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比较乳晕周围和肿瘤周围注射放射性示踪剂与蓝色染料用于保乳手术中前哨淋巴结检测的前瞻性多中心随机研究:FRANSENODE试验

Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial.

作者信息

Rodier Jean-François, Velten Michel, Wilt Marc, Martel Pierre, Ferron Gwanaël, Vaini-Elies Véronique, Mignotte Hervé, Brémond Alain, Classe Jean-Marc, Dravet François, Routiot Thierry, de Lara Christine Tunon, Avril Antoine, Lorimier Gérard, Fondrinier Eric, Houvenaeghel Gilles, Avigdor Sandrine

机构信息

French Comprehensive Cancer Centers of Strasbourg, Toulouse, Lyon, Nantes, Bordeaux, Marseille, France.

出版信息

J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.

DOI:10.1200/JCO.2006.08.4228
PMID:17485709
Abstract

PURPOSE

To determine the optimal injection path for blue dye and radiocolloid for sentinel lymph node (SLN) biopsy in early breast cancer.

PATIENTS AND METHODS

A prospective randomized multicentric study was initiated to compare the peritumoral (PT) injection site to the periareolar (PA) site in 449 patients.

RESULTS

The detection rate of axillary SLN by lymphoscintigraphy was significantly higher (P = .03) in the PA group (85.2%) than in the PT group (73.2%). Intraoperative detection rate by blue dye and/or gamma probe was similar (99.11%) in both groups. The rate of SLN detection was somewhat higher in the PA group than in the PT group: 95.6% versus 93.8% with blue dye (P = .24) and 98.2% versus 96.0% by probe (P = .16), respectively. The number of SLNs detected by lymphoscintigraphy and by probe was significantly higher in the PA group than in the PT group, 1.5 versus 1.2 (P = .001) and 1.9 versus 1.7 (P = .02). The blue and hot concordance was 95.6% in the PA group and 91.5% in the PT group (P = .08). The mean ex vivo count of the SLN was significantly higher in the PA group than in the PT group (P < .0001).

CONCLUSION

This study strongly validates the PA injection technique given the high detection rate (99.1%) of SLN and the high concordance (95.6%) between blue dye and the radiotracer, as well as higher significant ex and in vivo counts, improving SLN probe detection.

摘要

目的

确定早期乳腺癌前哨淋巴结(SLN)活检中蓝色染料和放射性胶体的最佳注射路径。

患者与方法

开展一项前瞻性随机多中心研究,比较449例患者瘤周(PT)注射部位与乳晕周围(PA)注射部位。

结果

PA组(85.2%)腋窝SLN的淋巴闪烁显像检测率显著高于PT组(73.2%)(P = 0.03)。两组术中蓝色染料和/或γ探测器的检测率相似(99.11%)。PA组SLN的检测率略高于PT组:蓝色染料检测率分别为95.6%和93.8%(P = 0.24),探测器检测率分别为98.2%和96.0%(P = 0.16)。PA组蓝色与热点一致性为95.6%,PT组为91.5%(P = 0.08)。PA组SLN的平均体外计数显著高于PT组(P < 0.0001)。

结论

鉴于SLN的高检测率(99.1%)、蓝色染料与放射性示踪剂之间的高一致性(95.6%)以及体内外计数更高,本研究有力地验证了PA注射技术,改善了SLN探测器检测。

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