Intra-Arterial Rhenium-188 Lipiodol in the Treatment of Inoperable Hepatocellular Carcinoma: Results of an IAEA-Sponsored Multination Study

Journal Article · Sat Dec 01 00:00:00 EST 2007 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2007.05.009· OSTI ID:21039667

Bernal, Patricia ^[1]; Raoul, Jean-Luc ^[2]; Vidmar, Gaj ^[3]; Sereegotov, Erdenechimeg ^[4]; Sundram, Felix X ^[5]; Kumar, Ajay ^[6]; Jeong, Jae Min ^[7]; Pusuwan, Pawana ^[8]; Divgi, Chaitanya ^[9]; Zanzonico, Pat ^[9]; Stare, Janez ^[3]; Buscombe, John ^[10]; Thi Minh, Chau Trinh ^[11]; Saw, Maung Maung ^[5]; Shaoliang, Chen ^[12]; Ogbac, Ruben ^[13]; Padhy, Ajit K ^[5]

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1. Fundacion Santa Fe De Bogota, Bogota (Colombia)
2. Centre Regional de Lutte Contre le Cancer, Centre Eugene Marquis, University of Rennes, Rennes (France)
3. IBMI, Faculty of Medicine, University of Ljubljana, Ljubljana (Slovenia)
4. First State Central Clinic, National Medical University of Mongolia, Ulaanbaatar (Mongolia)
5. Singapore General Hospital (Singapore)
6. All India Institute of Medical Sciences, New Delhi (India)
7. Seoul National University Hospital, Seoul (Korea, Republic of)
8. Siriraj Hospital, Mahidol University, Bangkok (Thailand)
9. Memorial Sloan-Kettering Cancer Center, New York, NY (United States)
10. Royal Free Hospital, London (United Kingdom)
11. Cho Ray Hospital, Ho Chi Minh City (Viet Nam)
12. Zhongshan Hospital, Fudan University, Shanghai (China)
13. St. Luke's Medical Centre, Quezon City (Philippines)

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.

• OSTI ID: 21039667
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 69, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2007.05.009; PII: S0360-3016(07)00837-1; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
BONE MARROW
COST
DEVELOPING COUNTRIES
EVALUATION
HEPATOMAS
IAEA
IODINE 131
LIPIODOL
LIVER
LUNGS
ORAL CAVITY
PATIENTS
PROTEINS
RADIATION DOSES
RADIOTHERAPY
RHENIUM 188
TOXICITY