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

Hyun Young Woo, Si Hyun Bae, 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

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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.

Original languageEnglish
Pages (from-to)373-382
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Volume65
Issue number2
DOIs
Publication statusPublished - 2010 Jan 1

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All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Woo, H. Y., Bae, S. H., Park, J. Y., Han, K. H., Chun, H. J., Choi, B. G., Im, H. U., Choi, J. Y., Yoon, S. K., Cheong, J. Y., Cho, S. W., Jang, B. K., Hwang, J. S., Kim, S. G., Kim, Y. S., Seo, Y. S., Yim, H. J., & Um, S. H. (2010). A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma. Cancer Chemotherapy and Pharmacology, 65(2), 373-382. https://doi.org/10.1007/s00280-009-1126-2