NcXHF

WHITE AND DEMICHELE
signed with appropriate endpoints, sample size, and patient
populations. pCR may be a proximate surrogate endpoint
that can speed the process of identifying promising new therapies,
but its ability to accurately predict meaningful, longterm
outcomes has not yet been established. More work is
necessary to determine the magnitude of increase in pCR
within specifıc breast cancer populations that will lead to improvement
in EFS, so that only the most promising agents
move forward to confırmatory trials. In the interim, increases
in pCR may lead to accelerated approval of new drugs or new
therapeutic strategies with existing agents that can benefıt patients.
But these proximate benefıts must be weighed against
toxicity and treatment effect of these agents that could potentially
undermine later outcomes.
Disclosures of Potential Conflicts of Interest
Relationships are considered self-held and compensated unless otherwise noted. Relationships marked “L” indicate leadership positions. Relationships marked “I” are those held by an immediate
family member; those marked “B” are held by the author and an immediate family member. Institutional relationships are marked “Inst.” Relationships marked “U” are uncompensated.
Employment: None. Leadership Position: None. Stock or Other Ownership Interests: None. Honoraria: Angela DeMichele, Pfizer Oncology. Julia R. White,
Bayer Healthcare, Genomic Health, Qfix, Varian. Consulting or Advisory Role: None. Speakers’ Bureau: None. Research Funding: Angela DeMichele, Bayer
(Inst), Calithera (Inst), Genentech (Inst), GlaxoSmithKline (Inst), Incyte (Inst), Millenium (Inst), Pfizer (Inst), Veridex (Inst), Wyeth-Ayerst (Inst). Patents,
Royalties, or Other Intellectual Property: None. Expert Testimony: None. Travel, Accommodations, Expenses: Angela DeMichele, Pfizer Oncology.
Other Relationships: None.
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