Association of cisplatin and intra-arterial injection of 131I-lipiodol in treatment of hepatocellular carcinoma: results of phase II trial.
OBJECTIVE
Intra-arterial injections of 131I-lipiodol (131I-Lip) provide an effective treatment for hepatocellular carcinoma. In hepatocellular carcinoma cell cultures, concurrent administration of cisplatin increases the cytotoxicity of 131I. The efficacy and tolerance of intra-arterial injections of 131I-Lip combined with systemic cisplatin was tested in a phase II trial.


METHODS
The inclusion criteria were proven unresectable nonmetastatic hepatocellular carcinoma, compensated liver disease, and adequate laboratory test findings. Treatment comprised the combination of intra-arterial injection of 131I-Lip (2.2 GBq) with intravenous infusion of low-dose cisplatin. The combined treatment could be repeated.


RESULTS
A total of 41 patients were included; 37 had cirrhosis and 38 had measurable tumors. One to four treatments (median, two) were given. The cisplatin dose was 75 mg for the first course and 72 mg for the second. Grade 3-4 (n/n) adverse effects were observed in 14 patients, polymorphonuclear leukocytes (3/0), platelets (5/1), asthenia (1/0), pain (1/0), and vomiting (1/0). Four patients developed pulmonary toxicity; 2 cases were likely related to 131I-Lip administration and 1 was fatal. The response rate was 47% (18 of 38), and the 1- and 2-year survival rate was 73% +/- 7% and 48% +/- 9%, respectively.


CONCLUSIONS
This combination had a tolerable toxicity profile and provided an objective response rate, warranting a phase III trial.
Raoul
Jean-Luc
JL
Department of Medical Oncology, Centre E Marquis, Rennes, France. raoul@rennes.fnclcc.fr
Boucher
Eveline
E
Olivie
Damien
D
Guillygomarc'h
Anne
A
Boudjema
Karim
K
Garin
Etienne
E
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D007459:Iodized Oil / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011877:Radionuclide Imaging
D000970:Antineoplastic Agents; D007459:Iodized Oil; D002945:Cisplatin