Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable
locally advanced or metastatic gastric or gastroesophageal junction cancer:
randomized, double-blind, phase III study (AVATAR study).
Author(s): Shen L(1), Li J, Xu J, Pan H, Dai G, Qin S, Wang L, Wang J, Yang Z, Shu Y, Xu R,
Chen L, Liu Y, Yu S, Bu L, Piao Y.
Affiliation(s): Author information:
(1)Peking University Cancer Hospital and Institute, No 52 Fucheng Road, Haidian
District, Beijing, China, Lin100@medmail.com.cn.
Publication date & source: 2015, Gastric Cancer. , 18(1):168-76
BACKGROUND: In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab
did not significantly improve overall survival (OS) versus fluoropyrimidine and
cisplatin plus placebo in patients with advanced gastric cancer. Geographic
differences in efficacy were observed in AVAGAST, but the study only included 12
Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized,
double-blind, phase III study conducted in Chinese patients with advanced gastric
cancer.
METHODS: Patients more than 18 years of age with gastric adenocarcinoma were
randomized 1:1 to capecitabine-cisplatin plus either bevacizumab or placebo. The
primary endpoint was OS; secondary endpoints included progression-free survival
(PFS) and safety.
RESULTS: In total, 202 patients were included (placebo n = 102; bevacizumab n =
100). Baseline characteristics were well balanced. The primary analysis result
did not show a difference in OS for the bevacizumab arm compared to the placebo
arm [hazard ratio, 1.11 (95% CI, 0.79-1.56); P = 0.5567]. Median PFS was also
similar in both arms. Bevacizumab plus capecitabine-cisplatin was well tolerated.
Grade 3-5 adverse events (AEs) occurred in 60% of bevacizumab-treated and 68% of
placebo-treated patients, respectively. Grade 3-5 AEs of special interest with
bevacizumab occurred in 8% of bevacizumab-treated patients and 15% of
placebo-treated patients, mainly grade 3-5 hemorrhage (bevacizumab 4%, placebo
12%).
CONCLUSIONS: Addition of bevacizumab to capecitabine-cisplatin in Chinese
patients with advanced gastric cancer did not improve outcomes in AVATAR. There
was no difference in OS between the two arms and PFS was similar in both arms.
Safety findings were as previously experienced with bevacizumab, including
AVAGAST; no new safety signals were reported.
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