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J Natl Cancer Inst Monogr. 2011;2011(43):120-3. doi: 10.1093/jncimonographs/lgr034.

Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer.

Author information

1
Academic Department of Biochemistry, Royal Marsden Hospital, London SW3 6JJ, UK. mitch.dowsett@icr.ac.uk

Abstract

The preoperative setting is increasingly popular for the clinical investigation of hormonal agents and new biological drugs. The effectiveness of endocrine agents is well established for estrogen receptor-positive disease, and the emphasis in preoperative studies is on their combination with agents targeted at resistance mechanisms over 3 or more months. New agents are also being assessed for early evidence of clinical efficacy in shorter-term window-of-opportunity studies. The establishment of Ki67 as an intermediate marker of treatment benefit and of long-term outcome, with endocrine drugs, provides the opportunity for new trial designs with Ki67 as the primary endpoint. The PeriOperative Endocrine Therapy for Individualizing Care (POETIC) trial is randomizing (2:1) 4000 estrogen receptor-positive patients to 2 weeks presurgical treatment with a nonsteroidal aromatase inhibitor or no presurgical treatment. It provides a unique opportunity for detailed study of the determinants of response and resistance to estrogen deprivation as well as testing the role of presurgical therapy for improved biomarker-based estimates of prognosis.

PMID:
22043057
DOI:
10.1093/jncimonographs/lgr034
[Indexed for MEDLINE]

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