Woo, Hyun Young; Bae, Si Hyun; Park, Jun Yong; Han, Kwang Hyub; Chun, Ho Jong; Choi, Byung Gil; Im, Hyeon U; Choi, Jong Young; Yoon, Seung Kew; Cheong, Jae Youn; Cho, Sung Won; Jang, Byoung Kuk; Hwang, Jae Seok; Kim, Sang Gyune; Kim, Young Seok; Seo, Yeon Seok; Yim, Hyung Joon; Um, Soon Ho
Cancer chemotherapy and pharmacology
2010Jan ; 65 ( 2 ) :373-82.
PMID : 19763572
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Woo, Hyun Young -
Bae, Si Hyun -
Park, Jun Yong -
Han, Kwang Hyub -
Chun, Ho Jong -
Choi, Byung Gil -
Im, Hyeon U -
Choi, Jong Young -
Yoon, Seung Kew -
Cheong, Jae Youn -
Cho, Sung Won -
Jang, Byoung Kuk -
Hwang, Jae Seok -
Kim, Sang Gyune -
Kim, Young Seok -
Seo, Yeon Seok -
Yim, Hyung Joon -
Um, Soon Ho -
ABSTRACT
PURPOSE: Hepatic arterial infusion chemotherapy (HAIC) has been reported to be effective in patients with advanced hepatocellular carcinoma (HCC).
METHODS: In this multicenter, prospective, open-labeled, clinical trial, we randomly assigned 68 patients with advanced HCC to receive either low-dose [n = 32, 5-fluorouracil (FU), 170 mg/m(2) and cisplatin, 7 mg/m(2) on days 1-5] or high-dose HAIC (n = 36, 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.
RESULTS: A total of 207 cycles of HAIC was given to the 68 patients. Overall, 6 patients (8.8%) achieved a partial response and 21 patients (30.9%) had stable disease. The objective response rate (CR + PR) was significantly improved in the high-dose group compared to the low-dose group (16.7% vs. 0%, P = 0.024). The median time to disease progression and overall survival were slightly prolonged in the high-dose group compared to the low-dose group (median survival, 193 vs. 153 days; P = 0.108; median time to disease progression, 145 vs. 90 days; P = 0.095). Multivariate analysis showed that tumor response to treatment [P = 0.007, RR 2.27 (95% CI, 1.248-4.132)] was the only factor associated with overall survival. All adverse events were tolerable and successfully managed in both treatment groups.
CONCLUSIONS: Both HAIC regimens are safe and effective in patients with advanced HCC. High-dose HAIC achieves a better tumor response compared to low-dose HAIC.
Hepatocellular carcinoma, Hepatic arterial infusion chemotherapy, High dose, Low dose, 5-Fluorouracil, Cisplatin
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse, Carcinoma, Hepatocellular/*drug therapy/mortality/pathology, Cisplatin/administration & dosage, Drug Administration Schedule, Female, Fluorouracil/administration & dosage, Hepatic Artery, Humans, Infusions, Intra-Arterial, Liver Neoplasms/*drug therapy/mortality/pathology, Male, Middle Aged, Prognosis, Prospective Studies, Survival Rate
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