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
Cancer chemotherapy and pharmacology
2015Apr ; 75 ( 4 ) :739-46.
PMID : 25663125
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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 -
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 (??0 years) and serum AFP level (??00 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.
Hepatocellular carcinoma, Hepatic arterial infusion chemotherapy, 5-Fluorouracil, Cisplatin
MESH
Adolescent, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse, Carcinoma, Hepatocellular/*drug therapy/pathology, Cisplatin/administration & dosage/adverse effects/therapeutic use, Disease-Free Survival, Doxorubicin/administration & dosage/adverse effects/therapeutic use, Female, Fluorouracil/administration & dosage/adverse effects/therapeutic use, Hepatic Artery, Humans, Infusions, Intra-Arterial, Kaplan-Meier Estimate, Liver Neoplasms/*drug therapy/pathology, Male, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult
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