Intra-arterial rhenium-188 lipiodol in the treatment of inoperable hepatocellular carcinoma: Results of an IAEA-sponsored multination study Journal Article
| Authors: | Bernal, P.; Raoul, J. L.; Vidmar, G.; Sereegotov, E.; Sundram, F. X.; Kumar, A.; Jeong, J. M.; Pusuwan, P.; Divgi, C.; Zanzonico, P.; Stare, J.; Buscombe, J.; Minh, C. T. T.; Saw, M. M.; Chen, S.; Ogbac, R.; Padhy, A. K. |
| Article Title: | 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 (αFP) 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 αFP level. Conclusions: IAI of 188Re-Lip in developing countries is feasible, safe, cost-effective, and deserves a phase III trial. © 2007 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer survival; treatment response; aged; aged, 80 and over; middle aged; unclassified drug; major clinical study; clinical trial; drug tolerability; hepatocellular carcinoma; cancer growth; diarrhea; drug efficacy; drug safety; liver cell carcinoma; liver cirrhosis; side effect; carcinoma, hepatocellular; liver neoplasms; cancer patient; biological markers; liver toxicity; pain; phase 2 clinical trial; blood toxicity; lung disease; vomiting; radiotherapy; cohort analysis; hemoglobin; hemoglobin blood level; oncology; alanine aminotransferase blood level; aspartate aminotransferase blood level; fever; cost effectiveness analysis; alanine aminotransferase; aspartate aminotransferase; bilirubin; gastrointestinal toxicity; hypotension; hospitalization; disease severity; feasibility study; digestive system ulcer; multicenter study; scoring system; thrombocyte count; remission induction; inoperable cancer; developing country; leukocyte count; maximum tolerated dose; radioisotope; regression analysis; radioisotopes; radiation dose distribution; bilirubin blood level; biological organs; statistics, nonparametric; alpha fetoprotein; radiation protection; cancer of the liver italian program score; lipiodol re 188; injections, intra-arterial; iodized oil; rhenium; drug dosage; 188 rhenium; internal radiotherapy; radiolabeled lipiodol; iodinated poppyseed oil i 131 |
| Journal Title: | International Journal of Radiation Oncology, Biology, Physics |
| Volume: | 69 |
| Issue: | 5 |
| ISSN: | 0360-3016 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2007-12-01 |
| Start Page: | 1448 |
| End Page: | 1455 |
| Language: | English |
| DOI: | 10.1016/j.ijrobp.2007.05.009 |
| PUBMED: | 17692473 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 16" - "Export Date: 17 November 2011" - "CODEN: IOBPD" - "Source: Scopus" |
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