title: Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer.
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.
authors: Academic Department of Biochemistry, Royal Marsden Hospital, London SW3 6JJ, UK. mitch.dowsett@icr.ac.uk
authors: Mitch
authors: M
authors: Dowsett
authors: Ian
authors: I
authors: Smith
authors: John
authors: J
authors: Robertson
authors: Laura
authors: L
authors: Robison
authors: Isabel
authors: I
authors: Pinhel
authors: Lindsay
authors: L
authors: Johnson
authors: Janine
authors: J
authors: Salter
authors: Anita
authors: A
authors: Dunbier
authors: Helen
authors: H
authors: Anderson
authors: Zara
authors: Z
authors: Ghazoui
authors: Tony
authors: T
authors: Skene
authors: Abigail
authors: A
authors: Evans
authors: Roger
authors: R
authors: A'Hern
authors: Amanda
authors: A
authors: Iskender
authors: Maggie
authors: M
authors: Wilcox
authors: Judith
authors: J
authors: Bliss
mesh_terms: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic / Q000941:ethics; D000069347:Erlotinib Hydrochloride; D005260:Female; D000077156:Gefitinib; D006801:Humans; D019394:Ki-67 Antigen / Q000378:metabolism; D000077341:Lapatinib; D058990:Molecular Targeted Therapy; D015337:Multicenter Studies as Topic; D020360:Neoadjuvant Therapy / Q000379:methods; D009570:Nitriles / Q000008:administration & dosage; D011237:Predictive Value of Tests; D057234:Preoperative Period; D011799:Quinazolines / Q000008:administration & dosage; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D019394:Ki-67 Antigen; D009570:Nitriles; D011799:Quinazolines; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D014230:Triazoles; D013629:Tamoxifen; D000077341:Lapatinib; C060523:vorozole; D000077384:Anastrozole; D000069347:Erlotinib Hydrochloride; D000077156:Gefitinib