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02 August 2014 : Original article  

Initial Study of Radiological and Clinical Efficacy Radioembolization Using 188Re-Human Serum Albumin (HSA) Microspheres in Patients with Progressive, Unresectable Primary or Secondary Liver Cancers

Mirosław L. NowickiABDEF, Jarosław B. ĆwiklaABCDEFG, Artur J. SankowskiBDE, Sergey ShcherbininBCDEF, Josh GrimmesBCDEF, Anna CellerABCDEF, John R. BuscombeCDE, Andrzej BatorBCDE, Maciej PechCDE, Renata MikołajczakACDE, Dariusz PawlakBEF

DOI: 10.12659/MSM.890480

Med Sci Monit 2014; 20:1353-1362

Abstract

BACKGROUND: The aim of this initial study was to evaluate the clinical and radiological effectiveness of radioembolization (RE) using 188Re-Human Serum Albumin (HSA) microspheres in patients with advanced, progressive, unresectable primary or secondary liver cancers, not suitable to any other form of therapy.

MATERIAL AND METHODS: Overall, we included 13 patients with 20 therapy sessions. Clinical and radiological responses were assessed at 6 weeks after therapy, and then every 3 months. The objective radiological response was classified according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 by sequential MRI. Adverse events were evaluated using NCI CTCAE v.4.03.

RESULTS: There were 4 patients with hepatocellular carcinoma (HCC), 6 with metastatic colorectal cancer (mCRC), 2 with neuroendocrine carcinoma (NEC), and 1 patient with ovarian carcinoma. Mean administered activity of 188Re HSA was 7.24 GBq (range 3.8–12.4) A high microspheres labeling efficacy of over 97±2.1% and low urinary excretion of 188Re (6.5±2.3%) during first 48-h follow-up. Median overall survival (OS) for all patients was 7.1 months (CI 6.2–13.3) and progression-free survival (PFS) was 5.1 months (CI 2.4–9.9). In those patients who had a clinical partial response (PR), stable disease (SD), and disease progression (DP) as assessed 6 weeks after therapy, the median OS was 9/5/4 months, respectively, and PFS was 5/2/0 months, respectively. The treatment adverse events (toxicity) were at an acceptable level. Initially and after 6 weeks, the CTC AE was grade 2, while after 3 months it increased to grade 3 in 4 subjects. This effect was mostly related to rapid cancer progression in this patient subgroup.

CONCLUSIONS: The results of this preliminary study indicate that RE using 188Re HSA is feasible and a viable option for palliative therapy in patients with extensive progressive liver cancer. It was well tolerated by most patients, with a low level of toxicity during the 3 months of follow-up.

Keywords: Embolization, Therapeutic - methods, Image Processing, Computer-Assisted, Liver Neoplasms - radiotherapy, Magnetic Resonance Imaging, Microspheres, Palliative Care - methods, Radioisotopes - therapeutic use, Rhenium - therapeutic use, Serum Albumin - therapeutic use, Survival Analysis

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750