A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma

Myeong Jun Song, Si Hyun Bae, Ho Jong Chun, Jong Young Choi, Seung Kew Yoon, Jun Young Park, Kwang Hyub Han, Young Seok Kim, Hyung Joon Yim, Soon Ho Um, Woo Jin Chung, Jae Seok Hwang, Sung Bum Cho, Jong Ryul Eun

Research output: Contribution to journalArticle

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Abstract

Purpose: This multicenter, randomized, open-labeled, clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil (5-FU) hepatic arterial infusion chemotherapy (CF-HAIC) versus adriamycin adding to CF-HAIC (ACF-HAIC) in advanced HCC patients. Methods: Fifty-six patients with advanced HCC were randomized to two treatment groups: (1) CF-HAIC group [n = 29, 5-FU, 500 mg/m2 on days 1-3, and cisplatin, 60 mg/m2 on day 2] and (2) ACF-HAIC group [n = 27, adriamycin, 50 mg/m2 on day 1, 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. Primary efficacy endpoint was overall survival (OS). Treatment response and time to progression were secondary endpoints. Results: Treatment response rates did not differ significantly between the two treatment groups. Time to progression (5.4 vs. 5.8 months, P = 0.863) and OS (11.1 vs. 8.8 months, P = 0.448) were not significantly different. When the factors affecting patient OS were analyzed, disease control rate [P < 0.001, HR 6.437 (95 % CI 2.580-16.064)] was independently associated with OS. Age (≥60 years) and serum AFP level (≥200 ng/dL) also were significant factors for OS [P = 0.007, HR 4.945 (95 % CI 1.543-15.850), P = 0.048, HR 2.677 (95 % CI 1.010-7.095), respectively]. Grade 4 treatment-related toxicity and mortality was not observed in both groups. Conclusions: Although both HAIC regimens are safe and effective in patients with advanced HCC, HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC.

Original languageEnglish
Pages (from-to)739-746
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume75
Issue number4
DOIs
Publication statusPublished - 2015 Apr

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Chemotherapy
Fluorouracil
Doxorubicin
Cisplatin
Hepatocellular Carcinoma
Drug Therapy
Liver
Survival
Disease control
Therapeutics
Reaction Time
Toxicity
Tumors
Clinical Trials
Safety
Mortality

All Science Journal Classification (ASJC) codes

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

Cite this

Song, Myeong Jun ; Bae, Si Hyun ; Chun, Ho Jong ; Choi, Jong Young ; Yoon, Seung Kew ; Park, Jun Young ; Han, Kwang Hyub ; Kim, Young Seok ; Yim, Hyung Joon ; Um, Soon Ho ; Chung, Woo Jin ; Hwang, Jae Seok ; Cho, Sung Bum ; Eun, Jong Ryul. / A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma. In: Cancer Chemotherapy and Pharmacology. 2015 ; Vol. 75, No. 4. pp. 739-746.
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title = "A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma",
abstract = "Purpose: This multicenter, randomized, open-labeled, clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil (5-FU) hepatic arterial infusion chemotherapy (CF-HAIC) versus adriamycin adding to CF-HAIC (ACF-HAIC) in advanced HCC patients. Methods: Fifty-six patients with advanced HCC were randomized to two treatment groups: (1) CF-HAIC group [n = 29, 5-FU, 500 mg/m2 on days 1-3, and cisplatin, 60 mg/m2 on day 2] and (2) ACF-HAIC group [n = 27, adriamycin, 50 mg/m2 on day 1, 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. Primary efficacy endpoint was overall survival (OS). Treatment response and time to progression were secondary endpoints. Results: Treatment response rates did not differ significantly between the two treatment groups. Time to progression (5.4 vs. 5.8 months, P = 0.863) and OS (11.1 vs. 8.8 months, P = 0.448) were not significantly different. When the factors affecting patient OS were analyzed, disease control rate [P < 0.001, HR 6.437 (95 {\%} CI 2.580-16.064)] was independently associated with OS. Age (≥60 years) and serum AFP level (≥200 ng/dL) also were significant factors for OS [P = 0.007, HR 4.945 (95 {\%} CI 1.543-15.850), P = 0.048, HR 2.677 (95 {\%} CI 1.010-7.095), respectively]. Grade 4 treatment-related toxicity and mortality was not observed in both groups. Conclusions: Although both HAIC regimens are safe and effective in patients with advanced HCC, HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC.",
author = "Song, {Myeong Jun} and Bae, {Si Hyun} and Chun, {Ho Jong} and Choi, {Jong Young} and Yoon, {Seung Kew} and Park, {Jun Young} and Han, {Kwang Hyub} and Kim, {Young Seok} and Yim, {Hyung Joon} and Um, {Soon Ho} and Chung, {Woo Jin} and Hwang, {Jae Seok} and Cho, {Sung Bum} and Eun, {Jong Ryul}",
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A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma. / Song, Myeong Jun; Bae, Si Hyun; Chun, Ho Jong; Choi, Jong Young; Yoon, Seung Kew; Park, Jun Young; Han, Kwang Hyub; Kim, Young Seok; Yim, Hyung Joon; Um, Soon Ho; Chung, Woo Jin; Hwang, Jae Seok; Cho, Sung Bum; Eun, Jong Ryul.

