Intra-arterial rhenium-188 lipiodol in the treatment of inoperable hepatocellular carcinoma: results of an IAEA-sponsored multination study.
Int J Radiat Oncol Biol Phys
; 69(5): 1448-55, 2007 Dec 01.
Article
em En
| MEDLINE
| ID: mdl-17692473
ABSTRACT
PURPOSE:
Intra-arterial injections (IAI) of 131I-lipiodol is effective in treating hepatocellular carcinoma patients, but is expensive and requires a 7-day hospitalization in a radioprotection room. 188Re is inexpensive, requires no patient isolation, and can be used with lipiodol. METHODS AND MATERIALS This International Atomic Energy Agency-sponsored phase II trial aimed to assess the safety and the efficacy of a radioconjugate 188Re + lipiodol (188Re-Lip) in a large cohort of hepatocellular carcinoma patients from developing countries. A scout dose is used to determine the maximal tolerated dose (lungs <12 Gy, normal liver <30 Gy, bone marrow <1.5 Gy) and then the delivery of the calculated activity. Efficacy was assessed using response evaluation criteria in solid tumor (RECIST) and alpha-feto-protein (alpha FP) levels and severe adverse events were graded using the Common Toxicity Criteria of the National Cancer Institute scale v2.0.RESULTS:
The trial included 185 patients from eight countries. The procedure was feasible in all participating centers. One treatment was given to 134 patients; 42, 8, and 1 received two, three, and four injections, respectively. The injected activity during the first treatment was 100 mCi. Tolerance was excellent. We observed three complete responses and 19 partial responses (22% of evaluable patients, 95% confidence interval 16-35%); 1- and 2-year survivals were 46% and 23%. Some factors affected survival country of origin, existence of a cirrhosis, Cancer of the Liver Italian Program score, tumor dose, absence of progression, and posttreatment decrease in alpha FP level.CONCLUSIONS:
IAI of 188Re-Lip in developing countries is feasible, safe, cost-effective, and deserves a phase III trial.
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Base de dados:
MEDLINE
Métodos Terapêuticos e Terapias MTCI:
Terapias_biologicas
Assunto principal:
Radioisótopos
/
Rênio
/
Óleo Iodado
/
Carcinoma Hepatocelular
/
Neoplasias Hepáticas
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Idioma:
En
Revista:
Int J Radiat Oncol Biol Phys
Ano de publicação:
2007
Tipo de documento:
Article
País de afiliação:
Colômbia