title: Barriers prevent patient access to personalized therapies identified by molecular tumor profiling of gynecologic malignancies.
abstract: OBJECTIVE
  This study was designed to evaluate the ability of commercial molecular tumor profiling to discover actionable mutations and to identify barriers that might prevent patient access to personalized therapies.
  
  
  METHODS
  We conducted an IRB-approved retrospective review of 26 patients with gynecologic malignancies who underwent commercial tumor profiling at our institution during the first 18 months of test availability. Tumor profiles reported targeted therapies and clinical trials matched to patient-specific mutations. Data analysis consisted of descriptive statistics.
  
  
  RESULTS
  Most patients who underwent tumor profiling had serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (46%). Patients underwent profiling after undergoing a median of two systemic therapies (range 0 to 13). A median of one targeted therapy was suggested per patient profile. Tumor profiling identified no clinically actionable mutations for seven patients (27%). Six patients sought insurance approval for a targeted therapy and two were declined (33%). One patient (4%) received a targeted therapy and this was discontinued due to tumor progression.
  
  
  CONCLUSIONS
  There are formidable barriers to targeted therapy for patients with gynecologic malignancies. These barriers include a dearth of FDA-approved targeted agents for gynecologic malignancies, lack of third party insurance coverage and limited geographic availability of clinical trials.
authors.affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. rhillman@ucsd.edu.
authors.forename: R Tyler
authors.initials: RT
authors.lastname: Hillman
authors.affiliation: Division of Gynecologic Oncology, College of Medicine-Jacksonville, University of Florida, Jacksonville, FL 32209, USA. kristy.k.ward@gmail.com.
authors.forename: Kristy
authors.initials: K
authors.lastname: Ward
authors.affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. csaenz@ucsd.edu.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Saenz
authors.affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. mtmchale@ucsd.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: McHale
authors.affiliation: Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA. splaxe@ucsd.edu.
authors.forename: Steven
authors.initials: S
authors.lastname: Plaxe
keywords: genetics; molecular biology; next generation sequencing; targeted therapies; tumor markers