Sentinel node procedure under local anesthesia in breast cancer patients. Lessons learned from a prematurely closed randomized clinical trial
Breast Cancer Reports
Purpose: Ideally, sentinel node status is known prior to breast surgery in breast cancer patients, so a treatment plan can be made before breast surgery. If indicated, a one-step surgical procedure can then be performed (breast surgery and axillary lymph node dissection at once). Previously, we demonstrated that 36.5% of breast cancer patients younger than 60 years with a breast carcinoma larger than 20 millimeters have macrometastatic axillary nodes. Therefore, we aimed that sentinel node
... sentinel node procedure (SNP) under local anesthesia (LA) reduces the number of two-stage surgical procedures in these patients with 30%. Methods: The AMBULANT study was a prospective trial examining patients aged 18 to 60 years with a breast carcinoma larger than 20 millimeters and without clinically or ultrasound-guided cytological evidence of axillary node involvement. Patients were randomized to undergo SNP under LA versus usual care. Number of operations, periprocedural parameters and psychological outcomes were evaluated. Results: The trial was prematurely closed, because of lower than expected patient accrual and new insights on breast cancer treatment. Twelve patients were included; five patients were randomized to SNP under LA and seven to usual care. Baseline characteristics were similar. SNP under LA did not reduce the number of twostage surgical procedures. Duration of SNP was significantly longer when performed under LA and three of five patients experienced too much pain during SNP under LA. Finally, SNP under LA negatively influences physical health. Conclusion: SNP under LA does not reduce the number of two-stage surgical procedures in breast cancer patients.