MammaRAD Prevention and prognostic factors of a radioembolization-induced liver disease (REILD)RAD289

• Conditions: C50; C78.7; Malignant neoplasm of breast; Secondary malignant neoplasm of liver and intrahepatic bile duct

• Registration Number: DRKS00011509
• Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary

RE and high conformal liver irradiation techniques are limited by potential adverse RILD development. RILD prophylaxis with PTX, UDCA and LMWH appears to have an independent positive impact on OS in patients with metastatic breast cancer after RE compared to prophylaxis with UDCA and prednisolone and may reduce the frequency and severity of RILD. However, mild or severe RILD events proved rare in the overall cohort, which limits the value of the results. Both drug regimens employed for post-therapeutic RILD prophylaxis were well tolerated. Results of this study as well as pathophysiological considerations warrant further investigations of RILD prophylaxis presumably targeting combinations of anticoagulation (MP) and antiinflammation (SP). In effect, advances in RILD prevention may help increasing tolerable RE or liver irradiation doses to improve patient outcomes.

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-03-13
• Study Start: 2017-04-21
• Results First Posted: 2021-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

Diagnosis of non-resectable liver metastases, from breast cancer (BCLM)
Sufficient liver function

Exclusion Criteria

Hepatic failure
Bleeding
Pulmonary shunt of the arteria hepatica
Complete occlusion of the portal vein

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The intensified REILD prophylaxis with enoxaparin, pentoxifylline and ursodeoxycholic acid is superior to classical REILD prophylaxis with prednisolone and ursodeoxycholic acid

Secondary Outcome Measures

Name	Time	Method
Identification of risk factors for the development of a REILD, recording the frequencies and severity of further complications, response rate of radioembolisation, especially in liver metastases resulting from breast carcinoma, survival time analysis