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Long-term Survival and Biomarker Correlates of Tasquinimod Efficacy in a Multicenter Randomized Study of Men with Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.
- Armstrong, A J (författare)
-
- Häggman, Michael (författare)
- Uppsala universitet,Urologkirurgi
- Stadler, W M (författare)
- visa fler...
- Gingrich, J R (författare)
- Assikis, V (författare)
- Polikoff, J (författare)
- Damber, J E (författare)
- Belkoff, L (författare)
- Nordle, O (författare)
- Forsberg, G (författare)
- Carducci, M A (författare)
- Pili, R (författare)
- visa färre...
- (creator_code:org_t)
- 2013
- 2013
- Engelska.
- Ingår i: Clinical Cancer Research. - 1078-0432 .- 1557-3265. ; 19:24, s. 6891-6901
- Tidskriftsartikel (refereegranskat)
Abstract
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- PURPOSE: Tasquinimod (Active Biotech) is an oral immunomodulatory, anti-angiogenic, and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). Here, we report long-term survival with biomarker correlates from this trial.EXPERIMENTAL DESIGN: Two hundred and one (134 tasquinimod and 67 placebo) men with mCRPC were evaluated. Forty-one men randomized to placebo crossed over to tasquinimod. Survival data were collected with a median follow-up time of 37 months. Exploratory biomarker studies at baseline and over time were collected to evaluate potential mechanism-based correlates with tasquinimod efficacy including progression-free survival (PFS) and overall survival (OS).RESULTS: With 111 mortality events, median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall, and 34.2 versus 27.1 months in men with bone metastases (n = 136), respectively. Multivariable analysis demonstrated an adjusted HR of 0.52 [95% confidence interval (CI), 0.35-0.78; P = 0.001] for PFS and 0.64 (95% CI, 0.42-0.97; P = 0.034) for OS, favoring tasquinimod. Time-to-symptomatic progression was improved with tasquinimod (P = 0.039, HR = 0.42). Toxicities tended to be mild in nature and improved over time. Biomarker analyses suggested a favorable impact on bone alkaline phosphatase and lactate dehydrogenase (LDH) over time and a transient induction of inflammatory biomarkers, VEGF-A, and thrombospondin-1 levels with tasquinimod. Baseline levels of thrombospondin-1 less than the median were predictive of treatment benefit.CONCLUSIONS: The survival observed in this trial of men with minimally symptomatic mCRPC suggests that the prolongation in PFS with tasquinimod may lead to a survival advantage in this setting, particularly among men with skeletal metastases, and has a favorable risk:benefit ratio.
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- Armstrong, A J
- Häggman, Michael
- Stadler, W M
- Gingrich, J R
- Assikis, V
- Polikoff, J
- visa fler...
- Damber, J E
- Belkoff, L
- Nordle, O
- Forsberg, G
- Carducci, M A
- Pili, R
- visa färre...
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- Uppsala universitet
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