Less than half of the patients with occult nodal metastases in the NSABP B-04 trial, developed clinically detectable lymph nodes during follow-up, none of these patients received adjuvant systemic or RT. For instance, it is assumed that biology plays an important role in dormancy of nodal metastases. Several factors besides surgery have proven to decrease RR rates. Therefore, axillary ultrasound improves preoperative selection of node negative patients, as it selects patients with a more favourable tumour load and confidently excludes advanced nodal disease. Furthermore, a negative axillary ultrasound excludes the presence of four or more lymph node metastases, with a negative predictive value of 93–96% in the general breast cancer population. The sensitivity of axillary ultrasound (in combination with tissue sampling where deemed necessary) is approximately 80%. In the Netherlands, axillary ultrasound is part of standard preoperative axillary work-up. Preoperative nodal staging with physical examination has a low accuracy, with a sensitivity of only 32%. Since the outcome of the SLNB has no clinical consequence, the value of the SLNB itself is being questioned.Ĭlinically node negative status in the NSABP B-04, ACOSOG Z0011 and IBCSG 23–01 trials was based on negative physical examination of the axilla. These studies indicated that completion ALND can be safely omitted in presence of positive SLN(s) in patients treated with BCT and adjuvant systemic treatment. Despite the fact that nodal metastases remained in situ in a considerable percentage of patients in the ‘watchful waiting’ groups, omitting completion ALND did not result in inferior regional recurrence (RR) rates, DFS and OS after 5-years of follow-up. Additional lymph node metastases beyond the SLN were detected in 27% (ACOSOG Z0011) and 11% (IBCSG 23–01) in the ALND groups. Patients in these trials were randomized to completion ALND or watchful waiting. Most patients were treated with adjuvant systemic treatment (both 97%). The IBCSG 23–01 trial only included patients with a micrometastasis in the SLN, but gave no restriction on type of breast surgery. The ACOSOG Z0011 trial included patients with 1–2 macrometastatic SLN(s) who were treated with breast conserving therapy (BCT). The more recent American College of Surgeons Oncology Group (ACOSOG) Z0011 and International Breast Cancer Study Group (IBCSG) 23–01 trials investigated whether completion ALND can be safely omitted in patients with a metastasis in the SLN. Nevertheless, omitting ALND in clinically node negative patients did not affect DFS and OS, even after 25 years of follow-up and without adjuvant RT or systemic therapy. During follow-up, ipsilateral lymph nodes became clinically apparent in less than half of these patients (18.6%). About 40% of the patients who underwent mastectomy-only had lymph node metastases that were not removed at the time of initial surgery. Patients were randomized for mastectomy-only, mastectomy with ALND or mastectomy with axillary radiotherapy (RT). This trial revealed that omitting ALND in clinically node negative patients did not affect disease-free survival (DFS) and overall survival (OS). Įver since the National Surgical Adjuvant Breast and Bowel Project (NSABP B-04) trial, the need for completion axillary treatment for clinically node negative patients has been questioned. Most reported complications are axillary seroma, wound infections, hematoma, anaphylactic reaction, axillary paresthesia, and lymphedema, which is described in 8% of patients after a follow-up of only 3 years, resulting in significant reduction of quality of life (QoL) of breast cancer survivors. Although SLNB is less invasive compared to ALND, short-term complications still occur in 25% of the patients. The SLN is negative in approximately 74% of patients in a general breast cancer population. In case of a negative sentinel lymph node (SLN) an axillary lymph node dissection (ALND) was omitted. More than fifteen years ago, the sentinel lymph node biopsy (SLNB) was introduced in clinically node negative breast cancer patients to evaluate their lymph node status for diagnostic purposes.
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