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

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 methylthionium 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 P0.05).With a median follow-up of 26 months(7-48 month),only two patients had regional lymph node relapse(0.82%,P0.05).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.