Abstract
5134 Background: Carboplatin is the mainstay of primary ovarian cancer and is often used in recurrent ovarian cancer. The ability to identify tumors that will respond to this drug prior to selection of therapy would allow patients to avoid ineffective treatments and should lead to an improvement in outcome. Methods: We evaluated an ex vivo chemoresponse assay in predicting progression-free interval (PFI) in patients with ovarian cancer in response to Carboplatin-containing regimens. 128 women with primary or recurrent ovarian carcinoma, who were subsequently treated with a Carboplatin-containing regimen, had tumors tested with an ex vivo chemoresponse assay between 4/30/1997 and 4/30/2002. The assay results were scored for sensitivity or resistance based on live cell number after exposure to varied concentrations of Carboplatin. PFI and assay results were linked by an independent contract research organization. Cox Proportional Hazard Model analysis was used to identify independent prognostic factors. Results: Results of the Carboplatin assays for these patients were a significant independent predictor of PFI (p=0.049, Hazard Ratio (HR) of cases with a Resistant assay result vs. a Sensitive assay result (HRR-S)=2.52 [95% CI: 1.01 to 6.30], HR of patients with a Resistant assay result vs. an Intermediate assay result (HRR-I)=1.59 [95% CI: 1.00 to 2.51]). Further, the predictive accuracy of the assay improved as process improvements were implemented: 70 primary assays before 1/1/2001 were suggestive (p=0.16, HRR-S=2.60 [95% CI: 0.69 to 9.86]); whereas 43 primary assays since 1/1/2001 were significant (p=0.048, HRR-S =4.58 [95% CI: 1.01 to 20.80]). Conclusion: These data demonstrate the utility of an ex vivo chemoresponse assay in predicting the clinical outcome of ovarian cancer patients treated with Carboplatin-containing regimens. Moreover, continuous quality improvements enhanced the efficacy of the ex vivo chemoresponse assay. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Precision Therapeutics, Inc. Precision Therapeutics, Inc. Precision Therapeutics, Inc.
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