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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 
Citation
 CANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.75(4) : 739-746, 2015-04 
Journal Title
 CANCER CHEMOTHERAPY AND PHARMACOLOGY 
ISSN
 0344-5704 
Issue Date
2015-04
MeSH
Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols / administration & dosage ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use* ; Carcinoma, Hepatocellular / drug therapy* ; Carcinoma, Hepatocellular / pathology ; Cisplatin / administration & dosage ; Cisplatin / adverse effects ; Cisplatin / therapeutic use ; Disease-Free Survival ; Doxorubicin / administration & dosage ; Doxorubicin / adverse effects ; Doxorubicin / therapeutic use ; Female ; Fluorouracil / administration & dosage ; Fluorouracil / adverse effects ; Fluorouracil / therapeutic use ; Hepatic Artery ; Humans ; Infusions, Intra-Arterial ; Kaplan-Meier Estimate ; Liver Neoplasms / drug therapy* ; Liver Neoplasms / pathology ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Young Adult
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/m(2) on days 1-3, and cisplatin, 60 mg/m(2) on day 2] and (2) ACF-HAIC group [n = 27, adriamycin, 50 mg/m(2) on day 1, 5-FU, 500 mg/m(2) on days 1-3, and cisplatin, 60 mg/m(2) 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.
Full Text
https://link.springer.com/article/10.1007%2Fs00280-015-2692-0
DOI
10.1007/s00280-015-2692-0
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/178449
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