Patricia BernalJean Luc RaoulGaj VidmarErdenechimeg SereegotovFelix X. SundramAjay KumarJae Min JeongPawana PusuwanChaitanya DivgiPat ZanzonicoJanez StareJohn BuscombeChau Trinh Thi MinhMaung Maung SawShaoliang ChenRuben OgbacAjit K. PadhyFundacion Santa Fe de BogotaCentre Eugene Marquis RennesUniversity of Ljubljana Faculty of MedicineMongolian National University of Medical SciencesSingapore General HospitalAll India Institute of Medical Sciences, New DelhiSeoul National University HospitalMahidol UniversityMemorial Sloan-Kettering Cancer CenterUniversity of PennsylvaniaUCLCho Ray HospitalFudan UniversitySt. Luke’s Medical CenterInternational Atomic Energy Agency, Vienna2018-08-242018-08-242007-12-01International Journal of Radiation Oncology Biology Physics. Vol.69, No.5 (2007), 1448-1455036030162-s2.0-36148934869https://repository.li.mahidol.ac.th/handle/20.500.14594/24079Purpose: 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.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyMedicinePhysics and AstronomyArticleSCOPUS10.1016/j.ijrobp.2007.05.009