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

  • Hyun Young Woo
  • Si Hyun BaeEmail author
  • Jun Yong Park
  • Kwang Hyub Han
  • Ho Jong Chun
  • Byung Gil Choi
  • Hyeon U. Im
  • Jong Young Choi
  • Seung Kew Yoon
  • Jae Youn Cheong
  • Sung Won Cho
  • Byoung Kuk Jang
  • Jae Seok Hwang
  • Sang Gyune Kim
  • Young Seok Kim
  • Yeon Seok Seo
  • Hyung Joon Yim
  • Soon Ho Um
  • Korean Liver Cancer Study Group
Clinical Trial Report

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.

Keywords

Hepatocellular carcinoma Hepatic arterial infusion chemotherapy High dose Low dose 5-Fluorouracil Cisplatin 

Notes

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.

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Hyun Young Woo
    • 1
  • Si Hyun Bae
    • 2
    Email author
  • Jun Yong Park
    • 3
  • Kwang Hyub Han
    • 3
  • Ho Jong Chun
    • 4
  • Byung Gil Choi
    • 4
  • Hyeon U. Im
    • 5
  • Jong Young Choi
    • 2
  • Seung Kew Yoon
    • 2
  • Jae Youn Cheong
    • 6
  • Sung Won Cho
    • 6
  • Byoung Kuk Jang
    • 7
  • Jae Seok Hwang
    • 7
  • Sang Gyune Kim
    • 8
  • Young Seok Kim
    • 8
  • Yeon Seok Seo
    • 9
  • Hyung Joon Yim
    • 9
  • Soon Ho Um
    • 9
  • Korean Liver Cancer Study Group
  1. 1.Department of Internal Medicine, College of MedicinePusan National UniversityBusanKorea
  2. 2.Division of Hepatology, Department of Internal Medicine, College of MedicineThe Catholic University of KoreaSeoulKorea
  3. 3.Department of Internal MedicineYonsei University College of MedicineSeoulKorea
  4. 4.Department of Radiology, College of MedicineThe Catholic University of KoreaSeoulKorea
  5. 5.Department of Preventive Medicine, College of MedicineThe Catholic University of KoreaSeoulKorea
  6. 6.Department of Internal MedicineAjou University School of MedicineSuwonKorea
  7. 7.Department of Internal MedicineKeimyung University College of MedicineDaeguKorea
  8. 8.Department of Internal MedicineSoon Chun Hyang University College of MedicineSeoulKorea
  9. 9.Department of Internal MedicineKorea University College of MedicineSeoulKorea

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