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- W2792539640 abstract "// Bernhard Josef Eigl 1 , Kim Chi 1 , Dongsheng Tu 2 , Sebastien J. Hotte 3 , Eric Winquist 4 , Christopher M. Booth 5 , Christina Canil 6 , Kylea Potvin 4 , Richard Gregg 2 , Scott North 7 , Muhammad Zulfiqar 1 , Susan Ellard 8 , Joseph Dean Ruether 9 , Lyly Le 10 , A. Saranya Kakumanu 11 , Mohammad Salim 12 , Alison L. Allan 4 , Harriet Feilotter 2 , Ashley Theis 2 and Lesley Seymour 2 1 BC Cancer Agency, Vancouver, BC, Canada 2 Canadian Cancer Trials Group, Kingston, ON, Canada 3 Juravinski Cancer Centre, Hamilton, ON, Canada 4 London Health Sciences Centre, London, ON, Canada 5 Cancer Centre of Southeastern Ontario, Kingston, ON, Canada 6 Ottawa Regional Cancer Center, Ottawa, ON, Canada 7 Cross Cancer Centre, Edmonton, AB, Canada 8 BC Cancer Agency, Kelowna, BC, Canada 9 Tom Baker Cancer Centre, Calgary, AB, Canada 10 BC Cancer Agency, Surrey, BC, Canada 11 Cancer Care Manitoba, Winnipeg, MB, Canada 12 Regina Cancer Centre, Regina, SK, Canada Correspondence to: Bernhard Josef Eigl, email: Bernie.eigl@bccancer.bc.ca Keywords: prostate cancer; oncolytic viruses; chemotherapy; clinical trial Received: October 12, 2017 Accepted: January 02, 2018 Published: January 17, 2018 ABSTRACT Background: Pelareorep is an oncolytic virus with activity in many cancers including prostate. It has in vitro synergism with microtubule-targeted agents. We undertook a clinical trial evaluating pelareorep in mCRPC patients receiving docetaxel. Patients and Methods: In this randomized, open-label phase II study, patients received docetaxel 75mg/m 2 on day 1 of a 21-day cycle and prednisone 5mg twice daily, in combination with pelareorep (arm A) or alone (arm B). The primary endpoint was 12 weeks lack of disease progression rate (LPD). Results: Eighty-five pts were randomized. Median age was 69, ECOG performance status was 0/1/2 in 31%/66%/3% of patients. Bone/regional lymph node/liver metastases were present in 98%/24%/6%. The median prognostic score was slightly higher in Arm A (144 vs. 129 p= 0.005). Adverse events were as expected but more prevalent in arm A. The 12-week LPD rate was 61% and 52.4% in arms A/B (p=0.51). Median survival was 19.1 on Arm A and 21.1 months on Arm B (HR 1.83; 95% CI 0.96 to 3.52; p=0.06). No survival benefit of pelareorep was found. Conclusion: Pelareorep with docetaxel was tolerable with comparable LPD in both arms but response and survival were inferior and so this combination does not merit further study." @default.
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- W2792539640 date "2018-01-17" @default.
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- W2792539640 title "A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209" @default.
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- W2792539640 doi "https://doi.org/10.18632/oncotarget.24263" @default.
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