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. 2015 Jun 10;2015(51):90–96. doi: 10.1093/jncimonographs/lgv023

Table 1.

Summary of most relevant recommendations*

Levels of recommendations Evidence
A core biopsy is essential for histological diagnosis in the initial assessment of a woman with a suspected breast tumor and to assess histological grade, HR status, and HER2 status Prospective cohort studies and expert opinion
Cytological examination is acceptable only to verify metastatic spread in the axillary lymph nodes Expert opinion
It is uncertain whether genomic signatures could add clinically useful information to standard immunohistochemistry in the prediction of patients with higher chance of pathological complete response after neoadjuvant chemotherapy Expert opinion
The best sequence of anthracyclines and taxanes still remain uncertain in neoadjuvant setting Randomized clinical trials and expert opinion
Due to its additive cardiac toxicity, trastuzumab should be combined with taxanes and not with anthracyclines Randomized clinical trials and expert opinion
Current evidence do not support the addition of antiangiogenic agents such as bevacizumab to neoadjuvant chemotherapy Randomized clinical trials and expert opinion
Platinum-based neoadjuvant therapy could be an option for triple-negative breast cancer Randomized clinical trials and expert opinion
Dual targeting of HER2 in combination with neoadjuvant chemotherapy is an option for HER2-positive disease Randomized clinical trials and expert opinion
Neoadjuvant endocrine therapy is an option in patients with HR-positive and HER2-negative breast cancer Randomized clinical trials and expert opinion
pCR do not satisfy the surrogacy criteria of long-term efficacy of neoadjuvant chemotherapy in unselected breast cancer Trial-based meta-analyses of randomized clinical trials
pCR can be a valid surrogate of treatment benefit in studies recruiting patients with high-risk triple-negative or HER2- positive breast cancer Expert opinion
ER-positive status is a negative predictor factor for pCR in HER2-positive breast cancer patients receiving neoadjuvant HER2-targeted therapies plus chemotherapy Randomized clinical trials and expert opinion
There is not enough evidence to support the in-course change of the initial PST regimen on the basis of the clinical response obtained after two chemotherapy cycles, outside a clinical trial Expert opinion
Ki67 expression measured either after short-term endocrine therapy or at posttreatment residual disease following neoadjuvant chemotherapy is a valid prognostic parameter, and a potential surrogate parameter of endocrine therapy efficacy Prospective cohort studies and expert opinion
PEPI score do not provide additional predictive information compared with posttreatment Ki67 alone Expert opinion
MRI is the reference imaging technique for the assessment of the extension of residual disease after PST Expert opinion
None of the imaging techniques available (ie, mammography, ultrasound, and FDG PET) provide sufficient accuracy in predicting the pathological residual disease Expert opinion
Residual disease after PST has a prognostic significance Prospective cohort studies and expert opinion
No adjuvant chemotherapy is recommended in patients with triple-negative breast cancer having a residual disease in breast or lymph nodes after a full course of neoadjuvant chemotherapy Expert opinion
There is not enough evidence supporting the omission or limitation of RT for women who achieve a pCR after PST Expert opinion
SLN biopsy after neoadjuvant chemotherapy is an accurate method of axillary staging; dual tracer detection and removal at least of two SLNs is mandatory to minimize the false-negative rate of the procedure Prospective clinical studies and expert opinion

*ER = estrogen receptor; FDG = fluorodeoxyglucose; HR = hormone receptor; MRI = magnetic resonance imaging; pCR = pathological complete response, PEPI = preoperative endocrine prognostic index; PET = positron emission tomography; PST = primary (neoadjuvant) systemic therapy; RT = radiotherapy; SLN = sentinel lymph node.