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Neoadjuvant Trials
•
Good
:
–
Small, fast
–
Pick-a-winner
–
pCR is a good surrogate
endpoint (FDA registrational
option)
–
DFS/OS can be collected in
same cohort
•
Bad
:
–
pCR only validated endpoint.
Irrelevant in many (ER+)
–
Quantitative relationship pCR to
DFS/OS not established
•
Trials underpowered for these
endpoints
–
Macromet = micromet?
–
Drugs must be well known
Newly diagnosed pt
Tumor in place
Therapeutic intent and
duration
Post-treatment clinical
and correlative data
Drug Rx