In: Cancer Chemotherapy and Pharmacology, Vol. 75, No. 4, 04.2015, p. 739-746.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma

AU - Song, Myeong Jun

AU - Bae, Si Hyun

AU - Chun, Ho Jong

AU - Choi, Jong Young

AU - Yoon, Seung Kew

AU - Park, Jun Young

AU - Han, Kwang Hyub

AU - Kim, Young Seok

AU - Yim, Hyung Joon

AU - Um, Soon Ho

AU - Chung, Woo Jin

AU - Hwang, Jae Seok

AU - Cho, Sung Bum

AU - Eun, Jong Ryul

PY - 2015/4

Y1 - 2015/4

N2 - Purpose: This multicenter, randomized, open-labeled, clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil (5-FU) hepatic arterial infusion chemotherapy (CF-HAIC) versus adriamycin adding to CF-HAIC (ACF-HAIC) in advanced HCC patients. Methods: Fifty-six patients with advanced HCC were randomized to two treatment groups: (1) CF-HAIC group [n = 29, 5-FU, 500 mg/m2 on days 1-3, and cisplatin, 60 mg/m2 on day 2] and (2) ACF-HAIC group [n = 27, adriamycin, 50 mg/m2 on day 1, 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. Primary efficacy endpoint was overall survival (OS). Treatment response and time to progression were secondary endpoints. Results: Treatment response rates did not differ significantly between the two treatment groups. Time to progression (5.4 vs. 5.8 months, P = 0.863) and OS (11.1 vs. 8.8 months, P = 0.448) were not significantly different. When the factors affecting patient OS were analyzed, disease control rate [P < 0.001, HR 6.437 (95 % CI 2.580-16.064)] was independently associated with OS. Age (≥60 years) and serum AFP level (≥200 ng/dL) also were significant factors for OS [P = 0.007, HR 4.945 (95 % CI 1.543-15.850), P = 0.048, HR 2.677 (95 % CI 1.010-7.095), respectively]. Grade 4 treatment-related toxicity and mortality was not observed in both groups. Conclusions: Although both HAIC regimens are safe and effective in patients with advanced HCC, HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC.

AB - Purpose: This multicenter, randomized, open-labeled, clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil (5-FU) hepatic arterial infusion chemotherapy (CF-HAIC) versus adriamycin adding to CF-HAIC (ACF-HAIC) in advanced HCC patients. Methods: Fifty-six patients with advanced HCC were randomized to two treatment groups: (1) CF-HAIC group [n = 29, 5-FU, 500 mg/m2 on days 1-3, and cisplatin, 60 mg/m2 on day 2] and (2) ACF-HAIC group [n = 27, adriamycin, 50 mg/m2 on day 1, 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. Primary efficacy endpoint was overall survival (OS). Treatment response and time to progression were secondary endpoints. Results: Treatment response rates did not differ significantly between the two treatment groups. Time to progression (5.4 vs. 5.8 months, P = 0.863) and OS (11.1 vs. 8.8 months, P = 0.448) were not significantly different. When the factors affecting patient OS were analyzed, disease control rate [P < 0.001, HR 6.437 (95 % CI 2.580-16.064)] was independently associated with OS. Age (≥60 years) and serum AFP level (≥200 ng/dL) also were significant factors for OS [P = 0.007, HR 4.945 (95 % CI 1.543-15.850), P = 0.048, HR 2.677 (95 % CI 1.010-7.095), respectively]. Grade 4 treatment-related toxicity and mortality was not observed in both groups. Conclusions: Although both HAIC regimens are safe and effective in patients with advanced HCC, HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC.

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