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J. Pers. Med. 2015, 5(2), 165-173; doi:10.3390/jpm5020165

Barriers Prevent Patient Access to Personalized Therapies Identified by Molecular Tumor Profiling of Gynecologic Malignancies

1
Rebecca and John Moores UCSD Cancer Center, Department of Reproductive Medicine, Division of Gynecologic Oncology, La Jolla, CA 92093, USA
2
Division of Gynecologic Oncology, College of Medicine-Jacksonville, University of Florida, Jacksonville, FL 32209, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Stephen B. Liggett
Received: 8 March 2015 / Accepted: 14 May 2015 / Published: 21 May 2015
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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. View Full-Text
Keywords: targeted therapies; tumor markers; genetics; molecular biology; next generation sequencing targeted therapies; tumor markers; genetics; molecular biology; next generation sequencing
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Hillman, R.T.; Ward, K.; Saenz, C.; McHale, M.; Plaxe, S. Barriers Prevent Patient Access to Personalized Therapies Identified by Molecular Tumor Profiling of Gynecologic Malignancies. J. Pers. Med. 2015, 5, 165-173.

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