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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

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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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Acknowledgments

This work was supported by JSPS KAKENHI Grant Number 23591816. We thank the members of Institute of Human Research Promotion and Drug Development (Dr. Masakatsu Nishikawa, Dr. Satoshi Tamaru, and Dr. Tomomi Yamada) for their support with the data management and advice related to statistical methods. We also thank the members of the study committee for safety and efficacy monitoring (Dr. Shigeaki Narimatsu and Dr. Tsuneo Ishiguchi) and the members of the committee for efficacy evaluation (Dr. Hiroshi Kondo, Dr. Yozo Sato, and Dr. Hideyuki Nishiofuku).

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Radiology, Mie University School of Medicine, Mie, Japan

    Haruyuki Takaki & Koichiro Yamakado

  2. Department of Radiology, Shimane University Faculty of Medicine, Izumo, Japan

    Masakatsu Tsurusaki

  3. Department of Radiology, Toyonaka Municipal Hospital, Toyonaka, Japan

    Taku Yasumoto

  4. Department of Radiology, Kagoshima University, Kagoshima, Japan

    Yasutaka Baba

  5. Department of Radiology, Kawasaki Municipal Hospital, Kawasaki, Japan

    Yoshiaki Narimatsu

  6. Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

    Masashi Shimohira

  7. Center for Endovascular Therapy, Kobe University Graduate School of Medicine, Kobe, Japan

    Masato Yamaguchi

  8. Department of Radiology, Narumi Hospital, Hirosaki, Japan

    Kunihiro Matsuo

  9. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan

    Yoshitaka Inaba

  10. Department of Radiology, Suita Municipal Hospital, Suita, Japan

    Koji Mikami

  11. Department of Surgery, Matsuyama Shimin Hospital, Matsuyama, Japan

    Ryohei Watanabe

  12. Department of Radiology, Osaka City University Graduate School of Medicine, Osaka, Japan

    Norifumi Nishida

  13. Department of Radiology, Nara Medical University, Kashiwara, Japan

    Hiroshi Anai

  14. Department of Diagnostic Radiology, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan

    Hideaki Kakizawa

  15. Department of Radiology, Hyogo College of Medicine, Nishinomiya, Japan

    Shozo Hirota

  16. Department of Interventional Radiology, Mie University School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan

    Haruyuki Takaki

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  1. Haruyuki Takaki
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Corresponding author

Correspondence to Haruyuki Takaki.

Additional information

On behalf of the Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization.

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Takaki, H., Yamakado, K., Tsurusaki, M. et al. 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. Int J Clin Oncol 20, 745–754 (2015). https://doi.org/10.1007/s10147-014-0773-4

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  • DOI: https://doi.org/10.1007/s10147-014-0773-4

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