The aim of this multicenter retrospective cohort study is to determine the safety of omission of axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy.
Chemotherapy before surgery, known as neoadjuvant chemotherapy (NAC), is often used to treat patients with advanced breast cancer or aggressive early-stage breast cancer. Research shows that about one in four early-stage breast cancer patients receives this treatment. For patients undergoing NAC, standard of care includes checking the lymph nodes under the arm (axillary lymph nodes) using a procedure called Sentinel lymph node biopsy to determine if the cancer has spread. In cases where the cancer has spread to the lymph nodes but then shrinks or disappears after chemotherapy, special techniques like dual tracer mapping, targeted axillary dissection, or the Marking Axillary Lymph Nodes with Iodine Seeds procedure are used to ensure accurate biopsy results. For patients whose cancer shrinks completely in the lymph nodes, it is generally safe to skip further surgery to remove more lymph nodes, a procedure called axillary lymph node dissection (ALND). However, if cancer remains in the lymph nodes, more lymph nodes are typically removed because there is a high chance that cancer is still present. An increasing number of surgeons are starting to omit ALND, especially when only tiny amounts of cancer (micrometastases) remain. To ensure this practice is safe, real-world data on patient outcomes over time is needed. This multicenter retrospective cohort study aims to assess the safety of omitting ALND in patients with residual micrometastases after NAC for breast cancer. The study analyzes data of breast cancer patients treated between 2013 and 2024 at more than 50 centers that are part of the Oncoplastic Breast Consortium. The results of this study will provide valuable information to help doctors determine the best treatment approach for their patients.
Study Type
OBSERVATIONAL
Enrollment
2,000
5-year rate of any axillary recurrence
Assessment of the incidence of any axillary recurrence, which is defined as isolated or combined with local or distant recurrence.
Time frame: 5 years
5-year rate of isolated axillary recurrence
Assessment of the incidence of isolated axillary recurrence.
Time frame: 5 years
Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection
The incidence of axillary recurrence is compared between patients that were treated with and without axillary dissection.
Time frame: 5 years
Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection
Assessment of the proportion of patients with additional micro- and macrometastases that were removed by axillary lymph node dissection.
Time frame: 5 years
5-year rates of locoregional and any invasive recurrence
Assessment of the incidence of locoregional and any invasive recurrence.
Time frame: 5 years
Comparison of 5-year rate of locoregional and any invasive recurrence in patients treated with and without axillary lymph node dissection
The incidence of locoregional and any invasive recurrence is compared between patients that were treated with and without axillary lymph node dissection.
Time frame: 5 years
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