title: Intra-arterial rhenium-188 lipiodol in the treatment of inoperable hepatocellular carcinoma: results of an IAEA-sponsored multination study.
abstract: OBJECTIVE
  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
  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: Fundacion Santa Fe De Bogota, Bogota, Colombia.
authors: Patricia
authors: P
authors: Bernal
authors: Jean-Luc
authors: JL
authors: Raoul
authors: Gaj
authors: G
authors: Vidmar
authors: Erdenechimeg
authors: E
authors: Sereegotov
authors: Felix X
authors: FX
authors: Sundram
authors: Ajay
authors: A
authors: Kumar
authors: Jae Min
authors: JM
authors: Jeong
authors: Pawana
authors: P
authors: Pusuwan
authors: Chaitanya
authors: C
authors: Divgi
authors: Pat
authors: P
authors: Zanzonico
authors: Janez
authors: J
authors: Stare
authors: John
authors: J
authors: Buscombe
authors: Chau Trinh Thi
authors: CT
authors: Minh
authors: Maung Maung
authors: MM
authors: Saw
authors: Shaoliang
authors: S
authors: Chen
authors: Ruben
authors: R
authors: Ogbac
authors: Ajit K
authors: AK
authors: Padhy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D007459:Iodized Oil / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000150:complications / Q000401:mortality; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011868:Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects; D012044:Regression Analysis; D012074:Remission Induction; D012211:Rhenium / Q000008:administration & dosage* / Q000009:adverse effects; D018709:Statistics, Nonparametric
chemical_list: D015415:Biomarkers; D011868:Radioisotopes; D012211:Rhenium; D007459:Iodized Oil; D001663:Bilirubin