Rossi Carlo Riccardo, De Salvo Gian Luca, Trifirò Giuseppe, Mocellin Simone, Landi Giorgio, Macripò Giuseppe, Carcoforo Paolo, Ricotti Giuseppe, Giudice Giuseppe, Picciotto Franco, Donner Davide, Di Filippo Franco, Montesco Maria Cristina, Casara Dario, Schiavon Mauro, Foletto Mirto, Baldini Federica, Testori Alessandro
Clinica Chirurgica 2, Università di Padova, Padova, Italy.
J Nucl Med. 2006 Feb;47(2):234-41.
An observational multicentric Italian trial on sentinel node biopsy (SNB) in melanoma patients was performed to diffuse a common SNB protocol nationwide (Italy). We report herein the results of this trial. The influence of some technical aspects on the outcome of SNB was also investigated, because a certain degree of variability was accepted in performing lymphoscintigraphy.
From January 2000 to December 2002, 1,313 consecutive patients with primary cutaneous melanoma (Breslow thickness, >1.0 mm or <1.0 mm but with ulceration, Clark level IV-V, presence of regression) were enrolled by 23 centers. One half to 1 mL of 99mTc-labeled human albumin colloid, at a suggested dosage of 5-15 or 30-70 MBq, was injected intradermally, closely around the scar, the same day or the day before SNB. Intraoperatively, Patent blue was associated when a definitive wide excision of the primary was required. A positive sentinel node (SN) was defined when containing melanoma cells detected by either hematoxylin-eosin or immunohistochemistry (S100 and HMB45 antibodies). All patients underwent regular follow-up. False-negative cases were considered when lymph node metastases occurred in the same lymphatic basin of SN biopsy (SNB) during follow-up. A quality control program has been performed for the surgical procedure and for the histologic diagnosis.
The SN identification rate was 99.3%. The axilla was the site of the SN in 52.5% of the cases. The mean number of SNs was 2.0 (range, 1-17) and only 1 node was removed in 45.4%. The positivity and false-negative rates were 16.9% and 14.7%, respectively (median follow-up, 31 mo). On multivariate analysis (logistic and linear regression) only the number of peritumor injections was inversely associated with the number of excised SNs (P = 0.002), whereas none of the technical variables showed an independent impact on SN status when Breslow thickness was included as a control variable.
The number of peritumor injections seems to influence the outcome of lymphoscintigrapy in melanoma patients undergoing SNB. If these results are confirmed in a controlled trial, 3 injections at least should be recommended.
开展了一项针对黑色素瘤患者前哨淋巴结活检（SNB）的意大利多中心观察性试验，目的是在全国范围（意大利）推广通用的SNB方案。我们在此报告该试验结果。还研究了一些技术方面对SNB结果的影响，因为在进行淋巴闪烁造影时存在一定程度的变异性。
2000年1月至2002年12月，23个中心连续纳入1313例原发性皮肤黑色素瘤患者（Breslow厚度>1.0 mm或<1.0 mm但伴有溃疡、Clark分级IV - V级、存在消退）。在SNB当天或前一天，在瘢痕周围皮内注射0.5至1 mL 99mTc标记的人白蛋白胶体，建议剂量为5 - 15或30 - 70 MBq。术中，当需要对原发灶进行确定性广泛切除时，联合使用专利蓝。当通过苏木精 - 伊红染色或免疫组化（S100和HMB45抗体）检测到前哨淋巴结（SN）含有黑色素瘤细胞时，定义为前哨淋巴结阳性。所有患者均接受定期随访。当随访期间在SN活检（SNB）的同一淋巴引流区发生淋巴结转移时，视为假阴性病例。已对手术操作和组织学诊断实施了质量控制程序。
SN识别率为99.3%。52.5%的病例中腋窝是SN的部位。SN的平均数量为2.0（范围1 - 17），45.4%的病例仅切除1个淋巴结。阳性率和假阴性率分别为16.9%和14.7%（中位随访时间31个月）。多因素分析（逻辑回归和线性回归）显示，仅肿瘤周围注射次数与切除的SN数量呈负相关（P = 0.002），而当将Breslow厚度作为对照变量时，没有一个技术变量对SN状态显示出独立影响。
肿瘤周围注射次数似乎会影响接受SNB的黑色素瘤患者的淋巴闪烁造影结果。如果这些结果在对照试验中得到证实，至少应推荐进行3次注射。
