乳腺癌前哨淋巴结活检替代腋窝清扫术前瞻性非随机对照临床研究

Prospective non-randomized clinical study of sentinel lymph node biopsy substituting axillary lymph node dissection in breast cancer

目的:探讨前哨淋巴结活检术(sentinellymphnodebiopsy,SLNB)替代腋淋巴结切除术(axillarylymphnodedissection,ALND)的可行性。方法:联合应用亚甲蓝和99mTc标记的硫胶体进行SLNB。2001年12月起山东省肿瘤医院乳腺病中心两个治疗组收治的临床T1、2N0M0乳腺癌病人进入本前瞻性非随机对照临床研究。A组病人SLNB后均行ALND。B组病人签署知情同意书,不同意SLNB替代ALND病人(B1组)治疗同A组;同意SLNB替代ALND病人(B2组)依据SLN状况,SLN阴性仅行SLNB,SLN阳性行ALND。结果:2001年12月～2005年6月共入组642例病人,其中A组114例(17.8%),B组528例(82.2%),B1组195例,B2组333例。B2组病人SLN阴性240例仅行SLNB;SLN阳性93例,其中87例接受ALND,另6例SLN镜下微小转移灶者中4例仅行SLNB,2例接受SLNB加区域淋巴结放疗。SLNB替代ALND者各项术后并发症显著低于ALND者(均P<0.05)。B2组244例仅行SLNB病人中位随访26个月(7～48个月),2例病人发现区域淋巴结复发(0.82%),与ALND腋淋巴结阴性组病人(0%)相比差异无统计学意义(P>0.05)。SLN术中冰冻快速病理诊断准确率98.5%,假阴性率5.4%。结论:SLNB可以缩小手术范围、减少病人术后并发症。SLN术中冰冻快速病理诊断具有较高的准确性,能够满足临床需要。

Objective To study the possibility of substituting axillary lymph node dissection （ALND） by sentinel lymph node biopsy （SLNB） in breast cancer. Method Sentinel lymph nodel （SLN） was detected with the combination of methyhhionium and ^99mTc-sulfur colloid. The Prospective non-randomized clinical study was started from Dec. 2001 in the breast diseases center of Shandong Cancer Hospital And Institute. All the patients in Group A received ALND after SLNB, while those in Group B1 did not agree with substiring ALND by SLNB, and Group B2 agreed with ALND in case of negative SLN. Results From Dec. 2001 to Jun. 2005, 642 patients entered into the study, with 114, 195, and 333 cases in Groups A, B1, and B2, respectively. In Group B2, 240 patients with negative SLNs received SLNB only. While 87 of 93 patients with positive SLNs received ALND, four of the six patients with micrometastasis of the SLNs received SLNB only, and the other two received SLNB plus radiotherapy to the axilla. The complications of the SLNB cases were significantly less than the ALND cases （all P〈0.05）. With a median follow-up of 26 months （7-48 month）, only two patients had regional lymph node relapse （0.82%, P〉0.05）. The false negative rate and accuracy rate of SLN intra-operative frozen section diagnosis were 5.4% and 98.5%, respectively. Conclusions SLNB instead of ALND could decrease the extent of surgery and postoperative complications in breast cancer patients with negative SLN. Intra-operative frozen section detection of SLN has a high accuracy rate and a low false negative rate.