Table 2.
Parameter | Neoadjuvant trials | Adjuvant trials |
---|---|---|
Definition | Treatment given before surgery | Treatment given after surgery |
Sample size | Smaller | Larger |
End points | Response rates and duration (pCR, EFS) | Relapse and survival (DFS, overall survival) |
Time taken to complete | Months | Years |
Costs | Lower | Higher |
Advantages | Tumour downstaging—that is, converting a previously unresectable, locally advanced breast cancer to an operable tumour Enables early assessment of response to treatment Response-guided therapeutic planning is possible Enables comparison of the characteristics of pretreatment and post-treatment tumour samples (in those without a pCR), which might facilitate biomarker discovery, prognostication, patient stratification, and assessment of responses to therapy |
Designed to increase the chance of long-term survival Quality-of-life questionnaires can be used to assess the long-term effects of treatment in multiple domains |
Disadvantages | Local tumour control might be delayed Complicates pathological assessments and staging In some circumstances, duration of drug exposure is shorter, which might reduce its effectiveness Less long-term safety information is available Potential for selection of resistant clones owing to relatively high disease burden at the time of systemic treatment |
Risk of exposing a large number of patients to treatment that is more toxic and/or no more (or even less) effective than the current standard of care Precludes assessment of response to systemic treatment and, thus, does not enable response-guided treatment planning |
DFS, disease-free survival; EFS, event-free survival; pCR, pathological complete response.