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International Journal of Clinical Oncology
Published in: International Journal of Clinical Oncology 4/2015

01-08-2015 | Original Article

Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study

Authors: Haruyuki Takaki, Koichiro Yamakado, Masakatsu Tsurusaki, Taku Yasumoto, Yasutaka Baba, Yoshiaki Narimatsu, Masashi Shimohira, Masato Yamaguchi, Kunihiro Matsuo, Yoshitaka Inaba, Koji Mikami, Ryohei Watanabe, Norifumi Nishida, Hiroshi Anai, Hideaki Kakizawa, Shozo Hirota

Published in: International Journal of Clinical Oncology | Issue 4/2015

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Abstract

Purpose

This single-arm, multicenter, phase-II trial evaluated the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using fine-powder cisplatin and iodized-oil suspension in patients with intermediate- and advanced-stage [Barcelona Clinic Liver Cancer (BCLC) stage-B and stage-C] hepatocellular carcinomas (HCCs).

Methods

The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60–87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m2 and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety.

Results

The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %).

Conclusion

This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.
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Metadata
Title
Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study
Authors
Haruyuki Takaki
Koichiro Yamakado
Masakatsu Tsurusaki
Taku Yasumoto
Yasutaka Baba
Yoshiaki Narimatsu
Masashi Shimohira
Masato Yamaguchi
Kunihiro Matsuo
Yoshitaka Inaba
Koji Mikami
Ryohei Watanabe
Norifumi Nishida
Hiroshi Anai
Hideaki Kakizawa
Shozo Hirota
Publication date
01-08-2015
Publisher
Springer Japan
Published in
International Journal of Clinical Oncology / Issue 4/2015
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-014-0773-4

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