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2016 ; 10
(5
): 799-806
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A randomised controlled trial of meloxicam, a Cox-2 inhibitor, to prevent
hepatocellular carcinoma recurrence after initial curative treatment
#MMPMID26846471
Takami Y
; Eguchi S
; Tateishi M
; Ryu T
; Mikagi K
; Wada Y
; Saitsu H
Hepatol Int
2016[Sep]; 10
(5
): 799-806
PMID26846471
show ga
BACKGROUND: Because the recurrence rate of hepatocellular carcinoma (HCC) is
high, even after curative treatments such as hepatic resection and microwave
ablation, chemopreventive agents that can effectively suppress HCC recurrence are
required. Cyclooxygenase-2 (Cox-2) was recently found to be overexpressed in HCC.
Therefore, Cox-2 inhibitors may offer a chemopreventive therapy for HCC. This
randomised controlled trial (RCT) investigated the potential for meloxicam, a
clinically used Cox-2 inhibitor, to prevent HCC recurrence after initial curative
treatment. METHODS: A total of 232 consecutive patients underwent hepatic
resection and/or microwave ablation as initial therapy for HCC at our institute
between July 2008 and April 2011. Eight patients were excluded because of poor
renal function, history of non-steroidal anti-inflammatory drug-related
ulceration, or multiple cancers. The remaining 224 patients were randomised to a
control group (n = 113) or a meloxicam group (n = 111). To patients in the
meloxicam group, meloxicam was administered at 15 mg daily (5 mg three times a
day) as long as possible. The overall survival (OS) and disease-free survival
(DFS) rates were determined. RESULTS: The 1-, 3-, and 5-year OS rates of the
meloxicam group were 95.4, 82.4, and 70.1 %, respectively. Those of the control
group were 98.2, 85.1, and 71.5 %, respectively (p = 0.9549). The corresponding
DFS rates of the meloxicam group were 89.2, 53.9, and 44.0 % and those of control
group were 86.5, 57.0, and 43.4 %, respectively (p = 0.6722). In the OS and DFS
of subsets including patients with hepatitis B or C virus infection, we could not
find significant differences between the meloxicam and control groups. However,
in the subgroup of analysis of patients without viral hepatitis (NBNC-HCC),
significant differences were observed in the DFS between the meloxicam group
(1-year DFS, 92.3 %; 3-year DFS, 75.8 %; 5-year DFS, 70.4 %) and control group
(1-year DFS, 83.3 %; 3-year DFS, 48.1 %; 5-year DFS, not obtained) (p = 0.0211).
CONCLUSION: Administration of the Cox-2 inhibitor meloxicam may have a
possibility to suppress HCC recurrence after initial curative treatments in
patients with NBNC-HCC.