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

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8 Citations (Scopus)

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

Bibliographical note

Funding Information:
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).

Publisher Copyright:
© 2015 Springer-Verlag Berlin Heidelberg.

All Science Journal Classification (ASJC) codes

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

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