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A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma

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Abstract

Purpose

Hepatic arterial infusion chemotherapy (HAIC) has been reported to be effective in patients with advanced hepatocellular carcinoma (HCC).

Methods

In this multicenter, prospective, open-labeled, clinical trial, we randomly assigned 68 patients with advanced HCC to receive either low-dose [n = 32, 5-fluorouracil (FU), 170 mg/m2 and cisplatin, 7 mg/m2 on days 1–5] or high-dose HAIC (n = 36, 5-FU, 500 mg/m2 on days 1–3 and cisplatin, 60 mg/m2 on day 2) every 4 weeks via an implantable port system.

Results

A total of 207 cycles of HAIC was given to the 68 patients. Overall, 6 patients (8.8%) achieved a partial response and 21 patients (30.9%) had stable disease. The objective response rate (CR + PR) was significantly improved in the high-dose group compared to the low-dose group (16.7% vs. 0%, P = 0.024). The median time to disease progression and overall survival were slightly prolonged in the high-dose group compared to the low-dose group (median survival, 193 vs. 153 days; P = 0.108; median time to disease progression, 145 vs. 90 days; P = 0.095). Multivariate analysis showed that tumor response to treatment [P = 0.007, RR 2.27 (95% CI, 1.248–4.132)] was the only factor associated with overall survival. All adverse events were tolerable and successfully managed in both treatment groups.

Conclusions

Both HAIC regimens are safe and effective in patients with advanced HCC. High-dose HAIC achieves a better tumor response compared to low-dose HAIC.

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Acknowledgments

This work was supported by a National R & D Program grant for cancer control, Ministry of Health, Welfare and Family Affairs, Republic of Korea (R0620390-1).

Conflict of interest statement

All authors in present study have nothing to disclose.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea

    Hyun Young Woo

  2. Division of Hepatology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, #505 Banpodong, Seochogu, Seoul, 137-040, Korea

    Si Hyun Bae, Jong Young Choi & Seung Kew Yoon

  3. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea

    Jun Yong Park & Kwang Hyub Han

  4. Department of Radiology, College of Medicine, The Catholic University of Korea, Seoul, Korea

    Ho Jong Chun & Byung Gil Choi

  5. Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea

    Hyeon U. Im

  6. Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea

    Jae Youn Cheong & Sung Won Cho

  7. Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea

    Byoung Kuk Jang & Jae Seok Hwang

  8. Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Seoul, Korea

    Sang Gyune Kim & Young Seok Kim

  9. Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea

    Yeon Seok Seo, Hyung Joon Yim & Soon Ho Um

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  1. Hyun Young Woo
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  2. Si Hyun Bae
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  3. Jun Yong Park
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  5. Ho Jong Chun
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  7. Hyeon U. Im
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  8. Jong Young Choi
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  10. Jae Youn Cheong
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  11. Sung Won Cho
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  14. Sang Gyune Kim
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  15. Young Seok Kim
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  16. Yeon Seok Seo
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  17. Hyung Joon Yim
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  18. Soon Ho Um
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Korean Liver Cancer Study Group

Corresponding author

Correspondence to Si Hyun Bae.

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Woo, H.Y., Bae, S.H., Park, J.Y. et al. A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma. Cancer Chemother Pharmacol 65, 373–382 (2010). https://doi.org/10.1007/s00280-009-1126-2

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  • DOI: https://doi.org/10.1007/s00280-009-1126-2

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