Browsing by Author "Ajit K. Padhy"

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    Intra-Arterial Rhenium-188 Lipiodol in the Treatment of Inoperable Hepatocellular Carcinoma: Results of an IAEA-Sponsored Multination Study
    (2007-12-01) 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; Fundacion Santa Fe de Bogota; Centre Eugene Marquis Rennes; University of Ljubljana Faculty of Medicine; Mongolian National University of Medical Sciences; Singapore General Hospital; All India Institute of Medical Sciences, New Delhi; Seoul National University Hospital; Mahidol University; Memorial Sloan-Kettering Cancer Center; University of Pennsylvania; UCL; Cho Ray Hospital; Fudan University; St. Luke’s Medical Center; International Atomic Energy Agency, Vienna
    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.