BACKGROUND/AIM: Targeted radiotherapy of @entity409 has found to be effective in selected @entity1 . A key limiting factor of these therapies is the relatively low tolerance of the liver parenchyma to radiation. We sought to assess the preventive effects of a combined regimen of @entity1502 (PTX), @entity10055 (UDCA) and low-dose low molecular weight heparin (LMWH) on focal radiation-induced @entity99 (fRILI). METHODS AND MATERIALS: @entity1 with liver metastases from @entity14 who were scheduled for local ablation by radiotherapy (image-guided high-dose-rate interstitial brachytherapy) were prospectively randomized to receive PTX, UDCA and LMWH for 8 weeks (treatment) or no medication (control). Focal RILI at follow-up was assessed using functional hepatobiliary magnetic resonance imaging (MRI). A minimal threshold dose, i.e. the dose to which the outer rim of the fRILI was formerly exposed to, was quantified by merging MRI and dosimetry data. RESULTS: Results from an intended interim-analysis made a premature termination necessary. Twenty-two @entity1 were included in the per-protocol analysis. Minimal mean hepatic threshold dose 6 weeks after radiotherapy (primary endpoint) was significantly higher in the study treatment-group compared with the control (19.1 Gy versus 14.6 Gy, p=0.011). Qualitative evidence of fRILI by MRI at 6 weeks was observed in 45.5% of @entity1 in the treatment versus 90.9% of the control group. No significant differences between the groups were observed at the 12-week follow-up. CONCLUSIONS: The post-therapeutic application of PTX, UDCA and low-dose @entity6971 significantly reduced the extent and incidence fRILI at 6 weeks after radiotherapy. The development of subsequent fRILI at 12 weeks (4 weeks after cessation of PTX, UDCA and LMWH during weeks 1-8) in the treatment group was comparable to the control group thus supporting the observation that the agents mitigated fRILI. TRIAL REGISTRATION: EU clinical trials register 2008-002985-70 ClinicalTrials.gov NCT01149304.

Prospective randomized trial of enoxaparin, XXXX and @entity10055 for prevention of radiation-induced liver toxicity.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity409 :: ('MESH:D008107', 'Disease') :: ['liver malignancies'] @entity6971 :: ('MESH:D006495', 'Chemical') :: ['LMWH'] @entity1502 :: ('MESH:D010431', 'Chemical') :: ['pentoxifylline'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal carcinoma'] @entity99 :: ('MESH:D056486', 'Disease') :: ['liver injury'] @entity10055 :: ('MESH:D014580', 'Chemical') :: ['ursodeoxycholic acid']
@entity1502 :: (MESH:D010431,Chemical) :: ['pentoxifylline']
