title: Clinical and radiologic assessments to predict breast cancer pathologic complete response to neoadjuvant chemotherapy.
abstract: OBJECTIVE
  To prospectively compare the ability of clinical examination, mammography, vascularity-sensitive ultrasound, and magnetic resonance imaging (MRI) to determine pathologic complete response (CR) in breast cancer patients undergoing neoadjuvant chemotherapy.
  
  
  METHODS
  Participants were women with primary measurable, operable invasive breast cancer (Stages I-III) who presented to the University of Michigan Breast Care Center. Eligibility criteria were based on clinical need for chemotherapy as part of the overall treatment plan. The chemotherapy consisted of doxorubicin and docetaxel administered every 3 weeks for four cycles. Tumor size measurements by physical examination and by the three imaging modalities were performed before chemotherapy was initiated and after its completion, prior to definitive surgery. Response criteria were pre-specified in this prospective design, and study radiologists analyzed the mammographic, sonographic and MRI image sets blinded to information from the other modalities and blinded to final histological diagnosis. The pathologic CR rate obtained by the clinical and imaging modalities was compared to pathologic CR as determined pathologically.
  
  
  RESULTS
  41 of 43 enrolled patients had a determination of pathologic response, and 4 patients had a pathologic CR to this chemotherapy (9.8%). The accuracy of physical examination, mammography, ultrasound, and MRI in determining pathologic CR was 75, 89, 82, and 89% respectively (NS).
  
  
  CONCLUSIONS
  Biopsy after neoadjuvant chemotherapy remains absolutely necessary to determine pathologic CR to neoadjuvant chemotherapy, as the accuracy of current imaging modalities is insufficient to make this determination. The accuracy of mammography, vascularity-sensitive ultrasound, and MRI were not observed to be significantly different.
authors.affiliation: Hematology/Oncology Division, Department of Internal Medicine, University of Michigan, MI 48109-0848, USA. aschott@umich.edu
authors.forename: Anne F
authors.initials: AF
authors.lastname: Schott
authors.forename: Marilyn A
authors.initials: MA
authors.lastname: Roubidoux
authors.forename: Mark A
authors.initials: MA
authors.lastname: Helvie
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Celina G
authors.initials: CG
authors.lastname: Kleer
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Newman
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Pierce
authors.forename: Kent A
authors.initials: KA
authors.lastname: Griffith
authors.forename: Susan
authors.initials: S
authors.lastname: Murray
authors.forename: Karen A
authors.initials: KA
authors.lastname: Hunt
authors.forename: Chintana
authors.initials: C
authors.lastname: Paramagul
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Baker
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000494:pharmacology; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology*; D003952:Diagnostic Imaging / Q000379:methods; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000494:pharmacology; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008327:Mammography; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D018365:Neoplasm, Residual / Q000473:pathology*; D010173:Palpation; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D043823:Taxoids / Q000008:administration & dosage / Q000494:pharmacology; D016217:Ultrasonography, Mammary
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin