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• W3193629245 abstract "Objectives: We investigated prognostic associations between blood-based biomarkers and clinical outcomes as well as the change in biomarkers in response to treatment in the open-label phase II trial testing olaparib and cediranib in patients with recurrent ovarian, peritoneal, or tubal cancer (NCT02345265). Methods: Plasma samples collected at baseline, cycle 2 day 1 (C2D1), and end-of-treatment (EOT) were analyzed via multiplex ELISA for 25 angiogenic and inflammatory circulating protein biomarkers (the Angiome). The prognostic values of each marker for progression-free survival (PFS) and response rate (RR) were tested using Cox proportional hazards regression models, unadjusted and adjusted for performance status, platinum sensitivity, and homologous recombination repair gene mutation (HRRm) status. The Wald test P-values and Q-values, to account for multiple testing, were calculated. Wilcoxon rank sum tests were performed to evaluate biomarker change in response to treatment. Results: Samples for analysis included: baseline (n=70), C2D1 (n=62), and EOT (n=35). The median age was 62; 50% were platinum resistant; 41.4% had HRRm+ tumors. Four markers (osteopontin (OPN), interleukin-6 (IL-6), tissue inhibitor of metalloproteinase-1 (TIMP-1), and angiopoietin-2 (Ang-2) were negatively prognostic of PFS with or without adjusting for covariates (see Table). Patients were stratified as responders (complete responders (CR), n=6; partial responders (PR), n=34) and non-responders (stable disease (SD), n=23; progressive disease (PD), n=4). Baseline levels of TIMP-1 (p=0.005; q=0.1) and intercellular adhesion molecule-1 (ICAM-1) (p=0.04; q=0.4) were lower in responders compared to non-responders. Lower expression of OPN was also noted in responders, but the difference did not reach statistical significance (p=0.07). Five biomarkers were upregulated at C2D1 and EOT: hepatocyte growth factor (HGF) (1.5 and 2.7-fold); IL-6 (1.9, 2.0); vascular endothelial growth factor (VEGF)-A (5.4, 3.9); placental growth factor (PlGF) (6.0, 3.9); and VEGFR1 (1.6, 2.3). Conclusions: In this exploratory analysis, OPN, IL-6, TIMP-1, and Ang-2 were consistently observed to be negatively associated with PFS in patients receiving combination olaparib and cediranib. The Angiome will be further assessed in the upcoming NRG Oncology GY004 and GY005 studies comparing olaparib and cediranib to stand-ard-of-care therapies. Further evaluation is needed to explore clinical implications and potential value of these candidate biomarkers. We investigated prognostic associations between blood-based biomarkers and clinical outcomes as well as the change in biomarkers in response to treatment in the open-label phase II trial testing olaparib and cediranib in patients with recurrent ovarian, peritoneal, or tubal cancer (NCT02345265). Plasma samples collected at baseline, cycle 2 day 1 (C2D1), and end-of-treatment (EOT) were analyzed via multiplex ELISA for 25 angiogenic and inflammatory circulating protein biomarkers (the Angiome). The prognostic values of each marker for progression-free survival (PFS) and response rate (RR) were tested using Cox proportional hazards regression models, unadjusted and adjusted for performance status, platinum sensitivity, and homologous recombination repair gene mutation (HRRm) status. The Wald test P-values and Q-values, to account for multiple testing, were calculated. Wilcoxon rank sum tests were performed to evaluate biomarker change in response to treatment. Samples for analysis included: baseline (n=70), C2D1 (n=62), and EOT (n=35). The median age was 62; 50% were platinum resistant; 41.4% had HRRm+ tumors. Four markers (osteopontin (OPN), interleukin-6 (IL-6), tissue inhibitor of metalloproteinase-1 (TIMP-1), and angiopoietin-2 (Ang-2) were negatively prognostic of PFS with or without adjusting for covariates (see Table). Patients were stratified as responders (complete responders (CR), n=6; partial responders (PR), n=34) and non-responders (stable disease (SD), n=23; progressive disease (PD), n=4). Baseline levels of TIMP-1 (p=0.005; q=0.1) and intercellular adhesion molecule-1 (ICAM-1) (p=0.04; q=0.4) were lower in responders compared to non-responders. Lower expression of OPN was also noted in responders, but the difference did not reach statistical significance (p=0.07). Five biomarkers were upregulated at C2D1 and EOT: hepatocyte growth factor (HGF) (1.5 and 2.7-fold); IL-6 (1.9, 2.0); vascular endothelial growth factor (VEGF)-A (5.4, 3.9); placental growth factor (PlGF) (6.0, 3.9); and VEGFR1 (1.6, 2.3). In this exploratory analysis, OPN, IL-6, TIMP-1, and Ang-2 were consistently observed to be negatively associated with PFS in patients receiving combination olaparib and cediranib. The Angiome will be further assessed in the upcoming NRG Oncology GY004 and GY005 studies comparing olaparib and cediranib to stand-ard-of-care therapies. Further evaluation is needed to explore clinical implications and potential value of these candidate biomarkers." @default.
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• W3193629245 date "2021-08-01" @default.
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• W3193629245 title "Blood-based biomarkers in patients with platinum-sensitive and resistant ovarian cancer treated with olaparib and cediranib: results from the UM9825 trial" @default.
• W3193629245 doi "https://doi.org/10.1016/s0090-8258(21)00831-3" @default.
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