Moderated Poster

Poster, Podium & Video Sessions

MP41-11: A pilot clinical study to evaluate the efficacy and safety of docetaxel with ribavirin in patients with progressive castration-resistant prostate cancer targeting stem-cell related gene network.

Saturday, May 13
3:30 PM - 5:30 PM
Location: BCEC: Room 156

Presentation Authors: Takeo Kosaka*, Takahiro Maeda, Hirohiko Nagata, Shunsuke Yoshimine, Hiroshi Hongo, Toshiaki Shinojima, Mototsugu Oya, Tokyo, Japan

Introduction: We previously reported a novel cell reprogramming approach, termed drug efficacy reprogramming, as a new model for identifying candidate antitumor drugs targeting the cancer stemness-related gene network, and identified ribavirin as a candidate drug for overcoming docetaxel-resistant castration-resistant prostate cancer (CRPC). This nonrandomized, open-labeled pilot clinical study explored the safety and efficacy of ribavirin, an antiviral drug, in combination with docetaxel in patients with progressive CRPC.

Methods: In this clinical study, patients received intravenous docetaxel 60-70 mg/mm2 on day 1 of 3-6-week cycles plus ribavirin 600 mg twice daily. The primary endpoint was safety, prostate-specific antigen (PSA) response and objective response rate. Secondary endpoints included health-related quality of life and overall survival. Patients with progressive CRPC based on PSA and/or radiographic criteria, performance status (PS) 0-1, and normal renal and hepatic function were eligible.

Results: Five patients were enrolled in this study; medium age was 73. Median serum PSA concentration was 53.1 ng/ml (range: 5.1-370.5). The median cycle and total dose of docetaxel received before the study was 31 cycles and 3625 mg, respectively. Overall, 80% of patients had disease progression during docetaxel treatment. The median time from last docetaxel dose to disease progression before participation was 1.5 months. Safety: median number of treatment cycles were 7 (range: 3-8) cycles. Grade 3/4 adverse events requiring dose modification were not observed. Grade 3 anemia and neutropenia were seen in two patients. Common adverse events were less than Grade 2. Efficacy: 3 (60%) patients had some degree of PSA decline and 2 (40%) had a decline of 30%. Median follow-up was 10.0 months. Median progression-free survival was 6 months.

Conclusions: This combination of ribavirin with docetaxel was well tolerated with a promising response rate that justifies further investigations in docetaxel-resistant CRPC. This clinical study provides a useful drug re-positioning model in the area of translational medicine.

Source Of Funding: none

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MP41-11: A pilot clinical study to evaluate the efficacy and safety of docetaxel with ribavirin in patients with progressive castration-resistant prostate cancer targeting stem-cell related gene network.



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