What Is the Best Management of cN0pN1(sn) Breast Cancer Patients

Abstract

Although the majority of breast cancer patients are clinically node-negative (cN0) at diagnosis, 15-20% will have a metastatic sentinel lymph node (SLN, pN1(sn)). While a less radical approach regarding axillary surgery in cN0 patients with a positive SLN biopsy is advocated, the limitations of 5 published trials on axillary management in pN1(sn) are discussed intensely in the literature and support the performance of ongoing validation and extension trials, especially considering the lack of data in the setting of mastectomy. As locoregional radiotherapy has a significant effect on both recurrence and survival, a standardization of locoregional radiotherapy in the situation of SLN biopsy alone in pN1(sn) patients has to be defined in the future, and de-escalation trials should embrace a truly multidisciplinary approach. This is also of utmost importance considering the fact that high-volume nodal disease requires an intensified adjuvant chemotherapy strategy to which patients omitting axillary dissection cannot be stratified. Finally, there is mounting evidence that the therapeutic role of extensive axillary surgery in low-volume nodal disease is negligible, and multidisciplinary and translational efforts must be undertaken to individualize treatment in order to gain a reasonable balance between necessary staging information and unnecessary treatment-related morbidity.

Do clinical trials truly mirror their target population? An external validity analysis of national register versus trial data from the Swedish prospective SENOMIC trial on sentinel node micrometastases in breast cancer

“…However, the generalizability of results has been questioned [13][14][15][16]. Both ACOSOG Z0011 and IBCSG 23-01 closed early due to slow accrual and low event rates, and the majority of included patients had favorable prognostic tumor characteristics [17,18].…”

Do clinical trials truly mirror their target population? An external validity analysis of national register versus trial data from the Swedish prospective SENOMIC trial on sentinel node micrometastases in breast cancer

“…However, the generalizability of results has been questioned [13–16]. Both ACOSOG Z0011 and IBCSG 23-01 closed early due to slow accrual and low event rates, and the majority of included patients had favorable prognostic tumor characteristics [17, 18].…”

Axillary Clearance Following Positive Sentinel Lymph Node Biopsy in Symptomatic Breast Cancer

“…To determine the risk or adverse effects of adjuvant chemotherapy may no longer be based on axillary staging alone, thus, it may be possible to reduce the need for automatic progression to axillary clearance in the presence of positive nodes in low-risk tumours. Although there is general consensus that ANC is not necessary in almost any patient with SNB-detected micrometastases (foci of tumour >0.2 mm and <2 mm) or isolated tumour cells (<0.2 mm) (5), persistent clinical equipoise remains about the correct management of SNBs with positive macrometastases (defined as foci of >2 mm) (6)(7)(8)(9).…”