Omission of sentinel node biopsy for breast cancer: Historical context and future perspectives on a modern controversy

Abstract

For older patients with clinically lymph node-negative breast cancer who have estrogen receptor-positive tumors and are treated with tamoxifen, randomized trials comparing axillary lymph node dissection (ALND) versus no ALND show that the omission of ALND improves patient quality of life and has no adverse effects on mortality. These results have served to justify sentinel node biopsy (SNB) omission in selected older patients with breast cancer. More recently, clinical trials were launched to assess SNB omission in younger patients, with recurrence and survival as the primary outcomes of interest. Three important considerations serve as the basis for these ongoing trials. First, it is assumed that SNB omission will improve patient quality of life, although, to date, there is no level I evidence to support this assumption. Second, axillary surgery has never been shown to reduce breast cancer mortality, but it does reduce the risk of axillary recurrences, although adjuvant systemic therapy and radiotherapy also reduce these recurrence risks. Finally, nodal status is losing importance as a guide for adjuvant systemic therapy decision making because these decisions are now increasingly predicated on tumor biomarkers and gene profiling, but it is gaining importance for adjuvant radiotherapy decision making. Because quality-of-life considerations are the primary motivation for abandoning SNB, there is a need for randomized trials comparing SNB versus no SNB/no axillary surgery, with quality of life as the primary end point (level I evidence). Moreover, suitable alternatives to guide adjuvant radiotherapy decision making will require validation before SNB omission can be justified for patients of all ages who have clinically nodenegative breast cancer.

Prognostic value of pathological nodal burden after neoadjuvant chemotherapy in initially cN0-1 breast cancer patients: a dual-center, 10-year survival analysis

“…Since then, a number of clinical studies have advocated the omission of axillary surgery in patients with a low lymph node tumor burden. 9 , 10 , 22 – 25 However, the negative effects of omitting axillary surgery on patient outcomes must be avoided. There are few data regarding the pathological nodal burden after NAC in breast cancer patients with initial cN0-1 and its prognostic value for long-term survival outcomes.…”

Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): a randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer

“…Because QoL considerations are the primary motivation for abandoning SLNB, there is a need for randomized trials with QoL as a defined endpoint. 8 Here we report for the first time comprehensive QoL data using patient-reported outcomes (PROs) for clinically node-negative patients with and without SLNB (Rando 1) and for SLNB-positive patients with and without completion ALND (Rando 2).…”

The Lucerne Toolbox 2 to optimise axillary management for early breast cancer: a multidisciplinary expert consensus

“…Subsequently, the role of any axillary surgical intervention has been challenged in clinically node-negative scenarios (cN0), leading to attempts to identify specific patient populations in which sentinel lymph node biopsy (SLNB) can be omitted. 6 In parallel, its role in axillary staging in patients with cN + disease with a clinical remission on primary systemic treatment (ycN0) is also being challenged. Existing guidelines for locoregional axillary management with surgery and radiation 7 , 8 , 9 are progressively questioned regarding their relevance in light of highly effective systemic therapies and the improved understanding of tumour biology, leading to wide variations in clinical practice between centres and countries.…”