Bass S S, Cox C E, Ku N N, Berman C, Reintgen D S
H Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.
J Am Coll Surg. 1999 Aug;189(2):183-94. doi: 10.1016/s1072-7515(99)00130-1.
Lymphatic mapping and sentinel lymph node (SLN) biopsy are new techniques that accurately provide crucial staging information while inflicting far less morbidity than complete axillary dissection. As these techniques continue to gain acceptance, issues such as adequacy of training, certification, and outcomes measures become increasingly important. The purpose of this paper is to report the initial lymphatic mapping experience at the H Lee Moffitt Cancer Center and Research Institute and to provide a detailed description of the technical aspects of lymphatic mapping.
From April 1994 to April 1998, 700 patients with newly diagnosed breast cancers underwent an IRB-approved prospective trial of lymphatic mapping using a combination of Lymphazurin (USSC, Norwalk, CT) blue dye and filtered technetium 99m-labeled sulfur-colloid. Failure of the procedure was defined as the inability to detect an SLN by either radiocolloid uptake within a lymph node by the gamma probe or the inability to visualize blue staining of a lymph node. Learning curves were then generated as the failure rate versus serial number of patients for each of the 5 surgeons involved in this study.
The SLN was identified in 665 of 700 patients (95.0%). A total of 1,348 SLNs were successfully removed, of which 238 (17.7%) were positive for metastatic disease in 176 of 665 patients (26.5%). In patients who underwent a complete axillary dissection after SLN biopsy, SLNs were identified in 173 of 186 patients (93.0%). Of the 173 patients, 53 patients (30.6%) had positive SLNs and 120 patients (69.4%) had negative SLNs. In the 120 patients with negative SLNs, one patient was found to have disease on complete dissection, for a false-negative rate of 0.83% (95% CI: 0.02%, 4.6%). A learning curve representing the mean of the 5 surgeons' experience indicates that on average 23 patients are required by an individual surgeon to achieve a 90% +/- 4.5% success rate and 53 patients are required to achieve a 95% +/- 2.3% success rate (p = 0.05).
These data validate lymphatic mapping and SLN biopsy as indispensable tools in the surgical treatment of breast cancer. With adequate multidisciplinary training, these techniques can be readily implemented at institutions treating breast cancer.
淋巴绘图和前哨淋巴结(SLN)活检是新技术,能准确提供关键的分期信息,同时其造成的发病率远低于完整腋窝淋巴结清扫术。随着这些技术越来越被接受,诸如培训充分性、认证和结果测量等问题变得越来越重要。本文的目的是报告H·李·莫菲特癌症中心和研究所的初始淋巴绘图经验,并详细描述淋巴绘图的技术方面。
从1994年4月至1998年4月,700例新诊断乳腺癌患者接受了一项经机构审查委员会批准的前瞻性试验,使用Lymphazurin(USSC,诺沃克,康涅狄格州)蓝色染料和过滤后的锝99m标记硫胶体联合进行淋巴绘图。该操作失败定义为通过γ探针无法检测到淋巴结内的放射性胶体摄取,或无法看到淋巴结的蓝色染色。然后根据参与本研究的5位外科医生中每位医生的失败率与患者序列号生成学习曲线。
700例患者中有665例(95.0%)识别出前哨淋巴结。共成功切除1348个前哨淋巴结,其中238个(17.7%)在665例患者中的176例(26.5%)有转移疾病阳性。在前哨淋巴结活检后接受完整腋窝淋巴结清扫术的患者中,186例患者中有173例(93.0%)识别出前哨淋巴结。在这173例患者中,53例患者(30.6%)前哨淋巴结阳性,120例患者(69.4%)前哨淋巴结阴性。在120例前哨淋巴结阴性的患者中,1例患者在完整清扫时发现有疾病,假阴性率为0.83%(95%可信区间:0.02%,4.6%)。代表5位外科医生经验均值的学习曲线表明,每位外科医生平均需要23例患者才能达到90%±4.5%的成功率,需要53例患者才能达到95%±2.3%的成功率(p = 0.05)。
这些数据证实淋巴绘图和前哨淋巴结活检是乳腺癌外科治疗中不可或缺的工具。经过充分的多学科培训,这些技术可以在治疗乳腺癌的机构中轻松实施。