Department of Radiology, School of Medicine,
Health Sciences University of Mongolia,
Өгүүллийн PDF-ийг татах
This paper describes the results of a Phase I study conducted by the International Atomic Energy Agency (IAEA) to determine the safety of trans-arterial Re-188 Lipiodol (radio conjugate) in the treatment of patients with inoperable hepatocellular carcinoma (HCC). Adjuvant intra-arterial radioconjugate therapy could potentially reduce the rate of local recurrence and increase disease-free and overall survival. Rhenium-188 Lipiodol conjugate was prepared using a HDD (4-hexadecyl 1-2, 9, 9-tetramethyl-4, 7-diaza-1, 10-decanethiol) kit developed in Korea, and Lipiodol. 18 patients received one treatment of radioconjugate. The level of radio-conjugate administered was based on radiation-absorbed dose to critical normal organs, calculated following a "scout" dose. The organs at greatest risk for radiation toxicity were liver, lung and bone marrow. A specially designed EXCEL Spreadsheet was used to determine maximum tolerated dose (MTD), defined as the amount of radioactivity calculated to deliver no more than 12 Gy to lungs or 30 Gy to liver or 1,5 Gy to bone marrow. These doses have been found to be safe in multiple trials using external beam therapy and systemically administered radiopharmaceuticals. Patients were followed for at least twelve weeks after therapy, until recovery from all toxicity. The clinical parameters which were evaluated included toxicity; response as determined by contrast-enhanced CT; palliation of symptoms, and overall survival at six months; and quality of life parameters, including performance status (Karnofsky) and hepatic function (Child's classification). All 18 patients had both the "scout" dose and the treatment dose. In the majority of patients, from the "scout" dose studies, the radiation absorbed dose to normal liver was the limiting factor to the treatment dose, where the MTD was determined by the radiation dose to liver, or by dose to lung. Radiation dose to bone marrow was negligible and was thus not a factor for the MTD calculations. Side effects were minimal and usually presented as right hypochondrial discomfort and low-grade fever. Liver function tests at 24 and 72 hours showed no significant changes and complete blood counts at one week, four weeks and 12 weeks showed no changes (no bone-marrow suppression). The results of this Phase I study show that Rhenium-188 Lipiodol is a safe and cost-effective radiopharmaceutical for treatment of primary HCC via the transarterial route, and the new therapeutic procedures should be subjected to further evaluation to determine its efficacy.
