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).
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).
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DOI：
10.1007/s10120-014-0351-5
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发表时间：
2015-01
期刊：
影响因子：
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通讯作者：
Piao Y
中科院分区：
文献类型：
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作者：
Shen L;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
在 AVAGAST 研究中，与氟嘧啶和顺铂加安慰剂相比，氟嘧啶和顺铂加贝伐单抗并未显着改善晚期胃癌患者的总生存期 (OS)。 AVAGAST 观察到疗效存在地域差异，但该研究仅纳入 12 名中国患者。 AVATAR 是一项与 AVAGAST 设计类似的研究，是一项在中国晚期胃癌患者中进行的随机、双盲 III 期研究。 18 岁以上的胃腺癌患者按 1:1 的比例随机接受卡培他滨-顺铂加贝伐单抗或安慰剂。主要终点是 OS；次要终点包括无进展生存期（PFS）和安全性。总共纳入 202 名患者（安慰剂 n = 102；贝伐珠单抗 n = 100）。基线特征非常平衡。主要分析结果并未显示贝伐珠单抗组与安慰剂组的 OS 存在差异 [风险比，1.11（95% CI，0.79–1.56）； P = 0.5567]。两组的中位 PFS 也相似。贝伐珠单抗加卡培他滨-顺铂的耐受性良好。贝伐珠单抗治疗组和安慰剂组分别有 60% 和 68% 的患者发生 3-5 级不良事件 (AE)。贝伐单抗特别关注的 3-5 级 AE 发生在贝伐单抗治疗患者的 8% 和安慰剂治疗患者的 15% 中，主要是 3-5 级出血（贝伐单抗 4%，安慰剂 12%）。在中国晚期胃癌患者中，将贝伐单抗联合卡培他滨-顺铂治疗并没有改善 AVATAR 的预后。两组之间的 OS 没有差异，且 PFS 相似。安全性结果与之前使用贝伐珠单抗（包括 AVAGAST）时的经验相同；没有报告新的安全信号。
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. 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. 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 %). 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.