To address several questions that must be considered before adopting primary systemic therapy (PST) as a standard approach.
What is the response rate of primary therapy?
Will more patients be treated with breast-conservation therapy?
Will primary therapy improve the disease-free survival (DFS) and overall survival (OS) of patients with breast cancer?
Can response to primary therapy be correlated with outcome?
Are there clinical or biologic predictors of outcome?
Potential limitations of primary chemotherapy must also be considered.
Could an initially resectable tumour progress to an inoperable state?
How many patients will be overtreated?
Does the use of primary chemotherapy result in the loss of standard prognostic factors (e.g. tumour size, nodal involvement and hormone receptor status) that are normally used to guide the decision-making process for patients treated with standard post-operative adjuvant therapy?