Intra-arterial rhenium-188 lipiodol in the treatment of inoperable hepatocellular carcinoma: results of an IAEA-sponsored multination study.

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.

• Authors: Patricia Bernal, Jean-Luc Raoul, Gaj Vidmar, Erdenechimeg Sereegotov, Felix X Sundram, Ajay Kumar, Jae Min Jeong, Pawana Pusuwan, Chaitanya Divgi, Pat Zanzonico, Janez Stare, John Buscombe, Chau Trinh Thi Minh, Maung Maung Saw, Shaoliang Chen, Ruben Ogbac, Ajit K Padhy
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 69 Issue 5 Pg. 1448-55 (Dec 01 2007) ISSN: 0360-3016 [Print] United States
• PMID: 17692473 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Biomarkers
• Radioisotopes
• Rhenium
• Iodized Oil
• Bilirubin

Topics

• Adult
• Aged
• Aged, 80 and over
• Bilirubin (blood)
• Biomarkers (blood)
• Carcinoma, Hepatocellular (mortality, pathology, radiotherapy)
• Female
• Humans
• Injections, Intra-Arterial
• Iodized Oil (administration & dosage, adverse effects)
• Liver Cirrhosis (complications, mortality)
• Liver Neoplasms (mortality, pathology, radiotherapy)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Radioisotopes (administration & dosage, adverse effects)
• Regression Analysis
• Remission Induction
• Rhenium (administration & dosage, adverse effects)
• Statistics, Nonparametric