A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer
Article
Rutherford, Thomas, Orr, James, Jr., Grendys, Edward, Jr., Edwards, Robert, Krivak, Thomas C., Holloway, Robert, Moore, Richard G., Puls, Larry, Tillmanns, Todd, Schink, Julian C., Brower, Stacey L., Tian, Chunqiao, Herzog, Thomas J.
funding text
Some authors (SLB, CT) are paid employees of Precision Therapeutics, Inc., which sponsored this work. Other authors received compensation from Precision Therapeutics, Inc. for their participation in this clinical trial (TR, JO, EG, RE, TCK, RH, RGM, LP, TT, JCS) or as a member of an advisory board supporting this trial (TJH).
abstract
Objective. Use of in vitro chemoresponse assays for informing effective treatment selection is a compelling clinical question and a topic of debate among oncologists. A prospective study was conducted evaluating the use of a chemoresponse assay in recurrent ovarian cancer patients. Methods. Women with persistent or recurrent ovarian cancer were enrolled under an IRE-approved protocol, and fresh tissue samples were collected for chemoresponse testing. Patients were treated with one of 15 protocol-designated treatments empirically selected by the oncologist, blinded to the assay results. Each treatment was classified by the assay as: sensitive (S), intermediate (I), or resistant (R). Patients were prospectively monitored for progression-free survival (PFS) and overall survival (OS). Associations of assay response for the physician-selected treatment with PFS and OS were analyzed. Results. A total of 262 evaluable patients were enrolled. Patients treated with an assay-sensitive regimen demonstrated significantly improved PFS and OS while there was no difference in clinical outcomes between I and R groups. Median PFS was 8.8 months for S vs. 5.9 months for I + R (hazard ratio [HR] = 0.67, p = 0.009). The association with assay response was consistent in both platinum-sensitive and platinum-resistant tumors (HR: 0.71 vs. 0.66) and was independent of other covariates in multivariate analysis (HR = 0.66, p = 0.020). A statistically significant14-month improvement in mean OS (37.5 months for S vs. 23.9 months for I + R, HR = 0.61, p = 0.010) was demonstrated. Conclusions. This prospective study demonstrated improved PFS and OS for patients with either platinum-sensitive or platinum-resistant recurrent ovarian cancer treated with assay-sensitive agents. (C) 2013 The Authors. Published by Elsevier Inc All rights reserved.