Open Access
01-06-2015 | Original Article—Liver, Pancreas, and Biliary Tract
Survey of survival among patients with hepatitis C virus-related hepatocellular carcinoma treated with peretinoin, an acyclic retinoid, after the completion of a randomized, placebo-controlled trial
Authors:
Kiwamu Okita, Namiki Izumi, Kenji Ikeda, Yukio Osaki, Kazushi Numata, Masafumi Ikeda, Norihiro Kokudo, Kazuho Imanaka, Shuhei Nishiguchi, Shunsuke Kondo, Yoichi Nishigaki, Susumu Shiomi, Kazuomi Ueshima, Norio Isoda, Yoshiyasu Karino, Masatoshi Kudo, Katsuaki Tanaka, Shuichi Kaneko, Hisataka Moriwaki, Masatoshi Makuuchi, Takuji Okusaka, Norio Hayashi, Yasuo Ohashi, Hiromitsu Kumada, The Peretinoin Study Group
Published in:
Journal of Gastroenterology
|
Issue 6/2015
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Abstract
Background
This study examined the effects of peretinoin, an acyclic retinoid, on the survival of patients with hepatitis C virus-related hepatocellular carcinoma (HCC) who had completed curative therapy and participated in a randomized, placebo-controlled trial.
Methods
This study was an investigator-initiated retrospective cohort study. Subjects were all patients who were administered the investigational drug (peretinoin 600 mg/day, peretinoin 300 mg/day, or placebo) in the randomized trial. Survivals between the groups were compared using the log-rank test, and hazard ratios were estimated by Cox regression.
Results
Survey data were collected from all patients (n = 392) who participated in the randomized trial, all of whom were then divided into the peretinoin 600 mg/day (n = 132), peretinoin 300 mg/day (n = 131), and placebo (n = 129) groups. At the median follow-up of 4.9 years, 5-year cumulative survival rates for patients in the 600 mg/day, 300 mg/day, and placebo groups were 73.9, 56.8, and 64.3 %, respectively. Comparison of overall survival among patients classified as Child-Pugh A revealed that survival of the 600 mg/day group (n = 105) was significantly longer than that of the placebo group (n = 108) (hazard ratio 0.575, 95 % CI 0.341–0.967; P = 0.0347).
Conclusions
Administration of 600 mg/day peretinoin to patients with hepatitis C virus-related HCC who have completed curative therapy may improve survival for those classified as Child-Pugh A, for whom liver function is relatively stable.