Table 1.

Role of neoadjuvant and short presurgical studies in drug development in breast cancer

Type of studyEndpointNumber of patientsLength of follow-upTherapeuticUse for drug approvalCost
AdjuvantRelapse-free and overall survival1,000sYearsYesYesVery high
NeoadjuvantClinical and path CR100sMonthsYesYes (2013)High
Short presurgicalChange in biomarker (Ki67, TUNEL, P-AKT, etc.)Under 100WeeksNoNoNot as high

Abbreviation: TUNEL, terminal deoxynucleotidyl transferase–mediated dUTP nick end labeling.

Reproduced with modifications with permission from Dr. Mitch Dowsett, Royal Marsden Hospital, London, United Kingdom.