title: Specialized pathology review in patients with ovarian cancer: results from a prospective study.
abstract: BACKGROUND
  A significant number of ovarian borderline tumors (BOTs) and metastatic nonovarian primaries are erroneously diagnosed as ovarian carcinomas. If BOTs are misdiagnosed as cancer, patients may not only experience nonbeneficial morbidity but may have to cope with an incorrect diagnosis of cancer for the rest of their lives. In cases of metastatic disease mistaken for an ovarian primary, more adequate therapeutic modalities may be withheld from some patients. Finally, clinical trials may be biased through unintended disregard of histological inclusion criteria.
  
  
  METHODS
  Patients were recruited for central pathology review according to a translational subprotocol of a prospectively randomized phase 3 study led by the Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group. All original slides were requested, and a specialized central pathology review was performed by experienced gynecopathologists. In cases of clinically relevant diagnostic discrepancies, the pathologist responsible for the original diagnosis was contacted. If a given discrepancy could not be resolved, a panel of experts was involved for clarification.
  
  
  RESULTS
  Four hundred fifty-four patients with an original diagnosis of ovarian, tubal, or peritoneal epithelial carcinoma were recruited. In 6.8% (31 patients), a major diagnostic discrepancy of clinical relevance was found. Most frequently (15 patients), serous BOT had been misdiagnosed as invasive cancer. Ovarian metastases constituted the second most frequent misdiagnosis (13 patients). Minor discrepancies not affecting patient treatment were found in 28.2% (128 patients).
  
  
  CONCLUSIONS
  Specialized central pathology review could help to avoid overtreatment of patients with BOT and inappropriate treatment of patients with ovarian metastases. The implementation of a specialized case review process may translate into enhanced patient safety in clinical trials of ovarian carcinomas. Furthermore, central pathology review may increase the rigor and ultimately the transferability of clinical research into practice and should therefore become a standard procedure in study protocols evaluating new therapies.
authors.affiliation: *Universitäts-Frauenklinik Tübingen, Germany; †AGO Study Group, Wiesbaden, Germany; §Philipps-Universität Marburg, Koordinierungszentrum für klinische Studien, Marburg, Germany; ∥Luzerner Kantonsspital, Institute of Pathology, Luzern, Switzerland; ¶Institute of Pathology, Dueren, Germany; #Horst-Schmidt-Kliniken (HSK), Wiesbaden, Germany; ††Institute of Pathology, Mannheim, Germany; ‡Gynecologic Oncology Center, Kiel, Germany; and **Department Gynecology & Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Kommoss
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
authors.forename: Alexander
authors.initials: A
authors.lastname: Reuss
authors.forename: Joachim
authors.initials: J
authors.lastname: Diebold
authors.forename: Steffen
authors.initials: S
authors.lastname: Hauptmann
authors.forename: Christine
authors.initials: C
authors.lastname: Schmidt
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
authors.forename: Dietmar
authors.initials: D
authors.lastname: Schmidt
authors.forename: Friedrich
authors.initials: F
authors.lastname: Kommoss
mesh_terms: D002277:Carcinoma / Q000473:pathology*; D003951:Diagnostic Errors / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D010051:Ovarian Neoplasms / Q000473:pathology*; D010053:Ovary / Q000473:pathology*; D018024:Peer Review, Health Care; D011446:Prospective Studies