双示踪法应用在早期乳腺癌前哨淋巴结活检术的远期随访结果及预后分析

The long-term safety and prognosis analysis of tracer sentinel lymph node biopsy using indocyanine green and methylene blue in early breast cancer

目的探讨吲哚菁绿(ICG)联合亚甲蓝(MB)双示踪法行乳腺癌前哨淋巴结活检术(SLNB)的远期随访结果及安全性,分析早期乳腺癌患者的复发转移特征及预后。方法连续入组2014年1月1日至12月31日期间承德医学院附属医院收治的乳腺癌患者394例,分析符合纳入标准的222例患者的基线资料及临床病理特征。结果 222例患者中位随访时间57个月,单独使用ICG或MB的前哨淋巴结(SLN)检出率分别为96.4%和84.7%(P<0.001),检出SLN个数分别为740枚和604枚(P<0.001),阳性SLN检出率分别为100%和91%(P=0.014),阳性SLN检出个数分别为221枚和195枚(P<0.001)。未行腋窝淋巴结清扫(ALND)患者与行ALND患者的局部复发率分别为0.7%和1.4%(P=0.57),远处转移率分别为5.3%和15.7%(P=0.01),5年的总生存率(OS)分别为94.7%和91.7%(P=0.421),无病生存率(DFS)分别为90.8%和85.7%(P=0.285)。222例患者术后1、3、5年的OS分别为100%、96.8%、94.1%;DFS分别为100%、96.4%、89.2%。多因素COX回归模型显示:患者年龄≤50岁,分子分型为三阴性及原发肿瘤>2 cm均为影响患者预后的独立危险因素,其HR分别为3.254、7.321、3.507(均P<0.05)。结论吲哚菁绿联合亚甲蓝双示踪法行乳腺癌前哨淋巴结活检术是安全可靠的腋窝分期术式。患者年龄较小,分子分型为三阴性及原发肿瘤较大均为影响乳腺癌患者术后预后的独立危险因素。

Objective The aim of the study is analyze the recurrence,metastasis and prognosis of early breast cancer patients and evaluate the long-term safety of tracer sentinel lymph node biopsy(SLNB)using indocyanine green(ICG)and methylene blue(MB)in early breast cancer.Methods A total of 394 breast cancer patients were enrolled from Januaiy 1,2014 to December 31,2014 in Affiliated Hospital of Chengde Medical Lniversity.The baseline data and clinical characteristics of 222 patients who met llir inclusion criteria were analyzed.Results The median follow-up time of 222 patients was 57 months.The detection rate of sentinel lymph nodes(SLNs)using ICG or MB alone was 96.4%and 84.7%(P=0.02);the number of SLNs detected was 740 and 604(P<0.001);the positive SLN detection rates were 100%and 91%(P=0.014),and the positive SLNs were 221 and 195(P<0.001).The local rec urrence rates were 0.7%in patients without axillary lymph node dissection(ALND)and 1.4%(P=0.57)in patients with ALND,and the distant metastasis rates were 5.3%and 15.7%(P=0.01),respectively.I'he 5-year overall survival(OS)was 4.7%and 91.7%(P=0.421),and the disease-free survival(DFS)was 90.5%and 85.9%(P=0.285).The OS and DFS of the 222 patients were 100%,96.8%,94.1%and 100%,96.4%and 89.2%respectively at 1,3 and 5 years after 0.05).Conclusions Sentinel lymph node biopsy with indocyanine green combined with methylene blue is a safe and reliable method for axillary staging of breast cancer.The COX regression models showed that patients with younger age,three-negative molecular type and larger primary tumor were more likely to have adverse events.operation.Muhivariate COX regression model showed that age V5years old,triple negative molecular classification and primary tumor>2 cm were independent risk factors for prognosis,and HR were 3.254,7.321 and 3.507,respectively(all P<0.05).Conclusions Sentinel lymph node biopsy with indocyanine green combined with methylene blue is a safe and reliable method for axillary staging of breast cancer.The COX regression models showed that patients with younger age,three-negative molecular type and larger primary tumor were more likely to have adverse events.