ABC-03: A randomized, phase II/III study of cediranib (AZD2171) or placebo in combination with cisplatin/gemcitabine for patients with advanced biliary tract cancers.
ABC-03: A randomized, phase II/III study of cediranib (AZD2171) or placebo in combination with cisplatin/gemcitabine for patients with advanced biliary tract cancers.
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ABC-03：一项西地尼布 (AZD2171) 或安慰剂联合顺铂/吉西他滨治疗晚期胆道癌患者的随机 II/III 期研究。
DOI：
10.1200/jco.2010.28.15_suppl.tps218
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发表时间：
2010
影响因子：
45.3
通讯作者：
H. Wasan
中科院分区：
文献类型：
--
作者：
J. Valle;J. Bridgewater;M. Roughton;C. Dive;S. Hughes;H. Wasan
TPS 218背景：ABC-02试验（瓦莱ASCO 2009，摘要4503）是ABC迄今为止最大的随机III期试验，证明GemCis比Gem单独治疗具有显着的生存优势（11.7 vs. 8.2个月[log rank p=0.002]，风险比0.68 [95%-CI 0.53，0.86]），没有增加临床显着毒性。ABC与VEGF表达的增加相关，而VEGF表达的增加又与转移性疾病的存在相关。Cediranib是VEGF 2酪氨酸激酶和VEGF诱导的内皮细胞信号传导的高效抑制剂。预期西地尼布在长期口服给药时抑制VEGF驱动的血管生成，并因此抑制肿瘤生长。ABC-03将GemCis与西地尼布或安慰剂进行比较。这项随机II期试验将招募136名患者，无进展生存期（PFS）作为主要终点。方法：选择经组织学/细胞学证实的ABC患者，年龄≥18岁，ECOG体力状态0-2，血液学检查充分。
TPS218 Background: The ABC-02 trial (Valle ASCO 2009, abstr. 4503), the largest ever randomized phase III trial in ABC to date, demonstrated a significant survival advantage for GemCis over Gem alone (11.7 vs. 8.2 months [log rank p=0.002], with hazard ratio 0.68 [95%-CI 0.53, 0.86]) without added clinically significant toxicity. ABCs are associated with an increase in VEGF expression, which in turn correlates with the presence of metastatic disease. Cediranib is a highly potent inhibitor of VEGFR2 tyrosine kinase and VEGF-induced signaling in endothelial cells. Cediranib is expected, at chronic oral dosing, to inhibit VEGF driven angiogenesis and, as a consequence, constrain tumor growth. ABC-03 compares GemCis with either cediranib or with placebo. This randomized phase II trial, will recruit 136 pts, with progression-free survival (PFS) as the primary endpoint. Methods: Consenting pts with histologically/cytologically confirmed ABC, aged ≥18 years, ECOG performance status 0-2 and adequate haematologica...