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

Research output: Contribution to journalArticle

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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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Chemotherapy
Hepatocellular Carcinoma
Drug Therapy
Liver
Fluorouracil
Cisplatin
Survival
Disease Progression
Tumors
Neoplasms
Multivariate Analysis
Clinical Trials
Therapeutics

All Science Journal Classification (ASJC) codes

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

Cite this

Woo, Hyun Young ; Bae, Si Hyun ; Park, Jun Yong ; Han, Kwang Hyub ; Chun, Ho Jong ; Choi, Byung Gil ; Im, Hyeon U. ; Choi, Jong Young ; Yoon, Seung Kew ; Cheong, Jae Youn ; Cho, Sung Won ; Jang, Byoung Kuk ; Hwang, Jae Seok ; Kim, Sang Gyune ; Kim, Young Seok ; Seo, Yeon Seok ; Yim, Hyung Joon ; Um, Soon Ho. / A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma. In: Cancer Chemotherapy and Pharmacology. 2010 ; Vol. 65, No. 2. pp. 373-382.
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title = "A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma",
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.",
author = "Woo, {Hyun Young} and Bae, {Si Hyun} and Park, {Jun Yong} and Han, {Kwang Hyub} and Chun, {Ho Jong} and Choi, {Byung Gil} and Im, {Hyeon U.} and Choi, {Jong Young} and Yoon, {Seung Kew} and Cheong, {Jae Youn} and Cho, {Sung Won} and Jang, {Byoung Kuk} and Hwang, {Jae Seok} and Kim, {Sang Gyune} and Kim, {Young Seok} and Seo, {Yeon Seok} and Yim, {Hyung Joon} and Um, {Soon Ho}",
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Woo, HY, Bae, SH, Park, JY, Han, KH, Chun, HJ, Choi, BG, Im, HU, Choi, JY, Yoon, SK, Cheong, JY, Cho, SW, Jang, BK, Hwang, JS, Kim, SG, Kim, YS, Seo, YS, Yim, HJ & Um, SH 2010, 'A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma', Cancer Chemotherapy and Pharmacology, vol. 65, no. 2, pp. 373-382. https://doi.org/10.1007/s00280-009-1126-2

A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma. / Woo, Hyun Young; Bae, Si Hyun; Park, Jun Yong; Han, Kwang Hyub; Chun, Ho Jong; Choi, Byung Gil; Im, Hyeon U.; Choi, Jong Young; Yoon, Seung Kew; Cheong, Jae Youn; Cho, Sung Won; Jang, Byoung Kuk; Hwang, Jae Seok; Kim, Sang Gyune; Kim, Young Seok; Seo, Yeon Seok; Yim, Hyung Joon; Um, Soon Ho.

In: Cancer Chemotherapy and Pharmacology, Vol. 65, No. 2, 01.01.2010, p. 373-382.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma

AU - Woo, Hyun Young

AU - Bae, Si Hyun

AU - Park, Jun Yong

AU - Han, Kwang Hyub

AU - Chun, Ho Jong

AU - Choi, Byung Gil

AU - Im, Hyeon U.

AU - Choi, Jong Young

AU - Yoon, Seung Kew

AU - Cheong, Jae Youn

AU - Cho, Sung Won

AU - Jang, Byoung Kuk

AU - Hwang, Jae Seok

AU - Kim, Sang Gyune

AU - Kim, Young Seok

AU - Seo, Yeon Seok

AU - Yim, Hyung Joon

AU - Um, Soon Ho

PY - 2010/1/1

Y1 - 2010/1/1

N2 - 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.

AB - 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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U2 - 10.1007/s00280-009-1126-2

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