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Phase I/II study of a fine‐powder formulation of cisplatin for transcatheter arterial chemoembolization in hepatocellular carcinoma
Author(s) -
Moriguchi Masamichi,
Takayama Tadatoshi,
Nakamura Masahiko,
Aramaki Osamu,
Higaki Tokio,
Nakayama Hisashi,
Ohkubo Takao,
Fujii Masashi
Publication year - 2010
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/j.1872-034x.2009.00606.x
Subject(s) - medicine , hepatocellular carcinoma , transcatheter arterial chemoembolization , gastroenterology , tolerability , adverse effect , lipiodol , nausea , vomiting , leukocytopenia , cisplatin , anorexia , chemotherapy
Aim: The clinical feasibility of transcatheter arterial chemoembolization (TACE) with fine‐powder cisplatin (CDDP) in patients with hepatocellular carcinoma (HCC) has not been investigated. A phase I/II study was conducted to investigate the safety and tolerability of fine‐powder CDDP when it was used with lipiodol and gelatin sponge particles for TACE. Methods: Fine‐powder CDDP emulsified in lipiodol was injected into tumor arteries. Embolization was subsequently performed with gelatin sponge particles. The CDDP dose was started at 45 mg/m 2 (level 1) and increased to 65 mg/m 2 in 10 mg/m 2 increments. Results: Thirteen patients were enrolled in phase I study since no dose limiting toxicity was observed in any patients, even in seven patients at level 3 (65 mg/m 2 ), the recommended dose was 65 mg/m 2 . The major adverse event was grade 3 thrombocytopenia, which occurred in 8% of patients. The incidence of hematological toxicities was 15% for leukocytopenia, 84% for thrombocytopenia, and 84% for anemia. Increased serum total bilirubin was observed in 54% and increased aspartate aminotransferase or alanine aminotransferase in all patients. All digestive tract symptoms (nausea 77%, anorexia 84%, vomiting 31%) were grade 2 or lower. Total adverse events were grade 3 or higher in 44%. The response rate in 19 patients who received the recommended dose was 21%. Conclusions: TACE with a fine‐powder formulation of CDDP at a dose of 65 mg/m 2 is well tolerated in patients with unresectable HCC.