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• W2531337524 abstract "5143 Background: Ketoconazole (Keto) is an active second-line hormonal maneuver that induces PSA responses in 20–30% of CPPCA patients (pts). In addition to the suppression of testicular and adrenal androgen production, Keto inhibits ADCC, NK cell activity as well as IL-2 synthesis and subsequent T cell proliferation. Lenalidomide (LEN) is an immunomodulatory analogue of thalidomide with significant T cell stimulatory and antiangiogenic properties. We hypothesized that the immune stimulatory activity of LEN might augment the activity of Keto and tested the combination of Keto and LEN. Methods: Eligible CPPCA pts had PSA progression with or without limited bone and soft tissue metastasis. Pts were required to be chemotherapy naive and unexposed to ketoconazole/thalidomide. All pts received Keto at 400mg administered 3 times daily along with LEN 25 mg/day orally on D1–21 of a 28-day cycle. Low-dose aspirin was required for DVT prophylaxis. Endpoints included response, safety and biologic effects, including activation of DCs, Tregs, and Th1 cytokine production. Results: To date 19 of a total planned 34 pts are enrolled (4 with soft tissue disease, 9 with evidence of bone metastases; 6 with PSA-only disease). 18 pts are currently evaluable for response. Median age is 70 years (range, 48–85), median PSA of 12.7 ng/mL (range, 2.6–132.6). Pts have received a median of 2 cycles of treatment (range: 1–10+). Overall, 14 of 18 pts (74%) have experienced some reduction in PSA (3 between 1–30%; 1 between 30–50%; 3 between 50–75%; 1 between 75–90% and 6 >90%). Among pts with measurable disease (4/17), three have achieved a confirmed PR and one SD with tumor volume reduction by RECIST criteria. Seven pts have discontinued therapy (1 PD, 4 toxicity, and 2 withdrew consent). Grade (G) 1–2 fatigue was the most common toxicity observed in 94% of pts. G3 fatigue was observed in 2 pts. Only one pt developed G4 toxicity (CHF). PB cell phenotype analysis and cytokine levels indicate immune activation. Conclusions: The combination of Keto and LEN is relatively well tolerated with clear evidence of antitumor activity. Exploratory immune studies and their correlation with clinical response are underway and will be presented at the meeting. Accrual to this study is ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene, Dendreon, Merck, Novartis, Wyett Bayer/Onyx, Pfizer, Wyett Bayer, Celgene, Genentech, Novartis, Pfizer, Wyett" @default.
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• W2531337524 date "2008-05-20" @default.
• W2531337524 modified "2023-09-27" @default.
• W2531337524 title "Clinical activity of ketoconazole and lenalidomide in castrate progressive prostate carcinoma (CPPCA): Preliminary results of a phase II trial" @default.
• W2531337524 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.5143" @default.
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