title: A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer.
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 IRB-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.
authors: Yale University School of Medicine, New Haven, CT, USA.
authors: Thomas
authors: T
authors: Rutherford
authors: James
authors: J
authors: Orr
authors: Edward
authors: E
authors: Grendys
authors: Robert
authors: R
authors: Edwards
authors: Thomas C
authors: TC
authors: Krivak
authors: Robert
authors: R
authors: Holloway
authors: Richard G
authors: RG
authors: Moore
authors: Larry
authors: L
authors: Puls
authors: Todd
authors: T
authors: Tillmanns
authors: Julian C
authors: JC
authors: Schink
authors: Stacey L
authors: SL
authors: Brower
authors: Chunqiao
authors: C
authors: Tian
authors: Thomas J
authors: TJ
authors: Herzog
mesh_terms: D000368:Aged; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D004311:Double-Blind Method; D019008:Drug Resistance, Neoplasm; D004354:Drug Screening Assays, Antitumor; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
keywords: Chemoresponse assay; Ovarian cancer; Prospective clinical trial