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.