abnormal PET findings were studied by targeted conventional imaging and/or biopsy. FDG-PET scans were interpreted in a blinded fashion. Regional lymph node basins were staged by sentinel lymph node biopsy (SLNB). PET scan findings in regional lymph nodes were compared with histology of SLNB specimens. Abnormal distant PET scan findings were studied with repeat conventional scan imaging at 3-6 months and were correlated with the first site(s) of clinical disease recurrence. Blinded PET scan findings were correlated with all information to determine sensitivity and specificity.
There were 144 assessable patients with a mean tumor depth of 2.8 mm. The median follow-up for these patients was 41.4 months. Blinded interpretations of FDG-PET scan images showed that 31 patients (21%) had signs of metastatic disease, 13 patients had probable regional lymph node metastases, and 18 patients had 23 sites of possible distant metastases. SLNB and/or follow-up demonstrated regional lymph node metastases in 43 of 184 lymph node basins in 40 patients (27.8%). Compared with all clinical information, FDG-PET scan sensitivity for detection of regional lymph node metastases was 0.21 (95% confidence [CI], 0.10-0.36) and specificity was 0.97 (95% CI, 0.93-0.99). No distant sites were confirmed to be true positive by targeted conventional imaging/biopsy at the time of presentation. Thirty-four patients (23.6%) presented with 54 foci of metastatic disease at initial disease recurrence. FDG-PET scan sensitivity for prediction of the first site(s) of clinical disease recurrence was 0.11 (95% CI, 0.04-0.23). Excluding patients with brain metastases, FDG-PET scan sensitivity for detection of occult Stage IV disease in patients was 0.04 (95% CI, 0.001-0.20) and specificity was 0.86 (95% CI, 0.79-0.92).
FDG-PET scanning did not impact the care of patients with early-stage melanoma already staged by standard techniques. Routine FDG-PET scanning was not recommended for the initial staging evaluation in this population.
本研究的目的是确定初始F-18氟脱氧-D-葡萄糖正电子发射断层扫描（FDG-PET）对早期皮肤黑色素瘤患者隐匿性淋巴结及远处转移灶检测的敏感性和特异性。
作者进行了一项前瞻性非随机临床试验。纳入标准为皮肤黑色素瘤肿瘤 Breslow 厚度＞1.0 mm、局部疾病复发或孤立性皮内转移且经标准临床评估无区域淋巴结或远处转移的患者。所有患者在手术治疗前行全身FDG-PET扫描。对PET异常发现进行靶向传统成像和/或活检研究。FDG-PET扫描采用盲法解读。区域淋巴结区域通过前哨淋巴结活检（SLNB）进行分期。将区域淋巴结的PET扫描结果与SLNB标本的组织学结果进行比较。对异常的远处PET扫描发现，在3 - 6个月时进行重复传统扫描成像研究，并与临床疾病复发的首个部位相关联。将盲法PET扫描结果与所有信息相关联以确定敏感性和特异性。
有144例可评估患者，平均肿瘤深度为2.8 mm。这些患者的中位随访时间为41.4个月。FDG-PET扫描图像的盲法解读显示，31例患者（21%）有转移疾病迹象，13例患者可能有区域淋巴结转移，18例患者有23个可能的远处转移部位。SLNB和/或随访显示，40例患者（27.8%）的184个淋巴结区域中有43个存在区域淋巴结转移。与所有临床信息相比，FDG-PET扫描检测区域淋巴结转移的敏感性为0.21（95%置信区间[CI]，0.10 - 0.36），特异性为0.97（95% CI，0.93 - 0.99）。在就诊时，通过靶向传统成像/活检未确认有远处部位为真阳性。34例患者（23.6%）在初始疾病复发时出现54个转移病灶。FDG-PET扫描预测临床疾病复发首个部位的敏感性为0.11（95% CI，0.04 - 0.23）。排除脑转移患者后，FDG-PET扫描检测患者隐匿性IV期疾病的敏感性为0.04（95% CI，0.001 - 0.20），特异性为0.86（95% CI，0.79 - 0.92）。
FDG-PET扫描对已通过标准技术分期的早期黑色素瘤患者的治疗没有影响。不建议对该人群进行常规FDG-PET扫描用于初始分期评估。
