A multidisciplinary steering committee has developed a set of comprehensive clinical recommendations to serve as a toolbox for pursuing primary systemic therapy (PST) in patients with early-stage breast cancer. The set of care suggestions was recently published in The Lancet Oncology, and has specifically been devised to help providers surmount “clinical and technical obstacles” associated with PST, including those at diagnosis, response assessment, surgical planning, and surgery,” according to the authors.

They elaborated, “ultimately, this guidance could convince clinicians and patients of a major clinical advance purported by PST by supporting the use of less extensive and more targeted surgery to improve the lives of patients with breast cancer.”

The panel included members from European scientific oncology societies, clinical trial groups, and patient advocates. The panel was tasked with voting on 130 statements or questions that spanned topics from diagnosis to surgery. Although PST is commonly used to treat patients with early-stage breast cancer, guidance on the best practices for locoregional intervention is lacking, providing the impetus for the guidelines.

Continue Reading

The panelists first reached a consensus that, before PST is given, a multidisciplinary team should complete a full evaluation of the patient eligible for preoperative treatment. Panelists nearly unanimously agreed (93%) that patients who are undergoing PST should be presented to a multidisciplinary team, and further, that experts from the 5 “core specialties”—surgery, medical oncology, radiology, pathology, and radiation oncology—be present for the diagnostic discussion.

All panelists agreed that all staging examinations, breast imaging, and pathological work-up need to be available to guide treatment decisions in the instance of PST. Most (93%) supported the facilitation of regular clinical visits between the patient and the specialist overseeing PST.

Each panelist also stated that biomarker status and nuclear grading should be evaluated for all patients before PST initiation, and a consensus was reached that evaluating Ki-67 expression before PST should be considered standard practice (82%). For hormone receptor-positive and HER2-negative breast cancer, panelists indicated that gene expression assays could guide treatment.

Regarding assessment of tumor response to PST, panelists were in favor of determining tumor response approximately halfway through PST (79%). The imaging modality used to evaluate response in these instances should be the same as that used for diagnosis, they attested.

Surgical recommendations included offering breast-conserving surgery to patients with stable disease and limited axillary surgery in patients with limited nodal involvement (cN1) and clinical complete responses. More than 3 disease-positive (75%) or matted lymph nodes (68%) at diagnosis were broadly considered to be signals for axillary lymph node dissection.

Panelists were in agreement that patient-reported outcomes be collected and patients photographed at various points—before surgery, before radiotherapy, and a year after locoregional treatment completion—to allow for “evaluation of aesthetic outcome.”

The panelists noted that most of their recommendations were drawn from studies with “low” levels of evidence and that, in many instances, recommendations were based on the experience of “contemporary practice by the panel experts.”

“Endorsing and implementing this toolbox in ongoing, and planned PST trials and prospectively including surgical endpoints can strengthen the level of evidence of current recommendations and offer future patients access to more evidence-based treatments,” the panelists concluded.

Disclosures: Some of the authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.


Dubsky P, Pinker K, Cardoso F, et al. Breast conservation and axillary management after primary systemic therapy in patients with early-stage breast cancer: the Lucerne toolbox. Lancet Oncol. 2021;22(1):e18-e28. doi:10.1016/S1470-2045(20)30580-5