title: Response evaluation after primary systemic therapy of Her2 positive breast cancer – an observational cross-sectional study.
abstract: OBJECTIVE
  To evaluate (I) trastuzumab-containing primary systemic therapy (PST) in human epidermal growth factor receptor 2 (Her2) overexpressing breast carcinomas.; (II) compare the patients who achieved and those who did not achieve pathological complete remission (pCR), and (III) analyze the accuracy of different clinical-imaging modalities in tumor response monitoring.
  
  
  METHODS
  188 patients who received PST between 2008 and 2014 were reviewed and 43 Her2 overexpressing breast cancer patients (28 Luminal B/Her2-positive and 15 Her2-positive) were enrolled. 26 patients received mostly taxane-based PST without trastuzumab (Group 1) and 17 patients received trastuzumab-containing PST (Group 2). We compared the concordance between pCR and complete remission (CR) defined by breast-ultrasound, CR defined by standard 18F-fluoro-deoxy-glucose positron emission tomography and computerized tomography (FDG-PET/CT) criteria (Method 1) and CR defined by a novel, breast cancer specific FDG-PET/CT criteria (Method 2). Sensitivity (sens), specificity (spec), and positive (PPV) and negative predictive values (NPV) were calculated.
  
  
  RESULTS
  Ten patients (38.5%) in Group 1 and eight (47%) in Group 2 achieved pCR. pCR was significantly more frequent in Her2-positive than in Luminal B/Her2-positive tumors in both Group 1: (P=0.043) and Group 2: (P=0.029). PET/CT evaluated by the breast cancer specific criteria (Method 2) differentiated pCR from non-pCR more accurately in both groups (Group 1: sens=77.8%, spec=%, PPV=100%, NPV=71.4%; Group 2: sens=87.5%, spec=62.5%, PPV=70%, NPV=83.3%) than standard PET/CT criteria (Method 1) (Group 1: sens=22.2% spec=100% PPV=100% NPV=41.7%; in Group 2: sens=37.5%, spec=87.5%, PPV=75% NPV=58.3%) or breast ultrasound (Group 1, sens=83.3% spec=25% PPV=62.5% NPV=50%; Group 2, sens=100% spec=12.5% PPV=41.6% NPV=100%).
  
  
  CONCLUSIONS
  The benefit of targeted treatment with trastuzumab-containing PST in Her2 overexpressing breast cancer was defined in terms of pCR rate. Luminal B/Her2-positive subtype needs further subdivision to identify patients who would benefit from PST. Combined evaluation of tumor response by our novel, breast cancer specific FDG-PET/CT criteria accurately differentiated pCR from non-pCR patients.
authors.forename: Tímea
authors.initials: T
authors.lastname: Tőkés
authors.forename: Gyöngyvér
authors.initials: G
authors.lastname: Szentmártoni
authors.forename: László
authors.initials: L
authors.lastname: Torgyík
authors.forename: Kornélia
authors.initials: K
authors.lastname: Kajáry
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Lengyel
authors.forename: Tamás
authors.initials: T
authors.lastname: Györke
authors.forename: Béla Á
authors.initials: BÁ
authors.lastname: Molnár
authors.forename: Anna-Mária
authors.initials: AM
authors.lastname: Tőkés
authors.forename: Janina
authors.initials: J
authors.lastname: Kulka
authors.affiliation: Magdolna Dank, Semmelweis University, 1st Dept. of Internal Medicine, Oncological Division, Tömő street 25-29. 4th floor, Budapest, Hungary, H- 1083., tokes.timea@med.semmelweis-univ.hu.
authors.forename: Magdolna
authors.initials: M
authors.lastname: Dank
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D016190:Carboplatin / Q000008:administration & dosage; D003430:Cross-Sectional Studies; D000077143:Docetaxel; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D008875:Middle Aged; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012680:Sensitivity and Specificity; D043823:Taxoids / Q000008:administration & dosage; D014057:Tomography, X-Ray Computed; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D000077143:Docetaxel; D019788:Fluorodeoxyglucose F18; D019275:Radiopharmaceuticals; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human