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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 4/2015

01-04-2015 | Original Article

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

Authors: 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

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2015

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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.
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Metadata
Title
A randomized study of cisplatin and 5-FU hepatic arterial infusion chemotherapy with or without adriamycin for advanced hepatocellular carcinoma
Authors
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
Publication date
01-04-2015
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2015
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-015-2692-0

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